Recruiting

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

Concept Medical Inc. · NCT06182397

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation: Not posted. Ask the study team before screening.
Who can join: Ages 21+ · All sexes
Healthy volunteers: Not accepted (a condition is required)
Study type: Interventional · Not applicable
Target enrollment: 368
US sites recruiting: 25
Study start: January 16, 2025
Record last updated: January 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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:

MagicTouch PTA sirolimus coated balloon catheter (DCB) in addition to standard balloon angioplasty or
Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA).

Being studied: MagicTouch PTA Sirolimus drug coated balloon; Placebo balloon angioplasty

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

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)

Exclusion Criteria

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.

Recruiting US locations

Honor Health Research & Innovation Institute
Scottsdale, AZ 85258
Site contact: Kristen Rundio · krundio@honorhealth.com
Cedars-Sinai Medical Center
Los Angeles, CA 90048
Site contact: Keren Cervantes Sanchez · 562-440-2869 · keren.sanchezcervantes@csmns.org
Clearwater Cardiovascular Consultants
Clearwater, FL 33756
Site contact: Brianna Landon · 727-467-9393 · landonb@cccheart.com
Baptist Hospital of Miami
Miami, FL 33176
Site contact: Yanet Alfonso · yanet.alfonso@baptisthealth.net
University of South Florida
Tampa, FL 33606
Site contact: Jose Reyes · 813-753-7793 · josereyes@usf.edu
Vascular Institute of the Midwest
Davenport, IA 52807
Site contact: Ashlee Woods · 309-644-0407 · ashlee.woods@vimidwest.com
Unity Point Health Des Moines
Des Moines, IA 50309
Site contact: Heather Shaull · 515-313-5123 · heather.shaull@unitypoint.org
Deborah Heart and Lung Center
Browns Mills, NJ 08015
Site contact: Andrew McElvarr · 609-893-1200 · mcelvarra@deborah.org
Virtua Healthcare - Virtua Our Lady of Lourdes
Marlton, NJ 08053
Site contact: Jacquelyn Bordelon · (856) 325-3223 · JBORDELO@virtua.org
Northwell Health Long Island Jewish Medical Center
Lake Success, NY 11042
Site contact: Victoria Wairimu · 5162333614 · mwairimu@northwell.edu
NYU Langone Medical Center
New York, NY 10016
Site contact: Gina Bernardez · 914-770-9929 · gina.bernardez@nyulangone.org
The Mount Sinai Hospital
New York, NY 10029
Site contact: Chivelle Mendoza · 2676500453 · chivelle.mendoza@mountsinai.org
Columbia University Irving Medical center/NYPH
New York, NY 10032
Site contact: Suzanne Edwards · 2123425128 · sme2146@cumc.columbia.edu
New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery
New York, NY 10065
Site contact: Maureen Dominguez · 646-962-8440 · mdo2006@med.cornell.edu
Westchester Medical Center
Valhalla, NY 10595
Site contact: Falyn Katzman · (516) 314-0387 · Falyn.Katzman@wmchealth.org
The Christ Hospital Network Outpatient Center
Cincinnati, OH 45219
Site contact: Kasey Riffey · 513-585-1777 · kasey.riffey@thechristhospital.com
University Hospitals Cleveland Medical Center
Cleveland, OH 44106
Site contact: Sarah Loeser · Sarah.Loeser@uhhospitals.org
Lankenau Institute for Medical Research Bryn Mawr Hospital
Bryn Mawr, PA 19010
Site contact: Rachel Cohen · 215-680-6512 · CohenRac@mlhs.org
University of Pennsylvania - Penn Heart and Vascular Center
Philadelphia, PA 19104
Site contact: Alice Chen · 215-439-1902 · alice.chen1@pennmedicine.upenn.edu
Medical University of South Carolina(MUSC) Health Ashley River Tower
Charleston, SC 29425
Site contact: Samuel Smiley IV · (843) 792-7001 · smileyiv@musc.edu
Ascension Seton Medical Center Austin
Austin, TX 78705
Site contact: Angel Mkumbo · 512-324-3434 · angel.mkumbo@ascension.org
Baylor Research Institute
Dallas, TX 75226
Site contact: Reenie Regi · Reenie.Regi@BSWHealth.org
HOPE Vascular and Podiatry
Houston, TX 77054
Site contact: Mariana Burnier · 346-541-6421 · mburnier@hcic.io
The Heart Hospital Baylor Plano
Plano, TX 75093
Site contact: Erisa Stokes · Erisa.Stokes@BSWHealth.org
University of Washington Seattle
Seattle, WA 98104
Site contact: Allison Larimore · alari@uw.edu

Study contacts (from the official record)

Farhana Siddique · +919725495366 · farhana@conceptmedical.com
Dario Gattuso · +393292467132 · dario@conceptmedical.com