Clinical trial NCT00794014: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Angioplasty, Transluminal, Percutaneous Coronary
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-11-19
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Target vessel failure (TVF)
timeFrame: 12 months
Secondary outcomes:
measure: Cardiac death
timeFrame: 12 months
measure: Myocardial infarction (MI)
timeFrame: 12 months
measure: Target vessel revascularization (TVR)
timeFrame: 12 months
measure: Target lesion revascularization (TLR)
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 12 months
measure: Periprocedural enzyme elevation
timeFrame: during the hospitalization
measure: the incidence of binary angiographic restenosis in the main branch and side branch
timeFrame: 9 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyeon-Cheol Gwon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.