Zilver PTX Drug-Eluting Peripheral Stent Study

Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent

This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.

Inclusion Criteria:

• One de novo or restenosed artherosclerotic lesion with > 50% diameter stenosis
• Reference vessel diameter of 4 - 9 mm
• Rutherford category ≥ 2
• Resting ankle brachial index < 0.9

Exclusion Criteria:

• Prior stent in the study vessel
• Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure
• Lacks at least one patent runoff vessel
• Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery