PLATINUM Diversity

Study Overview
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Brief Summary
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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.

Official Title
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PLATINUM Diversity: Outcomes With the Promus PREMIER™ Stent in Women and Minorities (S2326)

Conditions
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Atherosclerosis, Coronary Artery Disease

Intervention / Treatment
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* Device: Percutaneous coronary intervention (Promus PREMIER)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PLATINUM Diversity (Overall)<br>PLATINUM Diversity (Overall) population. Test device is Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (CSS) | Device: Percutaneous coronary intervention (Promus PREMIER)<br>* Interventional coronary artery stenting with Promus PREMIER study stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR) | 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 | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | 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 | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| Myocardial Infarction (MI) | 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 | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| Target Vessel Revascularization (TVR) | 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 | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |