Zilver® PTX™ Global Registry

Evaluation of the Safety and Performance of the Zilver® PTX™ Drug-Eluting Stent for Treating De Novo or Restenotic Lesions of the Above-the-knee Femoropopliteal Artery

The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.

Inclusion Criteria:

• stenosis of the above-the-knee femoropopliteal artery
• appropriate size and location of the lesion

Exclusion Criteria:

• pregnant or breast feeding
• failure or inability to give informed consent
• simultaneously participating in another drug or device study