1,605
Participants
Start Date
May 20, 2025
Primary Completion Date
November 30, 2028
Study Completion Date
November 30, 2031
Sirolimus Drug Coated Balloon
Magic TouchTM (Concept Medical) is a semi-compliant sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and nanocarrier based drug delivery technology.
Drug eluting stents (DES)
For subjects randomized to the control group (DES), the treating physician will choose an FDA cleared DES (ZES or EES) and follow lesion preparation and stent deployment according to the Instructions per use (IFU) and institutional practices.
RECRUITING
Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital, New York
NOT_YET_RECRUITING
Columbia University/NYP, New York
RECRUITING
Montefiore Medical Center, The Bronx
NOT_YET_RECRUITING
North Shore University Hospital - Northwell, Manhasset
NOT_YET_RECRUITING
University Hospitals, Cleveland Medical Center, Brooklyn
NOT_YET_RECRUITING
University of Pittsburgh Medical center (UPMC), Pittsburgh
NOT_YET_RECRUITING
West Virginia University Heart & Vascular Institute, Morgantown
NOT_YET_RECRUITING
NC Heart and Vascular Research, LLC, Raleigh
NOT_YET_RECRUITING
Atlanta VA Medical Center, Decatur
NOT_YET_RECRUITING
Emory University Hospital /Emory School of Medice, Atlanta
NOT_YET_RECRUITING
University of Florida Health Sciences Center-Jacksonville, Jacksonville
NOT_YET_RECRUITING
Tallahassee Research Institute, Tallahassee
NOT_YET_RECRUITING
Tampa General Hospital / University of South Florida, Tampa
RECRUITING
Clearwater Cardiovascular and Interventional Consultants, Clearwater
NOT_YET_RECRUITING
North Mississippi Medical Center, Tupelo
NOT_YET_RECRUITING
University Hospitals, Cleveland Medical Center, Cleveland
NOT_YET_RECRUITING
Cleveland Clinic, Cleveland
NOT_YET_RECRUITING
Loyola University Medical Center, Maywood
NOT_YET_RECRUITING
University of Oklahoma Health Science Center, Oklahoma City
RECRUITING
Baylor Scott & White The Heart Hospital - Plano, Plano
NOT_YET_RECRUITING
Dignity Health - Mercy Gilbert Medical Center, Gilbert
NOT_YET_RECRUITING
Cedars-Sinai Medical Center, Los Angeles
NOT_YET_RECRUITING
Providence St. Vincent Medical Center, Portland
RECRUITING
Atlanticare Regional Medical Center, Pomona
Lead Sponsor
Cardiovascular Research Foundation, New York
OTHER
Concept Medical Inc.
INDUSTRY