🏛️ Verified NIH Record • Updated 2025-09-04

MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels (NCT06271590)

The MAGICAL SV Trial - A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Non Inferiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus-Coated Balloon in the Treatment of Small Vessels in Patients With Coronary Artery Disease.

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Concept Medical Inc.

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

This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm). A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees.

Who can join: Review the eligibility criteria below.

Location: Dignity Health - Mercy Gilbert Medical Center — Gilbert, Arizona

Age range: 18 Years to 80 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (24 Sites)

  • Dignity Health - Mercy Gilbert Medical Center — Gilbert, Arizona
  • Cedars-Sinai Medical Center — Los Angeles, California
  • Clearwater Cardiovascular and Interventional Consultants — Clearwater, Florida
  • University of Florida Health Sciences Center-Jacksonville — Jacksonville, Florida
  • Tallahassee Research Institute — Tallahassee, Florida
  • Tampa General Hospital / University of South Florida — Tampa, Florida
  • Emory University Hospital /Emory School of Medice — Atlanta, Georgia
  • Atlanta VA Medical Center — Decatur, Georgia
  • Loyola University Medical Center — Maywood, Illinois
  • North Mississippi Medical Center — Tupelo, Mississippi
  • Atlanticare Regional Medical Center — Pomona, New Jersey
  • University Hospitals, Cleveland Medical Center — Brooklyn, New York
  • North Shore University Hospital - Northwell — Manhasset, New York
  • Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital — New York, New York
  • Columbia University/NYP — New York, New York
  • Montefiore Medical Center — The Bronx, New York
  • NC Heart and Vascular Research, LLC — Raleigh, North Carolina
  • University Hospitals, Cleveland Medical Center — Cleveland, Ohio
  • Cleveland Clinic — Cleveland, Ohio
  • University of Oklahoma Health Science Center — Oklahoma City, Oklahoma
  • Providence St. Vincent Medical Center — Portland, Oregon
  • University of Pittsburgh Medical center (UPMC) — Pittsburgh, Pennsylvania
  • Baylor Scott & White The Heart Hospital - Plano — Plano, Texas
  • West Virginia University Heart & Vascular Institute — Morgantown, West Virginia

📞 Contact the Study Coordinator

Phone: +919725495366

Email: farhana@conceptmedical.com

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

💰 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 § 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.

💡 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.
🏛️ View Official NIH Record ↗