πŸ›οΈ Verified NIH Record β€’ Updated 2025-02-24

MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions (NCT05908331)

MagicTouch Sirolimus-coated Balloon for Treatment of In-Stent Restenosis in Coronary Artery Lesions

🟒 Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: Concept Medical Inc.

🩺 Plain-English Summary (8th-Grade Level)

A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouchβ„’ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis. Subjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouchβ„’ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States. The goal is to establish the safety and efficacy of the MagicTouchβ„’ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).

Who can join: Review the eligibility criteria below.

Location: Cardiology, PC - Princeton Baptist Medical Center β€” Birmingham, Alabama

Age range: 18 Years to 110 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (28 Sites)

Showing the first 25 of 28 sites.

  • Cardiology, PC - Princeton Baptist Medical Center β€” Birmingham, Alabama
  • Dignity Health - Mercy Gilbert Medical Center β€” Gilbert, Arizona
  • Cedars - Sinai Medical Center β€” Los Angeles, California
  • Yale University / Yale New Haven Hospital β€” New Haven, Connecticut
  • Cheek-Powell Heart and Vascular Pavilion β€” Clearwater, Florida
  • Clearwater Cardiovascular and Interventional Consultants β€” Clearwater, Florida
  • The Cardiac & Vascular Institute Research Foundation β€” Gainesville, Florida
  • Tampa General Hospital / University of South Florida β€” Tampa, Florida
  • Atlanta VA Medical Center β€” Decatur, Georgia
  • Beth Israel Deaconess Medical Center β€” Boston, Massachusetts
  • Metropolitan Heart and Vascular Institute β€” Coon Rapids, Minnesota
  • Minneapolis Heart Institute Foundation β€” Minneapolis, Minnesota
  • Cardiology Associates Research, LLC β€” Tupelo, Mississippi
  • Cardiology Associates Research, LLC β€” Tupelo, Mississippi
  • AtlantiCare Regional Medical Center β€” Pomona, New Jersey
  • VA New York Harbor Healthcare System β€” New York, New York
  • NYU Langone Health β€” New York, New York
  • Columbia University Medical Center/NYPH β€” New York, New York
  • Montefiore Medical Center - Moses Division β€” The Bronx, New York
  • NC Heart and Vascular Research, LLC β€” Raleigh, North Carolina
  • Cleveland Clinic β€” Cleveland, Ohio
  • Oklahoma University Health (OU Health) β€” Oklahoma City, Oklahoma
  • Providence St. Vincent Medical Center β€” Portland, Oregon
  • Prisma Health β€” Greenville, South Carolina
  • Centennial Medical Center β€” Nashville, Tennessee

πŸ“ž Contact the Study Coordinator

Phone: +393292467132

Email: dario@conceptmedical.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—