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The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.
The primary objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation by Pharmaceuticals and Medical Devices Agency (PMDA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XIENCE PRIME - Long Length (LL) | Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length).There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths. |
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| XIENCE PRIME - Core Size | Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XIENCE PRIME - Long Length (LL) | Device | Long Length |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Stent Thrombosis (ST) | Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation). | Time Frame: Acute (0-24 hours) |
| Number of Participants With Subacute Stent Thrombosis (ST) | Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation). | Subacute (>24 hours to 30 days) |
| Number of Participants With Late Stent Thrombosis (ST) | Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation). |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate: Percentage of Participants With Implant Success Rate by Device | Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA). | Participants will be followed for the duration of hospital stay, an average of 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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Only patients in Japan, who are eligible to receive treatment for coronary arteries using the XIENCE PRIME Everolimus-Eluting Stent System are to be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Ken Kozuma, MD | Teikyo University Hospital, Tokyo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Vascular Japan Co., Ltd. | Tokyo | 108-6304 | Japan |
To date, out of 536 patients, 524 (320 in LL arm and 204 in CS arm) have terminated the surveillance before completing their follow-ups
A total of 536 patients (213 in the Core Size (CS) arm and 323 in the Long Length (LL) arm) were recruited from the 25 sites between October 11, 2013 and June 30, 2013. All the patients except those terminated the surveillance have completed their follow-up at the end of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | XIENCE PRIME - Long Length (LL) | Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths. |
| FG001 | XIENCE PRIME - Core Size | Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | XIENCE PRIME - Long Length (LL) | Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Acute Stent Thrombosis (ST) | Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | Time Frame: Acute (0-24 hours) |
4 years
This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency&status of adverse device effects&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
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| 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 - Long Length (LL) and Core Size (CS) | The study has 2 arms depending upon the size of stent used for the treatment: Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length), whereas Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David R Rutledge | Abbott Vascular | (408) 845-3820 | david.rutledge@av.abbott.com |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D054059 | Coronary Occlusion |
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
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| XIENCE PRIME - Core Size |
| Device |
Core Size |
|
| Late (>30 days to 1 year) |
| Total Number of Participants With Overall Stent Thrombosis | Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation). | 1 year post index procedure |
| Success Rate: Percentage of Participants With Procedural Success by Lesion | Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (less than or equal to 7 days). | Participants will be followed for the duration of hospital stay, an average of 5 days |
| Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base) | Participants will be followed for the duration of hospital stay, an average of 5 days |
| Number of Participants With Target Lesion Failure (TLF) | Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR | 8 months post index procedure |
| Number of Participants With Target Lesion Failure (TLF) | Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR | 1 year post index procedure |
| Number of Participants With Target Lesion Failure (TLF) | Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR | 2 year post index procedure |
| Number of Participants With Target Lesion Failure (TLF) | Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR | 3 years post index procedure |
| Number of Participants With Target Lesion Failure (TLF) | Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR | 4 year post index procedure |
| Number of Participants With All Death/All MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 8 months post index procedure |
| Number of Participants With All Death/All MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 1 year post index procedure |
| Number of Participants With All Death/All MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 2 year post index procedure |
| Number of Participants With All Death/All MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 3 year post index procedure |
| Number of Participants With All Death/All MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 4 year post index procedure |
| Number of Participants With Target Vessel Failure (TVF) | Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR). | 8 months post index procedure |
| Number of Participants With Target Vessel Failure (TVF) | Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR). | 1 year post index procedure |
| Number of Participants With Target Vessel Failure (TVF) | Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR). | 2 year post index procedure |
| Number of Participants With Target Vessel Failure (TVF) | Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR). | 3 year post index procedure |
| Number of Participants With Target Vessel Failure(TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 4 year post index procedure |
| Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | 8 months post index procedure |
| Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | 1 year post index procedure |
| Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | 2 year post index procedure |
| Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | 3 year post index procedure |
| Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | 4 year post index procedure |
| Number of Participants With Death or Myocardial Infarction (MI) | All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI | 8 months post index procedure |
| Number of Participants With Death or Myocardial Infarction (MI) | All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI | 1 year post index procedure |
| Number of Participants With Death or Myocardial Infarction (MI) | All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI | 2 year post index procedure |
| Number of Participants With Death or Myocardial Infarction (MI) | All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI | 3 year post index procedure |
| Number of Participants With Death or Myocardial Infarction (MI) | All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI | 4 year post index procedure |
| Number of Participants With Cardiac Death or Myocardial Infarction (MI) | 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) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 8 months post index procedure |
| Number of Participants With Cardiac Death or Myocardial Infarction (MI) | 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) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 1 year post index procedure |
| Number of Participants With Cardiac Death or Myocardial Infarction (MI) | 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) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 2 year post index procedure |
| Number of Participants With Cardiac Death or Myocardial Infarction (MI) | 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) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 3 year post index procedure |
| Number of Participants With Cardiac Death or Myocardial Infarction (MI) | 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) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 4 year post index procedure |
| Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) | 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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction. | 8 months post index procedure |
| Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) | 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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction. | 1 year post index procedure |
| Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) | 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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction. | 2 year post index procedure |
| Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) | 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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction. | 3 year post index procedure |
| Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) | 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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction. | 4 year post index procedure |
| Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma | 8 months post index procedure |
| Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma | 1 year post index procedure |
| Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma | 2 year post index procedure |
| Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma | 3 year post index procedure |
| Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma | 4 year post index procedure |
| Number of Participants With Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 8 months post index procedure |
| Number of Participants With Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 1 year post index procedure |
| Number of Participants With Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 2 year post index procedure |
| Number of Participants With Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 3 year post index procedure |
| Number of Participants With Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 4 year post index procedure |
| Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 8 months post index procedure |
| Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 1 year post index procedure |
| Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 2 year post index procedure |
| Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 3 year post index procedure |
| Number of Participants With Target Lesion Revascularization(TLR) | Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 4 year post index procedure |
| Number of Participants With Non-Target Lesion Revascularization (Non-TLR) | Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. | 8 months post index procedure |
| Number of Participants With Non-Target Lesion Revascularization (Non-TLR) | Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. | 1 year post index procedure |
| Number of Participants With Non-Target Lesion Revascularization (Non-TLR) | Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. | 2 year post index procedure |
| Number of Participants With Non-Target Lesion Revascularization (Non-TLR) | Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. | 3 year post index procedure |
| Number of Participants With Non-Target Lesion Revascularization (Non-TLR) | Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. | 4 year post index procedure |
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR) | 8 months post index procedure |
| Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR) | 1 year post index procedure |
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR) | 2 year post index procedure |
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR) | 3 year post index procedure |
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR) | 4 year post index procedure |
| Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization. | 8 months post index procedure |
| Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization. | 1 year post index procedure |
| Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization. | 2 year post index procedure |
| Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization. | 3 year post index procedure |
| Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization. | 4 year post index procedure |
| Number of Participants With All Revascularization | All revascularization includes ischemia driven and non-ischemia driven revascularization. | 8 months post index procedure |
| Number of Participants With All Revascularization | All revascularization includes ischemia driven and non-ischemia driven revascularization. | 1 year post index procedure |
| Number of Participants With All Revascularization | All revascularization includes ischemia driven and non-ischemia driven revascularization. | 2 year post index procedure |
| Number of Participants With All Revascularization | All revascularization includes ischemia driven and non-ischemia driven revascularization. | 3 year post index procedure |
| Number of Participants With All Revascularization | All revascularization includes ischemia driven and non-ischemia driven revascularization. | 4 year post index procedure |
| Number of Participants Experienced Bleeding | Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding | 8 months post index procedure |
| Number of Participants Experienced Bleeding | Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding | 1 year post index procedure |
| Number of Participants Experienced Bleeding | Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding | 2 year post index procedure |
| Number of Participants Experienced Bleeding | Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding | 3 year post index procedure |
| Number of Participants Experienced Bleeding | Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding | 4 year post index procedure |
| Percent Diameter Stenosis (%DS) | The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). | Baseline |
| Percent Diameter Stenosis (%DS) | The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | Post procedure |
| Percent Diameter Stenosis (%DS) | The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | 8 months post index procedure |
| Acute Gain: In-stent, In-segment | The difference between post- and pre-procedural MLD. | 8 months post index procedure |
| Net Gain: In-stent, In-segment | Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss). | 8 months post index procedure |
| Late Loss(LL): In-stent, In-segment, Proximal, and Distal | Late loss is calculated as MLD post procedure - MLD at follow-up. | 8 months post index procedure |
| BG001 | XIENCE PRIME - Core Size | Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths. |
| BG002 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| ID | Title | Description |
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| OG000 | XIENCE PRIME - Long Length (LL) | Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths. |
| OG001 | XIENCE PRIME - Core Size | Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths. |
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| Primary | Number of Participants With Subacute Stent Thrombosis (ST) | Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | Subacute (>24 hours to 30 days) |
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| Primary | Number of Participants With Late Stent Thrombosis (ST) | Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | Late (>30 days to 1 year) |
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| Primary | Total Number of Participants With Overall Stent Thrombosis | Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
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| Secondary | Success Rate: Percentage of Participants With Implant Success Rate by Device | Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA). | The number of participants analyzed excludes subjects who were lost-to-follow-up. Implant Success rate is calculated per stent base. | Posted | Number | 95% Confidence Interval | percentage of devices | Participants will be followed for the duration of hospital stay, an average of 5 days | Device used | Device used |
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| Secondary | Success Rate: Percentage of Participants With Procedural Success by Lesion | Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (less than or equal to 7 days). | The number of participants analyzed excludes subjects who were lost-to-follow-up. Procedural Success rate is calculated per lesion base. | Posted | Number | 95% Confidence Interval | Percentage of Lesions | Participants will be followed for the duration of hospital stay, an average of 5 days | Lesions | Lesions |
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| Secondary | Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base) | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | percentage of participants | Participants will be followed for the duration of hospital stay, an average of 5 days |
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| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
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| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
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| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
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| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 years post index procedure |
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| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
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| Secondary | Number of Participants With All Death/All MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
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| Secondary | Number of Participants With All Death/All MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
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| Secondary | Number of Participants With All Death/All MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
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| Secondary | Number of Participants With All Death/All MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
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| Secondary | Number of Participants With All Death/All MI/All Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
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| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
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| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
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| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
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| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
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| Secondary | Number of Participants With Target Vessel Failure(TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
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| Secondary | Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
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| Secondary | Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
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| Secondary | Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
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| Secondary | Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
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| Secondary | Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
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| Secondary | Number of Participants With Death or Myocardial Infarction (MI) | All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
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| Secondary | Number of Participants With Death or Myocardial Infarction (MI) | All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
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| Secondary | Number of Participants With Death or Myocardial Infarction (MI) | All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
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| Secondary | Number of Participants With Death or Myocardial Infarction (MI) | All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
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| Secondary | Number of Participants With Death or Myocardial Infarction (MI) | All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
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| Secondary | Number of Participants With Cardiac Death or Myocardial Infarction (MI) | 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) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
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| Secondary | Number of Participants With Cardiac Death or Myocardial Infarction (MI) | 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) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
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| Secondary | Number of Participants With Cardiac Death or Myocardial Infarction (MI) | 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) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
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| Secondary | Number of Participants With Cardiac Death or Myocardial Infarction (MI) | 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) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
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| Secondary | Number of Participants With Cardiac Death or Myocardial Infarction (MI) | 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) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
|
|
|
| Secondary | Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) | 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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
|
|
|
| Secondary | Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) | 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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
|
|
|
| Secondary | Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) | 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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
|
|
|
| Secondary | Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) | 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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
|
|
|
| Secondary | Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) | 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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
|
|
|
| Secondary | Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
|
|
|
| Secondary | Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
|
|
|
| Secondary | Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
|
|
|
| Secondary | Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
|
|
|
| Secondary | Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
|
|
|
| Secondary | Number of Participants With Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
|
|
|
| Secondary | Number of Participants With Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
|
|
|
| Secondary | Number of Participants With Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
|
|
|
| Secondary | Number of Participants With Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
|
|
|
| Secondary | Number of Participants With Myocardial Infarction (MI) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
|
|
|
| Secondary | Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
|
|
|
| Secondary | Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
|
|
|
| Secondary | Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
|
|
|
| Secondary | Number of Participants With Target Lesion Revascularization (TLR) | Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
|
|
|
| Secondary | Number of Participants With Target Lesion Revascularization(TLR) | Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
|
|
|
| Secondary | Number of Participants With Non-Target Lesion Revascularization (Non-TLR) | Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
|
|
|
| Secondary | Number of Participants With Non-Target Lesion Revascularization (Non-TLR) | Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
|
|
|
| Secondary | Number of Participants With Non-Target Lesion Revascularization (Non-TLR) | Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
|
|
|
| Secondary | Number of Participants With Non-Target Lesion Revascularization (Non-TLR) | Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
|
|
|
| Secondary | Number of Participants With Non-Target Lesion Revascularization (Non-TLR) | Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
|
|
|
| Secondary | Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR) | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
|
|
|
| Secondary | Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR) | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
|
|
|
| Secondary | Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR) | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
|
|
|
| Secondary | Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR) | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
|
|
|
| Secondary | Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR) | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
|
|
|
| Secondary | Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
|
|
|
| Secondary | Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
|
|
|
| Secondary | Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
|
|
|
| Secondary | Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
|
|
|
| Secondary | Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
|
|
|
| Secondary | Number of Participants With All Revascularization | All revascularization includes ischemia driven and non-ischemia driven revascularization. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
|
|
|
| Secondary | Number of Participants With All Revascularization | All revascularization includes ischemia driven and non-ischemia driven revascularization. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
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|
|
| Secondary | Number of Participants With All Revascularization | All revascularization includes ischemia driven and non-ischemia driven revascularization. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
|
|
|
| Secondary | Number of Participants With All Revascularization | All revascularization includes ischemia driven and non-ischemia driven revascularization. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 3 year post index procedure |
|
|
|
| Secondary | Number of Participants With All Revascularization | All revascularization includes ischemia driven and non-ischemia driven revascularization. | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
|
|
|
| Secondary | Number of Participants Experienced Bleeding | Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 8 months post index procedure |
|
|
|
| Secondary | Number of Participants Experienced Bleeding | Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 1 year post index procedure |
|
|
|
| Secondary | Number of Participants Experienced Bleeding | Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 2 year post index procedure |
|
|
|
| Secondary | Number of Participants Experienced Bleeding | Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding | The number of participants analyzed excludes subjects who were lost-to-follow-up | Posted | Count of Participants | Participants | 3 year post index procedure |
|
|
|
| Secondary | Number of Participants Experienced Bleeding | Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding | The number of participants analyzed excludes subjects who were lost-to-follow-up. | Posted | Count of Participants | Participants | 4 year post index procedure |
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|
|
| Secondary | Percent Diameter Stenosis (%DS) | The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). | Posted | Mean | Standard Deviation | percentage of DS | Baseline | Number of lesion analyzed | Number of lesion analyzed |
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|
| Secondary | Percent Diameter Stenosis (%DS) | The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | Posted | Mean | Standard Deviation | percentage of DS | Post procedure | Number of lesion analyzed | Number of lesion analyzed |
|
|
|
| Secondary | Percent Diameter Stenosis (%DS) | The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | The number of participants analyzed includes subjects who had available follow up data at that time frame | Posted | Mean | Standard Deviation | percentage of DS | 8 months post index procedure | Number of lesion analyzed | Number of lesion analyzed |
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|
|
| Secondary | Acute Gain: In-stent, In-segment | The difference between post- and pre-procedural MLD. | Posted | Mean | Standard Deviation | mm | 8 months post index procedure | Lesions | Lesions |
|
|
|
| Secondary | Net Gain: In-stent, In-segment | Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss). | Posted | Mean | Standard Deviation | mm | 8 months post index procedure | Lesions | Lesions |
|
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|
| Secondary | Late Loss(LL): In-stent, In-segment, Proximal, and Distal | Late loss is calculated as MLD post procedure - MLD at follow-up. | Posted | Mean | Standard Deviation | mm | 8 months post index procedure | Lesions | Lesions |
|
|
|
| 47 |
| 536 |
| 221 |
| 536 |
| 254 |
| 536 |
| Acute heart failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angiopathy | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic aneurysm | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic dissection | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardio respiration | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chronic heart failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Complete atrioventricular block | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Contractile pericarditis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Heart failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intermittent claudication | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myocardial ischemia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral arterial obstructive disease | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral ischemia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Second degree atrioventricular block | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Supraventricular arrhythmia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular extrasystole | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness, vertigo | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Macular hole | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrophic gastritis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colon Bleeding | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colorectal polyp | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastrointestinal Bleeding | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ischemic colitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute cholangitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute cholecystitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bile duct stones | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Liver cirrhosis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Acute pyelonephritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Discitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Lymph node tuberculosis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Muscle abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Sepsis shock | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Urinary tract Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Cerebral contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Femoral fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Graft vascular occlusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Ligament tear | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Shunt obstruction | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Subdural hematoma | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Exercise test abnormal | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Motor test abnormality | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Crystalline joint disorder | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intervertebral stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intramuscular Bleeding | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Esophageal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Lung cancer metastatic | 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 |
|
| Malignant neoplasm of renal pelvis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Malignant neoplasm of the liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Malignant neoplasm of the tongue, stage unknown | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Metastatic pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Rectal sigmoid carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Recurrent liver malignant neoplasm | 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 |
|
| Altered state of consciousness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dementia with Lewy bodies | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Floating dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoglycaemic coma | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lacunar infarct | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Subarachnoid hemorrhage | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Transient ischemic attack | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chronic renal failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Kidney failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Renal dysfunction | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aspiration Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sleep apnea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Medical device related thrombosis | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Medical equipment blockage | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Unstable angina | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Supra ventricular arrhythmia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Complete atrioventricular block | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Second degree atrioventricular block | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Heart failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardio respiration | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary embolism | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myocardial ischemia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Contractile pericarditis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular extrasystole | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary dissection | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac puncture | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery no re flow phenomenon | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angiopathy | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic aneurysm | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic dissection | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intermittent claudication | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral ischemia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral arterial obstructive disease | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Reperfusion injury | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nose bleeding | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sleep apnea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ischemic colitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrophic gastritis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastrointestinal bleeding | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colorectal polyp | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colon bleeding | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute cholecystitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Liver cirrhosis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lumbar spinal canal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intramuscular hemorrhage | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Crystalline joint disorder | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intervertebral stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Renal dysfunction | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Medical device related thrombosis | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Medical device obstruction | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Increased myocardial enzyme | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Motor test abnormality | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Femoral fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Shunt obstruction | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Subdural hematoma | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Graft vascular occlusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Cerebral contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Coronary restenosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Ligament tear | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Can not pass target lesion | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Balloon rupture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Tearing | Product Issues | MedDRA (11.0) | Systematic Assessment |
|
| Stent damaged / deformed after indwelling-others | Product Issues | MedDRA (11.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Lymph node tuberculosis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Muscle abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal segment abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Disc flame | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Colon 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 |
|
| Liver malignant neoplasm | 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 |
|
| Malignant neoplasm of renal pelvis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Esophageal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Metastatic pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Malignant neoplasm of the tongue, stage unknown | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Metastatic lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness, vertigo | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Macular hole | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| State of consciousness transformation | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Carotid stenosis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Floating dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoglycemia coma | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Subarachnoid hemorrhage | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Transient ischemic attack | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lacunar infarct | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lewy body dementia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute heart failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chronic heart failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute cholangitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute pyelonephritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Rectal sigmoid carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Chronic renal failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Kidney failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
Not provided
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| Definite/Probable |
|
| Definite/Probable |
|
| Distal |
|
| Segment |
|