2,681
Participants
Start Date
May 31, 2012
Primary Completion Date
August 31, 2014
Study Completion Date
June 30, 2018
PROMUS Element Plus Coronary Stent System
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent) and a drug product (a formulation of everolimus contained in a polymer coating).
Aspirin
Aspirin should be taken daily (81 mg) for 3 days prior to the procedure or as a peri-procedural loading dose of 250-500 mg. A maintenance dose of aspirin of at least 81 mg daily, or as indicated by the treating physician, should be continued indefinitely.
P2Y12 antagonist
"Patients to take one of the following P2Y12 antagonists; maintenance doses to be continued per ACC/AHA/SCAI guidelines for PCI.~* Clopidogrel: Per treating physician, peri-procedural loading dose (300-600 mg), subsequent maintenance dose (75 mg daily)~* Prasugrel: Per treating physician, peri-procedural loading dose (60 mg), subsequent maintenance dose (10 or 5 mg daily per product labeling)~* Ticagrelor: Per treating physician, peri-procedural loading dose (180 mg), subsequent maintenance dose (90 mg 2x daily); maintenance aspirin doses \>100 mg may reduce ticagrelor effectiveness and should be avoided.~* Ticlopidine: Per treating physician, if allergy/intolerance to clopidogrel, prasugrel, and/or ticagrelor, loading dose (500 mg), subsequent maintenance dose (250 mg 2x daily)"
New York University Medical Center, New York
St. Elizabeth Medical Center, Utica
Doylestown Hospital, Doylestown
Presbyterian University of Pennsylvania Medical Center, Philadelphia
Christiana Hospital, Newark
Chippenham Medical Center, Richmond
Carilion Roanoke Memorial Hospital, Roanoke
Novant Health Presbyterian Medical Center, Charlotte
Grand Strand Regional Medical Center, Myrtle Beach
University Medical Center-Greenville Memorial Hospital, Greenville
St. Francis Health System - St. Francis Hospital, Greenville
Redmond Regional Medical Center, Rome
Piedmont Hospital, Atlanta
Coliseum Medical Center, Macon
Bay Medical Center, Panama City
North Florida Regional Medical Center, Gainesville
Orlando Regional Medical Center, Orlando
Memorial Regional Hospital, Hollywood
Mount Sinai Medical Center, Miami Beach
Brandon Regional Hospital, Brandon
Martin Memorial Health Systems - Martin Memorial Medical Center, Stuart
Huntsville Hospital - The Heart Center, PC, Huntsville
Springhill Medical Center, Mobile
Forest County General Hospital, Hattiesburg
St. Joseph Hospital, Lexington
IU Health North Medical Center, Carmel
Franciscan St. Francis Hospital, Indianapolis
Community Heart and Vascular Hospital, Indianapolis
Lakeland Hospitals at St. Joseph, Saint Joseph
Meriter Hospital, Madison
United Hospital - St. Paul Heart Clinic, Saint Paul
North Memorial Medical Center, Minneapolis
Mercy Hospital, Coon Rapids
Marshfiled Clinic, Weston
Avera Heart Hospital of South Dakota, Sioux Falls
Rapid City Regional Hospital, Rapid City
Blessing Hospital, Quincy
St. John's Regional Health Center (Springfield), Springfield
Cox Medical Centers, Springfield
Cardiovascular Research, LLC, Shreveport
NEA Baptist Memorial Hospital, Jonesboro
St. Bernard's Medical Center, Jonesboro
St. Francis Hospital, Tulsa
VA North Texas Health Care System, Dallas
Presbyterian Hospital of Dallas, Dallas
South Austin Hospital, Austin
University of Utah Hospital and Clinics, Salt Lake City
Loma Linda University Medical Center, Loma Linda
Mercy General Hospital, Sacramento
Eastern Maine Medical Center, Bangor
Cape Cod Hospital, Hyannis
Hackensack University Medical Center, Hackensack
Lead Sponsor
Boston Scientific Corporation
INDUSTRY