Comparison of Double-kissing Crush and Double-kissing Culotte Stenting in Patients With True Bifurcation Lesion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- MACE (major adverse cardiovascular events)
研究概览
简要总结
True bifurcation lesions (TBLs) are not rare clinical conditions and may be associated with adverse cardiovascular outcomes due to their complex anatomy and the variety of interventional therapy. Although the provisional stenting is still effective in suitable lesions, double stent techniques can be required in selected patients. In previous studies, double kissing crush (DK-crush) stenting was revealed as superior to provisional stenting in TBL of left main coronary artery. Additionally, in recent studies, double kissing approach facilitates and highlights double kissing culotte (DK-culotte) stenting with lower stent malapposition compared to DK-crush stenting. However, to the best of our knowledge, there is no study about comparing DK-crush and DK-culotte stenting in TBLs. Our aim in this study is to compare DK-crush and DK-culotte stenting in patients with TBL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with de novo true bifurcation lesion (Medina classification 1,1,1 or 0,1,1 or 1,0,1)
- •The main vessel diameter is least 2.5 mm and the side branch diameter is at least 2.25 mm
排除标准
- •Patients presenting with ST segment elevation myocardial infarction, cardiogenic shock and Killip class III-IV heart failure
- •Patients with a history of coronary artery bypass grafting surgery
- •Patients with a chronic total occlusion in the bifurcation area
- •Lesions with severe calcification that needs additional intervention such as atherectomy
- •Patients who are not suitable to use long term dual antiplatelet therapy and patients not participating in clinical follow-up
- •Patients with hematological disorders, malignancy, end stage renal (GFR<30 ml/min) and hepatic failure
- •Patients with active bleeding
- •Pregnant women
- •Patients with life-expectancy < 1 year
结局指标
主要结局
MACE (major adverse cardiovascular events)
时间窗: 12 months
target vessel revascularization, myocardial infarction and cardiac death
次要结局
- target lesion failure(24, 36 months)
- MACCEs (major adverse cerebral and cardiovascular events)(12, 24, 36 months)
研究者
Serkan Kahraman
Associate Professor
Istanbul Mehmet Akif Ersoy Educational and Training Hospital