At a glance
ClinicalIndex Comparison Record- ✓Up to 2 documented stenotic or occluded atherosclerotic lesions (up to 14 cm long) in the above-the-knee femoropopliteal artery
- ✓De novo or restenotic lesion(s) with >50% stenosis and no prior stent in target lesion
- ✓Symptomatic peripheral arterial disease classified as Rutherford Category 2 or greater
- ✓Resting Ankle Brachial Index (ABI) <0.9 or abnormal exercise ABI; if ABI >1.2, then Toe Brachial Index (TBI) <0.8
- ✕Significant stenosis or occlusion of inflow tract not successfully treated before procedure
- ✕Previous stenting of target vessel
- ✕Antiplatelet and/or anticoagulant therapy contraindicated
- ✕Known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel, or nitinol that cannot be adequately premedicated
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
In Brief
A clinical study evaluating Zilver® PTX™ Drug Eluting Vascular Stent and Angioplasty for Peripheral Vascular Diseases. Completed, enrolled 474 participants across 52 sites in 3 countries.
Detailed Summary
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 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 Food and Drug Administration (FDA).
Study Details
Timeline
Interventions
Stenting of the Superfemoropopliteal Artery
Angioplasty of the Superfemoropopliteal Artery