Peripheral Vascular Disease - DURABILITY II

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Trial Sponsor
eV3

Principal Investigator
Jeff Goldstein, MD

Trial Name
The US Study for Evaluating Endovascular Trestments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By UsIng the Protege EverfLex Nitinol Stent System II

Purpose
This is a study that will be conducted at multiple centers throughout the United States. The purpose of this study is to compare ballooning of the SFA (thigh artery in the leg) and primary stenting of the same leg artery using a single PROTÉGÉ® EverFlex™ stent in patients that suffer from claudication (pain in the legs with walking) due to blockages or narrowings that restrict the blood flow in the leg artery.

Ages eligible for the study
18 years or older

Genders eligible for the study
Both

Inclusion Criteria

• Subjects with narrowings or blockages in the arteries in their legs, specifically in the thigh (superficial femoral artery or SFA) or the knee artery (popliteal) that have not been previously treated with a stent.
• Subjects that have symptoms of claudication (pain in their legs with walking) that is caused by these narrowings or blockages.
• Willing to comply with all follow-up evaluations at the specified times.
• Provides written informed consent prior to enrollment in the study.

Exclusion Criteria

• Subjects that have previously had a stent placed in their leg artery or subjects that have had bypass surgery on their leg arteries
• Life expectancy of less than 12 months.

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