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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Arterial Disease of Legs, Below-the-knee Obstruction, PAD - Peripheral Arterial Disease

In brief

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).

Key facts

Study ID

NCT06182397

Run by

Concept Medical Inc.

People needed

368

Starts

2025-01-16

Expected to finish

2031-02-01

Last updated by the study team

2026-01-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Intraoperative Inclusion Criteria:
• 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.
• 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…

• 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
• Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputation. This includes subjects with:
• Osteomyelitis including and/or proximal to the metatarsal head
• Gangrene involving the plantar skin of the forefoot, midfoot,or heel
• Deep ulcer or large shallow ulcer (> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel
• Full thickness heel ulcer with/without calcaneal involvement
• Any wound with calcaneal bone involvement
• Wounds that are deemed to be neuropathic or non-ischemic in nature
• Wounds that would require flap coverage or complex wound management for large soft tissue defect
• Full thickness wounds on the dorsum of the foot with exposed tendon or bone
• Prior bypass surgery of target vessel
• Planned amputation of the target limb (major)
• Previously implanted stent in the target lesion
• Vulnerable or protected adults
• Bleeding diathesis or another disorder (i.e. gastrointestinal ulceration,etc) which would prevent the use of mandated antiplatelet agents
• Known allergy to sirolimus
• Subjects with severe (Stage 4) renal disease, defined eGFR < 30.
• Intraoperative exclusion criteria:
• Failure to successfully cross the target lesion with a guide wire
• Target vessel has lesions extending beyond the ankle joint
• Failure to obtain <30% residual stenosis prior to randomization
• Lesions requiring treatment through retrograde access . Retrograde wire crossing is allowed but treatment must be performed from the antegrade approach.
• Use of commercially available DCBs, bare metal stents, drug eluting stents, specialty balloons or atherectomy devices at the target lesions. (Non-compliant balloons are not considered specialty balloons). For Inflow and non-target lesions all the approved devices are allowed.

Where it is running

• University of Washington Seattle — Seattle, Washington, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Baylor Research Institute — Dallas, Texas, United States (enrolling)
• HOPE Vascular and Podiatry — Houston, Texas, United States (enrolling)
• The Heart Hospital Baylor Plano — Plano, Texas, United States (enrolling)
• Honor Health Research & Innovation Institute — Scottsdale, Arizona, United States (enrolling)
• Clearwater Cardiovascular Consultants — Clearwater, Florida, United States (enrolling)
• Baptist Hospital of Miami — Miami, Florida, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Vascular Institute of the Midwest — Davenport, Iowa, United States (enrolling)
• Unity Point Health Des Moines — Des Moines, Iowa, United States (enrolling)
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States (enrolling)
• Virtua Healthcare - Virtua Our Lady of Lourdes — Marlton, New Jersey, United States (enrolling)
• Northwell Health Long Island Jewish Medical Center — Lake Success, New York, United States (enrolling)
• NYU Langone Medical Center — New York, New York, United States (enrolling)
• The Mount Sinai Hospital — New York, New York, United States (enrolling)
• Columbia University Irving Medical center/NYPH — New York, New York, United States (enrolling)
• New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery — New York, New York, United States (enrolling)
• Westchester Medical Center — Valhalla, New York, United States (enrolling)
• The Christ Hospital Network Outpatient Center — Cincinnati, Ohio, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Lankenau Institute for Medical Research Bryn Mawr Hospital — Bryn Mawr, Pennsylvania, United States (enrolling)
• University of Pennsylvania - Penn Heart and Vascular Center — Philadelphia, Pennsylvania, United States (enrolling)
• Medical University of South Carolina(MUSC) Health Ashley River Tower — Charleston, South Carolina, United States (enrolling)
• Ascension Seton Medical Center Austin — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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