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

Conditions

Peripheral Artery Disease

What is the purpose of this trial?

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.


Participation Guidelines

Age:
35 Years - 80 Years
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Cordis
Dates:
02/12/2014
Last Updated:
Study HIC#:
1311012969