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PLATINUM Diversity

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ClinicalTrials.gov Identifier: NCT02240810
Recruitment Status : Completed
First Posted : September 16, 2014
Results First Posted : May 10, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment
Atherosclerosis Coronary Artery Disease Device: Percutaneous coronary intervention (Promus PREMIER)

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1501 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: PLATINUM Diversity: Outcomes With the Promus PREMIER™ Stent in Women and Minorities (S2326)
Actual Study Start Date : October 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
PLATINUM Diversity (Overall)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR) [ Time Frame: 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 :
  1. Death [ Time Frame: 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

  2. Myocardial Infarction (MI) [ Time Frame: 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

  3. Target Vessel Revascularization (TVR) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population will be selected from clinical locations where subjects are treated with at least one Promus PREMIER everolimus-eluting coronary stent.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240810


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Roxana Mehran, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Wayne Batchelor, MD Tallahassee Memorial Hospital
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02240810    
Other Study ID Numbers: S2326
First Posted: September 16, 2014    Key Record Dates
Results First Posted: May 10, 2019
Last Update Posted: May 15, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Coronary Artery Disease
Atherosclerosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases