Evaluation of Effectiveness and Safety of the GENOUS STENT in ST-Segment Elevation Myocardial Infarction

Seung-Jung Park16 sites in 1 country464 target enrollmentMay 2010

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Seung-Jung Park
Enrollment: 464
Locations: 16
Primary Endpoint: composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Status: Completed
Last Updated: 10 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 GENOUS EPC-coated stent in patients with STEMI with other drug-eluting stents (DESs).

Detailed Description

This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of GENOUS stent in STEMI patients with other-type DESs.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

June 2014

Last Updated

10 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

•STEMI Patients requiring primary PCI.
•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 with cardiogenic shock

Outcomes

Primary Outcomes

composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)

Time Frame: 12 months post procedure

Secondary Outcomes

TVR(yearly up to 5 years)
Death (all cause and cardiac)(yearly up to 5 years)
MI(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)
Target-lesion revascularization (TLR)(6 months)
Stent thrombosis (ARC criteria)(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)(in-hospital)