Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
- Conditions
- DiabetesEnd Stage Renal Disease
- Interventions
- Device: EchoMark/EchoSureProcedure: Standard of Care
- Registration Number
- NCT06190717
- Lead Sponsor
- Sonavex, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 304
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diagnostic Arm EchoMark/EchoSure 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. Standard of Care 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.
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint 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 6 months Time to clinical maturation
- Secondary Outcome Measures
Name Time Method EchoSure Diameter Comparison 6 Months Difference between EchoSure and CoreLab measurement of diameter for assessment of measurement agreement in the diagnostic arm.
EchoMark/EchoSure System Technical Success 4 Months Technical Success defined as the successful implantation of the EchoMark implant and the ability to complete each scan to determine the blood flow, diameter, and depth measurements at the EchoMark using the EchoSure diagnostic ultrasound system from baseline to Clinical Maturation, fistula failure, or 4 months, whichever is sooner.
AV Fistula Maturation Rate 6 Months Percent of AVFs created that mature by 180 days by subject group.
Difference between EchoSure and Duplex Flow Measurements 6 Months Difference between log10-transformed EchoSure and Duplex flow measurements of blood flow for assessment of measurement agreement in the diagnostic arm.
Freedom from Events through 30 and 90 Days 30 Days and 90 Days Freedom from the following through 30 and 90 days from the baseline procedure 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 antibiotic treatment.
4. Complication requiring explantation of the EchoMark implant.EchoSure Depth Comparison 6 Months Difference between EchoSure and CoreLab measurements of depth for assessment of measurement agreement in the diagnostic arm.
Total Cost of Care 6 Months Total cost of care, defined by National average Medicare payment rate (facility and professional fees) for procedures and care provided to subject by subject group from baseline to Clinical Maturation.
CVC Removal 6 Months Time to CVC removal by subject group
Rate of Hospitalization 6 Months Rate of hospitalization(s) by subject group from baseline to Clinical Maturation.
Trial Locations
- Locations (13)
Atrium Health
🇺🇸Concord, North Carolina, United States
Aqua Research Institute Llc
🇺🇸Houston, Texas, United States
Trinity Research Group
🇺🇸Dothan, Alabama, United States
Southwest Kidney Institute
🇺🇸Phoenix, Arizona, United States
Orlando Health Heart and Vascular Institute
🇺🇸Orlando, Florida, United States
Capital Medical Center
🇺🇸Pennington, New Jersey, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
Prisma Health
🇺🇸Greenville, South Carolina, United States
Medical University of South Carolina Health Orangeburg
🇺🇸Orangeburg, South Carolina, United States
Fresenius Vascular Care Memphis MSO
🇺🇸Memphis, Tennessee, United States
Baylor Scott & White Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Physicians Care of Virginia
🇺🇸Roanoke, Virginia, United States
Sentara Health
🇺🇸Virginia Beach, Virginia, United States