Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis

Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface to Treat de Novo and/or Restenotic Lesions of the Superficial Femoral Artery (SFA)

The purpose of this study is to confirm the safety and performance of the 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral Artery.

Inclusion Criteria:

• Lifestyle-limiting claudication or rest pain (meeting angiographic entry criteria) affecting a lower extremity (Rutherford Categories 2-4).
• A written informed consent form, which has been reviewed and approved by the Ethics Committee, has been read, understood and signed by the subject (or their legally authorized representative).
• At least 21 years of age.
• Noninvasive lower extremity arterial studies (ankle-brachial index, ABI) prior to (within 45 days) or at the time of the study procedure demonstrating a resting ankle-brachial index (ABI) ≤ 0.9 in the study limb. If ABI > 0.9, patient is eligible for study if toe-brachial index (TBI) is ≤ 0.5.
• A staged ipsilateral vascular procedure was not completed less than 30-days prior to the study procedure. Resting ABIs were completed prior to the study procedure a minimum of 30-days after the staged vascular procedure.
• Vascular treatment on the non-study leg for bilateral claudication was not performed less than 30-days prior to study procedure. Resting ABIs on the study limb were completed prior to the study procedure a minimum of 30-days after treatment on the non-study leg.
• 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.
• Projected life expectancy of greater than three years.
• The ability to comply with protocol follow-up requirements and required testing.
• Angiographic and Lesion Requirements (assessed intraoperatively):
• Lesion length of 20-35 cm located in the region beginning 1 cm below origin of the profunda femoris artery and ending 1 cm above the origin of the intercondylar fossa.
• De novo, post-percutaneous transluminal angioplasty (PTA), or post-atherectomy stenosis (> 50% at some point within the lesion by visual estimate) or occlusion of native SFA.
• Origin and proximal 1 cm of SFA are patent.
• Popliteal artery is patent from 1 cm above the origin of the intercondylar fossa distal to the radiographic knee joint.
• Reference vessel diameter of 4.0 - 7.5 mm in proximal and distal treatment segments within the SFA.
• Angiographic evidence of at least one patent tibial artery to the ankle that does not require intervention.
• Guidewire has successfully traversed lesion and is within the true lumen of the distal vessel.

Exclusion Criteria:

• Untreated flow-limiting aortoiliac occlusive disease.
• Any previous open surgical procedure in the target vessel or previous stent placement in the target vessel.
• Prior angioplasty on the target lesion performed less than 30 days prior to the study procedure (unless performed at time of the study procedure).
• Prior atherectomy on the target lesion performed less than 6 months prior to the study procedure (unless performed at time of the study procedure).
• Any previous treatment of the target vessel with a drug-eluting balloon.
• Femoral artery or popliteal artery aneurysm.
• Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis).
• Tibial artery disease requiring treatment.
• Prior ipsilateral femoral artery bypass.
• Severe medical comorbidities (untreated coronary artery disease, congestive heart failure, severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would preclude post-procedural ambulation.
• 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.
• Major distal amputation (above the transmetatarsal) in the study or non-study limb.
• Septicemia.
• Any previously known coagulation disorder, including hypercoagulability.
• 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, including heparin sensitivity, allergy, or previous incidence of heparin-induced thrombocytopenia (HIT) type II.
• History of prior life-threatening reaction to contrast agent.
• Currently participating in another clinical research trial, unless approved by W. L. Gore & Associates in advance of study enrollment.
• Subject has one limb currently enrolled in the study.
• Current peritoneal or hemodialysis.