AnginaNCT01721096
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
An observational study of Angina and Coronary Occlusion, run by Abbott Medical Devices at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angina, Coronary Occlusion, Coronary Artery Disease
- What is being tested?
- XIENCE PRIME - Long Length (LL) and XIENCE PRIME - Core Size
- Type of treatment
- Medical device
- How many people
- 536 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2012to Nov 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Patients with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent
- Patient provides Informed Consent Form
Who cannot join
- If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: XIENCE PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan
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.
Read the detailed description
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).
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis, Myocardial Ischemia
- Being tested
- XIENCE PRIME - Long Length (LL), XIENCE PRIME - Core Size
- Keywords
- Angioplasty, Drug eluting stents, Stents, Real world
- Medical subject headings
- Angina Pectoris, Coronary Occlusion, Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE PRIME - Long Length (LL)Device
Long Length
XIENCE PRIME - Core SizeDevice
Core Size
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: XIENCE PRIME - Long Length (LL) | |
| 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. Receives: Device: XIENCE PRIME - Core Size |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 year post index procedure
Secondary outcomes (84)
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).
Measured: Participants will be followed for the duration of hospital stay, an average of 5 days
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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 year post index procedure
Number of Participants With All Revascularization
All revascularization includes ischemia driven and non-ischemia driven revascularization.
Measured: 8 months post index procedure
Number of Participants With All Revascularization
All revascularization includes ischemia driven and non-ischemia driven revascularization.
Measured: 1 year post index procedure
Number of Participants With All Revascularization
All revascularization includes ischemia driven and non-ischemia driven revascularization.
Measured: 2 year post index procedure
Number of Participants With All Revascularization
All revascularization includes ischemia driven and non-ischemia driven revascularization.
Measured: 3 year post index procedure
Number of Participants With All Revascularization
All revascularization includes ischemia driven and non-ischemia driven revascularization.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 8 months post index procedure
Acute Gain: In-stent, In-segment
The difference between post- and pre-procedural MLD.
Measured: 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).
Measured: 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.
Measured: 8 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2014
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnginaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken Kozuma, MD, Study chair, Teikyo University Hospital, Tokyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721096
- Sponsor's protocol ID
- 12-398
- Status last verified
- May 2019
- First submitted
- 20 Sep 2012
- Last updated
- 20 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XIENCE PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan
- ClinicalTrials.gov ID
- NCT01721096
- Acronym / sponsor ID
- 12-398
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis, Myocardial Ischemia
- Keywords
- Angioplasty, Drug eluting stents, Stents, Real world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 5 Nov 2012 (estimated)
- Results
- Posted 19 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XIENCE PRIME - Long Length (LL) | – | Device: 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. |
| XIENCE PRIME - Core Size | – | Device: XIENCE PRIME - Core SizeCore 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Patients with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent
- Patient provides Informed Consent Form
Key exclusion criteria (1 listed)
- If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XIENCE PRIME - Long Length (LL)Long Length | Device | XIENCE PRIME - Long Length (LL) |
| XIENCE PRIME - Core SizeCore Size | Device | XIENCE PRIME - Core Size |
Primary outcome
Number of Participants With Acute Stent Thrombosis (ST)
Time frame: Time Frame: Acute (0-24 hours)
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).
Number of Participants With Subacute Stent Thrombosis (ST)
Time frame: Subacute (>24 hours to 30 days)
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).
Number of Participants With Late Stent Thrombosis (ST)
Time frame: Late (>30 days to 1 year)
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).
Total Number of Participants With Overall Stent Thrombosis
Time frame: 1 year post index procedure
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).
84 secondary outcomes
Success Rate: Percentage of Participants With Implant Success Rate by Device
Time frame: Participants will be followed for the duration of hospital stay, an average of 5 days
Success Rate: Percentage of Participants With Procedural Success by Lesion
Time frame: 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)
Time frame: Participants will be followed for the duration of hospital stay, an average of 5 days
Number of Participants With Target Lesion Failure (TLF)
Time frame: 8 months post index procedure
Number of Participants With Target Lesion Failure (TLF)
Time frame: 1 year post index procedure
Number of Participants With Target Lesion Failure (TLF)
Time frame: 2 year post index procedure
Number of Participants With Target Lesion Failure (TLF)
Time frame: 3 years post index procedure
Number of Participants With Target Lesion Failure (TLF)
Time frame: 4 year post index procedure
Number of Participants With All Death/All MI/All Revascularization (DMR)
Time frame: 8 months post index procedure
Number of Participants With All Death/All MI/All Revascularization (DMR)
Time frame: 1 year post index procedure
Number of Participants With All Death/All MI/All Revascularization (DMR)
Time frame: 2 year post index procedure
Number of Participants With All Death/All MI/All Revascularization (DMR)
Time frame: 3 year post index procedure
Number of Participants With All Death/All MI/All Revascularization (DMR)
Time frame: 4 year post index procedure
Number of Participants With Target Vessel Failure (TVF)
Time frame: 8 months post index procedure
Number of Participants With Target Vessel Failure (TVF)
Time frame: 1 year post index procedure
Number of Participants With Target Vessel Failure (TVF)
Time frame: 2 year post index procedure
Number of Participants With Target Vessel Failure (TVF)
Time frame: 3 year post index procedure
Number of Participants With Target Vessel Failure(TVF)
Time frame: 4 year post index procedure
Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
Time frame: 8 months post index procedure
Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
Time frame: 1 year post index procedure
Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
Time frame: 2 year post index procedure
Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
Time frame: 3 year post index procedure
Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
Time frame: 4 year post index procedure
Number of Participants With Death or Myocardial Infarction (MI)
Time frame: 8 months post index procedure
Number of Participants With Death or Myocardial Infarction (MI)
Time frame: 1 year post index procedure
Number of Participants With Death or Myocardial Infarction (MI)
Time frame: 2 year post index procedure
Number of Participants With Death or Myocardial Infarction (MI)
Time frame: 3 year post index procedure
Number of Participants With Death or Myocardial Infarction (MI)
Time frame: 4 year post index procedure
Number of Participants With Cardiac Death or Myocardial Infarction (MI)
Time frame: 8 months post index procedure
Number of Participants With Cardiac Death or Myocardial Infarction (MI)
Time frame: 1 year post index procedure
Number of Participants With Cardiac Death or Myocardial Infarction (MI)
Time frame: 2 year post index procedure
Number of Participants With Cardiac Death or Myocardial Infarction (MI)
Time frame: 3 year post index procedure
Number of Participants With Cardiac Death or Myocardial Infarction (MI)
Time frame: 4 year post index procedure
Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)
Time frame: 8 months post index procedure
Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)
Time frame: 1 year post index procedure
Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)
Time frame: 2 year post index procedure
Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)
Time frame: 3 year post index procedure
Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)
Time frame: 4 year post index procedure
Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
Time frame: 8 months post index procedure
Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
Time frame: 1 year post index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Kozuma, MD study chair
Teikyo University Hospital, Tokyo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina and Coronary Occlusion, run by Abbott Medical Devices at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Acute Stent Thrombosis (ST) (time frame: Time Frame: Acute (0-24 hours)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.