IN.PACT Global Clinical Study

Study Overview
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Brief Summary
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The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a real world patient population.

Detailed Description
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Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death. The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.

Official Title
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The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: IN.PACT Admiral™ Drug Eluting Balloon


Participation Criteria
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Eligibility Criteria
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General inclusion Criteria: Age ≥ 18 years or minimum age as required by local regulations. Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4. Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days. General exclusion Criteria: High probability of non-adherence to Clinical Investigation Protocol follow-up requirements. Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations). Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IN.PACT Admiral DEB<br>The subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as IN.PACT Admiral™ DEB)manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne, European Confirmity) marked medical device utilized within its intended use in the IN.PACT Global trial. | Device: IN.PACT Admiral™ Drug Eluting Balloon<br>* IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cohort ITT - Primary Effectiveness Endpoint | Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 12 months | 
| Clinical Cohort ITT - Primary Safety Endpoint | A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure. | 12 months | 
| Imaging Cohort ITT - Primary Effectiveness Endpoint | Primary Patency within 12 months post-index procedure, which is defined as: Freedom from clinically-driven TLR and Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4. Restenosis determined by either PSVR >2.4 as assessed by an independent DUS core lab or >50% stenosis as assessed by an independent angiographic core lab. | 12 months | 
| 150mm DEB ITT Cohort - Primary Effectiveness Endpoint | Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cohort ITT - MAEs | MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site. | 12 months | 
| Clinical Cohort ITT - TLR | Any Target lesion revascularisation | 12 months | 
| Clinical Cohort ITT - TVR | Any Target vessel revascularisation | 12 months. | 
| Clinical Cohort ITT - Device Success | Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP) | Index-procedure | 
| Clinical Cohort ITT - Clinical Success | Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge | prior to discharge | 
| Clinical Cohort ITT - MAEs | MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site. | 60 months | 
| Clinical Cohort ITT - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 60 months | 
| Clinical Cohort ITT - TVR |  | 60 months | 
| Clinical Cohort ITT - TLR |  | 60 months | 
| Clinical Cohort ITT - Time to First Clinically-driven TLR (Days) |  | 60 months | 
| Clinical Cohort ITT - MAEs | Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days. | 30 days | 
| Clinical Cohort ITT - MAEs | MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site | 6 Months | 
| Clinical Cohort ITT - MAEs | MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site. | 24 Months | 
| Clinical Cohort ITT - MAEs | MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site. | 36 Months | 
| Clinical Cohort ITT - MAEs | MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site. | 48 Months | 
| Clinical Cohort ITT - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 30 days | 
| Clinical Cohort ITT - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 6 Months | 
| Clinical Cohort ITT - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 24 Months | 
| Clinical Cohort ITT - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 36 Months | 
| Clinical Cohort ITT - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 48 Months | 
| Clinical Cohort ITT - TLR | Any Target lesion revascularisation | 6 Months | 
| Clinical Cohort ITT - TLR | Any Target lesion revascularisation | 24 Months | 
| Clinical Cohort ITT - TLR | Any Target lesion revascularisation | 36 Months | 
| Clinical Cohort ITT - TLR | Any Target lesion revascularisation | 48 Months | 
| Clinical Cohort ITT - TVR | Any Target lesion revascularisation | 24 Months | 
| Clinical Cohort ITT - TVR | Any Target lesion revascularisation | 36 Months | 
| Clinical Cohort ITT - TVR | Any Target lesion revascularisation | 48 Months | 
| Clinical Cohort ITT - TVR | Any Target lesion revascularisation | 6 Months | 
| Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure. | All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months | 60 months | 
| Clinical Cohort ITT - Primary Sustained Clinical Improvement | Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects | 6 Months | 
| Clinical Cohort ITT - Primary Sustained Clinical Improvement | Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects | 12 Months | 
| Clinical Cohort ITT - Primary Sustained Clinical Improvement | Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects | 24 Months | 
| Clinical Cohort ITT - Primary Sustained Clinical Improvement | Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects | 36 Months | 
| Clinical Cohort ITT - Secondary Sustained Clinical Improvement | Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 6 Months | 
| Clinical Cohort ITT - Secondary Sustained Clinical Improvement | Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 12 Months | 
| Clinical Cohort ITT - Secondary Sustained Clinical Improvement | Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 24 Months | 
| Clinical Cohort ITT - Secondary Sustained Clinical Improvement | Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 36 Months | 
| Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure | Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9 | Post procedure | 
| Clinical Cohort ITT - Sustained Hemodynamic Improvement | Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 6 Months | 
| Clinical Cohort ITT - Sustained Hemodynamic Improvement | Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 12 Months | 
| Clinical Cohort ITT - Sustained Hemodynamic Improvement | Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 24 Months | 
| Clinical Cohort ITT - Sustained Hemodynamic Improvement | Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 36 Months | 
| Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) |  | 6 Months | 
| Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) |  | 12 Months | 
| Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) |  | 24 Months | 
| Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) |  | 36 Months | 
| Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) | The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better. | 6 Months | 
| Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) | The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better. | 12 Months | 
| Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) | The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better. | 24 Months | 
| Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) | The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better. | 36 Months | 
| Clinical Cohort ITT - Procedural Success | Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate | at procedure | 
| Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion |  | at 12 months, or at the time of re-intervention | 
| Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion |  | At 12 months, or at the time of re-intervention | 
| 150mm DEB ITT Cohort - MAEs | Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days. | 30 days | 
| 150mm DEB ITT Cohort - MAEs | Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 6 months. | 6 months | 
| 150mm DEB ITT Cohort - MAEs | Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 12 months. | 12 months | 
| 150mm DEB ITT Cohort - MAEs | Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 24 months. | 24 months | 
| 150mm DEB ITT Cohort - MAEs | Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 36 months. | 36 months | 
| 150mm DEB ITT Cohort - MAEs | Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 48 months. | 48 months | 
| 150mm DEB ITT Cohort - MAEs | Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months. | 60 months | 
| 150mm DEB ITT Cohort - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 30 days | 
| 150mm DEB ITT Cohort - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 6 months | 
| 150mm DEB ITT Cohort - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 24 months | 
| 150mm DEB ITT Cohort - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 36 months | 
| 150mm DEB ITT Cohort - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 48 months | 
| 150mm DEB ITT Cohort - Clinically-driven TLR | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 60 months | 
| 150mm DEB ITT Cohort - TLR | Any Target lesion revascularisation | 6 Months | 
| 150mm DEB ITT Cohort - TLR | Any Target lesion revascularisation | 12 Months | 
| 150mm DEB ITT Cohort - TLR | Any Target lesion revascularisation | 24 Months | 
| 150mm DEB ITT Cohort - TLR | Any Target lesion revascularisation | 36 Months | 
| 150mm DEB ITT Cohort - TLR | Any Target lesion revascularisation | 48 Months | 
| 150mm DEB ITT Cohort - TLR | Any Target lesion revascularisation | 60 Months | 
| 150mm DEB ITT Cohort - TVR | Any Target lesion revascularisation | 6 Months | 
| 150mm DEB ITT Cohort - TVR | Any Target lesion revascularisation | 12 Months | 
| 150mm DEB ITT Cohort - TVR | Any Target lesion revascularisation | 24 Months | 
| 150mm DEB ITT Cohort - TVR | Any Target lesion revascularisation | 36 Months | 
| 150mm DEB ITT Cohort - TVR | Any Target lesion revascularisation | 48 Months | 
| 150mm DEB ITT Cohort - TVR | Any Target lesion revascularisation | 60 Months | 
| 150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days) |  | 60 months | 
| 150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure. | All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months | 60 months | 
| 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement | Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 6 months. | 
| 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement | Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 12 months. | 
| 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement | Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 24 months | 
| 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement | Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 36 months | 
| 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement | Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 6 Months | 
| 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement | Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 12 Months | 
| 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement | Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 24 Months | 
| 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement | Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 36 Months | 
| 150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure | Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9 | Post procedure | 
| 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement | Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 6 Months | 
| 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement | Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 12 Months | 
| 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement | Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 24 Months | 
| 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement | Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. | 36 Months | 
| 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) |  | 6 Months | 
| 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) |  | 12 Months | 
| 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) |  | 24 Months | 
| 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) |  | 36 Months | 
| 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) | The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better. | 6 Months | 
| 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) | The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better. | 12 Months | 
| 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) | The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better. | 24 Months | 
| 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) | The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better. | 36 Months | 
| 150mm DEB ITT Cohort - Device Success | Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP) | Index-procedure | 
| 150mm DEB ITT Cohort - Procedural Success | Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate | at procedure | 
| 150mm DEB ITT Cohort - Clinical Success | Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge | prior to discharge | 
| Clinical Cohort ITT - All-cause Mortality |  | 30 days | 
| Clinical Cohort ITT - All-cause Mortality |  | 6 Months | 
| Clinical Cohort ITT - All-cause Mortality |  | 12 Months | 
| Clinical Cohort ITT - All-cause Mortality |  | 24 Months | 
| Clinical Cohort ITT - All-cause Mortality |  | 36 Months | 
| Clinical Cohort ITT - All-cause Mortality |  | 48 Months | 
| Clinical Cohort ITT - All-cause Mortality | The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow: Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit. The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800) | 60 Months | 
| Clinical Cohort ITT - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 30 days | 
| Clinical Cohort ITT - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 6 Months | 
| Clinical Cohort ITT - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 12 Months | 
| Clinical Clinical Cohort ITT - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 24 Months | 
| Clinical Cohort ITT - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 36 Months | 
| Clinical Cohort ITT - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 48 Months | 
| Clinical Cohort ITT - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 60 Months | 
| Clinical Cohort ITT - Major Target Limb Amputation |  | 30 days | 
| Clinical Cohort ITT - Major Target Limb Amputation |  | 6 Months | 
| Clinical Cohort ITT - Major Target Limb Amputation |  | 12 Months | 
| Clinical Cohort ITT - Major Target Limb Amputation |  | 24 Months | 
| Clinical Cohort ITT - Major Target Limb Amputation |  | 36 Months | 
| Clinical Cohort ITT - Major Target Limb Amputation |  | 48 Months | 
| Clinical Cohort ITT - Major Target Limb Amputation |  | 60 Months | 
| 150mm DEB ITT Cohort - All-cause Mortality |  | 30 days | 
| 150mm DEB ITT Cohort - All-cause Mortality |  | 6 Months | 
| 150mm DEB ITT Cohort - All-cause Mortality |  | 12 Months | 
| 150mm DEB ITT Cohort - All-cause Mortality |  | 24 Months | 
| 150mm DEB ITT Cohort - All-cause Mortality |  | 36 Months | 
| 150mm DEB ITT Cohort - All-cause Mortality |  | 48 Months | 
| 150mm DEB ITT Cohort - All-cause Mortality |  | 60 Months | 
| 150mm DEB ITT Cohort - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 30 days | 
| 150mm DEB ITT Cohort - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 6 Months | 
| 150mm DEB ITT Cohort - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 12 Months | 
| 150mm DEB ITT Cohort - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 24 Months | 
| 150mm DEB ITT Cohort - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 36 Months | 
| 150mm DEB ITT Cohort - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 48 Months | 
| 150mm DEB ITT Cohort - Clinically-driven TVR | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI. | 60 Months | 
| 150mm DEB ITT Cohort - Major Target Limb Amputation |  | 30 days | 
| 150mm DEB ITT Cohort - Major Target Limb Amputation |  | 6 Months | 
| 150mm DEB ITT Cohort - Major Target Limb Amputation |  | 12 Months | 
| 150mm DEB ITT Cohort - Major Target Limb Amputation |  | 24 Months | 
| 150mm DEB ITT Cohort - Major Target Limb Amputation |  | 36 Months | 
| 150mm DEB ITT Cohort - Major Target Limb Amputation |  | 48 Months | 
| 150mm DEB ITT Cohort - Major Target Limb Amputation |  | 60 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Drug coated balloon, Superficial Femoral Artery, Popliteal Femoral Artery, Atherosclerosis, Drug eluting balloon