Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Recruiting now · Not applicable

Conditions studied: Diabetes, End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT06190717

Run by

Sonavex, Inc.

People needed

304

Starts

2024-02-21

Expected to finish

2027-02-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sentara Health — Virginia Beach, Virginia, United States (enrolling)
• Southwest Kidney Institute — Phoenix, Arizona, United States (enrolling)
• AKDHC Medical Research Services — Phoenix, Arizona, United States (enrolling)
• AKDHC Center Tucson — Tucson, Arizona, United States (enrolling)
• Orlando Health Heart and Vascular Institute — Orlando, Florida, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Kansas Nephrology Research Institute — Wichita, Kansas, United States (enrolling)
• Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• MSU Health Care Heart and Vascular — Lansing, Michigan, United States (enrolling)
• Capital Medical Center — Pennington, New Jersey, United States (enrolling)
• Northwell Health — New Hyde Park, New York, United States (enrolling)
• Atrium Health — Concord, North Carolina, United States (enrolling)
• Prisma Health — Greenville, South Carolina, United States (enrolling)
• Medical University of South Carolina Health Orangeburg — Orangeburg, South Carolina, United States (enrolling)
• Galen Medical Group — Chattanooga, Tennessee, United States (enrolling)
• Trinity Research Group — Dothan, Alabama, United States (enrolling)
• Baylor Scott & White Heart and Vascular Hospital — Dallas, Texas, United States (enrolling)
• Aqua Research Institute Llc — Houston, Texas, United States (enrolling)
• HealthQare Associates — Arlington, Virginia, United States (enrolling)
• Physicians Care of Virginia — Roanoke, Virginia, United States (enrolling)
• Fresenius Vascular Care Memphis MSO — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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