AngioplastyXV CHINA SASNCT01249027
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
An observational study of Angioplasty and Chronic Coronary Occlusion, run by Abbott Medical Devices at 1 site in United States.
Trial summary
This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to: Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use Evaluate patient… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angioplasty, Chronic Coronary Occlusion, Stent Thrombosis
- What is being tested?
- XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
- Type of treatment
- Medical device
- How many people
- 2,605 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jan 2017
- 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: General Chinese interventional cardiology population
Who may be able to join
- The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee-approved informed consent form (ICF).
- Only XIENCE V stent(s) is/are implanted into the coronary vasculature during the index procedure.
Who cannot join
- The inability to obtain a signed ICF
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to:
- Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use
- Evaluate patient compliance to dual antiplatelet therapy (DAPT)
- Conditions
- Angioplasty, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Being tested
- XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
- Keywords
- Drug eluting stents, Stents, China, DES, XIENCE V EECSS
- Medical subject headings
- Vascular Diseases, Myocardial Ischemia, Coronary Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)Device
Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). Receives: Device: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
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: 0 to 407 days
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
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: 0 to 772 days
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
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: 0 to 1137 days
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
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: 0 to 1502 days
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
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: 0 to 1867 days
Secondary outcomes (61)
Number of Participants With Stent Thrombosis
Definite Stent Thrombosis (ST) occurred by either angiographic/pathologic confirmation of ST.
Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48hours:
- Acute onset of ischemic symptoms at rest
- New ischemic ECG changes
- Typical rise\&fall in cardiac biomarkers
- Nonocclusive \&occlusive thrombus
Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.
Probable ST may occur due to:
- Unexplained death within first 30 days
- Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST\&in the absence of any other obvious cause.
Measured: 0 to 1867 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
All deaths includes
- 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: 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: 0 to 407 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
All deaths includes
- 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: 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: 0 to 772 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
All deaths includes
- 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: 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: 0 to 1137 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
All deaths includes
- 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: 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: 0 to 1502 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
All deaths includes
- 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: 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: 0 to 1867 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Cardiac Death: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).
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: 0 to 407 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Cardiac Death: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).
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: 0 to 772 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Cardiac Death: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).
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: 0 to 1137 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Cardiac Death: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).
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: 0 to 1502 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Cardiac Death: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).
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: 0 to 1867 days
Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 407 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 772 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 1137 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 1502 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 1867 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of
- Cardiac death,
- Myocardial infarction (Q wave and Non-Q wave),
- Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),
- Ischemia-driven target vessel revascularization by CABG or PCI.
Measured: 0 to 407 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of
- Cardiac death,
- Myocardial infarction (Q wave and Non-Q wave),
- Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),
- Ischemia-driven target vessel revascularization by CABG or PCI.
Measured: 0 to 772 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of
- Cardiac death,
- Myocardial infarction (Q wave and Non-Q wave),
- Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),
- Ischemia-driven target vessel revascularization by CABG or PCI.
Measured: 0 to 1137 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of
- Cardiac death,
- Myocardial infarction (Q wave and Non-Q wave),
- Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),
- Ischemia-driven target vessel revascularization by CABG or PCI.
Measured: 0 to 1502 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of
- Cardiac death,
- Myocardial infarction (Q wave and Non-Q wave),
- Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),
- Ischemia-driven target vessel revascularization by CABG or PCI.
Measured: 0 to 1867 days
Number of Participants With Composite Rate of All Death and Any MI
All deaths includes
- 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 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: 0 to 407 days
Number of Participants With Composite Rate of All Death and Any MI
All deaths includes
- 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 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: 0 to 772 days
Number of Participants With Composite Rate of All Death and Any MI
All deaths includes
- 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 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: 0 to 1137 days
Number of Participants With Composite Rate of All Death and Any MI
All deaths includes
- 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 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: 0 to 1502 days
Number of Participants With Composite Rate of All Death and Any MI
All deaths includes
- 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 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: 0 to 1867 days
Number of Participants Experiencing Death
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).
- Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 0 to 407 days
Number of Participants Experiencing Death
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).
- Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 0 to 772 days
Number of Participants Experiencing Death
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).
- Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 0 to 1137 days
Number of Participants Experiencing Death
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).
- Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 0 to 1502 days
Number of Participants Experiencing Death
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).
- Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 0 to 1867 days
Number of Participants With Any 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: 0 to 407 days
Number of Participants With Any 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: 0 to 772 days
Number of Participants With Any 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: 0 to 1137 days
Number of Participants With Any 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: 0 to 1502 days
Number of Participants With Any 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: 0 to 1867 days
Number of Participants With Revascularization
Revascularization:
- Target Lesion Revascularization (TLR) 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 target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
- Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
- Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
- Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Measured: 0 to 407 days
Number of Participants With Revascularization
Revascularization:
- Target Lesion Revascularization (TLR) 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 target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
- Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
- Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Measured: 0 to 772 days
Number of Participants With Revascularization
Revascularization:
- Target Lesion Revascularization (TLR) 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 target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
- Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
- Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Measured: 0 to 1137 days
Number of Participants With Revascularization
Revascularization:
- Target Lesion Revascularization (TLR) 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 target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
- Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
- Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Measured: 0 to 1502 days
Number of Participants With Revascularization
Revascularization:
Target Lesion Revascularization (TLR) 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 target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Measured: 0 to 1867 days
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
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: 0 to 407 days
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
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: 0 to 772 days
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
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: 0 to 1137 days
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
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: 0 to 1502 days
Number of Participants With Major Bleeding Complications (According to GUSTO Classification)
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: 0 to 1867 days
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.
Measured: 1 year
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.
Measured: 2 years
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Dual Anti-platelet Therapy (DAPT) is Aspirin \& Clopidogrel/Ticlopidine/Other.
Measured: 3 years
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Dual Anti-platelet Therapy (DAPT) is Aspirin \& Clopidogrel/Ticlopidine/Other.
Measured: 4 years
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Dual Anti-platelet Therapy (DAPT) is Aspirin \& Clopidogrel/Ticlopidine/Other.
Measured: 5 years
Number of Participants With All Target Lesions Revascularization
Target Lesion Revascularization (TLR) 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 target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
Measured: 0 to 407 days
Number of Participants With All Target Lesion Revascularization
Target Lesion Revascularization (TLR) 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 target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
Measured: 0 to 772 days
Number of Participants With All Target Lesions Revascularization
Target Lesion Revascularization (TLR) 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 target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
Measured: 0 to 1137 days
Number of Participants With All Target Lesion Revascularization
Target Lesion Revascularization (TLR) 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 target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
Measured: 0 to 1502 days
Number of Participants With All Target Lesion Revascularization
Target Lesion Revascularization (TLR) 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 target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
Measured: 0 to 1867 days
Number of Participants With All Target Vessel Revascularization
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
Measured: 0 to 407 days
Number of Participants With All Target Vessel Revascularization
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
Measured: 0 to 772 days
Number of Participants With All Target Vessel Revascularization
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
Measured: 0 to 1137 days
Number of Participants With All Target Vessel Revascularization
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
Measured: 0 to 1502 days
Number of Participants With All Target Vessel Revascularization
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
Measured: 0 to 1867 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2016
- Study completionJan 2017
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 AngioplastyStudies 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
- 2,605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, MB, MSc, MD, FACC, FESC, FSCAI, Principal investigator, Fudan UniversityJiyan Chen, MD, Principal investigator, Institute of Cardiovascular Guangdong, Guangdong Provincial People's HospitalYuJie Zhou, MD, Ph.D, Principal investigator, An Zhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249027
- Sponsor's protocol ID
- 10-388
- Acronym
- XV CHINA SAS
- Status last verified
- Oct 2018
- First submitted
- 24 Nov 2010
- Last updated
- 1 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
- ClinicalTrials.gov ID
- NCT01249027
- Acronym / sponsor ID
- XV CHINA SAS / 10-388
- Conditions
- Angioplasty, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Keywords
- Drug eluting stents, Stents, China, DES, XIENCE V EECSS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,605 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Nov 2010 (estimated)
- Results
- Posted 1 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to:
- Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use
- Evaluate patient compliance to dual antiplatelet therapy (DAPT)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Device: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General Chinese interventional cardiology population
Key inclusion criteria (2 listed)
- The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee-approved informed consent form (ICF).
- Only XIENCE V stent(s) is/are implanted into the coronary vasculature during the index procedure.
Key exclusion criteria (1 listed)
- The inability to obtain a signed ICF
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 V® Everolimus Eluting Coronary Stent System (EECSS)Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study. | Device | Observational |
Primary outcome
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Time frame: 0 to 407 days
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.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Time frame: 0 to 772 days
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.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Time frame: 0 to 1137 days
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.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Time frame: 0 to 1502 days
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.
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Time frame: 0 to 1867 days
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.
61 secondary outcomes
Number of Participants With Stent Thrombosis
Time frame: 0 to 1867 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
Time frame: 0 to 407 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
Time frame: 0 to 772 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
Time frame: 0 to 1137 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
Time frame: 0 to 1502 days
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization
Time frame: 0 to 1867 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Time frame: 0 to 407 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Time frame: 0 to 772 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Time frame: 0 to 1137 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Time frame: 0 to 1502 days
Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)
Time frame: 0 to 1867 days
Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Time frame: 0 to 407 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Time frame: 0 to 772 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Time frame: 0 to 1137 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Time frame: 0 to 1502 days
Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)
Time frame: 0 to 1867 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Time frame: 0 to 407 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Time frame: 0 to 772 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Time frame: 0 to 1137 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Time frame: 0 to 1502 days
Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))
Time frame: 0 to 1867 days
Number of Participants With Composite Rate of All Death and Any MI
Time frame: 0 to 407 days
Number of Participants With Composite Rate of All Death and Any MI
Time frame: 0 to 772 days
Number of Participants With Composite Rate of All Death and Any MI
Time frame: 0 to 1137 days
Number of Participants With Composite Rate of All Death and Any MI
Time frame: 0 to 1502 days
Number of Participants With Composite Rate of All Death and Any MI
Time frame: 0 to 1867 days
Number of Participants Experiencing Death
Time frame: 0 to 407 days
Number of Participants Experiencing Death
Time frame: 0 to 772 days
Number of Participants Experiencing Death
Time frame: 0 to 1137 days
Number of Participants Experiencing Death
Time frame: 0 to 1502 days
Number of Participants Experiencing Death
Time frame: 0 to 1867 days
Number of Participants With Any MI
Time frame: 0 to 407 days
Number of Participants With Any MI
Time frame: 0 to 772 days
Number of Participants With Any MI
Time frame: 0 to 1137 days
Number of Participants With Any MI
Time frame: 0 to 1502 days
Number of Participants With Any MI
Time frame: 0 to 1867 days
Number of Participants With Revascularization
Time frame: 0 to 407 days
Number of Participants With Revascularization
Time frame: 0 to 772 days
Number of Participants With Revascularization
Time frame: 0 to 1137 days
Number of Participants With Revascularization
Time frame: 0 to 1502 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 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.
Junbo Ge, MB, MSc, MD, FACC, FESC, FSCAI principal investigator
Fudan University
Jiyan Chen, MD principal investigator
Institute of Cardiovascular Guangdong, Guangdong Provincial People's Hospital
YuJie Zhou, MD, Ph.D principal investigator
An Zhen Hospital
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 Angioplasty and Chronic Coronary Occlusion, run by Abbott Medical Devices at 1 site in United States.
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 1 Mar 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 United States. 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 1 Mar 2019). 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 Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) (time frame: 0 to 407 days). The study lists 5 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 1 Mar 2019.