Zilver® PTX® V Clinical Study

Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study

The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.

Inclusion Criteria:

• Patient has signed and dated the informed consent.
• Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
• Patient agrees to return for the required follow-up assessments.

Exclusion Criteria:

• Patient is < 18 years of age.
• Patient has significant stenosis of inflow tract not successfully treated before this procedure.
• Patient lacks at least one patent vessel of runoff with < 50% stenosis throughout its course.