Evaluation of the GORE TIGRIS Vascular Stent

Inclusion Criteria: * Rutherford Class 2 - 4. * Abnormal ankle brachial index (ABI ≤0.9). * At least 21 years of age. * Reasonable expectation of survival of at least 12 months after the procedure. * Male, infertile female, or female practicing an effective method of preventing pregnancy. * One de novo or restenotic lesion of the SFA/PPA with a cumulative length visually estimated to be ≤24cm * Arteries with reference vessel diameter of 4.0 - 6.5 mm within the SFA/PPA, estimated visually. * Angiographic evidence of at least one patent tibial artery (\<50% stenosis angiographically). * Guidewire has successfully traversed the lesion to be treated and is within the true lumen of the distal vessel. * Lesion has been pre-dilated before stent deployment. Exclusion Criteria: * Prior enrollment in this study. * Vascular access/catheterization in the target leg within 30 days of study enrollment. * Prior treatment of the SFA/PPA in the target leg with stenting or bypass. * Flow-limiting aortoiliac disease. * Additional ipsilateral femoropopliteal or tibial disease, outside of the lesion to be stented, requiring intervention. * Arterial aneurysm in the target leg. * Co-morbid conditions which would preclude compliance with study protocol. * Obstructive or occlusive non-atherosclerotic disease. * Creatinine greater than 2.5 mg/dl. * Amputation above the metatarsals, resulting from vascular disease, in the target leg. * Septicemia or uncontrolled infection. * Contraindication to anticoagulation or antiplatelet therapy, including allergy to heparin, or history of heparin induced thrombocytopenia (HIT), or a positive platelet factor 4 (PF4) antibody assay. * Abnormal platelet levels, i.e., platelet count at Baseline less than 80,000/microliter. * History of coagulopathy.