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The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lutonix Drug Coated Balloon | Experimental | Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter |
|
| Standard Uncoated Angioplasty Balloon | Active Comparator | PTA Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutonix Drug Coated Balloon | Device | Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure. | From index procedure to 60 months Post Index Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure | Number of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint) | 30 days post index procedure |
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Clinical Inclusion Criteria:
Male or non-pregnant female ≥18 years of age;
Rutherford Clinical Category 2-4;
Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;
Angiographic Lesion Inclusion Criteria:
Length ≤15 cm;
Up to two focal lesions or segments within the designated 15 cm length of vessel may be treated (e.g. two discrete segments, separated by several cm, but both falling within a composite length of <15 cm);
≥70% stenosis by visual estimate;
Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
De novo lesion(s) or non-stented restenotic lesion(s) >90 days from prior angioplasty procedure;
Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.
At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized (treatment of outflow disease is NOT permitted during the index procedure);
Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned 30 days after the protocol treatment in order to avoid confounding complications;
No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.
Exclusion Criteria:
Patients will be excluded if ANY of the following conditions apply:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Rosenfield, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mission Cardiovascular Research Institute | Fremont | California | 94538 | United States | ||
| Metro Health Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lutonix Drug Coated Balloon | Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries. |
| FG001 | Standard Uncoated Angioplasty Balloon | PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lutonix Drug Coated Balloon | Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure. | Posted | Count of Participants | Participants | From index procedure to 60 months Post Index Procedure |
|
Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lutonix Drug Coated Balloon | Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial occlusion puncture site | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma / bleeding puncture site - minor | General disorders | Systematic Assessment | AE entered in category "Access Site Complication" in the Clinical Study Report. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Lovas | Becton Dickinson | 7634452382 | anna.lovas@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2012 | May 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Standard PTA Balloon | Device | Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries. |
|
| Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure |
| 1, 6, 12, 24, 36, 48, and 60 months post index procedure (PPI) |
| Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure | Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR). | 6, 12, and 24 months post index procedure |
| Number of Acute Device Success at Time of Index Procedure | Device Success was defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system. | At time of index procedure |
| Number of Participants With Technical and Procedural Success | Technical Success is defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent. Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure. | At time of index procedure |
| Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure | 6, 12, and 24 months post index procedure |
| Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.0 and <3.0 at 6, 12, and 24 months post index procedure. DUS PSVR was calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase. | 6, 12, and 24 months post index procedure |
| Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 24 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened. | 6, 12, and 24 months post index procedure |
| Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | Mean change from baseline values. The Ankle Brachial Index (ABI) is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. | 6, 12, and 24 months from baseline |
| Wyoming |
| Michigan |
| 49519 |
| United States |
| Jackson Heart Clinic/St. Dominic's Hospital | Jackson | Mississippi | 39216 | United States |
| Mercy Hospital | Springfield | Missouri | 65804 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| New York Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | 10021 | United States |
| TriHealth Heart Institute | Cincinnati | Ohio | 45220 | United States |
| Mission Research Institute | New Braunfels | Texas | 78130 | United States |
| Standard Uncoated Angioplasty Balloon |
PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Rutherford Classification | Measure Description: Rutherford Classification is on an ascending scale from 0 to 6. Lower classifications on the scale indicate more favorable outcomes. 0- Asymptomatic
| Count of Participants | Participants |
|
|
|
| Secondary | Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure | Number of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint) | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Count of Participants | Participants | 30 days post index procedure |
|
|
|
| Secondary | Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Number | participants | 1, 6, 12, 24, 36, 48, and 60 months post index procedure (PPI) |
|
|
|
| Secondary | Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure | Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR). | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 6, 12, and 24 months post index procedure |
|
|
|
| Secondary | Number of Acute Device Success at Time of Index Procedure | Device Success was defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system. | Posted | Count of Units | Devices | At time of index procedure | Devices | Devices |
|
|
|
| Secondary | Number of Participants With Technical and Procedural Success | Technical Success is defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent. Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure. | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Count of Participants | Participants | At time of index procedure |
|
|
|
| Secondary | Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis | Posted | Number | participants | 6, 12, and 24 months post index procedure |
|
|
|
| Secondary | Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.0 and <3.0 at 6, 12, and 24 months post index procedure. DUS PSVR was calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase. | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Count of Participants | Participants | 6, 12, and 24 months post index procedure |
|
|
|
| Secondary | Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 24 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened. | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Count of Participants | Participants | 6, 12, and 24 months post index procedure |
|
|
|
| Secondary | Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | Mean change from baseline values. The Ankle Brachial Index (ABI) is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Mean | Standard Deviation | Ratio | 6, 12, and 24 months from baseline |
|
|
|
| 147 |
| 1,029 |
| 813 |
| 1,029 |
| 845 |
| 1,029 |
| EG001 | Standard Uncoated Angioplasty Balloon | PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries. | 17 | 160 | 125 | 160 | 126 | 160 |
| Hematoma / bleeding puncture site - major | General disorders | Systematic Assessment |
|
| Hematoma / bleeding puncture site - minor | General disorders | Systematic Assessment |
|
| Pseudo aneurysm | General disorders | Systematic Assessment |
|
| Puncture site infection | General disorders | Systematic Assessment |
|
| Vascular perforation / rupture | General disorders | Systematic Assessment |
|
| Retroperitoneal bleed | General disorders | Systematic Assessment |
|
| Significant blood loss | General disorders | Systematic Assessment |
|
| Other Access site complication | General disorders | Systematic Assessment | This category of SAEs is not broken down further in the Clinical Study Report. |
|
| Acute coronary syndrome | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Angina, stable | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Angina, unstable | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Arrhythmia - Bradycardia | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Arrhythmia - Tachycardia | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Arrhythmia - Other | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. This category is not broken down further in the Clinical Study Report. |
|
| Cardiac tamponade | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Cardiogenic shock | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Chronic heart failure | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Death | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Endocarditis | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Hypertension | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Hypotension | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Myocardial infarction | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Other Cardiovascular | Vascular disorders | Systematic Assessment | Category "Cardiovascular" in Clinical Study Report. |
|
| Diabetes Mellitus, Type I | Endocrine disorders | Systematic Assessment |
|
| Diabetes Mellitus, Type II | Endocrine disorders | Systematic Assessment |
|
| Hyperthroidism | Endocrine disorders | Systematic Assessment |
|
| Hypothroidism | Endocrine disorders | Systematic Assessment |
|
| Other Endocrine system | Endocrine disorders | Systematic Assessment | These SAEs are not broken down further in the Clinical Study Report. |
|
| Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
|
| Colon carcinoma | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Other infections / inflammatory | Gastrointestinal disorders | Systematic Assessment | Category of SAE not otherwise broken down in the Clinical Study Report. |
|
| Other infectious / inflammatory | Gastrointestinal disorders | Systematic Assessment | Category of SAE not otherwise broken down in the Clinical Study Report. |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Other Gastrointestinal | Gastrointestinal disorders | Systematic Assessment | Category of SAE not otherwise broken down in the Clinical Study Report. |
|
| Local infection | Infections and infestations | Systematic Assessment |
|
| Septic shock | Infections and infestations | Systematic Assessment |
|
| Septicemia / bacteremia | Infections and infestations | Systematic Assessment |
|
| Other Infectious | Infections and infestations | Systematic Assessment | Category of SAE not otherwise broken down in the Clinical Study report. |
|
| Confusion | Nervous system disorders | Systematic Assessment | Category "Neurological/Nervous System" in Clinical Study Report. |
|
| Death | Nervous system disorders | Systematic Assessment | Category "Neurological/Nervous System" in Clinical Study Report. |
|
| Depression | Nervous system disorders | Systematic Assessment | Category "Neurological/Nervous System" in Clinical Study Report. |
|
| Dizziness / vertigo | Nervous system disorders | Systematic Assessment | Category "Neurological/Nervous System" in Clinical Study Report. |
|
| Fainting / syncope | Nervous system disorders | Systematic Assessment | Category "Neurological/Nervous System" in Clinical Study Report. |
|
| Peripheral nervous system complication | Nervous system disorders | Systematic Assessment | Category "Neurological/Nervous System" in Clinical Study Report. |
|
| Seizure | Nervous system disorders | Systematic Assessment | Category "Neurological/Nervous System" in Clinical Study Report. |
|
| Stroke - hemorrhagic | Nervous system disorders | Systematic Assessment | Category "Neurological/Nervous System" in Clinical Study Report. |
|
| Stroke - ischemic | Nervous system disorders | Systematic Assessment | Category "Neurological/Nervous System" in Clinical Study Report. |
|
| TIA | Nervous system disorders | Systematic Assessment | Category "Neurological/Nervous System" in Clinical Study Report. |
|
| Other Neurological / nervous system | Nervous system disorders | Systematic Assessment | Category of SAE not otherwise broken down in the Clinical Study Report. Category "Neurological/Nervous System" in Clinical Study Report. |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Carcinoma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Other respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Category of SAE not otherwise broken down in Clinical Study Report. |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Category "Skeletal, Spine and Muscular System" in Clinical Study Report. |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture (bone) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteomyelitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Claudication | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other Skeletal, spine and muscular system | Musculoskeletal and connective tissue disorders | Systematic Assessment | Category of SAE not otherwise broken down in Clinical Study report. |
|
| Allergy | General disorders | Systematic Assessment | SAE entered as part of a Category titled "Systematic Complication" in Clinical Study Report. |
|
| Anaphylatic reaction | General disorders | Systematic Assessment | SAE entered as part of a Category titled "Systematic Complication" in Clinical Study Report. |
|
| Other Systematic complication | General disorders | Systematic Assessment | Category of SAE not further broken down in Clinical Study Report. SAE entered as part of a Category titled "Systematic Complication" in Clinical Study Report. |
|
| Aneurysm | General disorders | Systematic Assessment | This SAE was entered in "Target Vessel" category in Clinical Study Report. |
|
| Atherosclerosis | General disorders | Systematic Assessment | This SAE was entered in "Target Vessel" category in Clinical Study Report. |
|
| Dissection | General disorders | Systematic Assessment | This SAE was entered in "Target Vessel" category in Clinical Study Report. |
|
| Embolism | General disorders | Systematic Assessment | This SAE was entered in "Target Vessel" category in Clinical Study Report. |
|
| Occlusion / closure | General disorders | Systematic Assessment | This SAE was entered in "Target Vessel" category in Clinical Study Report. |
|
| Perforation | General disorders | Systematic Assessment | This SAE was entered in "Target Vessel" category in Clinical Study Report. |
|
| Restenosis | General disorders | Systematic Assessment | This SAE was entered in "Target Vessel" category in Clinical Study Report. |
|
| Thrombus - in-lesion | General disorders | Systematic Assessment | This SAE was entered in "Target Vessel" category in Clinical Study Report. |
|
| Other Target vessel | General disorders | Systematic Assessment | This SAE was entered in "Target Vessel" category in Clinical Study Report. SAE not otherwise broken down in the Clinical Study Report. |
|
| Bladder infection | Renal and urinary disorders | Systematic Assessment | SAE part of a category titled "Genito-urinary" in Clinical Study report. |
|
| Kidney stones | Renal and urinary disorders | Systematic Assessment | SAE part of a category titled "Genito-urinary" in Clinical Study report. |
|
| Prostate carcinoma | Renal and urinary disorders | Systematic Assessment | SAE part of a category titled "Genito-urinary" in Clinical Study report. |
|
| Prostate hypertrophy | Renal and urinary disorders | Systematic Assessment | SAE part of a category titled "Genito-urinary" in Clinical Study report. |
|
| Renal failure / insufficiency | Renal and urinary disorders | Systematic Assessment | SAE part of a category titled "Genito-urinary" in Clinical Study report. |
|
| Urinary infection | Renal and urinary disorders | Systematic Assessment | SAE part of a category titled "Genito-urinary" in Clinical Study report. |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment | SAE part of a category titled "Genito-urinary" in Clinical Study report. |
|
| Other Genito-urinary system | Renal and urinary disorders | Systematic Assessment | SAE part of a category titled "Genito-urinary" in Clinical Study report. SAE entry not otherwise broken down in Clinical Study Report. |
|
| Abscess | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. |
|
| Amputation | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. |
|
| Atypical chest pain | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. |
|
| Carcinoma (not specified elsewhere) | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. |
|
| Death (non-cardiac or neurological) | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. |
|
| Fatigue | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. |
|
| Fever | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. |
|
| Headache | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. |
|
| Hematuria | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. |
|
| Rash | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. |
|
| Sepsis | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. |
|
| Other | General disorders | Systematic Assessment | SAE entered in a category titled "Various" in the Clinical Study Report. Therefore, the SAE is hereby classified under "General Disorder" Organ System category. SAE "other" is not otherwise broken down in the Clinical Study Report. |
|
| Aneurysm | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Arterial occlusion | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Arterial thrombosis | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Atherosclerosis | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Dissection | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Embolism | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Hematoma / bleeding | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Perforation | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Restenosis | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Stent thrombosis (definite) | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Stent thrombosis (possible) | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Venous occlusion | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Venous thrombosis | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Ischemia | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Stenosis | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. |
|
| Other Vessel Specific | General disorders | Systematic Assessment | SAE entered in category "Vessel specific complications in the leg (not target lesion or target vessel)" in Clinical Study Report. SAE not otherwise broken down in the Clinical Study report. |
|
|
| Angina, Stable | Cardiac disorders | Systematic Assessment | AE entered in category "Cardiovascular" in clinical Study report. |
|
| Arrhythmia - Other | Cardiac disorders | Systematic Assessment | AE entered in category "Cardiovascular" in clinical Study report. AE (other) not otherwise broken down in Clinical Study Report. |
|
| Hypertension | Cardiac disorders | Systematic Assessment | AE entered in category "Cardiovascular" in clinical Study report. |
|
| Hypotension | Cardiac disorders | Systematic Assessment | AE entered in category "Cardiovascular" in clinical Study report. |
|
| Other Cardiovascular | Cardiac disorders | Systematic Assessment | AE entered in category "Cardiovascular" in clinical Study report. AE "Other" not otherwise broken down in the Clinical Study report. |
|
| Diabetes Mellitus, Type II | Endocrine disorders | Systematic Assessment |
|
| Other Endocrine system | Endocrine disorders | Systematic Assessment | AE (Other) not otherwise broken down in Clinical Study Report. |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Other Gastrointestinal | Gastrointestinal disorders | Systematic Assessment | AE (other) not otherwise broken down in Clinical Study Report. |
|
| Local infection | Infections and infestations | Systematic Assessment |
|
| Other infectious | Infections and infestations | Systematic Assessment | AE (Other) not otherwise broken down in the Clinical Study Report. |
|
| Dizziness / vertigo | Nervous system disorders | Systematic Assessment |
|
| Other Neurological / nervous system | Nervous system disorders | Systematic Assessment | AE (Other) not otherwise broken down in the Clinical Study Report. |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Other respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture (bone) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Claudication | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other skeletal, spine and muscular system | Musculoskeletal and connective tissue disorders | Systematic Assessment | AE (Other) not otherwise broken down in Clinical Study Report. |
|
| Dissection | General disorders | Systematic Assessment | AE entered in "Target Lesion" Category of Clinical Study Report. |
|
| Restenosis | General disorders | Systematic Assessment |
|
| Renal failure / insufficiency | Renal and urinary disorders | Systematic Assessment |
|
| Urinary infection | Renal and urinary disorders | Systematic Assessment |
|
| Other Genito-urinary system | General disorders | Systematic Assessment | AE (Other) not otherwise broken down in the Clinical Study Report. |
|
| Rash | General disorders | Systematic Assessment | AE reported in category "Various" in the Clinical Study Report. |
|
| Other | General disorders | Systematic Assessment | AE "Other" not otherwise broken down in the Clinical Study Report. |
|
| Restenosis | General disorders | Systematic Assessment | AE reported in category "Vessel specific complications in the leg (not target lesion or target vessel)"in the Clinical Study Report. |
|
| Stenosis | General disorders | Systematic Assessment | AE reported in category "Vessel specific complications in the leg (not target lesion or target vessel)"in the Clinical Study Report. |
|
| Other Vessel Specific | General disorders | Systematic Assessment | AE reported in category "Vessel specific complications in the leg (not target lesion or target vessel)"in the Clinical Study Report. AE (Other) not otherwise broken down in clinical Study Report. |
|
Not provided
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| Death : 6 months post index procedure |
|
|
| Death : 12 months post index procedure |
|
|
| Death : 24 months post index procedure |
|
|
| Death : 36 months post index procedure |
|
|
| Death : 48 months post index procedure |
|
|
| Death : 60 months post index procedure |
|
|
| Major Amputation : 1 month post index procedure |
|
|
| Major Amputation : 6 months post index procedure |
|
|
| Major Amputation : 12 months post index procedure |
|
|
| Major Amputation : 24 months post index procedure |
|
|
| Major Amputation : 36 months post index procedure |
|
|
| Major Amputation : 48 months post index procedure |
|
|
| Major Amputation : 60 months post index procedure |
|
|
| Minor Amputation : 1 month post index procedure |
|
|
| Minor Amputation : 6 months post index procedure |
|
|
| Minor Amputation : 12 months post index procedure |
|
|
| Minor Amputation : 24 months post index procedure |
|
|
| Minor Amputation : 36 months post index procedure |
|
|
| Minor Amputation : 48 months post index procedure |
|
|
| Minor Amputation : 60 months post index procedure |
|
|
| Amputation Free Survival : 1 month PPI |
|
|
| Amputation Free Survival : 6 months |
|
|
| Amputation Free Survival : 12 months PPI |
|
|
| Amputation Free Survival : 24 months PPI |
|
|
| Amputation Free Survival : 36 months PPI |
|
|
| Amputation Free Survival : 48 months PPI |
|
|
| Amputation Free Survival : 60 months PPI |
|
|
| Target Vessel Revascularization : 1 month PPI |
|
|
| Target Vessel Revascularization : 6 months PPI |
|
|
| Target Vessel Revascularization : 12 months PPI |
|
|
| Target Vessel Revascularization : 24 months PPI |
|
|
| Target Vessel Revascularization : 36 months PPI |
|
|
| Target Vessel Revascularization : 48 months PPI |
|
|
| Target Vessel Revascularization : 60 months PPI |
|
|
| Reintervention for thrombosis : 1 month |
|
|
| Reintervention for thrombosis : 6 months |
|
|
| Reintervention for thrombosis : 12 months |
|
|
| Reintervention for thrombosis : 24 months |
|
|
| Reintervention for thrombosis: 36 months |
|
|
| Reintervention for thrombosis : 48 months |
|
|
| Reintervention for thrombosis: 60 months |
|
|
| Cardiovascular Hospitalization : 1 month PPI |
|
|
| Cardiovascular Hospitalization : 6 months PPI |
|
|
| Cardiovascular Hospitalization : 12 months PPI |
|
|
| Cardiovascular Hospitalization : 24 months PPI |
|
|
| Cardiovascular Hospitalization : 36 months PPI |
|
|
| Cardiovascular Hospitalization : 48 months PPI |
|
|
| Cardiovascular Hospitalization : 60 months PPI |
|
|
| Major Vascular Complications : 1 month PPI |
|
|
| Major Vascular Complications : 6 months PPI |
|
|
| Major Vascular Complications : 12 months PPI |
|
|
| Major Vascular Complications : 24 months PPI |
|
|
| Major Vascular Complications : 36 months PPI |
|
|
| Major Vascular Complications : 48 months PPI |
|
|
| Major Vascular Complications : 60 months PPI |
|
|
| 12 months post index procedure |
|
|
| 24 months post index procedure |
|
|
| 12 months post index procedure |
|
|
| 24-Months Post-Index Procedure |
|
|
| DUS PSVR >=2.0: 12 months post index procedure |
|
|
| DUS PSVR >=2.0: 24 months post index procedure |
|
|
| DUS PSVR >=3.0: 6 months post index procedure |
|
|
| DUS PSVR >=3.0: 12 months post index procedure |
|
|
| DUS PSVR >=3.0: 24 months post index procedure |
|
|
| Same |
|
| Worsened |
|
| 12 months from baseline |
|
|
| 24 months from baseline |
|
|
| 12 months post index procedure |
|
|
| 24-Months Post-Index Procedure |
|
|