A Multi-center Prospective Study to Evaluate the Safety and Effectiveness 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
- 144
- 试验地点
- 29
- 主要终点
- Primary Patency of AVF
研究概览
简要总结
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow.
All patients will be implanted with the VasQ device and will be followed up for a duration of 24 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
- •Main study cohort: Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study and which are not indicated for a more distal fistula per treatment guidelines.
- •Supplementary study cohort: Patients referred for creation of a new forearm fistula who consent to take part in the study.
- •Male and female participants.
- •Age 18-80 years.
- •Patients willing and able to attend follow up visits over a period of 24 months.
排除标准
- •Patients with the planned index procedure being a revision surgery of an existing fistula.
- •Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner diameter by preoperative ultrasound.
- •Supplementary study cohort: Target artery smaller than 2 mm or larger than 4.1 mm in inner diameter by preoperative ultrasound.
- •Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative ultrasound.
- •Supplementary study cohort: Target vein smaller than 2 mm in inner diameter by preoperative ultrasound.
- •Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the area between the planned anastomosis site and the Axillary vein.)
- •Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
- •Patients with 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 ≥
- •Prior steal on the side of surgery.
- •Known allergy to nitinol.
- •Life expectancy less than 30 months.
- •Patients expecting to undergo kidney transplant within 6 months of enrollment.
- •Women of child bearing age without documented current negative pregnancy test.
- •Inability to give consent and/or comply with the study follow up schedule.
研究组 & 干预措施
VasQ device implantation
Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints.
Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints.
干预措施: VasQ (Device)
结局指标
主要结局
Primary Patency of AVF
时间窗: 6 months post AVF creation
Proportion of patients with freedom from intervention since device placement
Occurrence of safety events
时间窗: Device implantation to 6 months post AVF creation
The occurrence per patient access related safety events
次要结局
未报告次要终点