102
Participants
Start Date
February 28, 2009
Primary Completion Date
March 31, 2011
Study Completion Date
May 31, 2015
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).
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.
St. Vincents Public,, Fitzroy
Monash Medical Centre, Clayton
Ziekenhuis Oost Limburg, Genk
Columbia University Medical Center, New York
Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation, Greensboro
Wake Medical Center, Raleigh
Clinique Pasteur, Toulouse
Florida Hospital, Orlando
MediQuest Research Group Inc. at Munroe Regional Medical Center, Ocala
Jackson-Madison County General Hospital, Jackson
North Mississippi Medical Center, Tupelo
Ohio State University Medical Center, Columbus
Ohio Health Research and Innovation Institute, Columbus
Mercy St. Vincent Medical Center, Toledo
William Beaumont Hospital, Royal Oak
Northern Michigan Hospital, Petoskey
Abbott Northwestern Hospital, Minneapolis
Oklahoma Foundation for Cardiovascular Research, Oklahoma City
TexSAn Heart Hospital, San Antonio
Scripps Clinic, La Jolla
Alvarado Hospital, San Diego
Mercy General Hospital, Sacramento
Providence St. Vincent Medical Center, Portland
Providence Health & Services - Washington, Spokane
Maine Medical Center, Portland
UZ Gasthuisberg, Leuven
Shonan Kamakura General Hospital, Kamakura-shi
Sakurabashi Watanabe Hospital, Osaka
P. Stradins University Hospital, Riga
North Shore Hospital, Takapuna
Lead Sponsor
Boston Scientific Corporation
INDUSTRY