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Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System — OPEN  

Cardiovascular Diseases Clinical Trial

Official title:
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study

Clinical Trial Summary

This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal.

The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01355406
Study type Interventional
Source Cordis Corporation
Contact
Status Completed
Phase N/A
Start date September 16, 2011
Completion date April 10, 2018
View Details
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