Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease. A Multicenter, Prospective, Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- In-stent late lumen loss
研究概览
简要总结
The primary purpose of this study is to evaluate the long term effects of the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions.
详细描述
Calcification is an essential part of all atherosclerotic plaques. Its extent increases with the progression of atherosclerotic disease. Heavily calcified lesions form a particular threat to DES; both damage to the polymer coating during vigorous advancement and inadequate diffusion of the drug to the subintima through extensive calcium arcs could contribute to the ineffectiveness of DES when implanted into such lesions, or may lead to primary stent delivery or expansion failure. Rotational atherectomy can effectively ablate calcified plaques. In the DES era, data concerning rotational atherectomy are scarce. DES implantation following rotablation seems a rational combination, but is only poorly supported by controlled studies. In the present study, we are using the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions. This prospective, randomized, controlled study aims at evaluating the long term effects of both strategies in this complex cohort of patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angiographically proven coronary artery disease
- •Angina II-IV° following the Canadian Cardiovascular Society Classification criteria and/or reproducible ischemia in the target area by ECG or scintigraphy
- •The patient signing an informed written consent
- •From the following angiographic criteria, lesions must fulfil all first degree criteria and at least one second-degree criterion to be eligible for inclusion.
- •First degree criteria
- •De-novo lesion in a native coronary artery
- •Target reference vessel diameter between 2.5 and 4.0 mm by visual estimation
- •Luminal diameter reduction of 70-99% by visual estimation
- •Moderate to severe calcification of the target lesion (clearly defined)
- •Second degree criteria
- •Ostial location
- •Bifurcational lesions
- •Long lesions (≥ 15mm)
排除标准
- •Myocardial infarction within 4 weeks
- •Left ventricular ejection fraction < 30%
- •Limited long term prognosis due to other conditions
- •Angiographic exclusion criteria:
- •Unprotected left main lesions
- •Coronary artery bypass graft stenoses
- •In-stent restenoses
- •Chronic total occlusions
- •Target vessel thrombus
- •Target vessel dissection
研究组 & 干预措施
Rotational Atherectomy + PES
Elective lesion preparation with rotational atherectomy priot to stent implantation
干预措施: Rotational Atherectomy + PES (Procedure)
Standard Treatment (PES without Rotational Atherectomy)
Stenting without prior rotational atherectomy, usually preceeded with balloon dilatation
干预措施: Standard Treatment (PES without Rotational Atherectomy) (Procedure)
结局指标
主要结局
In-stent late lumen loss
时间窗: 9 months
次要结局
- Major adverse cardiac events (MACE)(9 months)
- In-segment late lumen loss(9 months)
- In-segment binary restenosis(9 months)
- Primary angiographic success(Immediate)
- Procedural duration and contrast dye amount(Immediate)
- Strategy success(Immediate)