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CompletedNCT00794014Updated Feb 13, 2013

Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

An interventional study of Conservative strategy and Aggressive strategy in Coronary Artery Disease, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-13.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
258
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Angioplasty, Transluminal, Percutaneous Coronary
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 258 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
258 participants (actual)

Study arms

  • Experimental
    Conservative strategy

    Procedure: Conservative strategy

  • Experimental
    Aggressive strategy

    Procedure: Aggressive strategy

Interventions

  • ProcedureConservative 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.

  • ProcedureAggressive 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.

06

What researchers measure

Primary outcomes

  1. Target vessel failure (TVF)

    composite of cardiac death, myocardial infarction, target vessel revascularization

    Time frame: 12 months

Secondary outcomes

  1. Cardiac death

    All deaths were considered cardiac unless a definite non-cardiac cause could be established.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  3. Target vessel revascularization (TVR)

    TVR was repeat revascularization of the target vessel by PCI or bypass graft surgery.

    Time frame: 12 months

  4. 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.

    Time frame: 12 months

  5. Stent thrombosis

    Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.

    Time frame: 12 months

  6. Periprocedural enzyme elevation

    Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure.

    Time frame: during the hospitalization

  7. the incidence of binary angiographic restenosis in the main branch and side branch

    as measured by 9-month quantitative coronary analysis

    Time frame: 9 months

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 27013152 ↗
  • 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. PubMed 23174637 ↗
  • 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. PubMed 20938098 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00794014
Lead sponsor
Samsung Medical Center
Responsible party
Hyeon-Cheol Gwon (Professor, Samsung Medical Center) — Principal investigator
First posted
Nov 19, 2008
Start date
Nov 2007
Primary completion
Jan 2012
Completion
Feb 2012
Last update
Feb 13, 2013

Study contacts

Hyeon-Cheol Gwon, MD,PhD
principal investigator · Samsung Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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