Zilver® PTX® in China

Evaluation of the Zilver® PTX® Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery

The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.

Inclusion Criteria:

• Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4
• Stenotic (>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery
• Reference vessel diameter of 4-9 mm
• Lesion length up to 140 mm

Exclusion Criteria:

• Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure
• Previous stent in the study vessel
• Bypass graft with an anastomosis in the study vessel
• Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion
• No patent vessel of runoff