GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease

To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.

This is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. Approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups.

Inclusion Criteria:

• Lifestyle-limiting claudication or rest pain.
• Subject (or their legal guardian) has read, understood and provided written informed consent.
• At least 21 years of age.
• Quality of life questionnaires completed.
• Noninvasive lower extremity arterial studies within 45-days prior to study procedure.
• If applicable, staged ipsilateral vascular procedure ≥ 14-days prior to study procedure.
• If applicable, vascular treatment on non-study leg for bilateral claudication ≥ 14-days prior to study procedure.
• Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test.
• Projected life expectancy of greater than three years.
• The ability to comply with protocol.
• Angiographic and Lesion Requirements meets protocol criteria.

Exclusion Criteria:

• Untreated flow-limiting aortoiliac occlusive disease.
• Any previous stenting or surgery in the target vessel.
• Subjects with arterial lesions requiring treatment with device diameters other than 6, 7, or 8 mm.
• Severe ipsilateral common femoral/profunda disease requiring surgical intervention.
• Femoral or popliteal aneurysm.
• Non-atherosclerotic disease resulting in occlusion.
• Tibial artery disease requiring treatment.
• Prior ipsilateral femoral artery bypass.
• Severe medical comorbidities.
• Popliteal artery vascular access at any time during procedure.
• Antegrade and retrograde vascular access on the same common femoral artery at the time of the SFA intervention.
• Serum creatinine > 2.5 mg/dL within 45 days prior to study procedure.
• Major distal amputation.
• Septicemia.
• Any previously known coagulation disorder.
• Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion).
• Contraindication to anticoagulation or antiplatelet therapy.
• Known allergies to stent/stent-graft components.
• History of prior life-threatening reaction to contrast agent.
• Currently participating in another clinical research trial.
• Current peritoneal or hemodialysis.