Arterial Disease of LegsMAGICAL BTKNCT06182397
Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
A study testing MagicTouch PTA Sirolimus drug coated balloon in people with Arterial Disease of Legs and Below-the-knee Obstruction, run by Concept Medical Inc. at 29 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Arterial Disease of Legs, Below-the-knee Obstruction, PAD - Peripheral Arterial Disease
- What is being tested?
- MagicTouch PTA Sirolimus drug coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 29 sitesUnited States
- Study dates
- 16 Jan 2025to 1 Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 25Show fewer
- 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.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
United States29 sites, 29 recruiting
- Recruiting
Ascension Seton Medical Center Austin
Austin, Texas, 78705
Angel Mkumbo, 512-324-3434, angel.mkumbo@ascension.org
Peter Monteleone
- Recruiting
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Andrew McElvarr, 609-893-1200, mcelvarra@deborah.org
Richard Kovach
- Recruiting
Lankenau Institute for Medical Research Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Rachel Cohen, 215-680-6512, CohenRac@mlhs.org
Antonis Pratsos
- Recruiting
Medical University of South Carolina(MUSC) Health Ashley River Tower
Charleston, South Carolina, 29425
Samuel Smiley IV, (843) 792-7001, smileyiv@musc.edu
Adam Tanious
- Recruiting
The Christ Hospital Network Outpatient Center
Cincinnati, Ohio, 45219
Kasey Riffey, 513-585-1777, kasey.riffey@thechristhospital.com
John Corl
- Recruiting
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
Brianna Landon, 727-467-9393, landonb@cccheart.com
Donald Kikta
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Sarah Loeser, Sarah.Loeser@uhhospitals.org
Tarek Hammad
- Recruiting
Baylor Research Institute
Dallas, Texas, 75226
Reenie Regi, Reenie.Regi@BSWHealth.org
Zachary Rosol
- Recruiting
Vascular Institute of the Midwest
Davenport, Iowa, 52807
Ashlee Woods, 309-644-0407, ashlee.woods@vimidwest.com
Eric Dippel
- Recruiting
Unity Point Health Des Moines
Des Moines, Iowa, 50309
Heather Shaull, 515-313-5123, heather.shaull@unitypoint.org
Eric Scott
- Not yet recruiting
Atria Vascular and Vein
Farmington Hills, Michigan, 48334
Joseph Dolce, 248-963-5510, jdolce@atriavascularandvein.com
Herman Kado
- Recruiting
HOPE Vascular and Podiatry
Houston, Texas, 77054
Mariana Burnier, 346-541-6421, mburnier@hcic.io
Miguel Montero Baker
- Recruiting
Northwell Health Long Island Jewish Medical Center
Lake Success, New York, 11042
Victoria Wairimu, 5162333614, mwairimu@northwell.edu
Yana Etkin
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Keren Cervantes Sanchez, 562-440-2869, keren.sanchezcervantes@csmns.org
Suhail Dohad
- Not yet recruiting
University of California Los Angeles
Los Angeles, California, 90095
Steven Stokes, 818-915-1975, sstokes@mednet.ucla.edu
Vincent Rowe
- Recruiting
Virtua Healthcare - Virtua Our Lady of Lourdes
Marlton, New Jersey, 08053
Jacquelyn Bordelon, (856) 325-3223, JBORDELO@virtua.org
Anthony Smeglin
- Recruiting
Baptist Hospital of Miami
Miami, Florida, 33176
Yanet Alfonso, yanet.alfonso@baptisthealth.net
Constantino Peña
- Recruiting
NYU Langone Medical Center
New York, New York, 10016
Gina Bernardez, 914-770-9929, gina.bernardez@nyulangone.org
Mikel Sadek
- Recruiting
The Mount Sinai Hospital
New York, New York, 10029
Chivelle Mendoza, 2676500453, chivelle.mendoza@mountsinai.org
Prakash Krishnan
- Recruiting
Columbia University Irving Medical center/NYPH
New York, New York, 10032
Suzanne Edwards, 2123425128, sme2146@cumc.columbia.edu
Sarjum Sethi
- Recruiting
New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery
New York, New York, 10065
Maureen Dominguez, 646-962-8440, mdo2006@med.cornell.edu
Brian DeRubertis
- Recruiting
University of Pennsylvania - Penn Heart and Vascular Center
Philadelphia, Pennsylvania, 19104
Alice Chen, 215-439-1902, alice.chen1@pennmedicine.upenn.edu
Liz Genovese
- Recruiting
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Erisa Stokes, Erisa.Stokes@BSWHealth.org
Tony Das
- Not yet recruiting
St. Francis Hospital and Heart Center
Roslyn, New York, 11576
Michele Piscitelli, 516-562-6790, michele.piscitelli-sharp@chsli.org
Lawrence Garcia
- Not yet recruiting
San Antonio Vascular and Endovascular Clinic
San Antonio, Texas, 78221
Brandon Galaviz, 210-990-5556, bgalaviz@orcaresearchgroup.com
Lyssa Ochoa
- Recruiting
Honor Health Research & Innovation Institute
Scottsdale, Arizona, 85258
Kristen Rundio, krundio@honorhealth.com
Venkatesh Ramaiah
- Recruiting
University of Washington Seattle
Seattle, Washington, 98104
Allison Larimore, alari@uw.edu
Niten Singh
- Recruiting
University of South Florida
Tampa, Florida, 33606
Jose Reyes, 813-753-7793, josereyes@usf.edu
Sashi Inkollu
- Recruiting
Westchester Medical Center
Valhalla, New York, 10595
Falyn Katzman, (516) 314-0387, Falyn.Katzman@wmchealth.org
Romeo Mateo
About this study
Official title: MAGICAL BTK: Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
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.
Read more
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).
Read the detailed description
The burden of limb loss because of peripheral arterial disease (PAD) is high and this problem is set to worsen globally. Treatment of PAD primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by many vascular centres. In recent years, studies have shown that local drug delivery using drug coated balloons (DCB) during angioplasty for PAD can successfully deliver effective local tissue concentrations of antiproliferative drugs to the lesions in the artery involved in the PAD. This offers the potential for sustained anti-restenotic efficacy.
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.
- Being tested
- MagicTouch PTA Sirolimus drug coated balloon, Placebo balloon angioplasty
- Keywords
- below the knee, PTA, Angioplasty, lower limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagicTouch PTA Sirolimus drug coated balloonDevice
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 angioplastyDevice
For participants randomized to a Placebo balloon angioplasty group, a Placebo balloon angioplasty in addition to standard balloon angioplasty will be performed.
| Study group | Role | What they receive |
|---|---|---|
| MagicTouch PTA sirolimus DCB | Active comparator | MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty Receives: Device: MagicTouch PTA Sirolimus drug coated balloon |
| Placebo balloon angioplasty | Placebo comparator | Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA) Receives: Device: Placebo balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Composite safety endpoint
Proportion of subjects who experienced any of the following:
- 6-month above ankle major amputation of the index limb,
- 6-month major re-intervention (i.e., angioplasty of target lesion, new bypass graft, jump/interposition graft, or thrombectomy or thrombolysis)
- Perioperative (30 day) mortality.
Measured: 6-months for n.1 and n.2; 30 days for n.3
Secondary outcomes (17)
Secondary Safety endpoint 1
Proportion of device and procedure related death
Measured: 1, 6, 12, 24, 36, 48 and 60 months
Secondary Safety endpoint 2
Proportion of subjects with death by any cause
Measured: 1, 6, 12, 24, 36, 48 and 60 months
Secondary Safety endpoint 3
Proportion of subjects with major target limb amputation
Measured: 1, 6, 12, 24, 36, 48 and 60 months
Secondary Safety endpoint 4
Proportion of subjects with target vessel thrombosis
Measured: From day 0 to day 14
Secondary Safety endpoint 5
Occurrence of adverse events (AEs), serious AEs and AEs related to device and procedure
Measured: From day 0 to 60 months
Secondary efficacy endpoints 1
Proportion of subjects with acute procedural success
Measured: From day 0 to 60 months
Secondary efficacy endpoints 2
Proportion of subjects who are free from clinically driven Target Lesion Revascularization (CD-TLR)
Measured: 6, 12, 24, and 36 months
Secondary efficacy endpoints 3
Proportion of subjects who are free from Target Vessel Revascularization (TVR)
Measured: 6,12,24 and 36 months
Secondary efficacy endpoints 4
Primary patency, defined as a composite of freedom from Target Vessel Occlusion, Binary Restenosis, Clinically Driven Target Lesion Revascularization and Major Amputation
Measured: 24 months
Secondary efficacy endpoints 5
Proportion of subjects with restenosis. Restenosis is defined by duplex ultrasonography-derived peak systolic velocity ratio of >2.0 and <4.0
Measured: 6, 12 and 24 months
Secondary efficacy endpoints 6
Amputation-free survival
Measured: 6, 12, 24, 36, 48 and 60 months
Secondary efficacy endpoints 7
Proportion of subjects with clinical success defined as Improvement of ≥1 category in Rutherford classification compared to the pre-procedure Rutherford classification
Measured: 6,12, 24, 36, 48 and 60 months
Secondary efficacy endpoints 8
Proportion of subjects with technical success
Measured: From day 0 to day 1
Secondary efficacy endpoints 9
Wound assessment. Follow-up will cease once wound completely heals as adjudicated by the core lab.
Measured: 1, 3, 6, and 12 months
Secondary efficacy endpoints 10
Mean change from baseline in Toe pressure and ABI assessment
Measured: 6, 12 and 24 months
Secondary Functional endpoints 1
Mean change from baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) health-related quality of life questionnaire's VAS score and utility index.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: 6,12, 24, and 36 months
Secondary Functional endpoints 2
Mean change from baseline in walking impairment questionnaire score. In the WIQ distance score, the degree of difficulty in the walking of specific distances is ranked on a 0 to 4 Likert scale, in which 0 represents the inability to walk the distance and 4 represents no difficulty. A Likert scale is an ordinal scale of consecutive, equidistant, numerical values (ie, 0 to 4).
Measured: 6,12, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start16 Jan 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Arterial Disease of LegsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Concept Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sahil Parikh, MD, Study chair, New York-Presbyterian/Columbia University Irving Pavilion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182397
- Sponsor's protocol ID
- CM-US-R04
- Acronym
- MAGICAL BTK
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 27539695Clever 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.
PubMed 27069105Verheye 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.
PubMed 28964764Patel 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.
PubMed 34227886Choke 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.
PubMed 34911383Rosenfield 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.
PubMed 26106946Steiner 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.
PubMed 29730375Zeller 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.
PubMed 25301459Mustapha 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.
PubMed 31368893
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAGICAL BTK: Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
- ClinicalTrials.gov ID
- NCT06182397
- Acronym / sponsor ID
- MAGICAL BTK / CM-US-R04
- Keywords
- below the knee, PTA, Angioplasty, lower limb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Concept Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The burden of limb loss because of peripheral arterial disease (PAD) is high and this problem is set to worsen globally. Treatment of PAD primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by many vascular centres. In recent years, studies have shown that local drug delivery using drug coated balloons (DCB) during angioplasty for PAD can successfully deliver effective local tissue concentrations of antiproliferative drugs to the lesions in the artery involved in the PAD. This offers the potential for sustained anti-restenotic efficacy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MagicTouch PTA sirolimus DCB | Active comparator | Device: MagicTouch PTA Sirolimus drug coated balloonMagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty |
| Placebo balloon angioplasty | Placebo comparator | Device: Placebo balloon angioplastyPlacebo balloon angioplasty in addition to standard balloon angioplasty (PTA) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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)
Key exclusion criteria (25 listed)
- 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:
- Prior bypass surgery of target vessel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagicTouch PTA Sirolimus drug coated balloonAll 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. | Device | MagicTouch PTA sirolimus DCB |
| Placebo balloon angioplastyFor participants randomized to a Placebo balloon angioplasty group, a Placebo balloon angioplasty in addition to standard balloon angioplasty will be performed. | Device | Placebo balloon angioplasty |
Primary outcome
Primary patency at 12 months defined as freedom from Target Vessel Occlusion, Binary Restenosis, Clinically-Driven Target Lesion Revascularization and Major Amputation.
Time frame: 12 months
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.
Composite safety endpoint
Time frame: 6-months for n.1 and n.2; 30 days for n.3
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.
17 secondary outcomes
Secondary Safety endpoint 1
Time frame: 1, 6, 12, 24, 36, 48 and 60 months
Secondary Safety endpoint 2
Time frame: 1, 6, 12, 24, 36, 48 and 60 months
Secondary Safety endpoint 3
Time frame: 1, 6, 12, 24, 36, 48 and 60 months
Secondary Safety endpoint 4
Time frame: From day 0 to day 14
Secondary Safety endpoint 5
Time frame: From day 0 to 60 months
Secondary efficacy endpoints 1
Time frame: From day 0 to 60 months
Secondary efficacy endpoints 2
Time frame: 6, 12, 24, and 36 months
Secondary efficacy endpoints 3
Time frame: 6,12,24 and 36 months
Secondary efficacy endpoints 4
Time frame: 24 months
Secondary efficacy endpoints 5
Time frame: 6, 12 and 24 months
Secondary efficacy endpoints 6
Time frame: 6, 12, 24, 36, 48 and 60 months
Secondary efficacy endpoints 7
Time frame: 6,12, 24, 36, 48 and 60 months
Secondary efficacy endpoints 8
Time frame: From day 0 to day 1
Secondary efficacy endpoints 9
Time frame: 1, 3, 6, and 12 months
Secondary efficacy endpoints 10
Time frame: 6, 12 and 24 months
Secondary Functional endpoints 1
Time frame: 6,12, 24, and 36 months
Secondary Functional endpoints 2
Time frame: 6,12, 24, and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Results publication: PubMed 27539695Giacoppo 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.
- Results publication: PubMed 27069105Clever 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.
- Results publication: PubMed 28964764Verheye 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.
- Results publication: PubMed 34227886Patel 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.
- Results publication: PubMed 34911383Choke 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.
- Results publication: PubMed 26106946Rosenfield 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.
- Results publication: PubMed 29730375Steiner 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.
- Results publication: PubMed 25301459Zeller 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.
- Results publication: PubMed 31368893Mustapha 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.
Related trials for Arterial Disease of Legs
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
Not yet recruitingPhase 4
Seltoplasmid Plus Revascularization for Diabetic Infrapopliteal Chronic Limb-Threatening Ischemia
Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer
Active, not recruitingObservational study
Geko™ Cross Therapy Registry - Wound
Wound, Venous Leg Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sahil Parikh, MD study chair
New York-Presbyterian/Columbia University Irving Pavilion
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagicTouch PTA Sirolimus drug coated balloon in people with Arterial Disease of Legs and Below-the-knee Obstruction, run by Concept Medical Inc. at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farhana Siddique (+919725495366, farhana@conceptmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency at 12 months defined as freedom from Target Vessel Occlusion, Binary Restenosis, Clinically-Driven Target Lesion Revascularization and Major Amputation. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06182397, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.