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The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
The objective of this continued follow-up of ILLUMENATE Pivotal Study subjects is to demonstrate the long term safety and effectiveness of the Stellarex DCB.
Each enrolled subject will be followed for 5 years (60 months) after treatment. A follow-up office visit will occur at 24 and 36 months. A follow-up telephone contact or an optional office visit will occur at 48 and 60 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB Subjects | Experimental | The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications
|
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| PTA Subjects | Placebo Comparator | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stellarex 0.035" OTW Drug-coated Angioplasty Balloon | Device | The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Target Vessel Patency at 24 Months Post-procedure | Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization. | 24 months post-procedure |
| Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure | The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days). | 24 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). |
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Inclusion Criteria - From ILLUMENATE Pivotal IDE population TP-1397E
Study subjects must fulfill the following clinical criteria:
Symptomatic leg ischemia, requiring treatment of the superficial femoral artery (SFA) and/or popliteal artery.
Greater than or equal to 18 years of age.
Willing to provide written informed consent, and capable and willing to comply with all required follow-up evaluations within the defined follow-up visit windows.
Will not undergo other planned vascular interventions within 14 days before and/or 30 days after the protocol treatment (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
Life expectancy >1 year.
Rutherford-Becker classification of 2, 3 or 4.
Study Subjects must fulfill the following angiographic criteria:
De novo or restenotic lesion (except for in-stent restenotic lesion) >70% within the SFA and/or popliteal artery in a single limb.
Single lesion which is ≥3 cm and ≤18cm in length (by visual estimation). NOTE: Tandem lesions can be treated. A tandem lesion is defined as two distinct lesions with 3 cm or less of healthy vessel separating the two diseased areas. The total cumulative length of the tandem lesions, including the healthy vessel, must not exceed 18 cm.
Lesion is treatable by no more than two (2) study devices.
Successful wire crossing of the lesion. The guidewire advancement should not be indicative of the presence of fresh thrombus in the lesion.
Target reference vessel diameter is ≥4 mm and ≤6 mm (by visual estimation).
Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as confirmed by angiography. Treatment of a target lesion is acceptable after successful treatment of inflow artery lesion(s). NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis <30% without death or major vascular complication.
Target limb with at least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior magnetic resonance (MR) angiography or computed tomography (CT) angiography (within 45 days prior to index procedure). NOTE: treatment of outflow disease is NOT permitted.
Exclusion Criteria -
Subject with any of the following clinical criteria should be excluded:
Females who are pregnant, lactating, or intend to become pregnant, or males who intend to father children during study participation.
Known aortic aneurysm(s) > 5 cm.
Contraindication to dual anti-platelet therapy.
Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
Current participation in an investigational drug or another device study.
History of hemorrhagic stroke within 3 months.
Previous or planned surgical or interventional procedure within 14 days before or 30 days after the index procedure (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
Prior endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. stents/stent grafts, cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure, or any previous placement of a bypass graft proximal to the target lesion.
Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter.
Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session.
Chronic renal insufficiency (dialysis dependent, or serum creatinine >2.5 mg/dL within 30 days of index procedure).
Subject with any of the following angiographic criteria should be excluded:
Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure.
No normal proximal arterial segment of the target vessel in which duplex ultrasound velocity ratios can be measured.
Known inadequate distal outflow.
Acute or sub-acute thrombus in the target vessel.
Aneurysmal target vessel.
Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) during the index procedure in the target lesion or target vessel.
Treatment of the contralateral limb during the same procedure or within 30 days following the study procedure (exclusive of the iliac arteries which can be treated prior to enrollment).
Presence of concentric calcification that precludes PTA pre-dilation.
Prior stent placement in the target vessel.
Residual stenosis of greater than 70%, stent placement or flow-limiting (Grade D or greater) dissection following pre-dilation.
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| Name | Affiliation | Role |
|---|---|---|
| Sean Lyden, MD | The Cleveland Clinic | Principal Investigator |
| Prakash Krishnan, MD | Mount Sinai Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuma Regional Medical Center | Yuma | Arizona | 85364 | United States | ||
| Mission Cardiovascular Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31567024 | Derived | Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DCB Subjects | The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2017 | Dec 8, 2021 |
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|
| EverCross™ 0.035 PTA Balloon Catheter | Device | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
| 24 months post-procedure |
| Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). | 36 months post-procedure |
| Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). | 48 months post-procedure |
| Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). | 60 months post-procedure |
| Rate of Clinically-driven Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion. | 24 months post-procedure |
| Rate of Clinically-driven Target Lesion Revascularization | Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion. | 36 months post-procedure |
| Rate of Clinically-driven Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion. | 48 months post-procedure |
| Rate of Clinically-driven Target Lesion Revascularization | Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion. | 60 months post-procedure |
| Rate of Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee | 24 months post-procedure |
| Rate of Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee | 36 months post-procedure |
| Rate of Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee | 48 months post-procedure |
| Rate of Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee | 60 months post-procedure |
| Rate of Clinically-driven Target Vessel Revascularization | Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index. | 24 months post-procedure |
| Rate of Clinically-driven Target Vessel Revascularization | Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index. | 36 months post-procedure |
| Rate of Clinically-driven Target Vessel Revascularization | Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index. | 48 months post-procedure |
| Rate of Clinically-driven Target Vessel Revascularization | Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index. | 60 months post-procedure |
| Rate of Target Limb Major Amputation | Number of subjects in which a major amputation occurred in the target limb | 24 months post-procedure |
| Rate of Target Limb Major Amputation | Number of subjects in which a major amputation occurred in the target limb | 36 months post-procedure |
| Rate of Target Limb Major Amputation | Number of subjects in which a major amputation occurred in the target limb | 48 months post-procedure |
| Rate of Target Limb Major Amputation | Number of subjects in which a major amputation occurred in the target limb | 60 months post-procedure |
| Mortality Rate | Number of subject who have died during the post-procedure follow up period | 24 months post-procedure |
| Mortality Rate | Number of subject who have died during the post-procedure follow up period | 36 months post-procedure |
| Mortality Rate | Number of subject who have died during the post-procedure follow up period | 48 months post-procedure |
| Mortality Rate | Number of subject who have died during the post-procedure follow up period | 60 months post-procedure |
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment | Rate of occurrence of arterial thrombosis of the treated segment | 24 months post-procedure |
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment | Rate of occurrence of arterial thrombosis of the treated segment | 36 months post-procedure |
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment | Rate of occurrence of arterial thrombosis of the treated segment | 48 months post-procedure |
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment | Rate of occurrence of arterial thrombosis of the treated segment | 60 months post-procedure |
| Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR | Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR | 24 months post-procedure |
| Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR | Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR | 36 months post-procedure |
| Change in Ankle-brachial Index (ABI) From Pre-procedure | The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease. | 24 months post-procedure |
| Change in Ankle-brachial Index (ABI) From Pre-procedure | The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease. | 36 months post-procedure |
| Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication | 24 months post-procedure |
| Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication | 36 months post-procedure |
| Change in Walking Distance From Pre-procedure | Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit. | 24 months post-procedure |
| Change in Walking Distance From Pre-procedure | Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit. | 36 months post-procedure |
| Change in Rutherford-Becker Classification From Pre-procedure | Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4*-Ischemic rest pain 5*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable *Categories 4, 5, and 6 are also described as critical limb ischemia. | 24 months post-procedure |
| Change in Rutherford-Becker Classification From Pre-procedure | Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4*-Ischemic rest pain 5*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable *Categories 4, 5, and 6 are also described as critical limb ischemia. | 36 months post-procedure |
| Change in EQ-5D Index From Pre-procedure | EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion. | 24 months post-procedure |
| Change in EQ-5D Index From Pre-procedure | EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion. | 36 months post-procedure |
| Change in EQ-5D VAS From Pre-procedure | EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion | 24 months post procedure |
| Change in EQ-5D VAS From Pre-procedure | EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion | 36 month post procedure |
| Fremont |
| California |
| 94538 |
| United States |
| Good Samaritan Hospital - Los Angeles | Los Angeles | California | 90017 | United States |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Cardiovascular Research of North Florida | Gainesville | Florida | 32605 | United States |
| Baptist Cardiac and Vascular Institute | Miami | Florida | 33176 | United States |
| Coastal Vascular and Interventional | Pensacola | Florida | 32504 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Advocate Health and Hospitals Corporation | Oakbrook Terrace | Illinois | 60181 | United States |
| St. Joseph Hospital | Fort Wayne | Indiana | 46802 | United States |
| Central Iowa Hospital Corporation | Des Moines | Iowa | 50309 | United States |
| Cardiac & Vascular Research Center of Northern Michigan | Petoskey | Michigan | 49770 | United States |
| Metro Health Hospital | Wyoming | Michigan | 15146 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Mission Hospital | Asheville | North Carolina | 28801 | United States |
| Wake Heart Research | Raleigh | North Carolina | 19010 | United States |
| Rex Hospital | Raleigh | North Carolina | 27607 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| North Ohio Research LTD. | Elyria | Ohio | 44035 | United States |
| Jobst Vascular Institute | Toledo | Ohio | 43606 | United States |
| Oklahoma Foundation for Cardiovascular Research | Oklahoma City | Oklahoma | 73120 | United States |
| Heritage Valley Health System | Beaver | Pennsylvania | 15009 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Pinnacle Health Cardiovascular Institute, INC. | Wormleysburg | Pennsylvania | 17043 | United States |
| Sanford Health Vascular Associates | Sioux Falls | South Dakota | 57117 | United States |
| University Surgical Associates | Chattanooga | Tennessee | 37403 | United States |
| Wellmont Holston Valley Medical | Kingsport | Tennessee | 37660 | United States |
| Premier Surgical Associates | Knoxville | Tennessee | 37909 | United States |
| Texas Health & Research Education Institution | Dallas | Texas | 75231 | United States |
| El Paso Cardiology Associates | El Paso | Texas | 79902 | United States |
| University of Texas Health Science Center - Houston | Houston | Texas | 77030 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| CAMC Clinical Trial Center | Charleston | West Virginia | 25304 | United States |
| Aurora Health Care | Milwaukee | Wisconsin | 53215 | United States |
| Medical University Graz | Graz | Austria |
| Hanusch Krankenhaus Wien | Vienna | Austria |
| FG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DCB Subjects | The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. |
| BG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Not all participants reported this demographic information. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Not all participants reported this demographic. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Ankle-Brachial Index | Data was analyzed by arm, not by total. ABI analysis returns measurement values of mmHg. Non-compressible indicates no measurement could be taken, therefore there is no measurement to analyze and report. | Mean | Standard Deviation | ratio |
| ||||||||||||||
| Rutherford-Becker Clinical Category | Count of Participants | Participants |
| ||||||||||||||||
| Peripheral Vascular Disease (PVD) | Count of Participants | Participants |
| ||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Hyperlipidemia | Count of Participants | Participants |
| ||||||||||||||||
| Myocardial Infarction (MI) | Count of Participants | Participants |
| ||||||||||||||||
| Angina Pectoris | Count of Participants | Participants |
| ||||||||||||||||
| Congestive Heart Failure (CHF) | Count of Participants | Participants |
| ||||||||||||||||
| Previous Percutaneous or Surgical Coronary Revascularization | Count of Participants | Participants |
| ||||||||||||||||
| Renal Insufficiency | Count of Participants | Participants |
| ||||||||||||||||
| Liver Disease | Count of Participants | Participants |
| ||||||||||||||||
| Cerebrovascular Disease | Count of Participants | Participants |
| ||||||||||||||||
| Chronic Obstructive Pulmonary Occlusion (COPD) | Count of Participants | Participants |
| ||||||||||||||||
| Deep Vein Thrombosis (DVT) | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes (Total) | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes - Type I | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes - Type II | Count of Participants | Participants |
| ||||||||||||||||
| Smoker | Count of Participants | Participants |
| ||||||||||||||||
| Previous Intervention of the Lower Limb | Count of Participants | Participants |
| ||||||||||||||||
| Previous Intervention of the Study Limb | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Target Vessel Patency at 24 Months Post-procedure | Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization. | Patency was defined as absence of target lesion restenosis (as assessed by the duplex ultrasound core laboratory based on PSVR ≤ 2.5) and CD-TLR through 24 months (defined as 730 ± 45 days, i.e., up to 775 days) or angiographic core laboratory assessment of restenosis. Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Primary | Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure | The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days). | Subject was considered a failure if they experienced device or procedure-related death within 30 days, or if they experienced target limb major amputation or CD-TLR within 24 months (defined as 730 ± 45 days, i.e., up to 775 days). Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 48 months post-procedure |
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| Secondary | Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 60 months post-procedure |
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| Secondary | Rate of Clinically-driven Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Rate of Clinically-driven Target Lesion Revascularization | Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Rate of Clinically-driven Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 48 months post-procedure |
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| Secondary | Rate of Clinically-driven Target Lesion Revascularization | Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 60 months post-procedure |
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| Secondary | Rate of Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Rate of Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Rate of Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 48 months post-procedure |
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| Secondary | Rate of Target Lesion Revascularization | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 60 months post-procedure |
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| Secondary | Rate of Clinically-driven Target Vessel Revascularization | Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Rate of Clinically-driven Target Vessel Revascularization | Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Rate of Clinically-driven Target Vessel Revascularization | Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 48 months post-procedure |
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| Secondary | Rate of Clinically-driven Target Vessel Revascularization | Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 60 months post-procedure |
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| Secondary | Rate of Target Limb Major Amputation | Number of subjects in which a major amputation occurred in the target limb | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Rate of Target Limb Major Amputation | Number of subjects in which a major amputation occurred in the target limb | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Rate of Target Limb Major Amputation | Number of subjects in which a major amputation occurred in the target limb | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 48 months post-procedure |
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| Secondary | Rate of Target Limb Major Amputation | Number of subjects in which a major amputation occurred in the target limb | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 60 months post-procedure |
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| Secondary | Mortality Rate | Number of subject who have died during the post-procedure follow up period | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Mortality Rate | Number of subject who have died during the post-procedure follow up period | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Mortality Rate | Number of subject who have died during the post-procedure follow up period | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 48 months post-procedure |
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| Secondary | Mortality Rate | Number of subject who have died during the post-procedure follow up period | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 60 months post-procedure |
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| Secondary | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | Rate of occurrence of arterial thrombosis of the treated segment | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | Rate of occurrence of arterial thrombosis of the treated segment | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | Rate of occurrence of arterial thrombosis of the treated segment | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 48 months post-procedure |
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| Secondary | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | Rate of occurrence of arterial thrombosis of the treated segment | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 60 months post-procedure |
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| Secondary | Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR | Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR | Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Change in Ankle-brachial Index (ABI) From Pre-procedure | The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Change in Ankle-brachial Index (ABI) From Pre-procedure | The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Change in Walking Distance From Pre-procedure | Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Change in Walking Distance From Pre-procedure | Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Change in Rutherford-Becker Classification From Pre-procedure | Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4*-Ischemic rest pain 5*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable *Categories 4, 5, and 6 are also described as critical limb ischemia. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Change in Rutherford-Becker Classification From Pre-procedure | Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4*-Ischemic rest pain 5*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable *Categories 4, 5, and 6 are also described as critical limb ischemia. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Change in EQ-5D Index From Pre-procedure | EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post-procedure |
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| Secondary | Change in EQ-5D Index From Pre-procedure | EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion. | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 months post-procedure |
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| Secondary | Change in EQ-5D VAS From Pre-procedure | EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 24 months post procedure |
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| Secondary | Change in EQ-5D VAS From Pre-procedure | EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion | Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled). | Posted | Count of Participants | Participants | 36 month post procedure |
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Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up.
The definitions are the same.
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 | DCB Subjects | The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. | 34 | 200 | 177 | 200 | 192 | 200 |
| EG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). | 19 | 100 | 85 | 100 | 95 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemorrhagic Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypchromic Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nephrogenic Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Aortic Valve Stenosis | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Atrioventricular Block | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac Disorder | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Coronary Artery Occlusion | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Coronary Artery Stenosis | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ischaemic Cardiomyopathy | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mitral Valve Incompetance | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sick Sinus Syndrome | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stress Cardiomyopathy | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Torsade de Pointes | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vertigo Positional | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Blindness Unilateral | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Macular Fibrosis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Retinal Artery Occlusion | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Barrett's Oesophagus | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea Haemorrhagic | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Duodenal Ulcer | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastritis Erosive | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrointestinal Angiodysplasia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrointestinal Angiodysplasia Haemorrhagic | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Large Intestine Polyp | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Retroperitoneal Haematoma | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Retroperitoneal Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Small Intestine Obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Umbilical Hernia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Catheter Site Hematoma | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Catheter Site Haemorrhage | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Device Deployment Issue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Device Occlusion | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Medical Device Complication | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sudden Cardiac Death | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ulcer | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vessel Puncture Site Thrombosis | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholangitis Acute | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholecystitis Chronic | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholelthiasis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hepatorenal Failure | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Appendicitis Perforated | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bursitis Infective | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Diabetic Foot Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Enfocarditis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Escherichia Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| FUNGAEMIA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| GANGRENE | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| GROIN ABSCESS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| H1N1 INFLUENZA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| ACCIDENT | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| ANAEMIA POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| ARTERIAL RESTENOSIS | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| ARTERIOVENOUS FISTULA SITE HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| CORONARY BYPASS THROMBOSIS | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| GASTROINTESTINAL STOMA COMPLICATION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| GRAFT HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| HEPATIC HAEMATOMA | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| MULTIPLE FRACTURES | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| MUSCLE RUPTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL REOCCLUSION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| POST PROCEDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| VASCULAR GRAFT COMPLICATION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| VASCULAR GRAFT OCCLUSION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| WOUND | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| BLOOD PRESSURE INCREASED | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| TROPONIN INCREASED | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DIABETIC COMPLICATION | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| FLUID OVERLOAD | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CERVICAL SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DUPUYTREN'S CONTRACTURE | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MOBILITY DECREASED | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MYOPATHY | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SYNOVIAL CYST | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SYNOVITIS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ADENOCARCINOMA OF THE CERVIX | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| BONE NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| CERVIX CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| CERVIX CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| COLON ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| HEPATOCELLULAR CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| LARYNGEAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| LUNG CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| METASTATIC MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| NEOPLASM PROSTATE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| OESOPHAGEAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| SALIVARY GLAND NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| SPLENIC NEOPLASM MALIGNANCY UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| CAROTID ARTERY OCCLUSION | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CEREBROVASCULAR DISORDER | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CERVICAL MYELOPATHY | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYDROCEPHALUS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| IVTH NERVE PARALYSIS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| POSTICTAL STATE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| RADICULOPATHY | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| STATUS EPILEPTICUS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| UNRESPONSIVE TO STIMULI | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ALCOHOL ABUSE | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DEPENDENCE | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ACUTE PRERENAL FAILURE | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| INCONTINENCE | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| RENAL ARTERY STENOSIS | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| RENAL FAILURE CHRONIC | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| URINARY TRACT INFLAMMATION | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| BRONCHITIS CHRONIC | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Infected Seroma | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pasteurella Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Staphylococcal Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ANGIOPLASTY | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| AORTIC VALVE REPLACEMENT | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| CATARACT OPERATION | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| KNEE ARTHROPLASTY | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| OBESITY SURGERY | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERY ANGIOPLASTY | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Viral Pharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERY BYPASS | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL REVASCULARISATION | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| RESECTION OF RECTUM | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| SURGERY | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| TOE AMPUTATION | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| WOUND DRAINAGE | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| ACCELERATED HYPERTENSION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| AORTIC STENOSIS | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ARTERIAL STENOSIS | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| BLUE TOE SYNDROME | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| FEMORAL ARTERY DISSECTION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| FEMORAL ARTERY OCCLUSION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HAEMORRHAGE | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| INTERMITTENT CLAUDICATION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ISCHAEMIA | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERY DISSECTION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERY STENOSIS | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERY THROMBOSIS | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL EMBOLISM | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL VASCULAR DISORDER | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| THROMBOPHLEBITIS SUPERFICIAL | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| VARICOSE VEIN | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| VENOUS INSUFFICIENCY | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| LOCAL SWELLING | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| FEMORAL ARTERY DISSECTION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| INTERMITTENT CLAUDICATION | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| PERIPHERAL ARTERY STENOSIS | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
Research Institution and PI shall have the right to publish, present or otherwise publicly disclose the results to their own activity conducted in the trial. Proposals must be submitted to the sponsor for review 30 days prior to publishing submission. Sponsor has the right to require confidentially sensitive information be removed (not including results) and/or delay publication for an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Aguirre | Philips | 612-297-6655 | nicolas.aguirre@philips.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2016 | May 10, 2023 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
Not provided
Not provided
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| United States |
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| Non-Compressible |
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| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| PTA Subjects |
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| PTA Subjects |
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| PTA Subjects |
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| PTA Subjects |
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| PTA Subjects |
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| PTA Subjects |
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| OG001 | PTA Subjects | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| PTA Subjects |
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
|
|
| PTA Subjects |
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
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| PTA Subjects |
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
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| PTA Subjects |
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). |
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