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.
Brief Title
PLATINUM Diversity
Categories
Completion Date
Completion Date Type
Actual
Conditions
Atherosclerosis
Coronary Artery Disease
Eligibility 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:
* Not applicable
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02240810
Org Class
Industry
Org Full Name
Boston Scientific Corporation
Org Study Id
S2326
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
PLATINUM Diversity: Outcomes With the Promus PREMIER™ Stent in Women and Minorities (S2326)
Primary Outcomes
Outcome Description
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
Outcome Measure
Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)
Outcome Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
Outcome Measure
Death
Outcome Description
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
Outcome Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
Outcome Measure
Myocardial Infarction (MI)
Outcome Description
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
Outcome Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
Outcome Measure
Target Vessel Revascularization (TVR)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Population will be selected from clinical locations where subjects are treated with at least one Promus PREMIER everolimus-eluting coronary stent.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Robert Pyo
Investigator Email
rpyo@montefiore.org
Investigator Phone
Categories Mesh Debug
Blood Disorders --- CORONARY ARTERY DISEASE
Heart/Cardiovascular --- CORONARY ARTERY DISEASE
Heart/Cardiovascular --- ARTERIOSCLEROSIS
Heart/Cardiovascular --- ARTERIAL OCCLUSIVE DISEASES
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- MYOCARDIAL ISCHEMIA
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
MeSH Terms
ATHEROSCLEROSIS
CORONARY ARTERY DISEASE
ARTERIOSCLEROSIS
ARTERIAL OCCLUSIVE DISEASES
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
CORONARY DISEASE
MYOCARDIAL ISCHEMIA
HEART DISEASES
PERCUTANEOUS CORONARY INTERVENTION
ENDOVASCULAR PROCEDURES
VASCULAR SURGICAL PROCEDURES
CARDIOVASCULAR SURGICAL PROCEDURES
SURGICAL PROCEDURES, OPERATIVE
MINIMALLY INVASIVE SURGICAL PROCEDURES