Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Coronary Artery Disease Clinical Trial

Official title:

Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794014
• Other study ID #: 2007-08-073
• Status: Completed
• Phase: N/A
• First received: November 17, 2008
• Last updated: February 12, 2013
• Start date: November 2007
• Est. completion date: February 2012

Study information

• Verified date: February 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vessel failure (TVF)	composite of cardiac death, myocardial infarction, target vessel revascularization	12 months	Yes
Secondary	Cardiac death	All deaths were considered cardiac unless a definite non-cardiac cause could be established.	12 months	Yes
Secondary	Myocardial infarction (MI)	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.	12 months	Yes
Secondary	Target vessel revascularization (TVR)	TVR was repeat revascularization of the target vessel by PCI or bypass graft surgery.	12 months	No
Secondary	Target lesion revascularization (TLR)	TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.	12 months	No
Secondary	Stent thrombosis	Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.	12 months	Yes
Secondary	Periprocedural enzyme elevation	Periprocedural enzyme elevation was defined as a rise in CK-MB =3 times the upper normal limit after the index procedure.	during the hospitalization	No
Secondary	the incidence of binary angiographic restenosis in the main branch and side branch	as measured by 9-month quantitative coronary analysis	9 months	No