Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease (NCT04511234) | Clinical Trial Compass
RecruitingNot Applicable
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
Singapore279 participantsStarted 2020-09-08
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Age ≥ 21 years or minimum age
✓. Rutherford class 3 to 6 in the target limb
✓. 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
✓. 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.
✓. At least one non-occluded crural vessel (ie. without significant stenosis) with angiographically documented run off to the foot.
Exclusion criteria
✕. Comorbid conditions limiting life expectancy ≤ 1 year
✕. Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
✕. Subject is pregnant or planning to become pregnant during the course of the study