Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
NCT ID: NCT06182397
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
368 participants
INTERVENTIONAL
2025-01-16
2031-02-01
Brief Summary
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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).
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Detailed Description
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Randomized trials have shown superiority of Paclitaxel DCBs over just plain-balloon angioplasty for treatment of femoropopliteal occlusive disease, and DCB is now considered the standard of care in many regions. However, the efficacy of Paclitaxel below the knee is less clear, as multiple randomized trials evaluating Paclitaxel-coated DCBs below the knee have failed to meet their primary endpoints. Alternative drugs for DCBs are therefore needed and sirolimus may offer an attractive alternative. Compared to Paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety. It has a high transfer rate to the vessel wall and has been shown to effectively inhibit neointimal hyperplasia in the porcine coronary model. In the coronary artery interventions, preliminary clinical studies using Sirolimus DCBs have also shown excellent procedural and 6- \& 12- months patency. This study aims to conduct a single blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty in patients with below the knee arterial disease.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Study Groups
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MagicTouch PTA sirolimus DCB
MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty
MagicTouch PTA Sirolimus drug coated balloon
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.
Placebo balloon angioplasty
Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA)
Placebo balloon angioplasty
For participants randomized to a Placebo balloon angioplasty group, a Placebo balloon angioplasty in addition to standard balloon angioplasty will be performed.
Interventions
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MagicTouch PTA Sirolimus drug coated balloon
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.
Placebo balloon angioplasty
For participants randomized to a Placebo balloon angioplasty group, a Placebo balloon angioplasty in addition to standard balloon angioplasty will be performed.
Eligibility Criteria
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Inclusion Criteria
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.
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)
Exclusion Criteria
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
5. Any wound with calcaneal bone involvement
6. Wounds that are deemed to be neuropathic or non-ischemic in nature
7. Wounds that would require flap coverage or complex wound management for large soft tissue defect
8. Full thickness wounds on the dorsum of the foot with exposed tendon or bone
5. Prior bypass surgery of target vessel
6. Planned amputation of the target limb (major)
7. Previously implanted stent in the target lesion
8. Vulnerable or protected adults
9. Bleeding diathesis or another disorder (i.e. gastrointestinal ulceration,etc) which would prevent the use of mandated antiplatelet agents
10. Known allergy to sirolimus
11. Subjects with severe (Stage 4) renal disease, defined eGFR \< 30.
12. Failure to successfully cross the target lesion with a guide wire
13. Target vessel has lesions extending beyond the ankle joint
14. Failure to obtain \<30% residual stenosis prior to randomization
15. Lesions requiring treatment through retrograde access . Retrograde wire crossing is allowed but treatment must be performed from the antegrade approach.
16. 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.
21 Years
ALL
No
Sponsors
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Concept Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sahil Parikh, MD
Role: STUDY_CHAIR
New York-Presbyterian/Columbia University Irving Pavilion
Locations
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Honor Health Research & Innovation Institute
Scottsdale, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Vascular Institute of the Midwest
Davenport, Iowa, United States
Unity Point Health Des Moines
Des Moines, Iowa, United States
Atria Vascular and Vein
Farmington Hills, Michigan, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Virtua Healthcare - Virtua Our Lady of Lourdes
Marlton, New Jersey, United States
Northwell Health Long Island Jewish Medical Center
Lake Success, New York, United States
NYU Langone Medical Center
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Columbia University Irving Medical center/NYPH
New York, New York, United States
New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery
New York, New York, United States
St. Francis Hospital and Heart Center
Roslyn, New York, United States
Westchester Medical Center
Valhalla, New York, United States
The Christ Hospital Network Outpatient Center
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Lankenau Institute for Medical Research Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
University of Pennsylvania - Penn Heart and Vascular Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina(MUSC) Health Ashley River Tower
Charleston, South Carolina, United States
Ascension Seton Medical Center Austin
Austin, Texas, United States
Baylor Research Institute
Dallas, Texas, United States
HOPE Vascular and Podiatry
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
San Antonio Vascular and Endovascular Clinic
San Antonio, Texas, United States
University of Washington Seattle
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CM-US-R04
Identifier Type: -
Identifier Source: org_study_id
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