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Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

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Samsung Medical Center

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Procedure: Conservative strategy
Procedure: Aggressive strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT00794014
2007-08-073

Details and patient eligibility

About

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

Full 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.

Enrollment

258 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

258 participants in 2 patient groups

Conservative strategy
Experimental group
Treatment:
Procedure: Conservative strategy
Aggressive strategy
Experimental group
Treatment:
Procedure: Aggressive strategy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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