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Comparison of the SUpera® PERipheral System to a Performance Goal derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery (The SUPERB Study)Carotid Trial

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Trial Conditions
  • Superficial Femoral Artery Disease
What is the purpose of this trial?

To demonstrate the safety and effectiveness of the IDEV Supera Nitinol Stent System in treating subjects with obstructive superficial femoral artery disease. The primary endpoint will be the primary patency rate greater than 66% at 12 months.

Date & Status

Recruiting

Eligibility

Must be 18 yrs old, lifestyle limiting claudication or rest pain, a superficial femoral artery lesion of >60% stenosis or occlusion.

Follow up involves a one month office visit, 6 mth phone call, and yearly office visit with testing for 3 years.

Facilities
  • St. Elizabeth's Medical Center - Recruiting
Other Information

Sponsor: IDEV Technologies
Trial ID: Superficial Femoral Artery Disease
Volunteers:  Not Accepting Healthy Volunteers

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