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

November 17, 2008
February 12, 2013
November 2007
January 2012   (final data collection date for primary outcome measure)
Target vessel failure (TVF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
composite of cardiac death, myocardial infarction, target vessel revascularization
9-month target vessel revascularization (TVR) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00794014 on ClinicalTrials.gov Archive Site
  • 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
  • Patients-oriented composite outcomes, including all cause death, any myocardial infarction, and any revascularization by Academic Research Consortium Proposed Standard [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • 9-month angiographic restenosis rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • 9-month stent thrombosis rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Periprocedural CK-MB elevation [ Time Frame: during the index hospitalization ] [ Designated as safety issue: Yes ]
  • Procedure success rate [ Time Frame: at the end of the index procedure ] [ Designated as safety issue: No ]
  • Procedure time [ Time Frame: at the end of the index procedure ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion
Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • 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.
  • 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.
  • Experimental: Conservative strategy
    Intervention: Procedure: Conservative strategy
  • Experimental: Aggressive strategy
    Intervention: Procedure: Aggressive strategy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
258
February 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00794014
2007-08-073
Not Provided
Hyeon-Cheol Gwon, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Hyeon-Cheol Gwon, MD,PhD Samsung Medical Center
Samsung Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP