A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 19
- 主要终点
- Primary patency of AV fistula
研究概览
简要总结
This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.
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
- •Patients referred for creation of a new brachiocephalic or radiocephalic fistula who consent to take part in the study.
- •Age 18-80 years
- •Male and female participants
- •Patients willing and able to attend follow up visits over a period of 12 months
排除标准
- •Patients with the planned index procedure being a revision surgery of an existing fistula.
- •Target Brachial artery smaller than 2.5 mm or larger than 6 mm or Radial artery smaller than 2.5 mm or larger than 4 mm in outer diameter by preoperative ultrasound
- •Target vein outer diameter smaller than 2.5 mm by preoperative ultrasound
- •Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on pre-op ultrasound (scan should include the area between the planned anastomosis site and the Axillary vein)
- •Unusual anatomy or vessel dimensions (observed on pre-operative US or intraoperatively) and which preclude adequate fit of the VasQ.
- •Patients with prior central venous stenosis or obstruction on the side of surgery
- •Depth of vein greater than 8 mm (on ultrasound) on side of surgery
- •Known coagulation disorder
- •Congestive heart failure NYHA class ≥ 3
- •Prior steal on the side of surgery as evident from the patient's medical history
- •Known allergy to nitinol
- •Life expectancy less than 18 months
- •Patients expected to undergo kidney transplant within 6 months of enrollment
- •Women of child bearing potential without documented current negative pregnancy test
- •Inability to give consent and/or comply with the study follow up schedule
结局指标
主要结局
Primary patency of AV fistula
时间窗: 6 months post AVF creation
Freedom from any intervention designed to maintain or reestablish patency since device placement and demonstrate flow on Doppler US. 1 = Success = Intervention free access patency determined by Doppler ultrasound. 0 = Failure = Access occluded determined by Doppler ultrasound and/or underwent intervention
次要结局
未报告次要终点