Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Conservative strategy; Procedure: Aggressive strategy

• Registration Number: NCT00794014
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-19
• Primary Completion: 2012-01
• Study Completion: 2012-02
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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)
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative strategy	Conservative strategy	-
Aggressive strategy	Aggressive strategy	-

Primary Outcome Measures

Name	Time	Method
Target vessel failure (TVF)	12 months	composite of cardiac death, myocardial infarction, target vessel revascularization

Secondary Outcome Measures

Name	Time	Method
the incidence of binary angiographic restenosis in the main branch and side branch	9 months	as measured by 9-month quantitative coronary analysis
Cardiac death	12 months	All deaths were considered cardiac unless a definite non-cardiac cause could be established.
Myocardial infarction (MI)	12 months	MI was defined as elevated cardiac enzymes (troponin or MB fraction of creatine kinase, CK-MB) more than the upper limit of the normal value with ischemic symptoms or electrocardiography findings indicative of ischemia that was not related to the index procedure.
Target vessel revascularization (TVR)	12 months	TVR was repeat revascularization of the target vessel by PCI or bypass graft surgery.
Target lesion revascularization (TLR)	12 months	TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.
Stent thrombosis	12 months	Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.
Periprocedural enzyme elevation	during the hospitalization	Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of