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Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.
This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China.
This study has no primary outcome measure. All observations are of equal weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | Device | Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. | ≤ 7 days after index procedure (Hospitalization) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. |
Inclusion Criteria:
Exclusion Criteria:
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Cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in realworld settings in China.
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| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, MB, MSc, MD | Fudan University | Principal Investigator |
| Fang Chen, MD | Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Vascular | Santa Clara | California | 95054 | United States |
Of the 2140 registered subjects,138 subjects withdrew from the study due to incomplete consent forms, no implanted study stents and repeated entry in voice interactive selection system. Among the final analysis population (n=2002), a total of 151 subjects failed to complete the follow-up period.
A total of 2140 patients were registered from 35 centres in China. First patients was enrolled on July 12, 2013 & enrollment was completed on Sep11, 2014 through the Interactive Voice Response System (IVRS) excluding those without consent and those without stent implants & duplicate entries. Thus the analysis population includes 2002 participants .
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| ID | Title | Description |
|---|---|---|
| FG000 | XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2014 | Aug 7, 2017 |
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| 0 through 1885 Days |
| Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints | All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. | ≤ 7 days after index procedure (Hospitalization) |
| Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints | All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. | 0 through 1885 Days |
| Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.
This study has no primary or secondary endpoints, all endpoints are of equal weight. | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.
This study has no primary or secondary endpoints, all endpoints are of equal weight. | 0 through 1885 Days |
| Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI) | All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI) | All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. | 0 through 1885 Days |
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight. | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight. | 0 through 1885 Days |
| Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight. | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight. | 0 through 1885 Days |
| Number of All Death (Cardiac, Vascular, and Non-cardiovascular) | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight. - Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight. | ≤ 7 days after index procedure (Hospitalization) |
| Number of All Death (Cardiac, Vascular, and Non-cardiovascular) | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight. - Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight. | 0 through 1885 Days |
| Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | Myocardial Infarction (MI)
| ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | Myocardial Infarction (MI)
| 0 through 1885 Days |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight. | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight. | 0 through 1885 Days |
| Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG]) | This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG]) | This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention | 0 through 1885 Days |
| Number of Participants With Acute Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | 0 to 1 day |
| Number of Participants With Sub-acute Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | > 1 day to 30 days |
| Number of Participants With Early Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | 0 - 30 days |
| Number of Participants With Late Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | 31 to 365 days |
| Number of Participants With Very Late Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | > 365 days |
| Number of Participants With Overall Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | 0 to 1885 days |
| Number of Participants With Target Vessel ARC MI | This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With Target Vessel ARC MI | This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 0 to 1885 days |
| Number of Participants With All TVR (TLR and TVR, Non-target Lesion) | This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion) | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With All TVR (TLR and TVR, Non-target Lesion) | This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion) | 0 to 1885 days |
| Number of Participants With All TLR | This study has no primary or secondary endpoints, all endpoints are of equal weight. | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With All TLR | This study has no primary or secondary endpoints, all endpoints are of equal weight. | 0 to 1885 days |
| Number of Participants With ID-TLR | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With ID-TLR | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | 0 to 1885 days |
| Number of Participants With ID-TVR, Non-target Lesion | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With ID-TVR, Non-target Lesion | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | 0 to 1885 days |
| Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion) | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | ≤ 7 days after index procedure (Hospitalization) |
| Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion) | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | 0 to 1885 days |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
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| Other Pre-specified | Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 through 1885 Days |
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| Other Pre-specified | Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints | All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
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| Other Pre-specified | Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints | All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 through 1885 Days |
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| Other Pre-specified | Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.
This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
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| Other Pre-specified | Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.
This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 through 1885 Days |
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| Other Pre-specified | Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI) | All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
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| Other Pre-specified | Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI) | All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI):
This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 through 1885 Days |
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| Other Pre-specified | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
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| Other Pre-specified | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 through 1885 Days |
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| Other Pre-specified | Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
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| Other Pre-specified | Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 through 1885 Days |
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| Other Pre-specified | Number of All Death (Cardiac, Vascular, and Non-cardiovascular) | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight. - Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
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| Other Pre-specified | Number of All Death (Cardiac, Vascular, and Non-cardiovascular) | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight. - Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 through 1885 Days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | Myocardial Infarction (MI)
| Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | Myocardial Infarction (MI)
| Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 through 1885 Days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 through 1885 Days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG]) | This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG]) | This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 through 1885 Days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Acute Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 to 1 day |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Sub-acute Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | > 1 day to 30 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Early Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 - 30 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Late Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 31 to 365 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Very Late Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | > 365 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Overall Stent Thrombosis | This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation" | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 to 1885 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Target Vessel ARC MI | This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Target Vessel ARC MI | This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 to 1885 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With All TVR (TLR and TVR, Non-target Lesion) | This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion) | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With All TVR (TLR and TVR, Non-target Lesion) | This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion) | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 to 1885 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With All TLR | This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With All TLR | This study has no primary or secondary endpoints, all endpoints are of equal weight. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 to 1885 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With ID-TLR | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With ID-TLR | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 to 1885 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With ID-TVR, Non-target Lesion | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With ID-TVR, Non-target Lesion | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 to 1885 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion) | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | ≤ 7 days after index procedure (Hospitalization) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion) | This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR. | Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time. | Posted | Count of Participants | Participants | 0 to 1885 days |
|
|
5 years
Not provided
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 | XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) | 91 | 2,002 | 1,105 | 2,002 | 103 | 2,002 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BLOOD DISEASE | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MASSIVE ABDOMINAL HEMORRHAGE | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST PAIN-CARDIAC | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST PAIN AND CHEST TIGHTNESS (CHD) | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ACUTE HEART FAILURE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ACUTE NON - ST SEGMENT ELEVATION MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| UNSTABLE ANGINA PECTORIS | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST TIGHTNESS-CARDIAC | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ARRHYTHMIA PERMANENT PACEMAKER IMPLANTATION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ARRHYTHMIA, ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ATRIAL PREMATURE BEAT | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VENTRICULAR PREMATURE BEAT | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CORONARY HEART DISEASE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CARDIAC DYSFUNCTION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CARDIAC ENLARGEMENT | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CARDIAC INSUFFICIENCY | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CARDIAC RESPIRATORY ARREST | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHRONIC CORONARY INSUFFICIENCY | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HEART FAILURE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CONGENITAL ATRIAL SEPTAL DEFECT | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CORONARY ATHEROSCLEROTIC CARDIOPATHY | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CORONARY HEART DISEASE DEATH | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| EXTRASYSTOLE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HEART PALPITATIONS | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HYDROPERICARDIUM | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ISCHEMIC CARDIOMYOPATHY | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| LETHAL MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| OLD MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MYOCARDIAL BRIDGE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NON-TARGET VESSEL REVASCULARIZATION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PRECORDIAL DISTRESS | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SICK SINUS SYNDROME | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| TACHYCARDIA-BRADYCARDIA SYNDROME | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| TARGET LESION REVASCULARIZATION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| TRANSIENT ISCHEMIC ATTACK | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| TVR or TLR | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHRONIC HEART FAILURE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BINOCULAR CATARACT | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| LEFT EYE SENILE CATARACT | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| RIGHT EYE CATARACT | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| TRACTIONAL RETINAL DETACHMENT | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| RIGHT EYE SENILE CATARACT (MATURE PERIOD) | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BLACK STOOL | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHRONIC GASTRITIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHRONIC NON-ATROPHIC GASTRITIS WITH BILE REFLUX | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHRONIC NON-ATROPHIC GASTRITIS WITH EROSION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| GASTRIC ULCER WITH BLEEDING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| LEFT INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST PAIN AND CHEST TIGHTNESS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST TIGHTNESS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BREASTBONE HIND TIGHTENING FEELING | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST BLEEDING | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST DISTRESS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST HEART PALPITATIONS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DISCOMFORT IN THE ANTERIOR REGION OF THE HEART | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DIZZY | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| EDEMA | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| INTERMITTENT CHEST DISCOMFORT | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SYNCOPE | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NECK DISCOMFORT | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PALPITATION | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| THE AREA BEFORE THE HEART PALPITATIONS, SHORTNESS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| THE AREA BEFORE THE HEART TIGHTNESS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| THE LIMBS SWELLING | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| TO TREAT OTHER VASCULAR LESIONS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VERTIGO SYNDROME | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| WEAK | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ACUTE PANCREATITIS | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CONSTRICTIVE PERICARDITIS | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HEMORRHAGE OF LIVER | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| LIVER FAILURE | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NON-TARGET VESSEL PCI | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| PCI POSTOPERATIVE UPPER GASTROINTESTINAL BLEEDING | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| POSTOPERATIVE PCI | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| REVASCULARIZATION | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| REVASCULARIZATION OF LCX | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| REVIEW AFTER PCI | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| STENT THROMBOSIS | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| STENT RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| TOXIC MULTIPLE NEUROPATHY CAUSED BY DRUG | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| CORONARY HEART DISEASE AND POST- PCI | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| CORONARY HEART DISEASE REEXAMINATION | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| CORONORY ANGIOGRAPHY(NOS) | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DIABETIC KETOACIDOSIS CAUSE THE DEATH | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HYPERTHYREOSIS | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| GOUT | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| CANCER OF THE STOMACH | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| CANCER METASTASIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| COLORECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| DESCENDING COLON TUMOR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| ESOPHAGEAL MALIGNANT TUMOR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| LIVER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| LIVER CYST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| PROSTATIC HYPERPLASIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| PULMONARY HEMANGIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| SACRAL TUMOR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| STOMACH CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| BILATERAL OVARIAN CYSTS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| ACUTE BRAINSTEM INFARCTION | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ANGIONEUROEDEMA | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CEREBRAL INSUFFICIENCY | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CERVICAL HEADACHE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DEATH(CEREBRAL INFARCTION AND CEREBRAL HERNIA) | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| GUILLAIN-BARRE SYNDROME | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ISCHEMIC CEREBROVASCULAR DISEASE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| LACUNAR INFARCTION | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| LEFT TEMPORAL LOBE BRAIN CONTUSION | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| LUMBAR SPINAL STENOSIS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| STROKE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SUBARACHNOID HEMORRHAGE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BILATERAL URETERAL CALCULI | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| RIGHT HYDRONEPHROSIS WITH URETERAL STRICTURE | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ENDOMETRIAL LESIONS | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| OOPHORITIC CYST | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VAGINAL BLEEDING | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BRONCHIAL ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ANHELATION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST TIGHTNESS AND SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| COPD | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| LEFT PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| LUNG INFECTION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MAXILLARY SINUSITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MIXED LUNG VENTILATION DYSFUNCTION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PULMONARY INFECTION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PULMONARY MULTILOBE PNEUMONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SEVERE PNEUMONIA AND RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| TYPE I RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| LACERATION OF SCALP SOFT TISSUE | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ABDOMINAL ANEURYSM | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ABNORMAL VESSELS IN CORONARY ARTERIES | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ARTERIOSCLEROSIS OBLITERANS OF LOWER EXTREMITY | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ATHEROSCLEROSIS | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CAROTID ARTERY OCCLUSION | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CEREBRAL HEMORRHAGE | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| INSUFFICIENT BLOOD SUPPLY TO THE CEREBRAL ARTERY | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| POSTERIOR CIRCULATION ISCHEMIA | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SEQUELAE OF CEREBRAL INFARCTION | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VASCULAR STENOSIS | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VENTRICULAR ANEURYSM | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEMORRHOIDAL BLEEDING | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| AURICULAR FIBRILLATION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST PAIN - CARDIAC | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HEART FAILURE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MI | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PREMATURE BEAT | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| REPERFUSION ARRHYTHMIA | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| RESTING ANGINA | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| UNSTABLE ANGINA | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BLEEDING IN EYES | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DEFECATE HAEMORRHAGE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| GASTRIC COLIC | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| GASTROINTESTINAL BLEEDING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| UPSET STOMACH | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BLEEDING | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BLEEDING GUMS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST TIGHTEN AND CARDIOPALMUS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHEST TIGHTNESS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DIZZY | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| FEEL SUFFOCATED | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HEMORRHAGIC SPOT | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PALPITATION | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SHORT OF BREATH | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| STOMACHACHE | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SYNCOPE | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| TOOTHACHE | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| General disorders | MedDRA 11.0 | Systematic Assessment |
| ||
| OM1 SEGMENT OCCLUDED | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| CNI IS HIGHER THAN NORMAL VALUE | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| ELEVATED TROPOLIN T | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| ELEVATED TROPONIN I | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| LACUNAR INFARCTION | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VAGAL REFLEX | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VERTEBRAL STENOSIS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NOSE BLEEDING | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SUBCUTANEOUS HEMORRHAGE | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SKIN ALLERGY | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roy Leong | Abbott Vascular | +65 (6277) 3202 | roy.leong@abbott.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 20, 2017 | Feb 20, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D023903 | Coronary Restenosis |
| D009203 | Myocardial Infarction |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D023921 | Coronary Stenosis |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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