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