In-Stent Restenosis Post-Approval Study

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

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.

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