NCT01094678

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 788 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Arterial Disease
• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Zilver® PTX™ Stent	Stenting of the superfemoropopliteal artery.

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-01-01
• Completion: 2011-04-01
• First posted: 2010-03-29
• Last updated: 2014-09-11

Locations

4 sites across 2 countries: Germany, Italy