Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in 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 is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx. 50 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Europe, Australia and Asia. Each site will be capped at 30 maximum subjects recruited.
The main goal of this clinical trial is to determine the effectiveness and safety of the sirolimus drug coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of below the knee arterial disease.
Eligible subjects will be randomised in a 1:1 allocation ratio and stratified by recruiting countries. Each subject will be randomized to receive either:
1. MagicTouch PTA sirolimus coated balloon catheter (DCB) in addition to standard balloon angioplasty or 2. Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA).
Eligibility criteria
Qualifiers
Age ≥ 21 years or minimum age (is allowed the inclusion of subjects > 21 years OR adulthood minimum age (depending on the US state regulations)
Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population.
Rutherford class 5 to 6 in the target limb with documented WIFI score.
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 30 mm gap between lesions at discretion of investigator. Below the knee arteries are Tibio-peroneal trunk, Peroneal bifurcation, anterior tibial artery, posterior tibial artery and peroneal artery. With documented Distal Run off a maximum of two tibial vessels can be treated in the index procedure. 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 lactating, pregnant or planning to become pregnant during the course of the study
Osteomyelitis including and/or proximal to the metatarsal head
Trial design
Treatments tested in this trial
- MagicTouch PTA Sirolimus drug coated balloon
- Placebo balloon angioplasty
Treatment groups
368 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov