Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Launched by SONAVEX, INC. · Dec 19, 2023

Keywords

ClinConnect Summary

The Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial is a research study aimed at improving how we monitor the development of a special connection between a vein and an artery called an arteriovenous fistula (AVF), which is often needed for patients with diabetes and end-stage renal disease who are undergoing dialysis. This trial will use a specific ultrasound system, the EchoMark®/EchoSure®, to check on the AVF's progress every two weeks. The goal is to see if this method can help the AVF mature more quickly, which is important for starting dialysis treatment effectively.

To participate, individuals must be between 18 and 84 years old and have a serious kidney condition that requires the creation of an AVF. They should be able to walk (with assistance if necessary) and have a life expectancy of more than 18 months. Participants should also be able to attend follow-up appointments and provide consent for the study procedures. If you or a loved one meets these criteria, you could play an important role in helping researchers understand and improve the care for patients needing dialysis access. Participants will receive close monitoring and care throughout the study, helping to ensure their health and safety.

Gender

ALL

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.
• • Subject is not participating in another investigational clinical trial that has not met its primary end point. Participation in post-market registry is acceptable.
• 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.
• • 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.