Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion - Full Text View

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00794014

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

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

9-month target vessel revascularization (TVR) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	400
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Conservative strategy: Experimental	Procedure: Conservative strategy stenting of main vessel side branch dilation & kissing ballooning if there was Thrombolysis In Myocardial Infarction (TIMI) flow <3 in the side branch side branch stenting if TIMI flow <3 in the side branch after dilation
Aggressive strategy: Experimental	Procedure: Aggressive strategy stenting of main vessel side branch dilation & kissing ballooning if there was diameter stenosis >75% in the side branch side branch stenting if there was diameter stenosis >50% in the side branch or side branch dissection after dilation

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

Contacts

Contact: Hyeon-Cheol Gwon, MD,PhD	82-2-3410-3418	hcgwon@skku.edu
Contact: Young Bin Song, MD	82-2-3410-3419	youngbin.song@gmail.com

Locations

Korea, Republic of
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyoen-Cheol Gwon, MD,PhD 82-2-3410-3418 hcgwon@skku.edu
Contact: Young Bin Song, MD 82-2-3410-3419 youngbin.song@gmail.com

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:

Hyeon-Cheol Gwon, MD,PhD

Samsung Medical Center

More Information

Responsible Party:	Samsung Medical Center ( HC Gwon,MD,PhD/Professor )
Study ID Numbers:	2007-08-073
Study First Received:	November 17, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00794014
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

Angioplasty, Transluminal, Percutaneous Coronary

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009