Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Lesion Complicated by Coronary Dissection (RAISE)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- All cause death
研究概览
简要总结
This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure.
详细描述
Coronary artery dissection is a contraindication for the use of rotational atherectomy, since rotational atherectomy may propagate coronary dissection. In the presence of coronary dissection, conservative management is suggested for approximately 4 weeks to permit the dissection to heal prior to treatment with rotational atherectomy. However, a lot of patients have frequent angina attacks and some patients develop serious complications including abrupt vessel closure during this period. Thus, immediate strategies cope with coronary dissection induced by balloon dilation is needed for the early recovery of those patients. The present study was performed to compare the safety and efficacy of immediate RA and delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 30 and 85 years old
- •nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure
- •Coronary artery dissection type A, B and type C according to the National Heart, Lung and Blood Institute (NHLBI) coronary dissection criteria
排除标准
- •acute myocardial infarction
- •unprotected left main stenosis
- •chronic total occlusion
- •saphenous vein graft lesion
- •cardiomyopathy
- •severe valvular heart disease
- •NYHA functional class IV heart failure at baseline
- •chronic renal failure on hemodialysis
- •severe lung and liver disease or cancer
结局指标
主要结局
All cause death
时间窗: 4 years
cardiac death and non-cardiac death
次要结局
- Left ventricular ejection fraction (LVEF)(4 years)
- Stent thrombosis(4 years)
- New York Heart Association (NYHA) class IV heart failure(4 years)
- Non-fatal myocardial infarction(4 years)
- Cardiac tamponade(4 years)
- Stroke(4 years)
- 6-min walk distance (6MWD)(4 years)
- angina class(4 years)
- Target lesion revascularization(4 years)