A Prospective, Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Brachiocephalic Arteriovenous Fistula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events
研究概览
简要总结
This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence and promote laminar flow. The device is designed to improve short term maturation and long term patency of the fistula. The VasQ is a permanent implant intended for use as a subcutaneous arteriovenous conduit support for vascular access.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study.
- •Aged > 18
- •Male and female participants
- •Patients willing and able to attend follow up visits over a period of 6 months
排除标准
- •Patients who require revision surgery.
- •Having had previous arteriovenous fistula surgery is not a contraindication to recruitment provided the new procedure is not revision surgery
- •Target arteries smaller than 3 mm in diameter
- •Target vein smaller than 3 mm in diameter
- •Stenotic veins on the side of surgery as diagnosed on pre-op ultrasound
- •Patients with prior central venous stenosis or obstruction on the side of surgery
- •Depth of vein greater than 8 mm (on US) on side of surgery
- •Known coagulation disorder
- •Prior steal
- •Known allergy to nitinol
- •Life expectancy less than 6 months
- •Inability to give consent and/or comply with the study follow up schedule
- •Women of child bearing age
研究组 & 干预措施
AV fistula with VasQ
Implant VasQ over AV fistula
干预措施: VasQ (Device)
AV fistula
AV fistula without any adjunct device
结局指标
主要结局
Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events
时间窗: 6 months
次要结局
- Secondary efficacy endpoint: Percentage of AVF physiologically matured(3 months)
- Secondary efficacy endpoint: Primary patency of the study AVF, defined as percentage of patent AVF free from surgical or endovascular interventions(6 months)
- Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound(1, 3, and 6 months)
- Secondary efficacy endpoint: Secondary patency of the study AVF, defined as percentage of patent AVF following surgical or endovascular interventions(6 months)