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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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.

Farhana Siddique contact

+919725495366

farhana@conceptmedical.com

Dario Gattuso contact

+393292467132

dario@conceptmedical.com

29 sites in 1 country

United States29 sites, 29 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

    Recruiting

  • Atria Vascular and Vein

    Farmington Hills, Michigan, 48334

    Joseph Dolce, 248-963-5510, jdolce@atriavascularandvein.com

    Herman Kado

    Not yet 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

    Recruiting

  • University of California Los Angeles

    Los Angeles, California, 90095

    Steven Stokes, 818-915-1975, sstokes@mednet.ucla.edu

    Vincent Rowe

    Not yet 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

    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

    Not yet 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

    Recruiting

Other trials in United States

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:

  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).
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 groups in NCT06182397
Study groupRoleWhat they receive
MagicTouch PTA sirolimus DCBActive comparatorMagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty
Receives: Device: MagicTouch PTA Sirolimus drug coated balloon
Placebo balloon angioplastyPlacebo comparatorPlacebo 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.

  1. 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

  2. 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.

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

Secondary outcomes (17)

  1. Secondary Safety endpoint 1

    Proportion of device and procedure related death

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

  2. Secondary Safety endpoint 2

    Proportion of subjects with death by any cause

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

  3. Secondary Safety endpoint 3

    Proportion of subjects with major target limb amputation

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

  4. Secondary Safety endpoint 4

    Proportion of subjects with target vessel thrombosis

    Measured: From day 0 to day 14

  5. 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

  6. Secondary efficacy endpoints 1

    Proportion of subjects with acute procedural success

    Measured: From day 0 to 60 months

  7. 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

  8. Secondary efficacy endpoints 3

    Proportion of subjects who are free from Target Vessel Revascularization (TVR)

    Measured: 6,12,24 and 36 months

  9. 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

  10. 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

  11. Secondary efficacy endpoints 6

    Amputation-free survival

    Measured: 6, 12, 24, 36, 48 and 60 months

  12. 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

  13. Secondary efficacy endpoints 8

    Proportion of subjects with technical success

    Measured: From day 0 to day 1

  14. 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

  15. Secondary efficacy endpoints 10

    Mean change from baseline in Toe pressure and ABI assessment

    Measured: 6, 12 and 24 months

  16. 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

  17. 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.

  1. First posted26 Dec 2023
  2. Study start16 Jan 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Feb 2031 (estimated)

Resources

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)
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 27539695

  • 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.

    PubMed 27069105

  • 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.

    PubMed 28964764

  • 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.

    PubMed 34227886

  • 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.

    PubMed 34911383

  • 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.

    PubMed 26106946

  • 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.

    PubMed 29730375

  • 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.

    PubMed 25301459

  • 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.

    PubMed 31368893

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.

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