NCT01375465Unknown4 期
The 001-DIOR Multicenter Registry (A Novel Percutaneous Coronary Intervention With the New Paclitaxel-eluting Balloon DIOR in Ostial Bifurcated Lesions)
适应症
试验速览
- 阶段
- 4 期
- 发起方
- Eurocor GmbH
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Major adverse cardiac events (MACE)
研究概览
简要总结
The 001 DIOR study is a prospective, multicenter registry of percutaneous coronary intervention (PCI) to assess the clinical success, efficacy and safety of the Paclitaxel-eluting balloon DIOR (Eurocor GmbH, Germany) for the treatment of de novo ostial bifurcated lesions (001 of Medina classification). The DIOR balloon will be used to treat the stenotic site branch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •De novo bifurcated lesions 001 of Medina classification, with significant stenosis only in the ostium of the side branch and a reference vessel diameter is bigger or equal 2.0mm; the DIOR balloon will be used to the treat the side branch.
- •The patient has clinical evidence of myocardial ischemia (stable or unstable angina, acute and non acute myocardial infarction, silent ischemia: ECG, exercise test, etz...)
- •As the maximal length of the DIORTM balloon is 30 mm, all eligible lesions should be no longer than 25 mm to ensure an adequate drug elution in the treated segment, avoiding the phenomenon of "geographical miss" .
- •Target lesion(s) stenosis is more or equal 50% by visual estimation.
排除标准
- •Cardiogenic shock
- •Any serious disease that might limit patient survival to less than one year
- •Inability to perform clinical follow-up for a period of 1 year
- •Left main bifurcation lesions: ostial left circumflex or ostial left anterior descending artery stenosis.
- •Lesion length > 25 mm
- •Target vessel reference diameter < 2mm
- •Stenosis < 50% of the reference luminal diameter
- •Severe angiographic calcification at the level of the target lesion
结局指标
主要结局
Major adverse cardiac events (MACE)
时间窗: 6 months
MACE rate defined as the rate of cardiac death and/or myocardial infarction (MI) and/or target lesion revascularization (TLR)
次要结局
- Segment treated thrombosis (STT), according to ARC definitions(6 months)
- Late Lumen Loss(6 months)
- Binary restenosis rate(6 months)
- target vessel revascularization (TVR) rate, either symptom or ischemia-driven(6 months)
研究者
研究点 (3)
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