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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLATINUM Diversity (Overall) | PLATINUM Diversity (Overall) population. Test device is Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (CSS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention (Promus PREMIER) | Device | Interventional coronary artery stenting with Promus PREMIER study stent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Exclusion Criteria:
Not provided
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Population will be selected from clinical locations where subjects are treated with at least one Promus PREMIER everolimus-eluting coronary stent.
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| Name | Affiliation | Role |
|---|---|---|
| Roxana Mehran, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Wayne Batchelor, MD | Tallahassee Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Luke's Medical Center | Phoenix | Arizona | 85006 | United States | ||
| St Bernards Heart and Vascular |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29049508 | Background | 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. | |
| 38469035 |
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PLATINUM Diversity and PROMUS Element Plus US Post Approval study (PE Plus) are two separate studies that have been pooled.
Only the PLATINUM Diversity subjects (n=1501) are considered to be enrolled in the study. Results for the PROMUS Element Plus study are reported in record NCT01589978
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| ID | Title | Description |
|---|---|---|
| FG000 | PLATINUM Diversity (Overall) | Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent. Overall population. |
| FG001 | PROMUS Element Plus US Post Approval Study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
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| 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 |
| 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 |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Arkansas Cardiology/Baptist Health Medical Center | Little Rock | Arkansas | 72205 | United States |
| Central Cardiology Medical Clinic | Bakersfield | California | 93308 | United States |
| Sharp Chula Vista Medical Center | Chula Vista | California | 91911 | United States |
| Cardiovascular Consultants Heart Center | Fresno | California | 93720 | United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Mercy General Hospital | Sacramento | California | 95189 | United States |
| Capital Research Institute | Washington D.C. | District of Columbia | 20017 | United States |
| Bay Area Cardiology | Brandon | Florida | 33511 | United States |
| Research Physicians Network Alliance | Hollywood | Florida | 33021 | United States |
| Memorial Hospital Jacksonville | Jacksonville | Florida | 32216 | United States |
| Cardiovascular Institute of Northwest Florida | Panama City | Florida | 32401 | United States |
| Charlotte Heart & Vascular | Port Charlotte | Florida | 33592 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute | Tampa | Florida | 33613 | United States |
| Emory University | Atlanta | Georgia | 30308 | United States |
| University Hospital | Augusta | Georgia | 30901 | United States |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Presence Saint Joseph Medical Center | Joliet | Illinois | 60435 | United States |
| The Heart Center of Lake County | Merrillville | Indiana | 46410 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Cardiovascular Research, LLC (Willis-Knighton) | Shreveport | Louisiana | 71005 | United States |
| MedStar Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| Suburban Hospital | Bethesda | Maryland | 20814 | United States |
| Delmarva Heart Research Foundation | Salisbury | Maryland | 21804 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| CCA Research | Gulfport | Mississippi | 39503 | United States |
| North Kansas City Hospital | North Kansas City | Missouri | 64116 | United States |
| St. Louis Heart and Vascular | St Louis | Missouri | 63136 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Novant Health Heart and Vascular Institute | Charlotte | North Carolina | 28204 | United States |
| NC Heart and Vascular Research | Raleigh | North Carolina | 27610 | United States |
| INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Presbyterian University Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| Palmetto Health | Columbia | South Carolina | 29203 | United States |
| St. Francis Physician Services Inc., DBA Upstate Cardiology | Greenville | South Carolina | 29607 | United States |
| Seton Heart Institute | Austin | Texas | 78705 | United States |
| Methodist Hospital Dallas | Dallas | Texas | 75208 | United States |
| VA North Texas Health Care System | Dallas | Texas | 75216 | United States |
| Plaza Medical Center of Forth Worth | Fort Worth | Texas | 76104 | United States |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 | United States |
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Christus Santa Rosa Hospital-City Center | New Braunfels | Texas | 78130 | United States |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Virginia Mason | Seattle | Washington | 98101 | United States |
| Cardiac Study Center | Tacoma | Washington | 98405 | United States |
| CAMC Clinical Trials Center | Charleston | West Virginia | 25304 | United States |
| Derived |
| 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. |
| 37354778 | 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. |
| 33636137 | 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. |
| 30998393 | 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. |
PROMUS Element Plus US Post Approval Study
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PLATINUM Diversity (Overall) | Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent. Overall population. |
| BG001 | PROMUS Element Plus US Post Approval Study (Overall) | PROMUS Element Plus US Post Approval Study NOTE: Results for the PROMUS Element Plus study are reported in record NCT01589978 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | NOTE: Patients were able to self-identify as more than one racial/ethnic category | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with Current Diabetes Mellitus | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with History of Hyperlipidemia Requiring Medication | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with History of Hypertension Requiring Medication | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with Family History of Coronary Artery Disease (CAD) | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with History of Myocardial Infarction (MI) | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with History of Congestive Heart Failure (CHF) | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with History of Percutaneous Coronary Intervention (PCI) | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with History of Coronary Artery Bypass Graft (CABG) | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with History of Renal Disease | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with History of Peripheral Vascular Disease (PVD) | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with History of Multivessel Disease | Count of Participants | Participants |
| ||||||||||||||||
| Smoking Status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | the outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure). | Posted | Count of Participants | Participants | 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 | the outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure). | Posted | Count of Participants | Participants | 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 | The outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure). | Posted | Count of Participants | Participants | 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 | The outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure). | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
|
1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978.
Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total.
Adverse Events were assessed at each scheduled study follow-up with participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PLATINUM Diversity (Overall) | Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent. Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. | 60 | 1,501 | 154 | 1,501 | 26 | 1,501 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. |
|
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coronary artery dissection | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Electromechanical dissociation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Postinfarction angina | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Drowning | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac enzymes increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Aortic intramural haematoma | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Trials | Boston Scientific | 508-683-6678 | peter.maurer@bsci.com |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black, of African Heritage |
|
| Caucasian |
|
| Hispanic or Latino |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Not Disclosed |
|
| Type 1 |
|
| Type 2 |
|
| Unknown |
|
| 2-Vessel |
|
| 3-Vessel |
|
| Never |
|
| Previous |
|
| Unknown |
|
All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.
| OG003 | Minorities - PLATINUM Diversity and PE+ | All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study |
|
|
All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.
| OG003 | Minorities - PLATINUM Diversity and PE+ | All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study |
|
|
All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study. |
| OG003 | Minorities - PLATINUM Diversity and PE+ | All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study |
|
|