NCT01637896终止4 期
A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation: the ELICOPTER Trial
Leonardo Bolognese, MD1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2010年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- angiographic binary re-restenosis
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent implantation in terms of restenosis
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
- Double (Participant, Outcomes Assessor)
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
- •age> 18 years
- •angina or stress test positive for ischemia
- •de novo coronary stenosis>50%
排除标准
- •recent myocardial infarction (<72h)
- •severe chronic kidney disease
- •allergy to Paclitaxel
- •contraindication for combined antiplatelet treatment
- •life expectancy <1 year
- •hypersensitivity or contraindication to one of the study drugs
- •lack of consent
研究组 & 干预措施
DEB+BMS
Experimental
drug-eluting balloon predilation and bare metal stent implantation
干预措施: DEB+BMS (Device)
POBA+DES
Active Comparator
conventional balloon predilation and drug-eluting stent implantation
干预措施: POBA+DES (Device)
结局指标
主要结局
angiographic binary re-restenosis
时间窗: 9 months
incidence of angiographic binary re-restenosis
次要结局
- Late luminal loss(9 months)
- major adverse cardiac events(12 months)
研究者
Leonardo Bolognese, MD
Director
Ospedale San Donato
研究点 (1)
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