Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in Target Lumen assessed by optical coherence tomography
研究概览
简要总结
This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.
详细描述
Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18, < 80 years old, with unstable angina
- •Single-vessel or double-vessel disease
- •Length of target lesion < 25mm
- •Diameter of target vessel >2.5mm, < 3.5mm
排除标准
- •Left main disease
- •Chronic total occlusion
- •Severe Tortuosity
- •Heavy calcification
- •Severe liver failure, moderate or severe kidney failure
- •Malignant disease
- •Active infectious disease
- •Pregnancy or breastfeeding
研究组 & 干预措施
drug eluting balloon group
patients with unstable angina were randomised to drug eluting balloon group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon(Flextome Cutting Balloon, Boston Scientific Corporation, US) pre-dilation first and then drug eluting balloon(Sequent please; B. Braun, Melsungen, Germany) .
干预措施: drug eluting balloon; cutting balloon (Device)
drug eluting stent group
patients with unstable angina were randomised to this group for drug eluting stent (YINYI® Polymer-free Drug-coated (Paclitaxel) Coronary Stent System, Liaoning Biomedical Materials R&D Center Co., Ltd. China) implantation.
干预措施: drug eluting stent (Device)
结局指标
主要结局
Changes in Target Lumen assessed by optical coherence tomography
时间窗: 12 months
A coronary de novo lesion in patient after intervened was measured with optical coherence tomography .To measure the changes in target lumen at 12 months.
次要结局
- Incidence rate of MACE(Incidence rate of MACE from baseline to 12 months)
研究者
Yun Dai Chen
MD
Chinese PLA General Hospital