Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
ID06182397

MAGICAL BTK: Randomized Controlled Trial of Sirolimus Coated Balloon Versus Standard Balloon Angioplasty for Below The Knee Arterial Disease

Led by Concept Medical Inc. · Updated on 2026-01-02

368

Participants Needed

29

Research Sites

217 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a sirolimus drug coated balloon compared to standard balloon angioplasty for treating below the knee arterial disease. This pivotal, prospective, randomized, two-arm, placebo-controlled trial will be conducted at about 80 sites worldwide, including the USA, Europe, Australia, and Asia. The study addresses the high burden of limb loss caused by peripheral arterial disease and explores sirolimus as an alternative to paclitaxel for drug coated balloons below the knee. Participants will be randomly assigned in equal groups to receive either the MagicTouch PTA sirolimus coated balloon catheter plus standard balloon angioplasty or a placebo balloon angioplasty plus standard balloon angioplasty. All patients first receive pre-dilation with a standard balloon angioplasty. The sirolimus coated balloon is used as an additional treatment after successful lesion preparation. The trial is single-blind and multicenter, aiming to compare outcomes between these two treated groups. During the study, participants will undergo assessments including angiographic evaluations and monitoring of limb health. The primary outcome is primary patency at 12 months, defined by freedom from vessel occlusion, restenosis, target lesion revascularization, and major amputation. Safety will also be evaluated at 6 months and 30 days with composite endpoints. Secondary outcomes include various safety and efficacy measurements up to 60 months. This comprehensive follow-up will help assess long-term treatment effects and participant safety throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 years or older or minimum adulthood age per local regulations
  • Rutherford class 4 with documented WIFI score, not exceeding 30% of participants
  • Rutherford class 5 to 6 in the target limb with documented WIFI score
  • Single or sequential de novo or re-stenotic lesions from 2 to 20 cm in below the knee arteries
  • Lesions with residual stenosis less than 30% after successful lesion preparation
  • Target vessel with angiographically unimpaired run off into named tibio-pedal arteries
  • Inflow lesions less than 50% stenosis or successfully treated to less than 30% residual stenosis before or during the procedure
Not Eligible

You will not qualify if you...

  • Life expectancy of 1 year or less due to other conditions
  • Participation in another investigational drug or device study that has not reached first primary endpoint
  • Lactating, pregnant, or planning pregnancy during the study
  • Extensive tissue loss requiring complex foot reconstruction or non-traditional amputation
  • Prior bypass surgery or major planned amputation of the target limb
  • Previously implanted stent in the target lesion
  • Vulnerable or protected adults
  • Bleeding disorders preventing use of antiplatelet agents
  • Known allergy to sirolimus
  • Severe renal disease with eGFR less than 30
  • Failure to cross target lesion with guide wire
  • Lesions extending beyond the ankle joint
  • Failure to achieve less than 30% residual stenosis prior to randomization
  • Lesions requiring retrograde access treatment
  • Use of other drug coated balloons, stents, specialty balloons, or atherectomy devices at the target lesion (non-compliant balloons allowed)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day 0 or single treatment procedure

Participants undergo angioplasty treatment of the lower limb arteries. This involves pre-dilatation with a standard balloon angioplasty followed by randomization to either a sirolimus drug coated balloon or a placebo balloon angioplasty in addition to the standard procedure.

1 treatment visit (in-person)

Long-term Monitoring

Duration - Up to 60 months

Participants are monitored for safety and effectiveness outcomes following the angioplasty treatment over several years.

Visits at 1, 3, 6, 12, 24, 36, 48 and 60 months

Trial Site Locations

Total: 29 locations

1

Honor Health Research & Innovation Institute

Scottsdale, Arizona, United States, 85258

Actively Recruiting

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

3

University of California Los Angeles

Los Angeles, California, United States, 90095

Not Yet Recruiting

4

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States, 33756

Actively Recruiting

5

Baptist Hospital of Miami

Miami, Florida, United States, 33176

Actively Recruiting

6

University of South Florida

Tampa, Florida, United States, 33606

Actively Recruiting

7

Vascular Institute of the Midwest

Davenport, Iowa, United States, 52807

Actively Recruiting

8

Unity Point Health Des Moines

Des Moines, Iowa, United States, 50309

Actively Recruiting

9

Atria Vascular and Vein

Farmington Hills, Michigan, United States, 48334

Not Yet Recruiting

10

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States, 08015

Actively Recruiting

11

Virtua Healthcare - Virtua Our Lady of Lourdes

Marlton, New Jersey, United States, 08053

Actively Recruiting

12

Northwell Health Long Island Jewish Medical Center

Lake Success, New York, United States, 11042

Actively Recruiting

13

NYU Langone Medical Center

New York, New York, United States, 10016

Actively Recruiting

14

The Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

15

Columbia University Irving Medical center/NYPH

New York, New York, United States, 10032

Actively Recruiting

16

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

New York, New York, United States, 10065

Actively Recruiting

17

St. Francis Hospital and Heart Center

Roslyn, New York, United States, 11576

Not Yet Recruiting

18

Westchester Medical Center

Valhalla, New York, United States, 10595

Actively Recruiting

19

The Christ Hospital Network Outpatient Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

20

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

21

Lankenau Institute for Medical Research Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States, 19010

Actively Recruiting

22

University of Pennsylvania - Penn Heart and Vascular Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

23

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

Charleston, South Carolina, United States, 29425

Actively Recruiting

24

Ascension Seton Medical Center Austin

Austin, Texas, United States, 78705

Actively Recruiting

25

Baylor Research Institute

Dallas, Texas, United States, 75226

Actively Recruiting

26

HOPE Vascular and Podiatry

Houston, Texas, United States, 77054

Actively Recruiting

27

The Heart Hospital Baylor Plano

Plano, Texas, United States, 75093

Actively Recruiting

28

San Antonio Vascular and Endovascular Clinic

San Antonio, Texas, United States, 78221

Not Yet Recruiting

29

University of Washington Seattle

Seattle, Washington, United States, 98104

Actively Recruiting

Loading map...

Research Team

F

Farhana Siddique

D

Dario Gattuso

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Trial to Investigate Shockwave Intravascular Lithotripsy (IV...

PAD - Peripheral Arterial Disease

Actively Recruiting

2 locations

FUTURE BTK: Randomized Controlled Trial of Sirolimus Drug Co...

Peripheral Artery Disease

Actively Recruiting

20 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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.

Daniele Giacoppo, Salvatore Cassese, Yukinori Harada...

https://pubmed.ncbi.nlm.nih.gov/27539695

The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes.

Stefan Verheye, Mathias Vrolix, Indulis Kumsars...

https://pubmed.ncbi.nlm.nih.gov/28964764

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.

Ankur Patel, Farah G Irani, Uei Pua...

https://pubmed.ncbi.nlm.nih.gov/34227886

MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months.

Edward Choke, Tjun Yip Tang, Eilane Peh...

https://pubmed.ncbi.nlm.nih.gov/34911383

12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment.

Sabine Steiner, Andrea Willfort-Ehringer, Horst Sievert...

https://pubmed.ncbi.nlm.nih.gov/29730375

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.

Thomas Zeller, Iris Baumgartner, Dierk Scheinert...

https://pubmed.ncbi.nlm.nih.gov/25301459

Drug-Coated vs Uncoated Percutaneous Transluminal Angioplasty in Infrapopliteal Arteries: Six-Month Results of the Lutonix BTK Trial.

Jihad A Mustapha, Marianne Brodmann, Patrick J Geraghty...

https://pubmed.ncbi.nlm.nih.gov/31368893