418
Participants
Start Date
July 6, 2020
Primary Completion Date
August 15, 2025
Study Completion Date
August 31, 2029
SELUTION SLR™ DEB
The SELUTION Sustained Limus Release (SLR)™ drug-eluting balloon (DEB) catheter is a combination product consisting of a standard percutaneous transluminal coronary angioplasty (PTCA) balloon catheter coated with a drug (Sirolimus).
Control
POBA or FDA-approved -limus DES
Amsterdam UMC, Academic Medical Centre, Amsterdam
UMC Utrecht, Utrecht
UMCG, Groningen
Mount Sinai Hospital, New York
St. Francis Hospital & Heart Center, Roslyn
Pennsylvania State University Milton S. Hershey Medical Center, Hershey
UPMC Pinnacle Health, Harrisburg
MedStar Heart Institute, Washington D.C.
Instituto Clinico Humanitas Milan, Milan
Clinique Valmy, Dijon
University of Maryland, Baltimore
HCA Chippenham/VA Cardiovascular Specialists, Richmond
Moses H. Cone Memorial Hospital, Greensboro
NC Heart and Vascular Research, LLC, Raleigh
Atlanta VA Medical Center, Atlanta
Piedmont Heart Institute, Atlanta
CHU Toulouse Rangueil, Toulouse
University of Florida Health, Jacksonville
Baptist Cardiac & Vascular Institute, Miami
Center Azienda Ospedaliero Universitaria de Padova, Padua
HCA Centennial, Nashville
The Christ Hospital, Cincinnati
Ascension St Vincents Heart Center, Indianapolis
Maria Cecilia Hospital, Cotignola
Beaumont Hospital, Royal Oak
Ascension St John Hospital, Southfield
Ascension Borgess Heart Institute, Kalamazoo
Minneapolis Heart Institute, Minneapolis
Ascension Via Christi, Wichita
Integris, Oklahoma City
Baylor Scott & White, Dallas
Clinique Saint Hilaire, Rouen
Baylor Scott & White, Temple
Texas Tech University Health Sciences Center, Lubbock
ClinRe 001-001, Thornton
Cedars-Sinai Medical Center, Los Angeles
Harbor-UCLA Medical Center, Torrance
Hôpital privé Jacques Cartier, Massy
Loma Linda University, Loma Linda
Beth Israel Deaconess Medical Centre, Harvard Medical School, Boston
Manchester Catholic Medical Center, Manchester
Morristown Medical Center, Morristown
Rutgers, Robert Wood Johnson Medical School, New Brunswick
Lifespan Cardiovascular Institute, Providence
HartCentrum Hasslet, Jessa Ziekenhuis, Hasselt
Instituto Dante Pazzanese de Cardiologia, São Paulo
Instituto do Coração - São Paulo University, São Paulo
Hamilton Health Sciences, Hamilton
Collaborators (1)
Iqvia Pty Ltd
INDUSTRY
Cordis Corporation
INDUSTRY
M.A. Med Alliance S.A.
INDUSTRY