GORE VIABAHN® Versus Plain Old Balloon Angioplasty (POBA) for Superficial Femoral Artery (SFA) In-Stent Restenosis

General Inclusion Criteria:

• Patient presenting with lifestyle-limiting claudication, rest pain or minor tissue loss (Rutherford classification from 2 to 5)

• Patient is willing to comply with specified follow-up evaluations at the specified times

• Patient is >18 years old

• Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study

• Patient has a projected life-expectancy of at least 24 months

• Noninvasive lower extremity arterial studies (resting or exercise) demonstrate ankle-brachial index ≤0.8

• Patient is eligible for treatment with the Viabahn® Endoprosthesis (W.L. Gore)

• Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure

Angiographic Inclusion Criteria

• Restenotic or reoccluded lesion located in a stent which was previously implanted (>30 days) in the superficial femoral artery, suitable for endovascular therapy

• Total target lesion length between 4 and 27 cm (comprising in-stent restenosis and adjacent stenotic disease)

• Minimum of 1.0cm of healthy vessel (non-stenotic) both proximal and distal to the treatment area

• Popliteal artery is patent at the intercondylar fossa of the femur to P3

• Target vessel diameter visually estimated to be >4mm and <7.6 mm at the proximal and distal treatment segments within the SFA

• Guidewire and delivery system successfully traversed lesion

• There is angiographic evidence of at least one-vessel-runoff to the foot, that does not require intervention (<50% stenotic)

Exclusion criteria :

• Untreated flow-limiting aortoiliac stenotic disease

• Presence of a chronic total occlusion, i.e. a complete occlusion of the failed bare stent that cannot be re-opened with thrombolysis or does not allow easy passage of the guidewire by the physician

• Any previous surgery in the target vessel

• Severe ipsilateral common/deep femoral disease requiring surgical reintervention

• Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment

• Femoral or popliteal aneurysm located at the target vessel

• Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)

• No patent tibial arteries (>50% stenosis)

• Prior ipsilateral femoral artery bypass

• Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy

• Serum creatinine >2.5mg/dL within 45 days prior to study procedure unless the subject is currently on dialysis

• Major distal amputation (above the transmetatarsal) in the study or non-study limb

• Septicemia or bacteremia

• Any previously known coagulation disorder, including hypercoagulability

• Contraindication to anticoagulation or antiplatelet therapy

• Known allergies to stent or stent graft components (nickel-titanium or ePTFE)

• Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure

• Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II

• Currently participating in another clinical research trial, unless approved by W.L. Gore & Associates in advance of study enrolment

• Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment

• Any planned surgical intervention/procedure within 30 days of the study procedure

• Target lesion access not performed by transfemoral approach.