1,530
Participants
Start Date
January 31, 2009
Primary Completion Date
September 30, 2010
Study Completion Date
December 31, 2014
PROMUS Coronary Stent System
PROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Coronary Stent System
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating that is the same as on the PROMUS \[XIENCE V\] stent).
Aspirin
Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.
Thienopyridine
Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
Ascot Angiography, Auckland
Middlemore Hospital, Otahuhu
Rigshospitalet Copenhagen, Copenhagen
St. Vincent's Hospital, Fitzroy
Monash Medical Centre, Clayton
Ziekenhuis Oost Limburg, Genk
The Prince Charles Hospital, Queensland
Royal Perth Hospital, Perth
Wellington Hospital, Wellington
Mount Sinai School Medical Center, New York
Columbia University Medical Center, New York
Universitatsklinik Charite Berlin, Berlin
Maimonides Medical Center, Brooklyn
St. Francis Hospital, Roslyn
Kaleida Health, Buffalo
Penn State Milton S Hershey Medical Center, Hershey
Pinnacle Health at Harrisburg Hospital, Harrisburg
Lankenau Institute for Medical Research, Bryn Mawr
Turku University Hospital, Turku
Washington Adventist Hospital, Takoma Park
Union Memorial Hospital, Baltimore
Sentara Norfolk General Hospital, Norfolk
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH, Bad Segeberg
Lynchburg General Hospital, Lynchburg
CHU de Besancon, Besançon
Wake Forest University School of Medicine, Winston-Salem
Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation, Greensboro
Wake Medical Center, Raleigh
Sisters of Charity Providence Hospital, Columbia
Centre Hopital Universitaire Rangueil, Toulouse
Clinique Pasteur, Toulouse
Medical Center of Central Georgia, Macon
Tallahassee Memorial Hospital, Tallahassee
Herz-und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
Florida Hospital, Orlando
Clinique St. Augustin, Bordeaux
Holy Cross Hospital, Fort Lauderdale
Tampere University Hospital, Tampere
MediQuest Research Group Inc. at Munroe Regional Medical Center, Ocala
Clinique du Millenaire, Montpellier
Baptist Medical Center Princeton, Birmingham
Baptist Memorial Hospital, Memphis
Jackson-Madison County General Hospital, Jackson
North Mississippi Medical Center, Tupelo
Jewish Hospital and St. Mary's Healthcare, Louisville
Ohio State University Medical Center, Columbus
Ohio Health Research and Innovation Institute, Columbus
Mercy St. Vincent Medical Center, Toledo
Firelands Regional Medical Center, Sandusky
Lindner Center for Research and Education at The Christ Hospital, Cincinnati
Good Samaritan Hospital, Cincinnati
Krannert Institute of Cardiology, Indianapolis
St. Vincent's Hospital, Indianapolis
William Beaumont Hospital, Royal Oak
Genesys Regional Medical Center, Grand Blanc
Spectrum Health Hospitals, Grand Rapids
Northern Michigan Hospital, Petoskey
Mercy Hospital Medical Center, Des Moines
Institut Jantung Negara, Kuala Lumpur
Aspirus Heart and Vascular Institute - Research and Education, Wausau
Abbott Northwestern Hospital, Minneapolis
St. Mary's Duluth Clinic Regional Heart Center, Duluth
Mayo Clinic Foundation, Rochester
Kerckhoff Klinik, Bad Nauheim
Southern Illinois University Memorial Medical Center, Springfield
St. John's Hospital, Springfield
Washington University School of Medicine, St Louis
Missouri Baptist Medical Center, St Louis
St. Luke's Hospital / Mid America Heart Institute, Kansas City
Nebraska Heart Institute, Lincoln
Universitat Heidelberg, Heidelberg
Arkansas Heart Hospital, Little Rock
Oklahoma Heart Hospital, Oklahoma City
Baylor Heart & Vascular Hospital, Dallas
Trinity Mother Frances Health System, Tyler
St. Luke's Episcopal Hospital, Houston
Methodist Texsan Hospital, San Antonio
Heart Hospital of Austin, Austin
South Denver Cardiology Associates, PC, Littleton
Medical Center of the Rockies (Loveland), Loveland
Banner Good Samaritan Regional Medical Center, Phoenix
Good Samaritan Hospital, Los Angeles
Oulu University Hospital, Oulu
Institut Cardiovasculaire - Paris Sud / Institut Hospitalier Jacques Cartier, Massy
Scripps Clinic, La Jolla
University of California San Diego, San Diego
Alvarado Hospital, San Diego
Bakersfield Memorial Hospital, Bakersfield
Sarawak General Hospital, Kota Samarahan
University of California Davis Medical Center, Sacramento
Mercy General Hospital, Sacramento
Providence St. Vincent Medical Center, Portland
Swedish Medical Center, Seattle
Deaconess Medical Center, Spokane
Providence Health & Services - Washington, Spokane
National Heart Centre Singapore, Singapore
Maine Medical Center, Portland
Tufts Medical Center, Boston
Baystate Medical Center, Springfield
Cooper Hospital/University Medical Center, Camden
Our Lady of Lourdes Medical Center, Camden
Allgemeines Krankenhauas AKH, Vienna
Academisch Ziekenhuis Middelheim, Antwerp
Universitair Ziekenhuis Gent, Ghent
UZ Gasthuisberg, Leuven
Skejby Sygehus, Aarhus
Herzzentrum Universitat Leipzig, Leipzig
Kokura Memorial Hospital, Kitakyushu-shi
Japan Community Health Care Organization Hokkaido Hospital, Sapporo
Shonan Kamakura General Hospital, Kamakura-shi
Saiseikai Yokohama-City Eastern Hospital, Yokohama
Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases, Fuchu-shi
Teikyo University Hospital, Itabashi-ku
Toho University Ohashi Medical Center, Meguro-ku
The Cardiovascular Institute Hospital, Minato-ku
Tokyo Women's Medical University Hospital, Shinjuku-ku
P. Stradins University Hospital, Riga
Sakurabashi Watanabe Hospital, Osaka
Medisch Centrum Alkmaar, Alkmaar
Amphia Ziekenhuis, Breda
Catherina Ziekenhuis, Eindhoven
St Antonius Ziekenhuis, Nieuwegein
Szpital Uniwersytecki, Bydgoszcz
SPZOZ Szpital Uniwersytecki w Krakowie, Krakow
National Institute of Cardiology, Warsaw
Military Hospital, Wroclaw
Hospital De Santa Cruz, Carnaxide
Guys and St. Thomas NHS Foundation Trust St. Thomas Hospital, London
James Cook University Hospital, Middlesbrough
John Radcliffe Infirmary Oxford II, Oxford
Royal Victoria Hospital, Belfast
Golden Jubilee National Hospital, Clydebank
Southampton University Hospital, Southampton
Lead Sponsor
Boston Scientific Corporation
INDUSTRY