NCT00827619

Zilver® Flex™ Vascular Stent Study

Evaluation of the Zilver® Flex™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for commercial use. The study is designed as a single arm non-randomized post-approval study.

Conditions

• Peripheral Arterial Disease (PAD)

Interventions

Type	Name	Description
DEVICE	Zilver® Flex™ Vascular Stent	Stenting of the Above-the-Knee Femoropopliteal Artery

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-11-01
• Completion: 2015-11-01
• First posted: 2009-01-23
• Last updated: 2015-12-04

Locations

3 sites across 1 country: Germany