PLATINUM Diversity

Completed

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.

Recruitment & Eligibility

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

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

Locations (52): St Luke's Medical Center
🇺🇸
Phoenix, Arizona, United States
St Bernards Heart and Vascular
🇺🇸
Jonesboro, Arkansas, United States
Arkansas Cardiology/Baptist Health Medical Center
🇺🇸
Little Rock, Arkansas, United States
Central Cardiology Medical Clinic
🇺🇸
Bakersfield, California, United States
Sharp Chula Vista Medical Center
🇺🇸
Chula Vista, California, United States
Cardiovascular Consultants Heart Center
🇺🇸
Fresno, California, United States
UCLA Medical Center
🇺🇸
Los Angeles, California, United States
Mercy General Hospital
🇺🇸
Sacramento, California, United States
Capital Research Institute
🇺🇸
Washington, District of Columbia, United States
Bay Area Cardiology
🇺🇸
Brandon, Florida, United States
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St Luke's Medical Center
🇺🇸Phoenix, Arizona, United States