Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-02-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conservative strategy

Group Type EXPERIMENTAL

Conservative strategy

Intervention Type PROCEDURE

* Main vessel stenting was performed.
* Side branch ballooning and kissing ballooning were done if Thrombolysis In Myocardial Infarction (TIMI) flow \<3 in the side branch after main vessel stenting in non-left main bifurcation (non-LM) subgroup, and diameter stenosis (DS) \>75% in LM subgroup.
* Side branch stenting was performed if TIMI flow \<3 in the Side branch after ballooning in non-LM subgroup, and DS \>50% or dissection in the Side branch after ballooning in LM subgroup.

Aggressive strategy

Group Type EXPERIMENTAL

Aggressive strategy

Intervention Type PROCEDURE

* Main vessel was performed.
* Side branch ballooning and kissing ballooning were done if DS \>75% in the side branch after main vessel stenting in non-LM subgroup, and DS \>50% in LM subgroup.
* Side branch stenting was performed if DS \>50% in the side branch after ballooning in non-LM subgroup, and DS \>30% or dissection in the side branch after ballooning in LM subgroup.

Interventions

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Conservative strategy

* Main vessel stenting was performed.
* Side branch ballooning and kissing ballooning were done if Thrombolysis In Myocardial Infarction (TIMI) flow \<3 in the side branch after main vessel stenting in non-left main bifurcation (non-LM) subgroup, and diameter stenosis (DS) \>75% in LM subgroup.
* Side branch stenting was performed if TIMI flow \<3 in the Side branch after ballooning in non-LM subgroup, and DS \>50% or dissection in the Side branch after ballooning in LM subgroup.

Intervention Type PROCEDURE

Aggressive strategy

* Main vessel was performed.
* Side branch ballooning and kissing ballooning were done if DS \>75% in the side branch after main vessel stenting in non-LM subgroup, and DS \>50% in LM subgroup.
* Side branch stenting was performed if DS \>50% in the side branch after ballooning in non-LM subgroup, and DS \>30% or dissection in the side branch after ballooning in LM subgroup.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No