NCT01798433
Completed
Not Applicable
A Prospective, Multi-center, Randomized Study to Evaluate the Optimal Strategy for Side Branch Treatment in Patients With Left Main Coronary Bifurcation Lesion
ConditionsCoronary Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Samsung Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Target lesion failure
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective 2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.
In patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique with mandatory final kissing ballooning is superior to 1-stent technique without kissing ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.
Investigators
Hyeon-Cheol Gwon
Professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Age ≥20 years
- •Left main bifurcation lesion on coronary angiography
- •Significant myocardial ischemia Main vessel (left main coronary artery and left anterior descending artery) and/or side branch (left circumflex artery) diameter stenosis \> 75%, or diameter stenosis 50-75% with angina and/or objective evidence of ischemia in the non-invasive stress test
- •Significant size of the main branch (left anterior descending artery) and side branch (left cirmflex artery) - The reference diameter of both branches ≥ 2.5 mm by visual estimation
Exclusion Criteria
- •The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus
- •Patients who have received DES implantation in the target lesion prior to enrollment
Outcomes
Primary Outcomes
Target lesion failure
Time Frame: 12-month
defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization
Secondary Outcomes
- Cardiac death(12-month)
- Angiographic in-segment restenosis rate(9 months)
- Target vessel revascularization (TVR)(12-month)
- Stent thrombosis(12-month)
- Myocardial infarction (MI)(12-month)
- Target lesion revascularization (TLR)(12-month)
- Periprocedural CK-MB elevation(the first 48 hours after PCI)
- Procedure success rate(the first 48 hours after PCI)
- Procedure time(immediate after PCI)
- Amount of contrast dye(immediate after PCI)
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
The European Bifurcation Club Left Main StudyPercutaneous Transluminal Coronary AngioplastyCoronary Artery DiseaseNCT02497014European Cardiovascular Research Center450
Recruiting
Not Applicable
The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte TechniqueCoronary Artery DiseaseNCT05488665Yonsei University512
Completed
Phase 3
European Bifurcation Club Trial - Two-stent Versus One-stent Technique for Large Bifurcation LesionsCoronary DiseaseNCT01560455Royal Sussex County Hospital200
Completed
Not Applicable
Interventional therapy of bifurcation lesions: A flow-guided concept to treat side branches in bifurcation lesions - a prospective randomized clinical study (THUEringer BIfurcation Study, THUEBIS-Study)ISRCTN22637771Berka Clinic, Department of Cardiology (Zentralklinik Bad Berka, Klinik für Kardiologie) (Germany)110
Completed
Not Applicable
Bifurcation Lesion Analysis and Stentingatherosclerotic plaquecoronary disease10011082NL-OMON33545Volcano Europe SA/NV15