Angioplasty, Chronic Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Restenosis, Myocardial Ischemia, Stent Thrombosis, Vascular Disease
Conditions
Keywords
Drug eluting stents, Stents, China, DES, XIENCE V EECSS
Brief 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 compliance to dual antiplatelet therapy (DAPT)
Interventions
Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
Sponsors
Study design
Eligibility
Inclusion criteria
* 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.
Exclusion criteria
* The inability to obtain a signed ICF
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization | 0 to 407 days | 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. |
| Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) | 0 to 407 days | 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. |
| Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) | 0 to 407 days | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
| Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) | 0 to 772 days | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
| Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) | 0 to 407 days | 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. |
| Number of Participants With Composite Rate of All Death and Any MI | 0 to 407 days | 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. |
| Number of Participants Experiencing Death | 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). \- Non-cardiac death is defined as a death not due to cardiac causes (as defined above). |
| Number of Participants With Stent Thrombosis | 0 to 1867 days | 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. |
| Number of Participants With Revascularization | 0 to 407 days | 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. |
| Number of Participants With Major Bleeding Complications (According to GUSTO Classification) | 0 to 407 days | 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. |
| Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) | 1 year | Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other. |
| Number of Participants With All Target Lesions Revascularization | 0 to 407 days | 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. |
| Number of Participants With All Target Lesion Revascularization | 0 to 772 days | 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. |
| Number of Participants With All Target Vessel Revascularization | 0 to 407 days | 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. |
| Number of Participants With Any MI | 0 to 407 days | 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. |
Countries
United States
Participant flow
Recruitment details
XIENCE V China SAS was designed to enroll approximately 2500 patients. The first patient was enrolled on November 26, 2010. The enrollment was completed on December 10, 2011, with a total of 2605 patients enrolled at 53 sites. Of 2605 patients, a total of 123 subjects were withdrawn. Per protocol population is 2482.
Pre-assignment details
A total of 123 subjects were withdrawn due to following reasons: 82 subjects had incomplete informed consent procedures;11 subjects enrolled repeatedly;1 subject did not have a stent at the starting point for surgery;18 subjects surgically implanted with other stents at the start;1 subject withdrew informed consent;10 subjects deregistered.
Participants by arm
| Arm | Count |
|---|---|
| Observational Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS).
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. | 2,482 |
| Total | 2,482 |
Baseline characteristics
| Characteristic | Observational |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 896 Participants |
| Age, Categorical Between 18 and 65 years | 1586 Participants |
| Age, Continuous | 60.69 years STANDARD_DEVIATION 11.13 |
| Sex: Female, Male Female | 626 Participants |
| Sex: Female, Male Male | 1856 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 113 / 2,482 |
| other Total, other adverse events | 113 / 2,482 |
| serious Total, serious adverse events | 574 / 2,482 |
Outcome results
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.
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | 84 Participants |
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.
Time frame: 0 to 772 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | 55 Participants |
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.
Time frame: 0 to 1137 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | 63 Participants |
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.
Time frame: 0 to 407 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | 33 Participants |
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.
Time frame: 0 to 1502 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) | 76 Participants |
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.
Time frame: 4 years
Population: Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) | 879 Participants |
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.
Time frame: 5 years
Population: Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) | 800 Participants |
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.
Time frame: 1 year
Population: Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) | 2231 Participants |
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.
Time frame: 2 years
Population: Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) | 1085 Participants |
Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)
Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.
Time frame: 3 years
Population: Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT) | 934 Participants |
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).
Time frame: 0 to 1502 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants Experiencing Death | 98 Participants |
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).
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants Experiencing Death | 113 Participants |
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).
Time frame: 0 to 407 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants Experiencing Death | 34 Participants |
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).
Time frame: 0 to 772 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants Experiencing Death | 64 Participants |
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).
Time frame: 0 to 1137 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants Experiencing Death | 75 Participants |
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.
Time frame: 0 to 1502 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With All Target Lesion Revascularization | 30 Participants |
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.
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With All Target Lesion Revascularization | 33 Participants |
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.
Time frame: 0 to 772 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With All Target Lesion Revascularization | 21 Participants |
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.
Time frame: 0 to 1137 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With All Target Lesions Revascularization | 25 Participants |
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.
Time frame: 0 to 407 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With All Target Lesions Revascularization | 12 Participants |
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.
Time frame: 0 to 407 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With All Target Vessel Revascularization | 20 Participants |
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.
Time frame: 0 to 1502 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With All Target Vessel Revascularization | 53 Participants |
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.
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With All Target Vessel Revascularization | 60 Participants |
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.
Time frame: 0 to 1137 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With All Target Vessel Revascularization | 42 Participants |
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.
Time frame: 0 to 772 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With All Target Vessel Revascularization | 36 Participants |
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.
Time frame: 0 to 407 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Any MI | 13 Participants |
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.
Time frame: 0 to 1502 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Any MI | 28 Participants |
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.
Time frame: 0 to 1137 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Any MI | 23 Participants |
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.
Time frame: 0 to 772 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Any MI | 20 Participants |
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.
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Any MI | 31 Participants |
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.
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of All Death and Any MI | 137 Participants |
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.
Time frame: 0 to 407 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of All Death and Any MI | 46 Participants |
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.
Time frame: 0 to 772 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of All Death and Any MI | 80 Participants |
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.
Time frame: 0 to 1137 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of All Death and Any MI | 92 Participants |
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.
Time frame: 0 to 1502 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of All Death and Any MI | 120 Participants |
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.
Time frame: 0 to 1137 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization | 191 Participants |
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.
Time frame: 0 to 407 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization | 90 Participants |
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.
Time frame: 0 to 772 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization | 154 Participants |
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.
Time frame: 0 to 1502 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization | 235 Participants |
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.
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization | 271 Participants |
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.
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) | 95 Participants |
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.
Time frame: 0 to 407 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) | 35 Participants |
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.
Time frame: 0 to 772 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) | 62 Participants |
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.
Time frame: 0 to 1137 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) | 71 Participants |
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.
Time frame: 0 to 1502 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR) | 87 Participants |
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.
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) | 136 Participants |
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.
Time frame: 0 to 1502 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) | 123 Participants |
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.
Time frame: 0 to 1137 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) | 100 Participants |
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.
Time frame: 0 to 772 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) | 86 Participants |
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.
Time frame: 0 to 407 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR)) | 50 Participants |
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
Time frame: 0 to 1867 days
Population: Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Major Bleeding Complications (According to GUSTO Classification) | 18 Participants |
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.
Time frame: 0 to 407 days
Population: Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Major Bleeding Complications (According to GUSTO Classification) | 14 Participants |
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
Time frame: 0 to 772 days
Population: Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Major Bleeding Complications (According to GUSTO Classification) | 18 Participants |
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
Time frame: 0 to 1137 days
Population: Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Major Bleeding Complications (According to GUSTO Classification) | 26 Participants |
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
Time frame: 0 to 1502 days
Population: Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Major Bleeding Complications (According to GUSTO Classification) | 31 Participants |
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.
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Revascularization | 154 Participants |
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.
Time frame: 0 to 407 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Revascularization | 49 Participants |
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.
Time frame: 0 to 772 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Revascularization | 83 Participants |
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.
Time frame: 0 to 1137 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Revascularization | 111 Participants |
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.
Time frame: 0 to 1502 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Revascularization | 132 Participants |
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.
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-followup, defined as subjects who are lost to followup through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Observational | Number of Participants With Stent Thrombosis | Definite | 5 Participants |
| Observational | Number of Participants With Stent Thrombosis | Definite & Probable | 10 Participants |
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).
Time frame: 0 to 772 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) | 60 Participants |
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).
Time frame: 0 to 1137 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) | 69 Participants |
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).
Time frame: 0 to 1502 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) | 85 Participants |
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).
Time frame: 0 to 1867 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) | 93 Participants |
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).
Time frame: 0 to 407 days
Population: Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR) | 35 Participants |