An observational study in Atherosclerosis and Coronary Artery Disease, sponsored by Boston Scientific Corporation. Completed at 52 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Boston Scientific Corporation · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 1,501 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Population will be selected from clinical locations where subjects are treated with at least one Promus PREMIER everolimus-eluting coronary stent.
Patient self-identifies as one or more of the following:
Exclusion Criteria:
PLATINUM Diversity (Overall) population. Test device is Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (CSS)
Device: Percutaneous coronary intervention (Promus PREMIER)
Interventional coronary artery stenting with Promus PREMIER study stent.
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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
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
Time frame: 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
Time frame: 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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
PLATINUM Diversity and PROMUS Element Plus US Post Approval study (PE Plus) are two separate studies that have been pooled. Only the PLATINUM Diversity subjects (n=1501) are considered to be enrolled in the study. Results for the PROMUS Element Plus study are reported in record NCT01589978
| Milestone | PLATINUM Diversity (Overall) | PROMUS Element Plus US Post Approval Study |
|---|---|---|
| Started | 1501 | 2681 |
| Completed | 1441 | 2621 |
| Not completed | 60 | 60 |
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 | PLATINUM Diversity (Overall) | Caucasian Males - PROMUS Element Plus US Post Approval Study | Females - PLATINUM Diversity and PE+ | Minorities - PLATINUM Diversity and PE+ |
|---|---|---|---|---|
| Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR) | 128 | 120 | 155 | 99 |
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 | PLATINUM Diversity (Overall) | Caucasian Males - PROMUS Element Plus US Post Approval Study | Females - PLATINUM Diversity and PE+ | Minorities - PLATINUM Diversity and PE+ |
|---|---|---|---|---|
| Death | 60 | 35 | 62 | 38 |
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 | PLATINUM Diversity (Overall) | Caucasian Males - PROMUS Element Plus US Post Approval Study | Females - PLATINUM Diversity and PE+ | Minorities - PLATINUM Diversity and PE+ |
|---|---|---|---|---|
| Myocardial Infarction (MI) | 38 | 17 | 34 | 32 |
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 | PLATINUM Diversity (Overall) | Caucasian Males - PROMUS Element Plus US Post Approval Study | Females - PLATINUM Diversity and PE+ | Minorities - PLATINUM Diversity and PE+ |
|---|---|---|---|---|
| Target Vessel Revascularization (TVR) | 58 | 86 | 84 | 56 |
Collected over 1 year. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PLATINUM Diversity (Overall) | 60/1,501 (4%) | 154/1,501 (10.3%) | 26/1,501 (1.7%) |
| Event | PLATINUM Diversity (Overall) |
|---|---|
| Acute myocardial infarctionCardiac disorders | 42/1501 |
| Myocardial infarctionCardiac disorders | 24/1501 |
| Coronary artery thrombosisCardiac disorders | 16/1501 |
| In-stent coronary artery restenosisInjury, poisoning and procedural complications | 12/1501 |
| Angina pectorisCardiac disorders | 10/1501 |
| Coronary artery dissectionCardiac disorders | 9/1501 |
| Cardiac arrestCardiac disorders | 8/1501 |
| Angina unstableCardiac disorders | 8/1501 |
| Cardio-respiratory arrestCardiac disorders | 6/1501 |
| DeathGeneral disorders | 6/1501 |
| Event | PLATINUM Diversity (Overall) |
|---|---|
| Myocardial infarctionCardiac disorders | 26/1501 |
| Age, Customized(Participants) | PLATINUM Diversity (Overall) | PROMUS Element Plus US Post Approval Study (Overall) | Total |
|---|---|---|---|
| 18 Years and Older | 1501 | 2681 | 4182 |
| Sex: Female, Male(Participants) | PLATINUM Diversity (Overall) | PROMUS Element Plus US Post Approval Study (Overall) | Total |
|---|---|---|---|
| Female | 1057 | 807 | 1864 |
| Male | 444 | 1874 | 2318 |
| Race/Ethnicity, Customized(Participants) | PLATINUM Diversity (Overall) | PROMUS Element Plus US Post Approval Study (Overall) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 28 | 9 | 37 |
| Asian | 14 | 14 | 28 |
| Black, of African Heritage | 483 | 189 | 672 |
| Caucasian | 733 | 2318 | 3051 |
| Hispanic or Latino | 260 | 95 | 355 |
| Native Hawaiian or Other Pacific Islander | 2 | 9 | 11 |
| Other | 13 | 20 | 33 |
| Not Disclosed | 0 | 37 | 37 |
| Region of Enrollment(Participants) | PLATINUM Diversity (Overall) | PROMUS Element Plus US Post Approval Study (Overall) | Total |
|---|---|---|---|
| United States | 1501 | 2681 | 4182 |
| Number of Participants with Current Diabetes Mellitus(Participants) | PLATINUM Diversity (Overall) | PROMUS Element Plus US Post Approval Study (Overall) | Total |
|---|---|---|---|
| Current Diabetes Mellitus | 676 | 989 | 1665 |
| Type 1 | 27 | 49 | 76 |
| Type 2 | 608 | 902 | 1510 |
| Unknown | 41 | 38 | 79 |
| Number of Participants with History of Hyperlipidemia Requiring Medication(Participants) | PLATINUM Diversity (Overall) | PROMUS Element Plus US Post Approval Study (Overall) | Total |
|---|---|---|---|
| Count of participants | 1107 | 2016 | 3123 |
| Number of Participants with History of Hypertension Requiring Medication(Participants) | PLATINUM Diversity (Overall) | PROMUS Element Plus US Post Approval Study (Overall) | Total |
|---|---|---|---|
| Count of participants | 1275 | 2077 | 3352 |
| Number of Participants with Family History of Coronary Artery Disease (CAD)(Participants) | PLATINUM Diversity (Overall) | PROMUS Element Plus US Post Approval Study (Overall) | Total |
|---|---|---|---|
| Count of participants | 839 | 1625 | 2464 |
8 further baseline measures are reported on the registry.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Boston Scientific Corporation