RecruitingArterial Disease of LegsBelow-the-knee ObstructionPAD - Peripheral Arterial Disease

Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

Eligible age

21+ yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this study

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).

Sponsor: Concept Medical Inc.

You may qualify if…

✓ 1. Age ≥ 21 years or minimum age (is allowed the inclusion of subjects \> 21 years OR adulthood minimum age (depending on the US state regulations)
✓ 2. Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population.
✓ 3. Rutherford class 5 to 6 in the target limb with documented WIFI score.
✓ Intraoperative Inclusion Criteria:
✓ 4. 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.
✓ 5. Target vessel has angiographically documented unimpaired (\<50% stenosis) run off into a named Tibio-pedal artery (Peroneal, Anterior Tibial/ Dorsalis Pedis/ Posterior Tibial Artery)

You may not qualify if…

✕ 1. Comorbid conditions limiting life expectancy ≤ 1 year
✕ 2. Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
✕ 3. Subject is lactating, pregnant or planning to become pregnant during the course of the study
✕ 4. Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputation. This includes subjects with:
✕ 1. Osteomyelitis including and/or proximal to the metatarsal head
✕ 2. Gangrene involving the plantar skin of the forefoot, midfoot,or heel
✕ 3. Deep ulcer or large shallow ulcer (\> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel
✕ 4. Full thickness heel ulcer with/without calcaneal involvement