Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

NCT00794014 | Completed

• 1 other identifier: 2007-08-073
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Angioplasty, Transluminal, Percutaneous Coronary

Outcome Measures

Primary Outcomes (1)

• Target vessel failure (TVF)

  composite of cardiac death, myocardial infarction, target vessel revascularization

  12 months

Secondary Outcomes (7)

• Cardiac death

  12 months

• Myocardial infarction (MI)

  12 months

• Target vessel revascularization (TVR)

  12 months

• Target lesion revascularization (TLR)

  12 months

• Stent thrombosis

  12 months

Study Arms (2)

Conservative strategy

EXPERIMENTAL

Procedure: Conservative strategy

Aggressive strategy

EXPERIMENTAL

Procedure: Aggressive strategy

Interventions

Conservative strategy PROCEDURE

* 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.

Conservative strategy

Aggressive strategy PROCEDURE

* 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.

Aggressive strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (3)

• Song YB, Park TK, Hahn JY, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC. Optimal Strategy for Provisional Side Branch Intervention in Coronary Bifurcation Lesions: 3-Year Outcomes of the SMART-STRATEGY Randomized Trial. JACC Cardiovasc Interv. 2016 Mar 28;9(6):517-26. doi: 10.1016/j.jcin.2015.11.037.

  PMID: 27013152 DERIVED

• Song YB, Hahn JY, Song PS, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC. Randomized comparison of conservative versus aggressive strategy for provisional side branch intervention in coronary bifurcation lesions: results from the SMART-STRATEGY (Smart Angioplasty Research Team-Optimal Strategy for Side Branch Intervention in Coronary Bifurcation Lesions) randomized trial. JACC Cardiovasc Interv. 2012 Nov;5(11):1133-40. doi: 10.1016/j.jcin.2012.07.010.

  PMID: 23174637 DERIVED

• Hahn JY, Song YB, Choi JH, Choi SH, Lee SY, Park HS, Hur SH, Lee S, Han KR, Rha SW, Cho BR, Park JS, Yoon J, Lim DS, Lee SH, Gwon HC; DATE Registry Investigators. Three-month dual antiplatelet therapy after implantation of zotarolimus-eluting stents: the DATE (Duration of Dual Antiplatelet Therapy AfterImplantation of Endeavor Stent) registry. Circ J. 2010 Nov;74(11):2314-21. doi: 10.1253/circj.cj-10-0347. Epub 2010 Oct 2.

  PMID: 20938098 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hyeon-Cheol Gwon, MD,PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

KR (1)