Skip to main content
OpenTrials
Completed

NCT Number: NCT01894152

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Angioplasty Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Disease Cardiovascular Diseases Coronary Artery Disease Coronary Disease Coronary Heart Disease Coronary Restenosis Coronary Stenosis Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Stent Thrombosis Vascular Disease Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott Vascular

Santa Clara, California, 95054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Device

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

Primary outcomes

  1. Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint

    Time frame: ≤ 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 outcomes

  1. Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint

    Time frame: 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.

  2. Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints

    Time frame: ≤ 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.

  3. Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints

    Time frame: 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.

  4. Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint

    Time frame: ≤ 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.

  5. Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint

    Time frame: 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.

  6. Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)

    Time frame: ≤ 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.

  7. Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)

    Time frame: 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.

  8. Number of Participants With Target Lesion Failure (TLF)

    Time frame: ≤ 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.

  9. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 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.

  10. Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)

    Time frame: ≤ 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.

  11. Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)

    Time frame: 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.

  12. Number of All Death (Cardiac, Vascular, and Non-cardiovascular)

    Time frame: ≤ 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.

  13. Number of All Death (Cardiac, Vascular, and Non-cardiovascular)

    Time frame: 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.

  14. Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)

    Time frame: ≤ 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.

  15. Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)

    Time frame: 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.

  16. Number of Participants With All Target Vessel Revascularization (TVR)

    Time frame: ≤ 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.

  17. Number of Participants With All Target Vessel Revascularization (TVR)

    Time frame: 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.

  18. Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])

    Time frame: ≤ 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

  19. Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])

    Time frame: 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

  20. Number of Participants With Acute Stent Thrombosis

    Time frame: 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"

  21. Number of Participants With Sub-acute Stent Thrombosis

    Time frame: > 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"

  22. Number of Participants With Early Stent Thrombosis

    Time frame: 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"

  23. Number of Participants With Late Stent Thrombosis

    Time frame: 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"

  24. Number of Participants With Very Late Stent Thrombosis

    Time frame: > 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"

  25. Number of Participants With Overall Stent Thrombosis

    Time frame: 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"

  26. Number of Participants With Target Vessel ARC MI

    Time frame: ≤ 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.

  27. Number of Participants With Target Vessel ARC MI

    Time frame: 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.

  28. Number of Participants With All TVR (TLR and TVR, Non-target Lesion)

    Time frame: ≤ 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)

  29. Number of Participants With All TVR (TLR and TVR, Non-target Lesion)

    Time frame: 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)

  30. Number of Participants With All TLR

    Time frame: ≤ 7 days after index procedure (Hospitalization)

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  31. Number of Participants With All TLR

    Time frame: 0 to 1885 days

    This study has no primary or secondary endpoints, all endpoints are of equal weight.

  32. Number of Participants With ID-TLR

    Time frame: ≤ 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.

  33. Number of Participants With ID-TLR

    Time frame: 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.

  34. Number of Participants With ID-TVR, Non-target Lesion

    Time frame: ≤ 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.

  35. Number of Participants With ID-TVR, Non-target Lesion

    Time frame: 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.

  36. Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)

    Time frame: ≤ 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.

  37. Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study 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.

Acronym: XP China SAS

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 10, 2013
Registry last updated
May 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.