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Clinical Trials/NCT00794014
NCT00794014CompletedNot Applicable

Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Samsung Medical Center2 sites in 1 country258 target enrollmentStarted: November 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
258
Locations
2
Primary Endpoint
Target vessel failure (TVF)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hyeon-Cheol Gwon

Professor

Samsung Medical Center

Study Sites (2)

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Optimal Strategy for Side Branch Stenting... | Clinical Trial