Evaluation of Effectiveness and Safety of XIENCE PRIME™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Seung-Jung Park29 sites in 1 country2,000 target enrollmentApril 2011

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Seung-Jung Park
Enrollment: 2000
Locations: 29
Primary Endpoint: composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in the "real world" daily practice as compared with other drug eluting stents (DESs)

Detailed Description

This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of XIENCE PRIME stents versus other DESs in patients with coronary artery disease.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

September 2017

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Seung-Jung Park

Responsible Party

Sponsor Investigator

Principal Investigator

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

CardioVascular Research Foundation, Korea

Eligibility Criteria

Inclusion Criteria

•Patients receiving XIENCE PRIME stents.
•The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria

•Patients with a mixture of other DESs
•Terminal illness with life expectancy \<1 year
•Patients presented with cardiogenic shock

Outcomes

Primary Outcomes

composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)

Time Frame: 12 months post procedure

Secondary Outcomes

Death (all cause and cardiac)(yearly up to 5 years)
MI(yearly up to 5 years)
TVR(yearly up to 5 years)
Target-lesion revascularization (TLR)(yearly up to 5 years)
Stent thrombosis (ARC criteria)(yearly up to 5 years)
Composite of death or MI(yearly up to 5 years)
Composite of cardiac death or MI(yearly up to 5 years)
Procedural success (defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization)(At discharge from the index hospitalization)