IRB Study Number 17-1440
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
TRANSCEND: The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil™ Drug-Coated Balloon in the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® Drug-Coated Balloon
Inclusion Criteria
Subject is ≥18 years.
Subject has target limb Rutherford classification 2, 3 or 4.
Exclusion Criteria
Subject has acute limb ischemia.
Subject underwent intervention involving the target vessel within the previous 90 days.
Subject underwent angioplasty of the target lesion using a drug coated balloon within the previous 180 days.
Subject underwent any lower extremity percutaneous treatment in the same limb using a paclitaxel-eluting stent or a drug coated balloon within the previous 90 days.
(Not inclusive)
