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

Coronary Artery Disease Clinical Trial

— XP China SAS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894152
• Other study ID #: 12-396
• Status: Completed
• Start date: July 2013
• Est. completion date: October 9, 2019

Study information

• Verified date: May 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2002
• Est. completion date: October 9, 2019
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angioplasty
• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Coronary Restenosis
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Stent Thrombosis
• Thrombosis
• Vascular Disease
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Abbott Vascular	Santa Clara	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint	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.	0 through 1885 Days
Other	Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints	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 days after index procedure (Hospitalization)
Other	Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints	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.	0 through 1885 Days
Other	Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint	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.	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint	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.	0 through 1885 Days
Other	Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)	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 days after index procedure (Hospitalization)
Other	Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)	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.	0 through 1885 Days
Other	Number of Participants With Target Lesion Failure (TLF)	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.	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With Target Lesion Failure (TLF)	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.	0 through 1885 Days
Other	Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)	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.	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)	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.	0 through 1885 Days
Other	Number of All Death (Cardiac, Vascular, and Non-cardiovascular)	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.	= 7 days after index procedure (Hospitalization)
Other	Number of All Death (Cardiac, Vascular, and Non-cardiovascular)	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.	0 through 1885 Days
Other	Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	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.	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	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.	0 through 1885 Days
Other	Number of Participants With All Target Vessel Revascularization (TVR)	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.	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With All Target Vessel Revascularization (TVR)	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.	0 through 1885 Days
Other	Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])	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	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])	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	0 through 1885 Days
Other	Number of Participants With Acute Stent Thrombosis	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"	0 to 1 day
Other	Number of Participants With Sub-acute Stent Thrombosis	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"	> 1 day to 30 days
Other	Number of Participants With Early Stent Thrombosis	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"	0 - 30 days
Other	Number of Participants With Late Stent Thrombosis	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"	31 to 365 days
Other	Number of Participants With Very Late Stent Thrombosis	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"	> 365 days
Other	Number of Participants With Overall Stent Thrombosis	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"	0 to 1885 days
Other	Number of Participants With Target Vessel ARC MI	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.	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With Target Vessel ARC MI	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.	0 to 1885 days
Other	Number of Participants With All TVR (TLR and TVR, Non-target Lesion)	This study has no primary or secondary endpoints, all endpoints are of equal weight.; All TVR (TLR and TVR, non-target lesion)	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With All TVR (TLR and TVR, Non-target Lesion)	This study has no primary or secondary endpoints, all endpoints are of equal weight.; All TVR (TLR and TVR, non-target lesion)	0 to 1885 days
Other	Number of Participants With All TLR	This study has no primary or secondary endpoints, all endpoints are of equal weight.	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With All TLR	This study has no primary or secondary endpoints, all endpoints are of equal weight.	0 to 1885 days
Other	Number of Participants With ID-TLR	This study has no primary or secondary endpoints, all endpoints are of equal weight.; Revascularization includes TLR, TVR, non-target lesion, and non TVR.	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With ID-TLR	This study has no primary or secondary endpoints, all endpoints are of equal weight.; Revascularization includes TLR, TVR, non-target lesion, and non TVR.	0 to 1885 days
Other	Number of Participants With ID-TVR, Non-target Lesion	This study has no primary or secondary endpoints, all endpoints are of equal weight.; Revascularization includes TLR, TVR, non-target lesion, and non TVR.	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With ID-TVR, Non-target Lesion	This study has no primary or secondary endpoints, all endpoints are of equal weight.; Revascularization includes TLR, TVR, non-target lesion, and non TVR.	0 to 1885 days
Other	Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)	This study has no primary or secondary endpoints, all endpoints are of equal weight.; Revascularization includes TLR, TVR, non-target lesion, and non TVR.	= 7 days after index procedure (Hospitalization)
Other	Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)	This study has no primary or secondary endpoints, all endpoints are of equal weight.; Revascularization includes TLR, TVR, non-target lesion, and non TVR.	0 to 1885 days
Primary	Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint	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.	= 7 days after index procedure (Hospitalization)