Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
Trial Parameters
Brief Summary
This study aims to conduct a randomized, double blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial and popliteal arterial disease.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 21 years or minimum age 2. Rutherford class 3 to 6 in the target limb Intraoperative Inclusion Criteria 3. Single or sequential de novo or re-stenotic lesions (stenosis of \> 50% or occlusions) from 2 to 20cm in the femoropopliteal arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Femoropopliteal arteries are superficial femoral artery, popliteal artery P1 and P2 4. Inflow free from flow limiting lesions (\<50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (\>50% stenosis) can be included if lesion had been treated successfully (\<30% residual stenosis) before or during the index procedure. 5. At least one non-occluded crural vessel (ie. without significant stenosis) with angiographically documented run off to the foot. Exclusion Criteria: 1. Comorbid conditions limiting life expectancy ≤ 1 year 2. Subject is currently participating in anothe