MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
Recruiting now · Not applicable
Conditions studied: Coronary Artery Disease, Native Coronary Artery Stenosis, Cardiovascular Diseases
In brief
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.
Key facts
- Study ID
- NCT06271590
- Run by
- Concept Medical Inc.
- People needed
- 1605
- Starts
- 2025-05-20
- Expected to finish
- 2031-11-01
- Last updated by the study team
- 2025-09-11
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Montefiore Medical Center — The Bronx, New York, United States (enrolling)
- Atlanticare Regional Medical Center — Pomona, New Jersey, United States (enrolling)
- Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital — New York, New York, United States (enrolling)
- Baylor Scott & White The Heart Hospital - Plano — Plano, Texas, United States (enrolling)
- Clearwater Cardiovascular and Interventional Consultants — Clearwater, Florida, United States (enrolling)
- Emory University Hospital /Emory School of Medice — Atlanta, Georgia, United States
- Atlanta VA Medical Center — Decatur, Georgia, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- North Mississippi Medical Center — Tupelo, Mississippi, United States
- University Hospitals, Cleveland Medical Center — Brooklyn, New York, United States
- North Shore University Hospital - Northwell — Manhasset, New York, United States
- Columbia University/NYP — New York, New York, United States
- NC Heart and Vascular Research, LLC — Raleigh, North Carolina, United States
- University Hospitals, Cleveland Medical Center — Cleveland, Ohio, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- University of Oklahoma Health Science Center — Oklahoma City, Oklahoma, United States
- Providence St. Vincent Medical Center — Portland, Oregon, United States
- University of Pittsburgh Medical center (UPMC) — Pittsburgh, Pennsylvania, United States
- Dignity Health - Mercy Gilbert Medical Center — Gilbert, Arizona, United States
- West Virginia University Heart & Vascular Institute — Morgantown, West Virginia, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- University of Florida Health Sciences Center-Jacksonville — Jacksonville, Florida, United States
- Tallahassee Research Institute — Tallahassee, Florida, United States
- Tampa General Hospital / University of South Florida — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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