XP China SAS: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT01894152

Collaborator

(none)

2,002

Enrollment

Location

75.3

Duration (Months)

26.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.

This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China.

This study has no primary outcome measure. All observations are of equal weight.

Condition or Disease	Intervention/Treatment	Phase
Angioplasty Cardiovascular Disease Coronary Artery Disease Coronary Heart Disease Coronary Restenosis Myocardial Infarction Stent Thrombosis Vascular Disease	Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Study Design

Study Type:

Observational

Actual Enrollment :

2002 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluate the Continued Safety and Effectiveness of the XIENCE PRIME EECSS in a Cohort of Real-world Patients Receiving the XIENCE PRIME EECSS During Commercial Use.

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Oct 9, 2019

Actual Study Completion Date :

Oct 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)	Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Arm

Intervention/Treatment

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Outcome Measures

Primary Outcome Measures

Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint [≤ 7 days after index procedure (Hospitalization)]
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 Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.

Other Outcome Measures

Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint [0 through 1885 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 Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints [≤ 7 days after index procedure (Hospitalization)]
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints [0 through 1885 Days]
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint [≤ 7 days after index procedure (Hospitalization)]
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): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction. Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint [0 through 1885 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): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction. Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI) [≤ 7 days after index procedure (Hospitalization)]
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI) [0 through 1885 Days]
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With Target Lesion Failure (TLF) [≤ 7 days after index procedure (Hospitalization)]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With Target Lesion Failure (TLF) [0 through 1885 Days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization) [≤ 7 days after index procedure (Hospitalization)]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization) [0 through 1885 Days]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of All Death (Cardiac, Vascular, and Non-cardiovascular) [≤ 7 days after index procedure (Hospitalization)]
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.) This study as no primary or secondary endpoints, all endpoints are of equal weight. - Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of All Death (Cardiac, Vascular, and Non-cardiovascular) [0 through 1885 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.) This study as no primary or secondary endpoints, all endpoints are of equal weight. - Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) [≤ 7 days after index procedure (Hospitalization)]
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 This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave) [0 through 1885 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 This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With All Target Vessel Revascularization (TVR) [≤ 7 days after index procedure (Hospitalization)]
Target Vessel Revascularization 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 which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With All Target Vessel Revascularization (TVR) [0 through 1885 Days]
Target Vessel Revascularization 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 which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [≤ 7 days after index procedure (Hospitalization)]
This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention
Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [0 through 1885 Days]
This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention
Number of Participants With Acute Stent Thrombosis [0 to 1 day]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Number of Participants With Sub-acute Stent Thrombosis [> 1 day to 30 days]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Number of Participants With Early Stent Thrombosis [0 - 30 days]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Number of Participants With Late Stent Thrombosis [31 to 365 days]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Number of Participants With Very Late Stent Thrombosis [> 365 days]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Number of Participants With Overall Stent Thrombosis [0 to 1885 days]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Number of Participants With Target Vessel ARC MI [≤ 7 days after index procedure (Hospitalization)]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (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 Target Vessel ARC MI [0 to 1885 days]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (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 All TVR (TLR and TVR, Non-target Lesion) [≤ 7 days after index procedure (Hospitalization)]
This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion)
Number of Participants With All TVR (TLR and TVR, Non-target Lesion) [0 to 1885 days]
This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion)
Number of Participants With All TLR [≤ 7 days after index procedure (Hospitalization)]
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With All TLR [0 to 1885 days]
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Number of Participants With ID-TLR [≤ 7 days after index procedure (Hospitalization)]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Number of Participants With ID-TLR [0 to 1885 days]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Number of Participants With ID-TVR, Non-target Lesion [≤ 7 days after index procedure (Hospitalization)]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Number of Participants With ID-TVR, Non-target Lesion [0 to 1885 days]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion) [≤ 7 days after index procedure (Hospitalization)]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion) [0 to 1885 days]
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient must be at least 18 years of age at the time of signing the informed consent.
The patient or his/her legally-authorized representative signs the European Commission (EC)-approved Informed Consent Form (ICF).
Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.

Exclusion Criteria:

No other exclusion criteria are specified for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abbott Vascular	Santa Clara	California	United States	95054

Sponsors and Collaborators

Abbott Medical Devices

Investigators

Principal Investigator: Junbo Ge, MB, MSc, MD, Fudan University
Principal Investigator: Fang Chen, MD, Anzhen Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT01894152

Other Study ID Numbers:

12-396

First Posted:

Jul 10, 2013

Last Update Posted:

May 26, 2020

Last Verified:

May 1, 2020

Keywords provided by Abbott Medical Devices

XIENCE PRIME SV (Small Vessel)

XIENCE PRIME LL (Long Lesion)

Coronary Artery Disease

Coronary Heart Disease

Cardiovascular Disease

Myocardial Infarction

Stent Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Myocardial Infarction

Study Results

Participant Flow

Recruitment Details	A total of 2140 patients were registered from 35 centres in China. First patients was enrolled on July 12, 2013 & enrollment was completed on Sep11, 2014 through the Interactive Voice Response System (IVRS) excluding those without consent and those without stent implants & duplicate entries. Thus the analysis population includes 2002 participants .
Pre-assignment Detail	Of the 2140 registered subjects,138 subjects withdrew from the study due to incomplete consent forms, no implanted study stents and repeated entry in voice interactive selection system. Among the final analysis population (n=2002), a total of 151 subjects failed to complete the follow-up period.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Period Title: Overall Study
STARTED	2002
COMPLETED	1851
NOT COMPLETED	151

Baseline Characteristics

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Overall Participants	2002
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1286 64.2%
>=65 years	716 35.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.42 (10.72)
Sex: Female, Male (Count of Participants)
Female	501 25%
Male	1501 75%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	2002 100%
Region of Enrollment (Count of Participants)
China	2002 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
Description	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 Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	7 0.3%

2. Other Pre-specified Outcome

Title	Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
Description	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 Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	0 through 1885 Days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	114 5.7%

3. Other Pre-specified Outcome

Title	Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints
Description	All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	8 0.4%

4. Other Pre-specified Outcome

Title	Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints
Description	All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	0 through 1885 Days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	330 16.5%

5. Other Pre-specified Outcome

Title	Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint
Description	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): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction. Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	5 0.2%

6. Other Pre-specified Outcome

Title	Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint
Description	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): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction. Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	0 through 1885 Days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	120 6%

7. Other Pre-specified Outcome

Title	Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)
Description	All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	8 0.4%

8. Other Pre-specified Outcome

Title	Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)
Description	All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	0 through 1885 Days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	156 7.8%

9. Other Pre-specified Outcome

Title	Number of Participants With Target Lesion Failure (TLF)
Description	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	5 0.2%

10. Other Pre-specified Outcome

Title	Number of Participants With Target Lesion Failure (TLF)
Description	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	0 through 1885 Days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	100 5%

11. Other Pre-specified Outcome

Title	Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	7 0.3%

12. Other Pre-specified Outcome

Title	Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	0 through 1885 Days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	180 9%

13. Other Pre-specified Outcome

Title	Number of All Death (Cardiac, Vascular, and Non-cardiovascular)
Description	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.) This study as no primary or secondary endpoints, all endpoints are of equal weight. - Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	3 0.1%

14. Other Pre-specified Outcome

Title	Number of All Death (Cardiac, Vascular, and Non-cardiovascular)
Description	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.) This study as no primary or secondary endpoints, all endpoints are of equal weight. - Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	0 through 1885 Days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	91 4.5%

15. Other Pre-specified Outcome

Title	Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Description	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 This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	6 0.3%

16. Other Pre-specified Outcome

Title	Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Description	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 This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	0 through 1885 Days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	75 3.7%

17. Other Pre-specified Outcome

Title	Number of Participants With All Target Vessel Revascularization (TVR)
Description	Target Vessel Revascularization 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 which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	0 0%

18. Other Pre-specified Outcome

Title	Number of Participants With All Target Vessel Revascularization (TVR)
Description	Target Vessel Revascularization 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 which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	0 through 1885 Days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	26 1.3%

19. Other Pre-specified Outcome

Title	Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	1 0%

20. Other Pre-specified Outcome

Title	Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention
Time Frame	0 through 1885 Days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	223 11.1%

21. Other Pre-specified Outcome

Title	Number of Participants With Acute Stent Thrombosis
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Time Frame	0 to 1 day

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	0 0%

22. Other Pre-specified Outcome

Title	Number of Participants With Sub-acute Stent Thrombosis
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Time Frame	> 1 day to 30 days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	2 0.1%

23. Other Pre-specified Outcome

Title	Number of Participants With Early Stent Thrombosis
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Time Frame	0 - 30 days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	2 0.1%

24. Other Pre-specified Outcome

Title	Number of Participants With Late Stent Thrombosis
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Time Frame	31 to 365 days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	1 0%

25. Other Pre-specified Outcome

Title	Number of Participants With Very Late Stent Thrombosis
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Time Frame	> 365 days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	0 0%

26. Other Pre-specified Outcome

Title	Number of Participants With Overall Stent Thrombosis
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"
Time Frame	0 to 1885 days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	3 0.1%

27. Other Pre-specified Outcome

Title	Number of Participants With Target Vessel ARC MI
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (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	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	2 0.1%

28. Other Pre-specified Outcome

Title	Number of Participants With Target Vessel ARC MI
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (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 1885 days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	23 1.1%

29. Other Pre-specified Outcome

Title	Number of Participants With All TVR (TLR and TVR, Non-target Lesion)
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion)
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	1 0%

30. Other Pre-specified Outcome

Title	Number of Participants With All TVR (TLR and TVR, Non-target Lesion)
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion)
Time Frame	0 to 1885 days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	84 4.2%

31. Other Pre-specified Outcome

Title	Number of Participants With All TLR
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	1 0%

32. Other Pre-specified Outcome

Title	Number of Participants With All TLR
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight.
Time Frame	0 to 1885 days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	58 2.9%

33. Other Pre-specified Outcome

Title	Number of Participants With ID-TLR
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	1 0%

34. Other Pre-specified Outcome

Title	Number of Participants With ID-TLR
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time Frame	0 to 1885 days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	37 1.8%

35. Other Pre-specified Outcome

Title	Number of Participants With ID-TVR, Non-target Lesion
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	0 0%

36. Other Pre-specified Outcome

Title	Number of Participants With ID-TVR, Non-target Lesion
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time Frame	0 to 1885 days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	22 1.1%

37. Other Pre-specified Outcome

Title	Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time Frame	≤ 7 days after index procedure (Hospitalization)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	1 0%

38. Other Pre-specified Outcome

Title	Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)
Description	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Time Frame	0 to 1885 days

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Measure Participants	1851
Count of Participants [Participants]	59 2.9%

Adverse Events

	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Time Frame	5 years
Adverse Event Reporting Description

Arm/Group Title	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Arm/Group Description	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	91/2002 (4.5%)
Serious Adverse Events
	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
	Affected / at Risk (%)	# Events
Total	1105/2002 (55.2%)
Blood and lymphatic system disorders
ANEMIA	1/2002 (0%)
BLOOD DISEASE	1/2002 (0%)
MASSIVE ABDOMINAL HEMORRHAGE	1/2002 (0%)
Cardiac disorders
CHEST PAIN-CARDIAC	16/2002 (0.8%)
CHEST PAIN AND CHEST TIGHTNESS (CHD)	4/2002 (0.2%)
ACUTE CORONARY SYNDROME	7/2002 (0.3%)
ACUTE HEART FAILURE	3/2002 (0.1%)
ACUTE NON - ST SEGMENT ELEVATION MYOCARDIAL INFARCTION	6/2002 (0.3%)
ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION	1/2002 (0%)
ANGINA PECTORIS	49/2002 (2.4%)
UNSTABLE ANGINA PECTORIS	169/2002 (8.4%)
CHEST TIGHTNESS-CARDIAC	9/2002 (0.4%)
ARRHYTHMIA	10/2002 (0.5%)
ARRHYTHMIA PERMANENT PACEMAKER IMPLANTATION	1/2002 (0%)
ARRHYTHMIA, ATRIAL FIBRILLATION	1/2002 (0%)
ATRIAL FIBRILLATION	13/2002 (0.6%)
ATRIAL FLUTTER	2/2002 (0.1%)
ATRIAL PREMATURE BEAT	1/2002 (0%)
VENTRICULAR PREMATURE BEAT	3/2002 (0.1%)
CORONARY HEART DISEASE	236/2002 (11.8%)
CARDIAC ARREST	1/2002 (0%)
CARDIAC DYSFUNCTION	1/2002 (0%)
CARDIAC ENLARGEMENT	1/2002 (0%)
CARDIAC INSUFFICIENCY	1/2002 (0%)
CARDIAC RESPIRATORY ARREST	1/2002 (0%)
CARDIAC TAMPONADE	1/2002 (0%)
CHRONIC CORONARY INSUFFICIENCY	1/2002 (0%)
HEART FAILURE	24/2002 (1.2%)
CONGENITAL ATRIAL SEPTAL DEFECT	1/2002 (0%)
CORONARY ATHEROSCLEROTIC CARDIOPATHY	13/2002 (0.6%)
CORONARY HEART DISEASE DEATH	2/2002 (0.1%)
EXTRASYSTOLE	1/2002 (0%)
HEART PALPITATIONS	1/2002 (0%)
HYDROPERICARDIUM	2/2002 (0.1%)
ISCHEMIC CARDIOMYOPATHY	3/2002 (0.1%)
LETHAL MYOCARDIAL INFARCTION	2/2002 (0.1%)
MYOCARDIAL INFARCTION	66/2002 (3.3%)
OLD MYOCARDIAL INFARCTION	7/2002 (0.3%)
MYOCARDIAL BRIDGE	1/2002 (0%)
NON-TARGET VESSEL REVASCULARIZATION	5/2002 (0.2%)
PRECORDIAL DISTRESS	2/2002 (0.1%)
SICK SINUS SYNDROME	1/2002 (0%)
TACHYCARDIA-BRADYCARDIA SYNDROME	1/2002 (0%)
TARGET LESION REVASCULARIZATION	1/2002 (0%)
TRANSIENT ISCHEMIC ATTACK	1/2002 (0%)
TVR or TLR	21/2002 (1%)
VENTRICULAR FIBRILLATION	2/2002 (0.1%)
CHRONIC HEART FAILURE	1/2002 (0%)
Eye disorders
BINOCULAR CATARACT	1/2002 (0%)
LEFT EYE SENILE CATARACT	1/2002 (0%)
RIGHT EYE CATARACT	1/2002 (0%)
TRACTIONAL RETINAL DETACHMENT	1/2002 (0%)
RIGHT EYE SENILE CATARACT (MATURE PERIOD)	1/2002 (0%)
Gastrointestinal disorders
UPPER GASTROINTESTINAL HEMORRHAGE	8/2002 (0.4%)
GASTROINTESTINAL HEMORRHAGE	19/2002 (0.9%)
BLACK STOOL	1/2002 (0%)
CHRONIC GASTRITIS	2/2002 (0.1%)
CHRONIC NON-ATROPHIC GASTRITIS WITH BILE REFLUX	1/2002 (0%)
CHRONIC NON-ATROPHIC GASTRITIS WITH EROSION	1/2002 (0%)
GASTRIC ULCER	1/2002 (0%)
GASTRIC ULCER WITH BLEEDING	3/2002 (0.1%)
LEFT INGUINAL HERNIA	1/2002 (0%)
General disorders
CHEST PAIN	58/2002 (2.9%)
CHEST PAIN AND CHEST TIGHTNESS	8/2002 (0.4%)
CHEST TIGHTNESS	63/2002 (3.1%)
BREASTBONE HIND TIGHTENING FEELING	1/2002 (0%)
CHEST BLEEDING	1/2002 (0%)
CHEST DISCOMFORT	3/2002 (0.1%)
CHEST DISTRESS	7/2002 (0.3%)
CHEST HEART PALPITATIONS	1/2002 (0%)
DEATH	42/2002 (2.1%)
DISCOMFORT IN THE ANTERIOR REGION OF THE HEART	1/2002 (0%)
DIZZY	4/2002 (0.2%)
EDEMA	1/2002 (0%)
INTERMITTENT CHEST DISCOMFORT	1/2002 (0%)
SYNCOPE	5/2002 (0.2%)
MULTI-ORGAN FAILURE	1/2002 (0%)
NECK DISCOMFORT	1/2002 (0%)
PALPITATION	9/2002 (0.4%)
THE AREA BEFORE THE HEART PALPITATIONS, SHORTNESS	1/2002 (0%)
THE AREA BEFORE THE HEART TIGHTNESS	1/2002 (0%)
THE LIMBS SWELLING	1/2002 (0%)
TO TREAT OTHER VASCULAR LESIONS	1/2002 (0%)
VERTIGO SYNDROME	1/2002 (0%)
WEAK	1/2002 (0%)
Hepatobiliary disorders
ACUTE PANCREATITIS	1/2002 (0%)
CONSTRICTIVE PERICARDITIS	1/2002 (0%)
HEMORRHAGE OF LIVER	1/2002 (0%)
LIVER FAILURE	2/2002 (0.1%)
Injury, poisoning and procedural complications
NON-TARGET VESSEL PCI	1/2002 (0%)
PCI POSTOPERATIVE UPPER GASTROINTESTINAL BLEEDING	1/2002 (0%)
POSTOPERATIVE PCI	1/2002 (0%)
REVASCULARIZATION	7/2002 (0.3%)
REVASCULARIZATION OF LCX	1/2002 (0%)
REVIEW AFTER PCI	1/2002 (0%)
STENT THROMBOSIS	3/2002 (0.1%)
STENT RESTENOSIS	1/2002 (0%)
TOXIC MULTIPLE NEUROPATHY CAUSED BY DRUG	1/2002 (0%)
Investigations
CORONARY HEART DISEASE AND POST- PCI	3/2002 (0.1%)
CORONARY HEART DISEASE REEXAMINATION	2/2002 (0.1%)
CORONORY ANGIOGRAPHY(NOS)	1/2002 (0%)
Metabolism and nutrition disorders
DIABETES MELLITUS	3/2002 (0.1%)
DIABETIC KETOACIDOSIS CAUSE THE DEATH	1/2002 (0%)
HYPERGLYCEMIA	2/2002 (0.1%)
HYPERTHYREOSIS	1/2002 (0%)
Musculoskeletal and connective tissue disorders
GOUT	1/2002 (0%)
PATHOLOGICAL FRACTURE	1/2002 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER	1/2002 (0%)
CANCER	2/2002 (0.1%)
CANCER OF THE STOMACH	1/2002 (0%)
CANCER METASTASIS	1/2002 (0%)
COLORECTAL CANCER	2/2002 (0.1%)
DESCENDING COLON TUMOR	1/2002 (0%)
ESOPHAGEAL MALIGNANT TUMOR	1/2002 (0%)
LIVER CANCER	1/2002 (0%)
LIVER CYST	1/2002 (0%)
LUNG CANCER	1/2002 (0%)
LYMPHOMA	1/2002 (0%)
PROSTATIC HYPERPLASIA	1/2002 (0%)
PULMONARY HEMANGIOMA	1/2002 (0%)
SACRAL TUMOR	1/2002 (0%)
SMALL CELL LUNG CANCER	1/2002 (0%)
STOMACH CANCER	1/2002 (0%)
BILATERAL OVARIAN CYSTS	1/2002 (0%)
Nervous system disorders
ACUTE BRAINSTEM INFARCTION	1/2002 (0%)
ANGIONEUROEDEMA	1/2002 (0%)
CEREBRAL INSUFFICIENCY	1/2002 (0%)
CERVICAL HEADACHE	1/2002 (0%)
DEATH(CEREBRAL INFARCTION AND CEREBRAL HERNIA)	1/2002 (0%)
GUILLAIN-BARRE SYNDROME	1/2002 (0%)
ISCHEMIC CEREBROVASCULAR DISEASE	1/2002 (0%)
LACUNAR INFARCTION	2/2002 (0.1%)
LEFT TEMPORAL LOBE BRAIN CONTUSION	1/2002 (0%)
LUMBAR SPINAL STENOSIS	1/2002 (0%)
STROKE	1/2002 (0%)
SUBARACHNOID HEMORRHAGE	1/2002 (0%)
Renal and urinary disorders
BILATERAL URETERAL CALCULI	2/2002 (0.1%)
RENAL FAILURE	2/2002 (0.1%)
RIGHT HYDRONEPHROSIS WITH URETERAL STRICTURE	1/2002 (0%)
Reproductive system and breast disorders
ENDOMETRIAL LESIONS	1/2002 (0%)
OOPHORITIC CYST	1/2002 (0%)
VAGINAL BLEEDING	1/2002 (0%)
Respiratory, thoracic and mediastinal disorders
BRONCHIAL ASTHMA	2/2002 (0.1%)
SHORTNESS OF BREATH	5/2002 (0.2%)
ANHELATION	2/2002 (0.1%)
CHEST TIGHTNESS AND SHORTNESS OF BREATH	2/2002 (0.1%)
COPD	1/2002 (0%)
LEFT PLEURAL EFFUSION	1/2002 (0%)
LUNG INFECTION	2/2002 (0.1%)
MAXILLARY SINUSITIS	1/2002 (0%)
MIXED LUNG VENTILATION DYSFUNCTION	1/2002 (0%)
PNEUMONIA	5/2002 (0.2%)
PULMONARY FIBROSIS	1/2002 (0%)
PULMONARY INFECTION	3/2002 (0.1%)
PULMONARY MULTILOBE PNEUMONIA	1/2002 (0%)
RESPIRATORY FAILURE	1/2002 (0%)
SEVERE PNEUMONIA AND RESPIRATORY FAILURE	1/2002 (0%)
TYPE I RESPIRATORY FAILURE	1/2002 (0%)
Skin and subcutaneous tissue disorders
LACERATION OF SCALP SOFT TISSUE	1/2002 (0%)
Vascular disorders
ABDOMINAL ANEURYSM	1/2002 (0%)
ABNORMAL VESSELS IN CORONARY ARTERIES	1/2002 (0%)
ARTERIOSCLEROSIS OBLITERANS OF LOWER EXTREMITY	1/2002 (0%)
ATHEROSCLEROSIS	1/2002 (0%)
CAROTID ARTERY OCCLUSION	1/2002 (0%)
CEREBRAL HEMORRHAGE	7/2002 (0.3%)
CEREBRAL INFARCTION	12/2002 (0.6%)
HYPERTENSION	7/2002 (0.3%)
INSUFFICIENT BLOOD SUPPLY TO THE CEREBRAL ARTERY	1/2002 (0%)
POSTERIOR CIRCULATION ISCHEMIA	5/2002 (0.2%)
PULMONARY EMBOLISM	1/2002 (0%)
SEQUELAE OF CEREBRAL INFARCTION	2/2002 (0.1%)
VASCULAR STENOSIS	1/2002 (0%)
VENTRICULAR ANEURYSM	2/2002 (0.1%)
Other (Not Including Serious) Adverse Events
	XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
	Affected / at Risk (%)	# Events
Total	103/2002 (5.1%)
Blood and lymphatic system disorders
HEMORRHOIDAL BLEEDING	2/2002 (0.1%)
Cardiac disorders
ANGINA PECTORIS	10/2002 (0.5%)
AURICULAR FIBRILLATION	1/2002 (0%)
CHEST PAIN - CARDIAC	1/2002 (0%)
CORONARY ARTERY DISEASE	3/2002 (0.1%)
HEART FAILURE	2/2002 (0.1%)
MI	2/2002 (0.1%)
PREMATURE BEAT	2/2002 (0.1%)
REPERFUSION ARRHYTHMIA	2/2002 (0.1%)
RESTING ANGINA	1/2002 (0%)
UNSTABLE ANGINA	10/2002 (0.5%)
Eye disorders
BLEEDING IN EYES	3/2002 (0.1%)
Gastrointestinal disorders
DEFECATE HAEMORRHAGE	2/2002 (0.1%)
GASTRIC COLIC	1/2002 (0%)
GASTROINTESTINAL BLEEDING	8/2002 (0.4%)
UPSET STOMACH	2/2002 (0.1%)
General disorders
BLEEDING	1/2002 (0%)
BLEEDING GUMS	6/2002 (0.3%)
CHEST PAIN	5/2002 (0.2%)
CHEST TIGHTEN AND CARDIOPALMUS	1/2002 (0%)
CHEST TIGHTNESS	4/2002 (0.2%)
DIZZY	1/2002 (0%)
FEEL SUFFOCATED	1/2002 (0%)
HEMORRHAGIC SPOT	1/2002 (0%)
PALPITATION	3/2002 (0.1%)
SHORT OF BREATH	1/2002 (0%)
STOMACHACHE	1/2002 (0%)
SYNCOPE	1/2002 (0%)
TOOTHACHE	1/2002 (0%)
	1/2002 (0%)
Injury, poisoning and procedural complications
OM1 SEGMENT OCCLUDED	1/2002 (0%)
Investigations
CNI IS HIGHER THAN NORMAL VALUE	1/2002 (0%)
ELEVATED TROPOLIN T	3/2002 (0.1%)
ELEVATED TROPONIN I	6/2002 (0.3%)
Nervous system disorders
LACUNAR INFARCTION	1/2002 (0%)
VAGAL REFLEX	1/2002 (0%)
VERTEBRAL STENOSIS	1/2002 (0%)
Respiratory, thoracic and mediastinal disorders
NOSE BLEEDING	2/2002 (0.1%)
Skin and subcutaneous tissue disorders
SUBCUTANEOUS HEMORRHAGE	5/2002 (0.2%)
PRURITUS	1/2002 (0%)
SKIN ALLERGY	1/2002 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title	Roy Leong
Organization	Abbott Vascular
Phone	+65 (6277) 3202
Email	roy.leong@abbott.com

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT01894152

Other Study ID Numbers:

12-396

First Posted:

Jul 10, 2013

Last Update Posted:

May 26, 2020

Last Verified:

May 1, 2020

XP China SAS: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Other Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

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Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact