Skip to main content
OpenTrials
Completed

NCT Number: NCT02240810

PLATINUM Diversity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Luke's Medical Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention (Promus PREMIER)

Device

Interventional coronary artery stenting with Promus PREMIER study stent.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2014
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.