NCT05324787已完成不适用
Single Arm, Multi-center Clinical Trial for the Safety and Effectiveness of Venous Stent System in the Treatment of Vein Stenosis or Occlusion
Hangzhou Endonom Medtech Co., Ltd.2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2019年8月22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
- 112
- 试验地点
- 2
- 主要终点
- Patency rate of venous stent
研究概览
简要总结
To evaluate the safety and effectiveness of Grency 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 effectiveness of a new dedicated venous stent system (Grency) in the treatment of iliac vein stenosis or occlusion. The Grency stent system has a hybrid oblique self-expanding design, which allows precise positioning at the iliocaval confluence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects aged 18-80 years;
- •CEAP clinical grade C >=3;
- •iliac vein stenosis >=50% or occlusion;
- •patients voluntarily sign informed consent and complete follow-up.
排除标准
- •subjects in pregnancy or lactation;
- •renal insufficiency;
- •subjects are allergic to contrast agents and anesthetics;
- •subjects are allergic to nitinol;
- •the life expectancy of cancer patients is less than 1 year;
- •the length of the stent is expected to exceed the length of the inguinal ligament;
- •both sides of iliac vein stents were required;
- •long term bedridden or wheelchair patients;
- •the target vessel of the subject has been implanted into the iliac vein stent;
- •subjects have anticoagulant contraindications or are unable to receive long-term new oral anticoagulant therapy;
- •the investigator judged that the subjects had poor compliance and could not complete the clinical trial;
- •subjects are participating in clinical trials of other drugs or medical devices and have not yet completed the primary end point of the study.
研究组 & 干预措施
Grency venous stent system
Experimental
干预措施: Grency venous stent system (Device)
结局指标
主要结局
Patency rate of venous stent
时间窗: 12 months post-intervention
Freedom from target vessel revascularization ; freedom from in-stent stenosis more than 50% by venography.
次要结局
- Change in the clinical symptoms(Baseline, 3 months,6 months, and12 months post-intervention)
- The rate of device related major adverse events(MAE)(3,6,12 months post-intervention)
- The rate of adverse events (AE)(3,6,12 months post-intervention)
- The rate of procedural technical success(During procedure)
研究者
研究点 (2)
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