Overview

This trial is active, not recruiting.

Conditions angioplasty, cardiovascular disease, coronary artery disease, coronary heart disease, coronary restenosis, myocardial infarction, stent thrombosis, vascular disease
Treatment xience prime everolimus eluting coronary stent system (eecss)
Sponsor Abbott Vascular
Start date July 2013
End date September 2019
Trial size 2003 participants
Trial identifier NCT01894152, 12-396

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
xience prime everolimus eluting coronary stent system (eecss)
Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Primary Outcomes

Measure
Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave)
time frame: 1 year
Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave)
time frame: 2 years
Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave)
time frame: 3 years
Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave)
time frame: 4 years
Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave)
time frame: 5 years
Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave)
time frame: 1 year
Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave)
time frame: 2 years
Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave)
time frame: 3 years
Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave)
time frame: 4 years
Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave)
time frame: 5 years
Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR)
time frame: 1 year
Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR)
time frame: 2 years
Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR)
time frame: 3 years
Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR)
time frame: 4 years
Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR)
time frame: 5 years
Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia driven target vessel revascularization (ID-TVR)
time frame: 1 year
Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia driven target vessel revascularization (ID-TVR)
time frame: 2 years
Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia driven target vessel revascularization (ID-TVR)
time frame: 3 years
Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia driven target vessel revascularization (ID-TVR)
time frame: 4 years
Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia driven target vessel revascularization (ID-TVR)
time frame: 5 years
Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition)
time frame: 1 year
Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition)
time frame: 2 years
Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition)
time frame: 3 years
Stent thrombosis (definite and probable, per Academic Research Consortium [ARC] definition)
time frame: 4 years
Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition)
time frame: 5 years
Death (cardiac, vascular, and non-cardiovascular)
time frame: 1 year
Death (cardiac, vascular, and non-cardiovascular)
time frame: 2 years
Death (cardiac, vascular, and non-cardiovascular)
time frame: 3 years
Death (cardiac, vascular, and non-cardiovascular)
time frame: 4 years
Death (cardiac, vascular, and non-cardiovascular)
time frame: 5 years
All MI (including Q-wave and non-Q-wave)
time frame: 1 year
All MI (including Q-wave and non-Q-wave)
time frame: 2 years
All MI (including Q-wave and non-Q-wave)
time frame: 3 years
All MI (including Q-wave and non-Q-wave)
time frame: 4 years
All MI (including Q-wave and non-Q-wave)
time frame: 5 years
Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG])
time frame: 1 year
Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG])
time frame: 2 years
Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG])
time frame: 3 years
Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG])
time frame: 4 years
Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG])
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 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.

Additional Information

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.
Principal investigator Junbo Ge, MB, MSc, MD, FACC, FESC, FSCAI
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Abbott Vascular.