Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- C. R. Bard
- 入组人数
- 80
- 试验地点
- 18
- 主要终点
- Primary Efficacy Endpoint:
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require hemodialysis vascular access.
详细描述
This is a 12 month multi-center non-randomized investigational study to evaluate the safety and efficacy of the FLEX system to create an endovascular AVF in patients with CKD who require hemodialysis vascular access.
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 —（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).
- •Established, non-reversible kidney failure requiring hemodialysis.
- •Written informed consent obtained.
排除标准
- •Functioning surgical access in the planned treatment arm.
- •Pregnant women.
- •New York Heart Association (NYHA) class III or IV heart failure.
- •Allergy to contrast dye.
研究组 & 干预措施
EndoAVF
The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
干预措施: The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access (Device)
结局指标
主要结局
Primary Efficacy Endpoint:
时间窗: within 3 months
The percentage of patients with fistula maturation/usability defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR patient was dialyzed using 2 needles.
次要结局
- Safety Endpoint(within 3 months)
- Cumulative Patency(3, 6 and 12 months)
- EndoAVF-related Re-intervention Rate(3, 6 and 12 months)
- Primary Patency(3, 6 and 12 months)
- Functional Usability(4 weeks post procedure, up to 12 months)