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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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