NCT02119845已完成不适用
A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol FLEX-1-001
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- C. R. Bard
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.
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
- •Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
- •Adult (age >18 years old).
- •Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis.
- •Written informed consent obtained
排除标准
- 未提供
研究组 & 干预措施
Endovascular AVF (EndoAVF)
Experimental
The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.
干预措施: Endovascular AVF (EndoAVF) (Device)
结局指标
主要结局
Adverse Events
时间窗: 6 months
The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.
次要结局
- Access Functionality(6 Months)
研究者
研究点 (2)
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