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PLATINUM Diversity

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ClinicalTrials.gov Identifier: NCT02240810
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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 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

Group/Cohort Intervention/treatment
Promus PREMIER Everolimus-Eluting Platinum Chromium CSS Device: Percutaneous coronary intervention (Promus PREMIER)
Interventional coronary artery stenting with Promus PREMIER study stent.




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 ]


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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:


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


  Show 52 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Roxana Mehran, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Wayne Batchelor, MD Tallahassee Memorial Hospital

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02240810     History of Changes
Other Study ID Numbers: S2326
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases