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XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study

XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01249027
Acronym
XV CHINA SAS
Enrollment
2605
Registered
2010-11-29
Start date
2010-11-30
Completion date
2017-01-31
Last updated
2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty, Chronic Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Restenosis, Myocardial Ischemia, Stent Thrombosis, Vascular Disease

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

Abbott Medical Devices
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frameDescription
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 daysCardiac 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

MeasureTime frameDescription
Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization0 to 407 daysAll 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 daysCardiac 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 daysTarget 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 daysTarget 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 daysIschemia-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 MI0 to 407 daysAll 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 Death0 to 407 daysCardiac 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 Thrombosis0 to 1867 daysDefinite 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 Revascularization0 to 407 daysRevascularization: * 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 daysBleeding 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 yearDual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.
Number of Participants With All Target Lesions Revascularization0 to 407 daysTarget 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 Revascularization0 to 772 daysTarget 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 Revascularization0 to 407 daysTarget 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 MI0 to 407 daysMyocardial 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

ArmCount
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
Total2,482

Baseline characteristics

CharacteristicObservational
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
896 Participants
Age, Categorical
Between 18 and 65 years
1586 Participants
Age, Continuous60.69 years
STANDARD_DEVIATION 11.13
Sex: Female, Male
Female
626 Participants
Sex: Female, Male
Male
1856 Participants

Adverse events

Event typeEG000
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

Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber 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
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber 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
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber 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
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber 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
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber 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
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants Compliance With Dual Anti-platelet Therapy (DAPT)879 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants Compliance With Dual Anti-platelet Therapy (DAPT)800 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants Compliance With Dual Anti-platelet Therapy (DAPT)2231 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants Compliance With Dual Anti-platelet Therapy (DAPT)1085 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants Compliance With Dual Anti-platelet Therapy (DAPT)934 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants Experiencing Death98 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants Experiencing Death113 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants Experiencing Death34 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants Experiencing Death64 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants Experiencing Death75 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With All Target Lesion Revascularization30 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With All Target Lesion Revascularization33 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With All Target Lesion Revascularization21 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With All Target Lesions Revascularization25 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With All Target Lesions Revascularization12 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With All Target Vessel Revascularization20 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With All Target Vessel Revascularization53 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With All Target Vessel Revascularization60 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With All Target Vessel Revascularization42 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With All Target Vessel Revascularization36 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Any MI13 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Any MI28 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Any MI23 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Any MI20 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Any MI31 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of All Death and Any MI137 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of All Death and Any MI46 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of All Death and Any MI80 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of All Death and Any MI92 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of All Death and Any MI120 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization191 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization90 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization154 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization235 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization271 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)95 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)35 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)62 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)71 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)87 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))136 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))123 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))100 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))86 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))50 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Major Bleeding Complications (According to GUSTO Classification)18 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Major Bleeding Complications (According to GUSTO Classification)14 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Major Bleeding Complications (According to GUSTO Classification)18 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Major Bleeding Complications (According to GUSTO Classification)26 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Major Bleeding Complications (According to GUSTO Classification)31 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Revascularization154 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Revascularization49 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Revascularization83 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Revascularization111 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Revascularization132 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Stent ThrombosisDefinite5 Participants
ObservationalNumber of Participants With Stent ThrombosisDefinite & Probable10 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)60 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)69 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)85 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)93 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ObservationalNumber of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)35 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026