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
π©Ί 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
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π 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
π 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.
π° 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.
More studies in In-Stent Restenosis
- A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort β Tucson, Arizona
- A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) β Birmingham, Alabama
Explore by condition: All In-Stent Restenosis clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.