SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial 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 below the knee arterial disease.
Eligibility criteria
Qualifiers
Age ≥ 21 years or minimum age
Rutherford class 4 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 proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Below the knee arteries are tibioperoneal trunk, anterior tibial artery, posterior tibial artery and peroneal artery
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
- POBA balloon
Treatment groups
219 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov