Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Inclusion Criteria:

• Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years ofage at the time of informed consent.

• Subject is able and willing to provide written informed consent prior to receivingany 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 fromthe patient's home to the clinic are reasonable for study participation andcompliance.

• 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 autologousarteriovenous fistula creation that is not transposed for hemodialysis access.

• Subjects who are currently on dialysis through a CVC or who imminently requiredialysis (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 notmet 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 arteriovenousfistula 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 EchoMarkimplantation.

• 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 toreduce the likelihood of partially treated infections that can seed the device andfistula.

• Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count <50,000), hypercoagulability, and history of recurrent deep vein thrombosis notrelated 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 atransplant within 6 months.

• Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.