NCT01899235终止4 期
The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Patient ≥ 18years old
- •Stable angina symptoms
- •Elective treatment to coronary lesion
- •Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection
排除标准
- •Left main stem lesion
- •Bifurcation lesions
- •Acute coronary syndrome (UAP, NSTEMI, STEMI)
- •Cardiogenic shock
- •Chronic total occlusion
- •Additional lesions requiring PCI
- •Platelet count ≤ 50 x 109/mm3
- •Left ventricular ejection fraction ≤ 30%
- •Patient life expectancy less than 12 months
- •Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel
- •Participation in another investigational drug or device study
- •Patient unable to give informed consent
研究组 & 干预措施
Stent
Active Comparator
drug eluting stent (Resolute)
干预措施: drug eluting stent (Device)
drug eluting balloon
Experimental
drug eluting balloon (Elutax)
干预措施: drug eluting balloon (Device)
结局指标
主要结局
Major adverse cardiac events
时间窗: 3 months
次要结局
未报告次要终点
研究者
Svend Eggert Jensen
Associate professor, MD, PhD
Aalborg University Hospital
研究点 (1)
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