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Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00794014
First received: November 17, 2008
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Coronary Artery Disease
 Procedure: Conservative strategy
Procedure: Aggressive strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Target vessel failure (TVF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    composite of cardiac death, myocardial infarction, target vessel revascularization


Secondary Outcome Measures:
  • Cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    All deaths were considered cardiac unless a definite non-cardiac cause could be established.

  • Myocardial infarction (MI) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    TVR was repeat revascularization of the target vessel by PCI or bypass graft surgery.

  • Target lesion revascularization (TLR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.

  • Periprocedural enzyme elevation [ Time Frame: during the hospitalization ] [ Designated as safety issue: No ]
    Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure.

  • the incidence of binary angiographic restenosis in the main branch and side branch [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    as measured by 9-month quantitative coronary analysis


Enrollment: 258
Study Start Date: November 2007
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conservative strategy Procedure: 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.
Experimental: Aggressive strategy 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794014

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Hyeon-Cheol Gwon, MD,PhD Samsung Medical Center
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00794014     History of Changes
Other Study ID Numbers: 2007-08-073
Study First Received: November 17, 2008
Last Updated: February 12, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Angioplasty, Transluminal, Percutaneous Coronary

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013