PLATINUM Diversity

Completed

Conditions: Atherosclerosis
Coronary Artery Disease

Interventions: Device: Percutaneous coronary intervention (Promus PREMIER)

Registration Number: NCT02240810

Lead Sponsor: Boston Scientific Corporation

Brief Summary: To compile acute procedural performance and clinical outcomes data for the Promus PREMIER everolimus-eluting coronary stent system in understudied/underserved patient populations including women and minorities.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1501

Inclusion Criteria

Patient must be at least 18 years of age
Patient must sign informed consent form
Patient has received at least one Promus PREMIER stent
Patient self-identifies as one or more of the following:
- Female
- Black of African Heritage
- Hispanic/Latino
- American Indian or Alaska native

Exclusion Criteria

Not applicable

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PLATINUM Diversity (Overall)	Percutaneous coronary intervention (Promus PREMIER)	PLATINUM Diversity (Overall) population. Test device is Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (CSS)

Primary Outcome Measures

Name	Time	Method
Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)	Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months	A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death, MI, TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978

Secondary Outcome Measures

Name	Time	Method
Death	Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months	A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
Target Vessel Revascularization (TVR)	Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months	A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
Myocardial Infarction (MI)	Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months	A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of MI to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978

Trial Locations

Locations (52): Tallahassee Memorial Hospital
🇺🇸
Tallahassee, Florida, United States
Cardiovascular Research, LLC (Willis-Knighton)
🇺🇸
Shreveport, Louisiana, United States
MedStar Union Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
UCLA Medical Center
🇺🇸
Los Angeles, California, United States
Presbyterian University Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Baystate Medical Center
🇺🇸
Springfield, Massachusetts, United States
Arkansas Cardiology/Baptist Health Medical Center
🇺🇸
Little Rock, Arkansas, United States
St Luke's Medical Center
🇺🇸
Phoenix, Arizona, United States
St Bernards Heart and Vascular
🇺🇸
Jonesboro, Arkansas, United States
University of Chicago Medical Center
🇺🇸
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
Cardiovascular Consultants Heart Center
🇺🇸
Fresno, California, United States
Capital Research Institute
🇺🇸
Washington, District of Columbia, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Redmond Regional Medical Center
🇺🇸
Rome, Georgia, United States
Research Physicians Network Alliance
🇺🇸
Hollywood, Florida, United States
Memorial Hospital Jacksonville
🇺🇸
Jacksonville, Florida, United States
Cardiovascular Institute of Northwest Florida
🇺🇸
Panama City, Florida, United States
University Hospital
🇺🇸
Augusta, Georgia, United States
The Heart Center of Lake County
🇺🇸
Merrillville, Indiana, United States
Presence Saint Joseph Medical Center
🇺🇸
Joliet, Illinois, United States
Delmarva Heart Research Foundation
🇺🇸
Salisbury, Maryland, United States
CCA Research
🇺🇸
Gulfport, Mississippi, United States
North Kansas City Hospital
🇺🇸
North Kansas City, Missouri, United States
St. Francis Physician Services Inc., DBA Upstate Cardiology
🇺🇸
Greenville, South Carolina, United States
Jersey Shore University Medical Center
🇺🇸
Neptune, New Jersey, United States
Novant Health Heart and Vascular Institute
🇺🇸
Charlotte, North Carolina, United States
Mount Sinai Hospital
🇺🇸
New York, New York, United States
INTEGRIS Baptist Medical Center
🇺🇸
Oklahoma City, Oklahoma, United States
NC Heart and Vascular Research
🇺🇸
Raleigh, North Carolina, United States
VA North Texas Health Care System
🇺🇸
Dallas, Texas, United States
Virginia Mason
🇺🇸
Seattle, Washington, United States
Cardiac Study Center
🇺🇸
Tacoma, Washington, United States
Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute
🇺🇸
Tampa, Florida, United States
Suburban Hospital
🇺🇸
Bethesda, Maryland, United States
Charlotte Heart & Vascular
🇺🇸
Port Charlotte, Florida, United States
Central Cardiology Medical Clinic
🇺🇸
Bakersfield, California, United States
Bay Area Cardiology
🇺🇸
Brandon, Florida, United States
CAMC Clinical Trials Center
🇺🇸
Charleston, West Virginia, United States
Sharp Chula Vista Medical Center
🇺🇸
Chula Vista, California, United States
St. Louis Heart and Vascular
🇺🇸
Saint Louis, Missouri, United States
Lankenau Medical Center
🇺🇸
Wynnewood, Pennsylvania, United States
Seton Heart Institute
🇺🇸
Austin, Texas, United States
Palmetto Health
🇺🇸
Columbia, South Carolina, United States
Methodist Hospital Dallas
🇺🇸
Dallas, Texas, United States
Plaza Medical Center of Forth Worth
🇺🇸
Fort Worth, Texas, United States
University of Texas Medical Branch at Galveston
🇺🇸
Galveston, Texas, United States
St. Luke's Episcopal Hospital
🇺🇸
Houston, Texas, United States
Christus Santa Rosa Hospital-City Center
🇺🇸
New Braunfels, Texas, United States
The University of Vermont Medical Center
🇺🇸
Burlington, Vermont, United States
Mercy General Hospital
🇺🇸
Sacramento, California, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States