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

The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The above-the-knee femoropopliteal artery is defined as the superficial femoral artery (SFA) and the region of the popliteal artery above the plane of the femoral epicondyles. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the FDA.

This study will include 480 patients who will receive the Zilver PTX stent or Percutaneous transluminal angioplasty (PTA) at up to 100 investigational sites. Clinical data will be captured on paper and electronic case report forms. Analyses will include evaluation of the composite event-free survival rate and the patency rate at 6- and 12-month follow-up. Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6. Patency will be assessed by duplex ultrasound in all patients. Patients may be randomized to one or more of the following sub-studies: IVUS and angiography at 6 months (stent patients only), angiography at 12 months, pharmacokinetic substudy (Zilver PTX patients only), or ultrasound (PTA patients only). The trial also includes provisions for patients experiencing PTA failure. These patients may be randomized to receive a Zilver PTX stent or a bare Zilver stent.

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.]