Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery (Zilver PTX)

Inclusion Criteria: Patient has signed and dated the informed consent. Patient has up to 2 documented stenotic or occluded atherosclerotic lesions (up ro 14 cm long) of the above-the-knee femoropopliteal artery, up to one in each limb, that meet all of the inclusion criteria and none of the exclusion criteria. Patient has a de novo or restenotic lesion(s) with >50% stenosis documented angiographically and no prior stent in the target lesion. Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater. Patient has a resting Ankle Brachial Index (ABI) <0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a Toe Brachial Index (TBI) <0.8. Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 months, 12 months, and at 2, 3, 4, and 5 years. Patient agrees to return for x-rays at 6 and 12 months. Patient agrees to return for angiography at 12 months. Patient agrees to be contacted by telephone at 1, 3, 9, and 18 months to assess clinical status. Exclusion Criteria: Patient is pregnant or breast-feeding. Patient is simultaneously participating in another investigational drug or device study. Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure. Patient has any planned surgical or interventional procedure within 30 days after the study procedure. Patient has had previous stenting of target vessel. Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated. Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol and, in the opinion of the investigator, cannot be adequately premedicated. Patient lacks at least one patent vessel of runoff with <50% stenosis throughout its course. Patient has untreated angiographically-evident thrombus in the target lesion. [Additional criteria may apply.]