PLATINUM Diversity

NCT02240810 | Completed Results

• 1 other identifier: S2326
• Study Type: observational
• Target: 1,501
• Locations: 1 country
• Sites: 52

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.

Conditions

Atherosclerosis; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)

  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 Outcomes (3)

• Death

  Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months

• Myocardial Infarction (MI)

  Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months

• Target Vessel Revascularization (TVR)

  Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months

Study Arms (1)

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)

Interventions

Percutaneous coronary intervention (Promus PREMIER) DEVICE

Interventional coronary artery stenting with Promus PREMIER study stent.

PLATINUM Diversity (Overall)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (52)

St Luke's Medical Center

Phoenix, Arizona, 85006, United States

Location

St Bernards Heart and Vascular

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Cardiology/Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States

Location

Central Cardiology Medical Clinic

Bakersfield, California, 93308, United States

Location

Sharp Chula Vista Medical Center

Chula Vista, California, 91911, United States

Location

Cardiovascular Consultants Heart Center

Fresno, California, 93720, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Mercy General Hospital

Sacramento, California, 95189, United States

Location

Capital Research Institute

Washington D.C., District of Columbia, 20017, United States

Location

Bay Area Cardiology

Brandon, Florida, 33511, United States

Location

Research Physicians Network Alliance

Hollywood, Florida, 33021, United States

Location

Memorial Hospital Jacksonville

Jacksonville, Florida, 32216, United States

Location

Cardiovascular Institute of Northwest Florida

Panama City, Florida, 32401, United States

Location

Charlotte Heart & Vascular

Port Charlotte, Florida, 33592, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute

Tampa, Florida, 33613, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

University Hospital

Augusta, Georgia, 30901, United States

Location

Redmond Regional Medical Center

Rome, Georgia, 30165, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Presence Saint Joseph Medical Center

Joliet, Illinois, 60435, United States

Location

The Heart Center of Lake County

Merrillville, Indiana, 46410, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Cardiovascular Research, LLC (Willis-Knighton)

Shreveport, Louisiana, 71005, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Delmarva Heart Research Foundation

Salisbury, Maryland, 21804, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

CCA Research

Gulfport, Mississippi, 39503, United States

Location

North Kansas City Hospital

North Kansas City, Missouri, 64116, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27610, United States

Location

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Presbyterian University Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Palmetto Health

Columbia, South Carolina, 29203, United States

Location

St. Francis Physician Services Inc., DBA Upstate Cardiology

Greenville, South Carolina, 29607, United States

Location

Seton Heart Institute

Austin, Texas, 78705, United States

Location

Methodist Hospital Dallas

Dallas, Texas, 75208, United States

Location

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Plaza Medical Center of Forth Worth

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Christus Santa Rosa Hospital-City Center

New Braunfels, Texas, 78130, United States

Location

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Virginia Mason

Seattle, Washington, 98101, United States

Location

Cardiac Study Center

Tacoma, Washington, 98405, United States

Location

CAMC Clinical Trials Center

Charleston, West Virginia, 25304, United States

Location

Related Publications (5)

• Batchelor W, Kandzari DE, Davis S, Tami L, Wang JC, Othman I, Gigliotti OS, Haghighat A, Singh S, Lopez M, Giugliano G, Horwitz PA, Chandrasekhar J, Underwood P, Thompson CA, Mehran R. Outcomes in Women and Minorities Compared With White Men 1 Year After Everolimus-Eluting Stent Implantation: Insights and Results From the PLATINUM Diversity and PROMUS Element Plus Post-Approval Study Pooled Analysis. JAMA Cardiol. 2017 Dec 1;2(12):1303-1313. doi: 10.1001/jamacardio.2017.3802.

  PMID: 29049508 BACKGROUND

• Epps K, Goel R, Mehran R, Kandzari D, Damluji A, Tehrani B, Sherwood M, Truesdell A, Davis S, Wang JC, Lopez M, Singh S, Underwood P, Allocco D, Batchelor W. Influence of Race/Ethnicity and Sex on Coronary Stent Outcomes in Diabetic Patients. J Soc Cardiovasc Angiogr Interv. 2023 Sep-Oct;2(5):101053. doi: 10.1016/j.jscai.2023.101053. Epub 2023 Aug 4.

  PMID: 38469035 DERIVED

• Beerkens FJ, Cao D, Batchelor W, Sartori S, Kandzari DE, Davis S, Tamis L, Wang JC, Othman I, Vogel B, Spirito A, Subramaniam V, Gigliotti OS, Haghighat A, Feng Y, Singh S, Lopez M, Giugliano G, Horwitz PA, Dangas G, Mehran R. Percutaneous Coronary Intervention in Men, Women, and Minorities With a Previous Coronary Artery Bypass Graft Surgery (from the Pooled PLATINUM Diversity and PROMUS Element Plus Registries). Am J Cardiol. 2023 Aug 1;200:204-211. doi: 10.1016/j.amjcard.2023.05.028. Epub 2023 Jun 22.

  PMID: 37354778 DERIVED

• Batchelor WB, Damluji AA, Yong C, Fiuzat M, Barnett SD, Kandzari DE, Sherwood MW, Epps KC, Tehrani BN, Allocco DJ, Meredith IT, Lindenfeld J, O'Connor CM, Mehran R. Does study subject diversity influence cardiology research site performance?: Insights from 2 U.S. National Coronary Stent Registries. Am Heart J. 2021 Jun;236:37-48. doi: 10.1016/j.ahj.2021.02.003. Epub 2021 Feb 24.

  PMID: 33636137 DERIVED

• Mehran R, Chandrasekhar J, Davis S, Nathan S, Hill R, Hearne S, Vismara V, Pyo R, Gharib E, Hawa Z, Chrysant G, Kandzari D, Underwood P, Allocco DJ, Batchelor W. Impact of Race and Ethnicity on the Clinical and Angiographic Characteristics, Social Determinants of Health, and 1-Year Outcomes After Everolimus-Eluting Coronary Stent Procedures in Women. Circ Cardiovasc Interv. 2019 Apr;12(4):e006918. doi: 10.1161/CIRCINTERVENTIONS.118.006918.

  PMID: 30998393 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Director, Clinical Trials
• Organization: Boston Scientific

peter.maurer@bsci.com

508-683-6678

Study Officials

• Roxana Mehran, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Wayne Batchelor, MD

  Tallahassee Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 16, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 15, 2019
• Results First Posted: May 10, 2019

Record last verified: 2019-05

Locations

US (52)