NCT04812444已完成不适用
Safety and Efficacy of Peripheral Venous Stent System in the Treatment of Patients With Iliac Vein Stenosis or Occlusion: a Prospective, Multicentre, Randomized Controlled Clinical Trial.
Zhejiang Zylox Medical Device Co., Ltd.1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2020年10月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Target vascular patency rate at 12 months after operation
研究概览
简要总结
Clinical study on safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusion.
详细描述
The purpose of this study was to evaluate the safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusive lesions compare with conventional venous stent.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 to 75 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
Zilver Vena Venous Stent Implantation
Active Comparator
Percutaneous stent placement in the iliofemoral veins
干预措施: Zilver Vena Venous Stent (Device)
Zylox Peripheral Venous Stent Implantation
Experimental
Percutaneous stent placement in the iliofemoral veins
干预措施: Zylox Peripheral Venous Stent (Device)
结局指标
主要结局
Target vascular patency rate at 12 months after operation
时间窗: 12 months
Target vascular patency rate
次要结局
- Adverse Event(Preoperative、Intraoperative、up to 1 month、3 month、6 month、12 month、2 years、3 years、5 years)
- The incidence of major adverse events(12 months)
研究者
研究点 (1)
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