Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorConcept Medical Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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
Heel gangrene
Trial design
Treatments tested in this trial
- MagicTouch PTA sirolimus drug coated balloon (DCB)
- POBA standard balloon
Treatment groups
279 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov