Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease (MAGICAL BTK)

December 30, 2025 updated by: Concept Medical Inc.

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.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

368

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health Research & Innovation Institute
        • Contact:
        • Principal Investigator:
          • Venkatesh Ramaiah
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Suhail Dohad
        • Contact:
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • University of California Los Angeles
        • Contact:
        • Principal Investigator:
          • Vincent Rowe
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Clearwater Cardiovascular Consultants
        • Contact:
        • Principal Investigator:
          • Donald Kikta
      • Miami, Florida, United States, 33176
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University Of South Florida
        • Principal Investigator:
          • Sashi Inkollu
        • Contact:
    • Iowa
      • Davenport, Iowa, United States, 52807
        • Recruiting
        • Vascular Institute of the Midwest
        • Principal Investigator:
          • Eric Dippel
        • Contact:
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Unity Point Health Des Moines
        • Contact:
        • Principal Investigator:
          • Eric Scott
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Not yet recruiting
        • Atria Vascular and Vein
        • Contact:
        • Principal Investigator:
          • Herman Kado
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Recruiting
        • Deborah Heart and Lung Center
        • Principal Investigator:
          • Richard Kovach
        • Contact:
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Virtua Healthcare - Virtua Our Lady of Lourdes
        • Contact:
        • Principal Investigator:
          • Anthony Smeglin
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health Long Island Jewish Medical Center
        • Principal Investigator:
          • Yana Etkin
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center
        • Contact:
        • Principal Investigator:
          • Mikel Sadek
      • New York, New York, United States, 10029
        • Recruiting
        • The Mount Sinai Hospital
        • Principal Investigator:
          • Prakash Krishnan
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center/NYPH
        • Contact:
        • Principal Investigator:
          • Sarjum Sethi
      • New York, New York, United States, 10065
        • Recruiting
        • New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery
        • Principal Investigator:
          • Brian DeRubertis
        • Contact:
      • Roslyn, New York, United States, 11576
        • Not yet recruiting
        • St. Francis Hospital and Heart Center
        • Principal Investigator:
          • Lawrence Garcia
        • Contact:
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Westchester Medical Center
        • Contact:
        • Principal Investigator:
          • Romeo Mateo
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital Network Outpatient Center
        • Contact:
        • Principal Investigator:
          • John Corl
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Tarek Hammad
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Recruiting
        • Lankenau Institute for Medical Research Bryn Mawr Hospital
        • Contact:
        • Principal Investigator:
          • Antonis Pratsos
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania - Penn Heart and Vascular Center
        • Contact:
        • Principal Investigator:
          • Liz Genovese
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina(MUSC) Health Ashley River Tower
        • Contact:
        • Principal Investigator:
          • Adam Tanious
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Ascension Seton Medical Center Austin
        • Principal Investigator:
          • Peter Monteleone
        • Contact:
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Baylor Research Institute
        • Contact:
        • Principal Investigator:
          • Zachary Rosol
      • Houston, Texas, United States, 77054
        • Recruiting
        • HOPE Vascular and Podiatry
        • Contact:
        • Principal Investigator:
          • Miguel Montero Baker
      • Plano, Texas, United States, 75093
        • Recruiting
        • The Heart Hospital Baylor Plano
        • Contact:
        • Principal Investigator:
          • Tony Das
      • San Antonio, Texas, United States, 78221
        • Not yet recruiting
        • San Antonio Vascular and Endovascular Clinic
        • Contact:
        • Principal Investigator:
          • Lyssa Ochoa
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington Seattle
        • Contact:
        • Principal Investigator:
          • Niten Singh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 21 years or minimum age (is allowed the inclusion of subjects > 21 years OR adulthood minimum age (depending on the US state regulations)
  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.

    Intraoperative Inclusion Criteria:

  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:

  1. Comorbid conditions limiting life expectancy ≤ 1 year
  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.

    Intraoperative exclusion criteria:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MagicTouch PTA sirolimus DCB
MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty
Device: 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 Comparator: Placebo balloon angioplasty
Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA)
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
6-months for n.1 and n.2; 30 days for n.3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Safety endpoint 1
Time Frame: 1, 6, 12, 24, 36, 48 and 60 months
Proportion of device and procedure related death
1, 6, 12, 24, 36, 48 and 60 months
Secondary Safety endpoint 2
Time Frame: 1, 6, 12, 24, 36, 48 and 60 months
Proportion of subjects with death by any cause
1, 6, 12, 24, 36, 48 and 60 months
Secondary Safety endpoint 3
Time Frame: 1, 6, 12, 24, 36, 48 and 60 months
Proportion of subjects with major target limb amputation
1, 6, 12, 24, 36, 48 and 60 months
Secondary Safety endpoint 4
Time Frame: From day 0 to day 14
Proportion of subjects with target vessel thrombosis
From day 0 to day 14
Secondary Safety endpoint 5
Time Frame: From day 0 to 60 months
Occurrence of adverse events (AEs), serious AEs and AEs related to device and procedure
From day 0 to 60 months
Secondary efficacy endpoints 1
Time Frame: From day 0 to 60 months
Proportion of subjects with acute procedural success
From day 0 to 60 months
Secondary efficacy endpoints 2
Time Frame: 6, 12, 24, and 36 months
Proportion of subjects who are free from clinically driven Target Lesion Revascularization (CD-TLR)
6, 12, 24, and 36 months
Secondary efficacy endpoints 3
Time Frame: 6,12,24 and 36 months
Proportion of subjects who are free from Target Vessel Revascularization (TVR)
6,12,24 and 36 months
Secondary efficacy endpoints 4
Time Frame: 24 months
Primary patency, defined as a composite of freedom from Target Vessel Occlusion, Binary Restenosis, Clinically Driven Target Lesion Revascularization and Major Amputation
24 months
Secondary efficacy endpoints 6
Time Frame: 6, 12, 24, 36, 48 and 60 months
Amputation-free survival
6, 12, 24, 36, 48 and 60 months
Secondary efficacy endpoints 8
Time Frame: From day 0 to day 1
Proportion of subjects with technical success
From day 0 to day 1
Secondary efficacy endpoints 10
Time Frame: 6, 12 and 24 months
Mean change from baseline in Toe pressure and ABI assessment
6, 12 and 24 months
Secondary efficacy endpoints 5
Time Frame: 6, 12 and 24 months
Proportion of subjects with restenosis. Restenosis is defined by duplex ultrasonography-derived peak systolic velocity ratio of >2.0 and <4.0
6, 12 and 24 months
Secondary efficacy endpoints 7
Time Frame: 6,12, 24, 36, 48 and 60 months
Proportion of subjects with clinical success defined as Improvement of ≥1 category in Rutherford classification compared to the pre-procedure Rutherford classification
6,12, 24, 36, 48 and 60 months
Secondary efficacy endpoints 9
Time Frame: 1, 3, 6, and 12 months
Wound assessment. Follow-up will cease once wound completely heals as adjudicated by the core lab.
1, 3, 6, and 12 months
Secondary Functional endpoints 1
Time Frame: 6,12, 24, and 36 months

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.
6,12, 24, and 36 months
Secondary Functional endpoints 2
Time Frame: 6,12, 24, and 36 months
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).
6,12, 24, and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Concept Medical Inc.

Investigators

  • Study Chair: Sahil Parikh, MD, New York-Presbyterian/Columbia University Irving Pavilion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM-US-R04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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