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Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Conservative strategy
Aggressive strategy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Angioplasty, Transluminal, Percutaneous Coronary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conservative strategy

Aggressive strategy

Arm Description

Outcomes

Primary Outcome Measures

Target vessel failure (TVF)
composite of cardiac death, myocardial infarction, target vessel revascularization

Secondary Outcome Measures

Cardiac death
All deaths were considered cardiac unless a definite non-cardiac cause could be established.
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.
Target vessel revascularization (TVR)
TVR was repeat revascularization of the target vessel by PCI or bypass graft surgery.
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.
Stent thrombosis
Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.
Periprocedural enzyme elevation
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
as measured by 9-month quantitative coronary analysis

Full Information

First Posted
November 17, 2008
Last Updated
February 12, 2013
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00794014
Brief Title
Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion
Official Title
Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Angioplasty, Transluminal, Percutaneous Coronary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative strategy
Arm Type
Experimental
Arm Title
Aggressive strategy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Conservative strategy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Aggressive strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Target vessel failure (TVF)
Description
composite of cardiac death, myocardial infarction, target vessel revascularization
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cardiac death
Description
All deaths were considered cardiac unless a definite non-cardiac cause could be established.
Time Frame
12 months
Title
Myocardial infarction (MI)
Description
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
Title
Target vessel revascularization (TVR)
Description
TVR was repeat revascularization of the target vessel by PCI or bypass graft surgery.
Time Frame
12 months
Title
Target lesion revascularization (TLR)
Description
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
Title
Stent thrombosis
Description
Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.
Time Frame
12 months
Title
Periprocedural enzyme elevation
Description
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
Title
the incidence of binary angiographic restenosis in the main branch and side branch
Description
as measured by 9-month quantitative coronary analysis
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeon-Cheol Gwon, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27013152
Citation
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.
Results Reference
derived
PubMed Identifier
23174637
Citation
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.
Results Reference
derived
PubMed Identifier
20938098
Citation
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.
Results Reference
derived

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Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

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