In-Stent Restenosis Post-Approval Study

Study Overview
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Brief Summary
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The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.

Official Title
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Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)

Conditions
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Peripheral Artery Disease, Vascular Disease

Intervention / Treatment
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* Device: Gore VIABAHN Endoprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a previously implanted (> 30 days) non-covered stent(s) located in the SFA Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5) Patient demonstrates an Ankle Brachial Index (ABI) <=0.9. If ABI >0.9 or not measurable, patient is eligible for study if Toe Brachial Index is <=0.5 Patient has >=50% in-stent restenosis and / or an occlusion in a previously implanted (>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch. Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease Patient has a reference vessel diameter between 4.0 and 6.5mm Patient has at least one patent infrapopliteal runoff vessel (<50% stenosis) not requiring reintervention Note: Additional Inclusion Criteria may apply Exclusion Criteria: Patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene) Patient has a known intolerance to anticoagulation or antiplatelet therapy Patient has known coagulation disorder, including hypercoagulability. Patient has major distal amputation (above the transmetatarsal) Patient has any previous surgery in the target vessel Patient has had previous target vessel in-stent restenosis treated by relining with another stent Patient has untreated flow-limiting aortoiliac stenotic disease Note: Additional Exclusion Criteria may apply

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 |
| --- | --- |
| Other: Gore VIABAHN Endoprosthesis<br>Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery | Device: Gore VIABAHN Endoprosthesis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness | Primary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis. | 12 Months | 
| Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure | Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Acute Procedural Success | Acute Procedural Success is defined as successful delivery of the study device and complete coverage of the target lesion without a procedure or device-related Serious Adverse Event prior to hospital discharge. | During hospitalization, approximately 1-2 days | 
| Primary Patency at 30 Days and 12, 24, and 36 Months | Primary patency is defined as patent blood flow through the study device, which requires either a PSVR measurement ≤ 2.5 or patent flow indicated by the Core Lab, without repeat intervention. | 30 days and 12, 24, and 36 months | 
| Primary Assisted Patency at 30 Days and 12, 24, and 36 Months | Primary assisted patency is defined as blood flow through the study device regardless of repeat interventions to maintain patency prior to occlusion. | 30 days and 12, 24, and 36 months | 
| Secondary Patency at 30 Days and 12, 24, and 36 Months | Secondary patency is defined as blood flow through the study device regardless of repeat interventions to restore patency after occlusion. | 30 days and 12, 24, and 36 months | 
| Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months | Target Lesion Revascularization is defined as a repeat intervention within the study device and 5 mm proximal or distal to the edge of the study device to maintain or re-establish patency. | 30 days and 12, 24, and 36 months | 
| Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months | Major Amputation is defined as removal of the study limb above the metatarsals, resulting from a vascular event. | 30 days and 12, 24, and 36 months | 
| Change in Ankle Brachial Index at 30 Days | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Pre-procedure and 30 Days | 
| Change in Ankle Brachial Index at 1 Year | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Pre-procedure and 1 Year | 
| Change in Ankle Brachial Index at 2 Years | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Pre-procedure and 2 Years | 
| Change in Ankle Brachial Index at 3 Years | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Pre-procedure and 3 Years | 
| Change in Rutherford Category at 30 Days | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Pre-procedure and 30 Days | 
| Change in Rutherford Category at 1 Year | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Pre-procedure and 1 Year | 
| Change in Rutherford Category at 2 Years | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Pre-procedure and 2 Years | 
| Change in Rutherford Category at 3 Years | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Pre-procedure and 3 Years | 
| Stent Fracture at 12, 24, and 36 Months | Device stent fractures that are clearly distinguishable from previously implanted stents will be assessed by the study core lab through x-ray images. | 12, 24, and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bare Metal Stent, In-Stent Restenosis