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The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESPRIT BVS | Other | Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESPRIT BVS | Device | Subjects receiving ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | Study device success is defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter. | On Day 0 (From start of index procedure to end of index procedure) |
| Technical Success | Technical success is defined on a per lesion basis, the attainment of a final residual stenosis of < 30% at the intended target lesion(s). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as technical success only if the above criteria are met. | On Day 0 (From start of index procedure to end of index procedure) |
| Clinical Success | Defined on a per subject basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications* within 2 days after the index procedure or at hospital discharge, whichever is sooner. (Note that in the ESPRIT I study, only a single target lesion per subject is permitted to be treated). *Includes the following: Death; Amputation; Scaffold Thrombosis; Target Lesion Revascularization (by any percutaneous or surgical means); Target Vessel Revascularization (by any percutaneous or surgical means). | > or = 2 days after the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above). |
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Inclusion Criteria:
Subject is ≥ 18 and ≤ 80 years of age at the time of signing informed consent.
Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 1-3).
For subjects with bilateral lesions, the higher Rutherford-Becker Clinical Category limb will be considered the target extremity to be treated in this trial.
If both limbs are of the same Rutherford Becker Clinical Category, the target extremity will be selected based on investigator discretion.
Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.
Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
Female subject of childbearing potential must: have had a negative pregnancy test within 14 days before treatment; not be nursing at the time of the study procedure and agree at time of consent to use birth control during participation in this trial.
Subject has life expectancy > 12 months.
Subject is able to take clopidogrel or prasugrel (or ticlopidine, if the subject cannot take clopidogrel or prasugrel) and acetylsalicylic acid (aspirin).
Subject must agree not to participate in any other clinical investigation for a period of 12 months following the index procedure. This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
Angiographic Inclusion Criteria
A single de novo native disease segment of the superficial femoral (SFA) or common or external iliac arteries of the target extremity located within the following anatomical parameters:
Iliac
SFA
Vessel diameter from ≥ 5.5 mm to ≤ 6.5 mm evaluated by on-line quantitative vascular angiography (QVA) after pre-dilatation per core laboratory guidelines
Target lesion is ≥ 50% DS
Target lesion length ≤ 50 mm
Patent inflow artery free from significant lesion (≥ 50% DS and < 100% DS) as confirmed by angiography (treatment of the target lesion acceptable after successful treatment of inflow artery lesion)
Patent popliteal artery free from significant lesion (≥ 50% DS) with at least one patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) that provides in-line circulation to the lower leg and foot, as confirmed by angiography
Exclusion Criteria:
Angiographic Exclusion Criteria
Contralateral lesion distal to the location of inguinal ligament that requires treatment within 30 days before or after the procedure. (Contralateral iliac artery lesions may be treated during the procedure if necessary for contralateral approach to the target lesion).
Target extremity has an angiographically significant (> 50% DS) lesion located distal to the target lesion.
Acute ischemia of the target extremity
Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.
Target vessel has been previously treated with any of the following: stent, laser, atherectomy, surgical bypass, or endarterectomy.
Total occlusion (100% DS) of the ipsilateral inflow artery.
Angiographic evidence of thrombus in target vessel.
The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) (e.g. but not limited to, directional atherectomy, excimer laser, rotational atherectomy, brachytherapy, cryoplasty, etc.)
Target lesion is within or adjacent to an aneurysm.
Subject has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion, or from crossing or pre-dilating the target lesion.
Target lesion has moderate-to-severe calcification with either of the following characteristics:
Subject has an abdominal aortic aneurysm > 3 cm or history of aortic revascularization.
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Lammer, Prof. Dr. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | ||||
| Abbott Vascular International BVBA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27282601 | Derived | Lammer J, Bosiers M, Deloose K, Schmidt A, Zeller T, Wolf F, Lansink W, Sauguet A, Vermassen F, Lauwers G, Scheinert D, Popma JJ, McGreevy R, Rapoza R, Schwartz LB, Jaff MR. Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results. JACC Cardiovasc Interv. 2016 Jun 13;9(11):1178-87. doi: 10.1016/j.jcin.2016.02.051. |
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A total of 35 subjects registered in this study were implanted with the ESPRIT BVS at 7 centers in 4 countries (Belgium, France, Germany and Austria) across Europe. First subject was registered in the ESPRIT I Clinical Investigation on December 20, 2011. The last subject was registered on August 28, 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | ESPRIT BVS | Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 1 Month Follow-up |
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| 1 month |
| Number of Participants With Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above). | 6 months |
| Number of Participants With Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above). | 1 year |
| Number of Participants With Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above). | 2 years |
| Number of Participants With Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above). | 3 years |
| Number of Participants With Any Amputation of Treated Limb (Minor and Major) | The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | 1 month |
| Number of Participants With Any Amputation of Treated Limb (Minor and Major) | The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | 6 months |
| Number of Participants With Any Amputation of Treated Limb (Minor and Major) | The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | 1 year |
| Number of Participants With Any Amputation of Treated Limb (Minor and Major) | The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | 2 years |
| Number of Participants With Any Amputation of Treated Limb (Minor and Major) | The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | 3 years |
| Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity | Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | 0 to 30 days |
| Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity | Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | 0 to 180 days |
| Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity | Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | 0 to 365 days |
| Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity | Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | 0 to 730 days |
| Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity | Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | 0 to 1095 days |
| Number of Participants With Scaffold Thrombosis | Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure. | 0 to 1 month |
| Scaffold Occlusion | Number of participants with Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure. | 1 month |
| Number of Participants With Scaffold Occlusion | Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure. | 6 months |
| Number of Participants With Scaffold Occlusion | Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure. | 1 year |
| Number of Participants With Scaffold Occlusion | Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure. | 2 years |
| Number of Participants With Scaffold Occlusion | Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure. | 0 to 3 years |
| Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 1 month |
| Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 6 months |
| Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 1 year |
| Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 2 years |
| Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 3 years |
| Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR) | A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. | 1 month |
| Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR) | A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. | 6 months |
| Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR) | A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. | 1 year |
| Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR) | A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. | 2 years |
| Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR) | A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. | 3 years |
| Number of Participants With Ipsilateral Extremity Revascularization (IER) | Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself. | 1 month |
| Number of Participants With Ipsilateral Extremity Revascularization (IER) | Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself. | 6 months |
| Number of Participants With Ipsilateral Extremity Revascularization (IER) | Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself. | 1 year |
| Number of Participants With Ipsilateral Extremity Revascularization (IER) | Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself. | 2 years |
| Number of Participants With Ipsilateral Extremity Revascularization (IER) | Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself. | 3 years |
| Number of Participants With Primary Patency | At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion. | 1 month |
| Number of Participants With Primary Patency | At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion. | 6 months |
| Number of Participants With Primary Patency | At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion. | 1 year |
| Number of Participants With Primary Patency | At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion. | 2 years |
| Number of Participants With Primary Patency | At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion. | 3 years |
| Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb | The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | 1 month |
| Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb | The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | 6 months |
| Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb | The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | 1 year |
| Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb | The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | 2 years |
| Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb | The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | 3 years |
| Ankle Brachial Index (ABI) for the Treated Limb | The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI) | At 1 month |
| Ankle Brachial Index (ABI) for the Treated Limb | The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI) | At 6 months |
| Ankle Brachial Index (ABI) for the Treated Limb | The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI) | At 1 year |
| Ankle Brachial Index (ABI) for the Treated Limb | The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI) | At 2 years |
| Ankle Brachial Index (ABI) for the Treated Limb | The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI) | At 3 years |
| Walking Impairment Questionnaire (WIQ) Scores | Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). | At 1 month |
| Walking Impairment Questionaire Scores | Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). | At 6 months |
| Walking Impairment Questionaire Scores | Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). | At 1 year |
| Walking Impairment Questionaire Scores | Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). | At 2 years |
| Walking Impairment Questionaire Scores | Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). | At 3 years |
| In-scaffold Peak Systolic Velocity (PSV) | In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound | 1 month |
| In-scaffold Peak Systolic Velocity (PSV) | In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound | 6 months |
| In-scaffold Peak Systolic Velocity (PSV) | In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound | 1 year |
| In-scaffold Peak Systolic Velocity (PSV) | In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound | 2 years |
| In-scaffold Peak Systolic Velocity (PSV) | In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound | 3 years |
| In-scaffold Peak Systolic Velocity Ratio (PSVR) | In-scaffold Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound | 1 month |
| In-scaffold Peak Systolic Velocity Ratio (PSVR) | Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound | 6 months |
| In-scaffold Peak Systolic Velocity Ratio (PSVR) | Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound | 1 year |
| In-Scaffold Peak Systolic Velocity Ratio (PSVR) | Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound | 2 years |
| In-scaffold Peak Systolic Velocity Ratio (PSVR) | Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound | 3 years |
| Treated Site Percent Diameter Stenosis (%DS) | Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.
| post-procedure |
| Treated Site Percent Diameter Stenosis (%DS) | Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.
| 12 months |
| Treated Site Late Loss | Mean in-lesion Late Loss is calculated as: (MLD post-procedure - MLD follow-up). The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, treated site or treated segment. Minimum Lumen Vessel Diameter (MLD) is visually estimated during angiography by the Investigator; it is measured during qualitative comparative analysis (QCA) by the Angiographic Core Lab. | 12 months |
| Binary Restenosis (≥50% DS) | Binary restenosis is defined as the presence of a hemodynamically significant stenosis ≥ 50% as determined by duplex ultrasound or quantitative angiography (QA). Scaffold Stenosis ≥ 50% by Duplex Ultrasound Only In-scaffold %DS ≥ 50% by Arteriogram Only | 1 year |
| Quality of Life Measures: Physical Functioning (PF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 month |
| Quality of Life Measures: Physical Functioning (PF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 6 months |
| Quality of Life Measures: Physical Functioning (PF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 year |
| Quality of Life Measures: Physical Functioning (PF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 2 years |
| Quality of Life Measures: Physical Functioning (PF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 3 years |
| Quality of Life Measures: Role Physical (RP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 month |
| Quality of Life Measures: Role Physical (RP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 6 months |
| Quality of Life Measures: Role Physical (RP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 year |
| Quality of Life Measures: Role Physical (RP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 2 years |
| Quality of Life Measures: Role Physical (RP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 3 years |
| Quality of Life Measures: Bodily Pain (BP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 month |
| Quality of Life Measures: Bodily Pain (BP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 6 months |
| Quality of Life Measures: Bodily Pain (BP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 year |
| Quality of Life Measures: Bodily Pain (BP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 2 years |
| Quality of Life Measures: Bodily Pain (BP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 3 years |
| Quality of Life Measures: General Health (GH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 month |
| Quality of Life Measures: General Health (GH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 6 months |
| Quality of Life Measures: General Health (GH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 year |
| Quality of Life Measures: General Health (GH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 2 years |
| Quality of Life Measures: General Health (GH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 3 years |
| Quality of Life Measures: Vitality (VT) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 month |
| Quality of Life Measures: Vitality (VT) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 6 months |
| Quality of Life Measures: Vitality (VT) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 year |
| Quality of Life Measures: Vitality (VT) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 2 years |
| Quality of Life Measures: Vitality (VT) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 3 years |
| Quality of Life Measures: Social Functioning (SF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 month |
| Quality of Life Measures: Social Functioning (SF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 6 months |
| Quality of Life Measures: Social Functioning (SF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 year |
| Quality of Life Measures: Social Functioning (SF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 2 years |
| Quality of Life Measures: Social Functioning (SF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 3 years |
| Quality of Life Measures: Role Emotional (RE) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 month |
| Quality of Life Measures: Role Emotional (RE) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 6 months |
| Quality of Life Measures: Role Emotional (RE) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 year |
| Quality of Life Measures: Role Emotional (RE) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 2 years |
| Quality of Life Measures: Role Emotional (RE) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 3 years |
| Quality of Life Measures: Mental Health (MH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 month |
| Quality of Life Measures: Mental Health (MH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 6 months |
| Quality of Life Measures: Mental Health (MH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 year |
| Quality of Life Measures: Mental Health (MH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 2 years |
| Quality of Life Measures: Mental Health (MH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 3 years |
| Quality of Life Measures: Physical Component Summary (PCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 month |
| Quality of Life Measures: Physical Component Summary (PCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 6 months |
| Quality of Life Measures: Physical Component Summary (PCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 year |
| Quality of Life Measures: Physical Component Summary (PCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 2 years |
| Quality of Life Measures: Mental Component Summary (MCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 month |
| Quality of Life Measures: Physical Component Summary (PCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 3 years |
| Quality of Life Measures: Mental Component Summary (MCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 6 months |
| Quality of Life Measures: Mental Component Summary (MCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 1 year |
| Quality of Life Measures: Mental Component Summary (MCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 2 years |
| Quality of Life Measures: Mental Component Summary (MCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | At 3 years |
| Vascular Quality of Life (VascuQol) Scores Summary | Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain. | At 1 month |
| Vascular Quality of Life (VascuQol) Scores Summary | Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain. | At 6 months |
| Vascular Quality of Life (VascuQol) Scores Summary | Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain. | At 1 year |
| Vascular Quality of Life (VascuQol) Scores Summary | Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain. | At 2 years |
| Vascular Quality of Life (VascuQol) Scores Summary | Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain. | At 3 years |
| Brussels |
| 0886.537.933 |
| Belgium |
| Sint-Blasius Hospital | Dendermonde | Belgium |
| Oost Limburg Ziekenhuis | Genk | Belgium |
| Gent University Hospital | Ghent | Belgium |
| Clinique Pasteur | Toulouse | France |
| Herzzentrum Bad Krozingen | Bad Krozingen | Germany |
| Park-Krankenhaus Leipzig | Leipzig | Germany |
| COMPLETED |
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| NOT COMPLETED |
|
| 6 Months Follow-up |
|
| 1 Year Follow-up |
|
| 2 Years Follow-up |
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| 3 Years Follow-up |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ESPRIT BVS | Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
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| Primary | Device Success | Study device success is defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter. | Intent-to-treat (ITT) population. | Posted | Number | percentage of devices | On Day 0 (From start of index procedure to end of index procedure) |
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| Primary | Technical Success | Technical success is defined on a per lesion basis, the attainment of a final residual stenosis of < 30% at the intended target lesion(s). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as technical success only if the above criteria are met. | ITT population. | Posted | Number | percentage of target lesions | On Day 0 (From start of index procedure to end of index procedure) |
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| Primary | Clinical Success | Defined on a per subject basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications* within 2 days after the index procedure or at hospital discharge, whichever is sooner. (Note that in the ESPRIT I study, only a single target lesion per subject is permitted to be treated). *Includes the following: Death; Amputation; Scaffold Thrombosis; Target Lesion Revascularization (by any percutaneous or surgical means); Target Vessel Revascularization (by any percutaneous or surgical means). | ITT population. | Posted | Number | percentage of participants | > or = 2 days after the index procedure |
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| Secondary | Number of Participants With Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants With Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above). | ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above). | ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above). | ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above). | ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With Any Amputation of Treated Limb (Minor and Major) | The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants With Any Amputation of Treated Limb (Minor and Major) | The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Any Amputation of Treated Limb (Minor and Major) | The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With Any Amputation of Treated Limb (Minor and Major) | The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With Any Amputation of Treated Limb (Minor and Major) | The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | ITT population. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity | Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 0 to 30 days |
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| Secondary | Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity | Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 0 to 180 days |
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| Secondary | Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity | Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 0 to 365 days |
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| Secondary | Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity | Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 0 to 730 days |
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| Secondary | Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity | Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations. | ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 0 to 1095 days |
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| Secondary | Number of Participants With Scaffold Thrombosis | Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure. | ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 0 to 1 month |
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| Secondary | Scaffold Occlusion | Number of participants with Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure. | ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants With Scaffold Occlusion | Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Scaffold Occlusion | Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With Scaffold Occlusion | Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With Scaffold Occlusion | Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 0 to 3 years |
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| Secondary | Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR) | A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR) | A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR) | A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR) | A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR) | A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With Ipsilateral Extremity Revascularization (IER) | Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants With Ipsilateral Extremity Revascularization (IER) | Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Ipsilateral Extremity Revascularization (IER) | Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With Ipsilateral Extremity Revascularization (IER) | Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With Ipsilateral Extremity Revascularization (IER) | Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With Primary Patency | At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants With Primary Patency | At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Primary Patency | At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With Primary Patency | At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With Primary Patency | At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb | The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb | The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb | The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb | The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb | The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Ankle Brachial Index (ABI) for the Treated Limb | The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI) | ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis. | Posted | Mean | Standard Deviation | ratio | At 1 month |
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| Secondary | Ankle Brachial Index (ABI) for the Treated Limb | The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI) | ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis. | Posted | Mean | Standard Deviation | ratio | At 6 months |
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| Secondary | Ankle Brachial Index (ABI) for the Treated Limb | The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI) | ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis. | Posted | Mean | Standard Deviation | ratio | At 1 year |
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| Secondary | Ankle Brachial Index (ABI) for the Treated Limb | The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI) | ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis. | Posted | Mean | Standard Deviation | ratio | At 2 years |
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| Secondary | Ankle Brachial Index (ABI) for the Treated Limb | The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI) | ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis. | Posted | Mean | Standard Deviation | ratio | At 3 years |
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| Secondary | Walking Impairment Questionnaire (WIQ) Scores | Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). | ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
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| Secondary | Walking Impairment Questionaire Scores | Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). | ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
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| Secondary | Walking Impairment Questionaire Scores | Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). | ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
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| Secondary | Walking Impairment Questionaire Scores | Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). | ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
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| Secondary | Walking Impairment Questionaire Scores | Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). | ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
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| Secondary | In-scaffold Peak Systolic Velocity (PSV) | In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound | PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable. | Posted | Mean | Standard Deviation | cm/sec | 1 month |
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| Secondary | In-scaffold Peak Systolic Velocity (PSV) | In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound | PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable. | Posted | Mean | Standard Deviation | cm/sec | 6 months |
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| Secondary | In-scaffold Peak Systolic Velocity (PSV) | In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound | PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable. | Posted | Mean | Standard Deviation | cm/sec | 1 year |
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| Secondary | In-scaffold Peak Systolic Velocity (PSV) | In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound | PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable. | Posted | Mean | Standard Deviation | cm/sec | 2 years |
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| Secondary | In-scaffold Peak Systolic Velocity (PSV) | In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound | PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable. | Posted | Mean | Standard Deviation | cm/sec | 3 years |
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| Secondary | In-scaffold Peak Systolic Velocity Ratio (PSVR) | In-scaffold Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound | PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable. | Posted | Mean | Standard Deviation | ratio | 1 month |
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| Secondary | In-scaffold Peak Systolic Velocity Ratio (PSVR) | Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound | PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable. | Posted | Mean | Standard Deviation | ratio | 6 months |
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| Secondary | In-scaffold Peak Systolic Velocity Ratio (PSVR) | Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound | PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable. | Posted | Mean | Standard Deviation | ratio | 1 year |
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| Secondary | In-Scaffold Peak Systolic Velocity Ratio (PSVR) | Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound | PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable. | Posted | Mean | Standard Deviation | ratio | 2 years |
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| Secondary | In-scaffold Peak Systolic Velocity Ratio (PSVR) | Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound | PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable. | Posted | Mean | Standard Deviation | ratio | 3 years |
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| Secondary | Treated Site Percent Diameter Stenosis (%DS) | Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.
| Posted | Mean | Standard Deviation | Percent Diameter stenosis | post-procedure |
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| Secondary | Treated Site Percent Diameter Stenosis (%DS) | Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.
| The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Mean | Standard Deviation | percent diameter stenosis | 12 months | Target lesions | Target lesions |
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| Secondary | Treated Site Late Loss | Mean in-lesion Late Loss is calculated as: (MLD post-procedure - MLD follow-up). The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, treated site or treated segment. Minimum Lumen Vessel Diameter (MLD) is visually estimated during angiography by the Investigator; it is measured during qualitative comparative analysis (QCA) by the Angiographic Core Lab. | The analysis population included subjects who had available follow up data at that time frame. | Posted | Mean | Standard Deviation | Millimeter | 12 months |
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| Secondary | Binary Restenosis (≥50% DS) | Binary restenosis is defined as the presence of a hemodynamically significant stenosis ≥ 50% as determined by duplex ultrasound or quantitative angiography (QA). Scaffold Stenosis ≥ 50% by Duplex Ultrasound Only In-scaffold %DS ≥ 50% by Arteriogram Only | ITT Population. The analysis population included subjects who had available follow up data at that time frame. | Posted | Number | percentage of participants | 1 year |
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| Secondary | Quality of Life Measures: Physical Functioning (PF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
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| Secondary | Quality of Life Measures: Physical Functioning (PF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
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| Secondary | Quality of Life Measures: Physical Functioning (PF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
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| Secondary | Quality of Life Measures: Physical Functioning (PF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
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| Secondary | Quality of Life Measures: Physical Functioning (PF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
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| Secondary | Quality of Life Measures: Role Physical (RP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
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| Secondary | Quality of Life Measures: Role Physical (RP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
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| Secondary | Quality of Life Measures: Role Physical (RP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
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| Secondary | Quality of Life Measures: Role Physical (RP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
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| Secondary | Quality of Life Measures: Role Physical (RP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
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| Secondary | Quality of Life Measures: Bodily Pain (BP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
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| Secondary | Quality of Life Measures: Bodily Pain (BP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
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| Secondary | Quality of Life Measures: Bodily Pain (BP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
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| Secondary | Quality of Life Measures: Bodily Pain (BP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
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| Secondary | Quality of Life Measures: Bodily Pain (BP) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
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| Secondary | Quality of Life Measures: General Health (GH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
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| Secondary | Quality of Life Measures: General Health (GH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
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| Secondary | Quality of Life Measures: General Health (GH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
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| Secondary | Quality of Life Measures: General Health (GH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
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| Secondary | Quality of Life Measures: General Health (GH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
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| Secondary | Quality of Life Measures: Vitality (VT) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
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| Secondary | Quality of Life Measures: Vitality (VT) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
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| Secondary | Quality of Life Measures: Vitality (VT) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Vitality (VT) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Vitality (VT) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
|
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| Secondary | Quality of Life Measures: Social Functioning (SF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Social Functioning (SF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Social Functioning (SF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Social Functioning (SF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Social Functioning (SF) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Role Emotional (RE) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Role Emotional (RE) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Role Emotional (RE) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Role Emotional (RE) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Role Emotional (RE) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Mental Health (MH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Mental Health (MH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Mental Health (MH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Mental Health (MH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Mental Health (MH) Summary | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Physical Component Summary (PCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Physical Component Summary (PCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Physical Component Summary (PCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Physical Component Summary (PCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Mental Component Summary (MCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Physical Component Summary (PCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Mental Component Summary (MCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Mental Component Summary (MCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Mental Component Summary (MCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Measures: Mental Component Summary (MCS) | The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. | ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
|
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| Secondary | Vascular Quality of Life (VascuQol) Scores Summary | Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain. | ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 month |
|
| ||||||||||||||||||||||||||
| Secondary | Vascular Quality of Life (VascuQol) Scores Summary | Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain. | ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 6 months |
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| Secondary | Vascular Quality of Life (VascuQol) Scores Summary | Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain. | ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Vascular Quality of Life (VascuQol) Scores Summary | Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain. | ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Vascular Quality of Life (VascuQol) Scores Summary | Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain. | ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point. | Posted | Mean | Standard Deviation | score on a scale | At 3 years |
|
|
3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ESPRIT BVS | Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries. ESPRIT BVS: Subjects receiving ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries | 0 | 35 | 22 | 35 | 25 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bleeding | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hematuria | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angina | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arrhythmia (Includes Brady And Tachy) | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cerebrovascular accident (CVA) | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Coronary artery disease (CAD) - Coronary stenosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnea | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial Infarction - Unknown | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Other | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Other | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Dissection | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Other | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Trauma | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Flank Pain | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Insufficiency | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Airway Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Claudication | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ischemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Occlusion | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral artery disease (PAD) | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral vascular disease (PVD) | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Restenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Angina | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arrhythmia (Includes Brady And Tachy) | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Other | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Insufficiency | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Other | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Trauma | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment | Neurologic Other Than Stroke |
|
| Hematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Claudication | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ischemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Occlusion | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral vascular disease (PVD) | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Restenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bleeding | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Epistaxis | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Benign cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CAD - Coronary stenosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial Infarction - Unknown | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac/Hemodynamic : Other | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Structural Heart | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bilary/Liver Disorder | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gallstones | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Infection : Other | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Viral, Bacterial And Fungal Infections | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Abnormal Lab Test | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Metabolic : Other | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| General disorders : Other | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Wound Complication Or Wound Infection | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Neurologic Other Than Stroke: Other | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral Neuropathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dissection | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Airway Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Sepsis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Sleep Disorder | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Cerebrovascular accident (CVA) | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral artery disease (PAD) | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadia bouhdi | Abbott Vascular | nadia.bouhdi@av.abbott.com |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D016491 | Peripheral Vascular Diseases |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D058729 | Peripheral Arterial Disease |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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| Title | Denominators | Categories | ||||
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