Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

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.

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.