Condition: In-Stent Restenosis · Cardiovascular Diseases · Coronary Artery Disease · Sponsor: Concept Medical Inc.
A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ 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 MagicTouch™ 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 MagicTouch™ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).
This description comes directly from the study's public registry record.
Dario Gattuso · +393292467132 · dario@conceptmedical.com
Farhana Siddique · +919725495366 · farhana@conceptmedical.com
Always discuss trial participation with your own doctor first.
| Cardiology, PC - Princeton Baptist Medical Center | Birmingham, Alabama, United States | Recruiting |
| Dignity Health - Mercy Gilbert Medical Center | Gilbert, Arizona, United States | Recruiting |
| Cedars - Sinai Medical Center | Los Angeles, California, United States | Recruiting |
| Yale University / Yale New Haven Hospital | New Haven, Connecticut, United States | Recruiting |
| Cheek-Powell Heart and Vascular Pavilion | Clearwater, Florida, United States | Recruiting |
| Clearwater Cardiovascular and Interventional Consultants | Clearwater, Florida, United States | Recruiting |
| The Cardiac & Vascular Institute Research Foundation | Gainesville, Florida, United States | Recruiting |
| Tampa General Hospital / University of South Florida | Tampa, Florida, United States | Recruiting |
| Atlanta VA Medical Center | Decatur, Georgia, United States | Recruiting |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts, United States | Not Yet Recruiting |
| Metropolitan Heart and Vascular Institute | Coon Rapids, Minnesota, United States | Not Yet Recruiting |
| Minneapolis Heart Institute Foundation | Minneapolis, Minnesota, United States | Recruiting |
+ 16 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05908331