Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 304
- 试验地点
- 41
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 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 patient'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).
- •CKD Stage 5 (eGFR less than 10) or ESRD subjects presenting for upper arm autologous arteriovenous fistula creation that is not transposed for hemodialysis access.
- •Subjects who are currently on dialysis through a CVC or who imminently require dialysis (GFR <10).
- •Vein diameter ≥ 2.5 mm at the antecubital fossa per vein mapping.
- •Artery diameter ≥ 2.5 mm per vein mapping.
- •Subject is not participating in another investigational clinical trial that has not met its primary end point. Participation in post-market registry is acceptable.
排除标准
- •CKD Stage 1-4 or subjects that do not require upper arm autologous arteriovenous fistula creation for hemodialysis access.
- •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 anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months.
- •Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.
研究组 & 干预措施
Diagnostic Arm
All subjects will have the EchoMark implanted. Subjects will be assessed every 2 weeks (+/- 1 week) (but no more frequently than weekly) with the EchoSure system until fistula maturation occurs and/or permanent access use is achieved.
干预措施: EchoMark/EchoSure (Device)
Standard of Care
Subjects will be evaluated per KDOQI guidelines (with physical examination at approximately 2 weeks (+/- 1 week) and between 4 and 6 weeks (+/- 1 week)). If evaluation yields abnormal findings, subjects will receive a Duplex ultrasound assessment (DUS). All SOC Arm subjects will be followed per the institution's standard of care until fistula maturation occurs and/or permanent access use is achieved but no more frequently than once per month.
干预措施: Standard of Care (Procedure)
结局指标
主要结局
Primary Safety Endpoint
时间窗: 6 months
Freedom from the following through 6 months as adjudicated by the CEC: 1. Clinically significant misplacement or migration of the EchoMark implant. 2. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention. 3. Infection of tissues surrounding the EchoMark implant requiring IV/ 4. Complication requiring explantation of the EchoMark implant.
Primary Effectiveness Endpoint
时间窗: 6 months
Time to clinical maturation
次要结局
- EchoSure Diameter Comparison(6 Months)
- EchoMark/EchoSure System Technical Success(4 Months)
- AV Fistula Maturation Rate(6 Months)
- Difference between EchoSure and Duplex Flow Measurements(6 Months)
- Freedom from Events through 30 and 90 Days(30 Days and 90 Days)
- EchoSure Depth Comparison(6 Months)
- Total Cost of Care(6 Months)
- CVC Removal(6 Months)
- Rate of Hospitalization(6 Months)