Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Samsung Medical Center1 site in 1 country258 target enrollmentNovember 2007

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Samsung Medical Center
Enrollment: 258
Locations: 1
Primary Endpoint: Target vessel failure (TVF)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to establish the optimal strategy for side branch stenting in coronary bifurcation lesion.

Detailed Description

The purpose of this study is to evaluate the relative efficacy and safety of conservative strategy compared to aggressive strategy for side branch stenting in coronary bifurcation lesion.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

February 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Hyeon-Cheol Gwon

Professor

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

•Parent vessel diameter stenosis \> 75%
•Parent vessel diameter stenosis 50% - 75% with angina and/or objective evidence of ischemia in the non-invasive stress test
•The reference diameter of both branches more than 2.3 mm by visual estimation

Exclusion Criteria

•Cardiogenic shock
•ST-elevation myocardial infarction within 48 hours of symptom onset
•Left ventricular dysfunction (echocardiographic left ventricular ejection fraction \< 25%)
•Graft vessels
•Patients who have to receive clopidogrel due to other conditions
•Patients who have to receive warfarin, cilostazol or other antiplatelet therapy
•Hypersensitivity to clopidogrel or aspirin
•Expectant survival less than 1 year
•Women who plan to become pregnant
•Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)

Outcomes

Primary Outcomes

Target vessel failure (TVF)

Time Frame: 12 months

composite of cardiac death, myocardial infarction, target vessel revascularization

Secondary Outcomes

the incidence of binary angiographic restenosis in the main branch and side branch(9 months)
Cardiac death(12 months)
Myocardial infarction (MI)(12 months)
Target vessel revascularization (TVR)(12 months)
Target lesion revascularization (TLR)(12 months)
Stent thrombosis(12 months)
Periprocedural enzyme elevation(during the hospitalization)