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

NCT06182397 | Recruiting DMC FDA Device

• 1 other identifier: CM-US-R04
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 29

Brief Summary

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

Conditions

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

Keywords

below the knee; PTA; Angioplasty; lower limb

Outcome Measures

Primary Outcomes (2)

• Primary patency at 12 months defined as freedom from Target Vessel Occlusion, Binary Restenosis, Clinically-Driven Target Lesion Revascularization and Major Amputation.

  Binary restenosis will be defined as the proportion of subjects with duplex ultrasonography-derived peak systolic velocity ratio of \> 2.0 with correlating factors. If the PSV at the reference area in the vessel is abnormal, the core laboratory will employ the following other criteria to diagnose a stenosis of \> 50%: * Monophasic/ low resistive waveforms (parvus tardus) at the stenotic area or distal to an acoustic shadow * Post-stenotic turbulence distal to the stenosis, along with a decrease in peak systolic velocities Gray scale/ B-mode imaging demonstrates significant plaque with stenosis along with a focal increase in the absolute PSV value. * Occlusion = Absence of color filling and spectral Doppler signal.

  12 months

• Composite safety endpoint

  Proportion of subjects who experienced any of the following: 1. 6-month above ankle major amputation of the index limb, 2. 6-month major re-intervention (i.e., angioplasty of target lesion, new bypass graft, jump/interposition graft, or thrombectomy or thrombolysis) 3. Perioperative (30 day) mortality.

  6-months for n.1 and n.2; 30 days for n.3

Secondary Outcomes (17)

• Secondary Safety endpoint 1

  1, 6, 12, 24, 36, 48 and 60 months

• Secondary Safety endpoint 2

  1, 6, 12, 24, 36, 48 and 60 months

• Secondary Safety endpoint 3

  1, 6, 12, 24, 36, 48 and 60 months

• Secondary Safety endpoint 4

  From day 0 to day 14

• Secondary Safety endpoint 5

  From day 0 to 60 months

Study Arms (2)

MagicTouch PTA sirolimus DCB

ACTIVE COMPARATOR

MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty

Device: MagicTouch PTA Sirolimus drug coated balloon

Placebo balloon angioplasty

PLACEBO COMPARATOR

Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA)

Device: Placebo balloon angioplasty

Interventions

MagicTouch PTA Sirolimus drug coated balloon DEVICE

All patients must first be treated with pre dilatation with a standard balloon angioplasty using any standard balloon catheters at the discretion of the operator. Magic Touch PTA Sirolimus coated balloon catheter is an adjunct treatment that should be used in combination with standard balloon angioplasty. Following successful crossing of wire across the lesion and plain balloon angioplasty of arterial lesion with successful lesion preparation with residual lesion \<30%, subjects will be randomized to receive study device balloon. If patients are assigned to MagicTouch PTA Sirolimus DCB, the Angioplasty of lower limb will be performed with this device in addition to standard balloon angioplasty.

MagicTouch PTA sirolimus DCB

Placebo balloon angioplasty DEVICE

For participants randomized to a Placebo balloon angioplasty group, a Placebo balloon angioplasty in addition to standard balloon angioplasty will be performed.

Placebo balloon angioplasty

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• Concept Medical Inc.: lead

Study Sites (29)

Honor Health Research & Innovation Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

RECRUITING

Baptist Hospital of Miami

Miami, Florida, 33176, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Vascular Institute of the Midwest

Davenport, Iowa, 52807, United States

RECRUITING

Unity Point Health Des Moines

Des Moines, Iowa, 50309, United States

RECRUITING

Atria Vascular and Vein

Farmington Hills, Michigan, 48334, United States

NOT YET RECRUITING

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

RECRUITING

Virtua Healthcare - Virtua Our Lady of Lourdes

Marlton, New Jersey, 08053, United States

RECRUITING

Northwell Health Long Island Jewish Medical Center

Lake Success, New York, 11042, United States

RECRUITING

NYU Langone Medical Center

New York, New York, 10016, United States

RECRUITING

The Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Columbia University Irving Medical center/NYPH

New York, New York, 10032, United States

RECRUITING

New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery

New York, New York, 10065, United States

RECRUITING

St. Francis Hospital and Heart Center

Roslyn, New York, 11576, United States

NOT YET RECRUITING

Westchester Medical Center

Valhalla, New York, 10595, United States

RECRUITING

The Christ Hospital Network Outpatient Center

Cincinnati, Ohio, 45219, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Lankenau Institute for Medical Research Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

RECRUITING

University of Pennsylvania - Penn Heart and Vascular Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Medical University of South Carolina(MUSC) Health Ashley River Tower

Charleston, South Carolina, 29425, United States

RECRUITING

Ascension Seton Medical Center Austin

Austin, Texas, 78705, United States

RECRUITING

Baylor Research Institute

Dallas, Texas, 75226, United States

RECRUITING

HOPE Vascular and Podiatry

Houston, Texas, 77054, United States

RECRUITING

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

RECRUITING

San Antonio Vascular and Endovascular Clinic

San Antonio, Texas, 78221, United States

NOT YET RECRUITING

University of Washington Seattle

Seattle, Washington, 98104, United States

RECRUITING

Related Publications (9)

• Giacoppo D, Cassese S, Harada Y, Colleran R, Michel J, Fusaro M, Kastrati A, Byrne RA. Drug-Coated Balloon Versus Plain Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials. JACC Cardiovasc Interv. 2016 Aug 22;9(16):1731-42. doi: 10.1016/j.jcin.2016.06.008.

  PMID: 27539695 RESULT

• Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Bohm M, Speck U, Scheller B. Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543. doi: 10.1161/CIRCINTERVENTIONS.115.003543.

  PMID: 27069105 RESULT

• Verheye S, Vrolix M, Kumsars I, Erglis A, Sondore D, Agostoni P, Cornelis K, Janssens L, Maeng M, Slagboom T, Amoroso G, Jensen LO, Granada JF, Stella P. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes. JACC Cardiovasc Interv. 2017 Oct 23;10(20):2029-2037. doi: 10.1016/j.jcin.2017.06.021. Epub 2017 Sep 27.

  PMID: 28964764 RESULT

• Patel A, Irani FG, Pua U, Tay KH, Chong TT, Leong S, Chan ES, Tan GWL, Burgmans MC, Zhuang KD, Quek LHH, Kwan J, Damodharan K, Gogna A, Tan BP, Too CW, Chan SXJM, Chng SP, Yuan W, Tan BS. Randomized Controlled Trial Comparing Drug-coated Balloon Angioplasty versus Conventional Balloon Angioplasty for Treating Below-the-Knee Arteries in Critical Limb Ischemia: The SINGA-PACLI Trial. Radiology. 2021 Sep;300(3):715-724. doi: 10.1148/radiol.2021204294. Epub 2021 Jul 6.

  PMID: 34227886 RESULT

• Choke E, Tang TY, Peh E, Damodharan K, Cheng SC, Tay JS, Finn AV. MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months. J Endovasc Ther. 2022 Oct;29(5):780-789. doi: 10.1177/15266028211064816. Epub 2021 Dec 15.

  PMID: 34911383 RESULT

• Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Muller-Hulsbeck S, Nehler MR, Benenati JF, Scheinert D; LEVANT 2 Investigators. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. 2015 Jul 9;373(2):145-53. doi: 10.1056/NEJMoa1406235. Epub 2015 Jun 24.

  PMID: 26106946 RESULT

• Steiner S, Willfort-Ehringer A, Sievert H, Geist V, Lichtenberg M, Del Giudice C, Sauguet A, Diaz-Cartelle J, Marx C, Strobel A, Schult I, Scheinert D; RANGER SFA Investigators. 12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment. JACC Cardiovasc Interv. 2018 May 28;11(10):934-941. doi: 10.1016/j.jcin.2018.01.276. Epub 2018 May 2.

  PMID: 29730375 RESULT

• Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M, Snead DB, Kent KC, Rocha-Singh KJ; IN.PACT DEEP Trial Investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014 Oct 14;64(15):1568-76. doi: 10.1016/j.jacc.2014.06.1198.

  PMID: 25301459 RESULT

• Mustapha JA, Brodmann M, Geraghty PJ, Saab F, Settlage RA, Jaff MR; Lutonix BTK Study Investigators. Drug-Coated vs Uncoated Percutaneous Transluminal Angioplasty in Infrapopliteal Arteries: Six-Month Results of the Lutonix BTK Trial. J Invasive Cardiol. 2019 Aug;31(8):205-211. doi: 10.25270/jic/19.3108.205.

  PMID: 31368893 RESULT

Study Officials

• Sahil Parikh, MD

  New York-Presbyterian/Columbia University Irving Pavilion

  STUDY CHAIR

Central Study Contacts

Farhana Siddique

CONTACT

+919725495366; farhana@conceptmedical.com

Dario Gattuso

CONTACT

+393292467132; dario@conceptmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a single-blinded clinical investigation in which subjects will be blinded.The physician performing the index procedure will not be blinded. It is recommended, where feasible, that a different physician, or qualified designee, who is blinded to the subject's treatment, conduct protocol-required follow-up visits. The Study Coordinator will be unblinded. The technologists performing follow-up ultrasound scans, the Clinical Events Committee, the Data Safety Monitoring Board and core laboratories will be blinded. In emergency situations, the treating physician is responsible for assessing whether unblinding the treatment assignment is necessary, with the subject's safety as the first priority in making such a decision. If the treating physician decides that unblinding is warranted, the investigator will contact Concept Medical or the CRO to obtain the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 26, 2023
• Study Start: January 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2031
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

US (29)