Safety and Efficacy of ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Iliac, Femoral and Popliteal Artery Stenosis or Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 主要终点
- Late Lumen Loss at 6 months after operation
研究概览
简要总结
Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion
详细描述
The purpose of this study was to evaluate the safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter (paclitaxel 3±1 μg/mm2 balloon surface area) in the treatment of iliac artery, femoral artery and popliteal stenosis or occlusive lesions compared with conventional PTA balloon dilatation catheter.
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
- Single (Participant)
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
- •Aged from 18 to 85 years old, male or female
- •Subject's target lesions were stenosis and/or occlusion
- •Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent
排除标准
- •Pregnant woman or who's pregnancy test is positive
- •Lactation period woman or woman/man with fertility plan
研究组 & 干预措施
Group A
subjects using the drug-eluting PTA balloon dilatation catheter
干预措施: ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter (Device)
Group B
subjects using the peripheral balloon dilatation catheter
干预措施: Peripheral Balloon Dilatation Catheter (Device)
结局指标
主要结局
Late Lumen Loss at 6 months after operation
时间窗: 6 months
Late Lumen Loss
次要结局
- The incidence of major adverse events(12 months)
- Adverse Event(Preoperative、Intraoperative、up to 1 month、3 months、6 months、9 months、12 months)