PLATINUM Diversity

May 13, 2019 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • St Luke's Medical Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • St Bernards Heart and Vascular
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cardiology/Baptist Health Medical Center
    • California
      • Bakersfield, California, United States, 93308
        • Central Cardiology Medical Clinic
      • Chula Vista, California, United States, 91911
        • Sharp Chula Vista Medical Center
      • Fresno, California, United States, 93720
        • Cardiovascular Consultants Heart Center
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Sacramento, California, United States, 95189
        • Mercy General Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20017
        • Capital Research Institute
    • Florida
      • Brandon, Florida, United States, 33511
        • Bay Area Cardiology
      • Hollywood, Florida, United States, 33021
        • Research Physicians Network Alliance
      • Jacksonville, Florida, United States, 32216
        • Memorial Hospital Jacksonville
      • Panama City, Florida, United States, 32401
        • Cardiovascular Institute of Northwest Florida
      • Port Charlotte, Florida, United States, 33592
        • Charlotte Heart & Vascular
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Hospital
      • Tampa, Florida, United States, 33613
        • Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University
      • Augusta, Georgia, United States, 30901
        • University Hospital
      • Rome, Georgia, United States, 30165
        • Redmond Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Joliet, Illinois, United States, 60435
        • Presence Saint Joseph Medical Center
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • The Heart Center of Lake County
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • Shreveport, Louisiana, United States, 71005
        • Cardiovascular Research, LLC (Willis-Knighton)
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • MedStar Union Memorial Hospital
      • Bethesda, Maryland, United States, 20814
        • Suburban Hospital
      • Salisbury, Maryland, United States, 21804
        • Delmarva Heart Research Foundation
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • CCA Research
    • Missouri
      • North Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Saint Louis, Missouri, United States, 63136
        • St. Louis Heart and Vascular
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Heart and Vascular Institute
      • Raleigh, North Carolina, United States, 27610
        • NC Heart and Vascular Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Baptist Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Presbyterian University Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health
      • Greenville, South Carolina, United States, 29607
        • St. Francis Physician Services Inc., DBA Upstate Cardiology
    • Texas
      • Austin, Texas, United States, 78705
        • Seton Heart Institute
      • Dallas, Texas, United States, 75216
        • VA North Texas Health Care System
      • Dallas, Texas, United States, 75208
        • Methodist Hospital Dallas
      • Fort Worth, Texas, United States, 76104
        • Plaza Medical Center of Forth Worth
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch at Galveston
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal Hospital
      • New Braunfels, Texas, United States, 78130
        • Christus Santa Rosa Hospital-City Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • The University of Vermont Medical Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason
      • Tacoma, Washington, United States, 98405
        • Cardiac Study Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Clinical Trials Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
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
Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
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
Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Wayne Batchelor, MD, Tallahassee Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 12, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2326

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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