Zilver PTX Delivery System

Zilver Paclitaxel(PTX) Thumbwheel Delivery System

The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.

Inclusion Criteria:

• Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
• Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery

Exclusion Criteria:

• Patient is < 18 years of age
• Patient unable to complete required follow-up assessments
• Patient unwilling to sign and date the informed consent
• Simultaneous participation in another investigational drug or device study
• Pregnant, breastfeeding or planning to become pregnant in the next 5 years
• Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan