A Prospective, Multi-center, Randomized Study to Evaluate the Optimal Strategy for Side Branch Treatment in Patients With Left Main Coronary Bifurcation Lesion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Target lesion failure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
One stent technique alone
One stent technique alone for non-true LM bifurcation
干预措施: One stent technique alone (Device)
One stent technique + Elective FKB
One stent technique + Elective FKB for non-true LM bifurcation
干预措施: One stent technique + Elective FKB (Device)
Provisional approach
Provisional approach for true LM bifurcation
干预措施: Provisional approach (Procedure)
Elective 2-stent
Elective 2-stent for true LM bifurcation
干预措施: Elective 2-stent (Device)
结局指标
主要结局
Target lesion failure
时间窗: 12-month
defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization
次要结局
- 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)
研究者
Hyeon-Cheol Gwon
Professor
Samsung Medical Center