Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Overview
- Phase
- N/A
- Intervention
- EchoMark/EchoSure
- Conditions
- Diabetes
- Sponsor
- Sonavex, Inc.
- Enrollment
- 304
- Locations
- 41
- Primary Endpoint
- Primary Safety Endpoint
- Status
- Recruiting
- Last Updated
- 19 days ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: EchoMark/EchoSure
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.
Intervention: Standard of Care
Outcomes
Primary Outcomes
Primary Safety Endpoint
Time Frame: 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
Time Frame: 6 months
Time to clinical maturation
Secondary Outcomes
- 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)