Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.
详细描述
This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to evaluate the feasibility and safety of the EchoMark and the EchoSure in subjects undergoing new upper arm autologous arteriovenous fistula creation who require hemodialysis. All subjects will provide informed consent prior to undergoing any study procedures. The study will consists of multiple follow-up visits during the 52 week duration. Subjects are able to re-consent and remain in follow-up for an additional year.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent
- •Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
- •Subject is willing and capable of complying with all required follow-up visits
- •Subject and/or Care Team agree that the distance and transportation resources from the subject's home to the clinic are reasonable for study participation and compliance
- •Subject has an estimated life expectancy > 18 months
- •Subject is ambulatory (cane or walker are acceptable)
- •Subjects presenting for upper arm autologous arteriovenous fistula creation
- •Vein diameter > 2.5 mm at the antecubital fossa via imaging
- •Artery diameter > 3 mm via imaging
- •Subject is not participating in another investigational clinical trial that has not met its primary endpoint. Participation in a post-market registry is acceptable.
排除标准
- •Subjects receiving a forearm fistula.
- •Subject has history of Steal Syndrome.
- •Subject who is immunocompromised or immunosuppressed.
- •Subject has had three previous failed AV fistulae for hemodialysis access
- •Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.
- •Known or suspected active infection on the day of the index procedure.
- •Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula
- •Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count <50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access
- •Subjects with active malignancy
- •Subjects with a history of poor compliance with the dialysis protocol
- •Subjects with a known or suspected allergy to any of the device materials
- •Subjects with an existing fistula or graft
- •Subjects who are pregnant, plan to become pregnant, or are breastfeeding.
研究组 & 干预措施
EchoMark/EchoSure
All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein.
The follow-up EchoSure scans will be conducted by the designated EchoSure user without the investigator and without the sonographer/RVT conducting the Duplex exam in the room, either during the routine work-up prior to the surgeon seeing the patient or after. The EchoSure results for flow, and vessel depth and diameter are shown as numerical values on the screen of the EchoSure device.
干预措施: EchoMark / EchoSure (Device)
结局指标
主要结局
Primary Safety Endpoint
时间窗: 30 Days
Composite of new major device related adverse events (MAEs) at 30 days post EchoMark implantation, as adjudicated by the Clinical Events Committee (CEC) including: * Device or procedure-related death * Device related infection * Device related interventions * Device related hospitalizations * Fistula failure * Fistula rupture * Aneurysm
Primary Feasibility Endpoint
时间窗: 4 Months
Rate of Technical Success defined as the successful implantation of the EchoMark implant. Technical success will be assessed from baseline to 4 months.
Rate of Technical Success Defined as the Successful Ability to Determine Blood Flow, Diameter, and Depth Measurements Using the EchoSure Diagnostic Ultrasound System. Technical Success Will be Assessed From Baseline to 4 Months.
时间窗: 4 Months
Rate of Technical Success defined as the successful ability to determine blood flow, diameter, and depth measurements using the EchoSure diagnostic ultrasound system. Technical success will be assessed from baseline to 4 months.
次要结局
未报告次要终点