Coronary Artery Disease Clinical Trial
Official title:
PLATINUM Diversity: Outcomes With the Promus PREMIER™ Stent in Women and Minorities (S2326)
| NCT number | NCT02240810 |
| Other study ID # | S2326 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2014 |
| Est. completion date | December 2016 |
| Verified date | May 2019 |
| Source | Boston Scientific Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 1501 |
| Est. completion date | December 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University | Atlanta | Georgia |
| United States | University Hospital | Augusta | Georgia |
| United States | Seton Heart Institute | Austin | Texas |
| United States | Central Cardiology Medical Clinic | Bakersfield | California |
| United States | MedStar Union Memorial Hospital | Baltimore | Maryland |
| United States | Suburban Hospital | Bethesda | Maryland |
| United States | Bay Area Cardiology | Brandon | Florida |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | The University of Vermont Medical Center | Burlington | Vermont |
| United States | CAMC Clinical Trials Center | Charleston | West Virginia |
| United States | Novant Health Heart and Vascular Institute | Charlotte | North Carolina |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | Sharp Chula Vista Medical Center | Chula Vista | California |
| United States | Palmetto Health | Columbia | South Carolina |
| United States | Methodist Hospital Dallas | Dallas | Texas |
| United States | VA North Texas Health Care System | Dallas | Texas |
| United States | Plaza Medical Center of Forth Worth | Fort Worth | Texas |
| United States | Cardiovascular Consultants Heart Center | Fresno | California |
| United States | University of Texas Medical Branch at Galveston | Galveston | Texas |
| United States | St. Francis Physician Services Inc., DBA Upstate Cardiology | Greenville | South Carolina |
| United States | CCA Research | Gulfport | Mississippi |
| United States | Research Physicians Network Alliance | Hollywood | Florida |
| United States | St. Luke's Episcopal Hospital | Houston | Texas |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | Memorial Hospital Jacksonville | Jacksonville | Florida |
| United States | Presence Saint Joseph Medical Center | Joliet | Illinois |
| United States | St Bernards Heart and Vascular | Jonesboro | Arkansas |
| United States | Arkansas Cardiology/Baptist Health Medical Center | Little Rock | Arkansas |
| United States | UCLA Medical Center | Los Angeles | California |
| United States | The Heart Center of Lake County | Merrillville | Indiana |
| United States | Jersey Shore University Medical Center | Neptune | New Jersey |
| United States | Christus Santa Rosa Hospital-City Center | New Braunfels | Texas |
| United States | Mount Sinai Hospital | New York | New York |
| United States | North Kansas City Hospital | North Kansas City | Missouri |
| United States | INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma |
| United States | Cardiovascular Institute of Northwest Florida | Panama City | Florida |
| United States | St Luke's Medical Center | Phoenix | Arizona |
| United States | Presbyterian University Hospital | Pittsburgh | Pennsylvania |
| United States | Charlotte Heart & Vascular | Port Charlotte | Florida |
| United States | NC Heart and Vascular Research | Raleigh | North Carolina |
| United States | Redmond Regional Medical Center | Rome | Georgia |
| United States | Mercy General Hospital | Sacramento | California |
| United States | St. Louis Heart and Vascular | Saint Louis | Missouri |
| United States | Delmarva Heart Research Foundation | Salisbury | Maryland |
| United States | Virginia Mason | Seattle | Washington |
| United States | Cardiovascular Research, LLC (Willis-Knighton) | Shreveport | Louisiana |
| United States | Baystate Medical Center | Springfield | Massachusetts |
| United States | Cardiac Study Center | Tacoma | Washington |
| United States | Tallahassee Memorial Hospital | Tallahassee | Florida |
| United States | Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute | Tampa | Florida |
| United States | Capital Research Institute | Washington | District of Columbia |
| United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Scientific Corporation |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Death | 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 | |
| Secondary | Myocardial Infarction (MI) | 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 | |
| Secondary | Target Vessel Revascularization (TVR) | 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 |
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