Maturation of Arteriovenous Fistula With Automated Sonogr... | NCT06190717

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic Arm	Experimental	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.	Device: EchoMark/EchoSure
Standard of Care	Active Comparator	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.	Procedure: Standard of Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EchoMark/EchoSure	Device	Subjects assigned to the Diagnostic Arm will have the EchoMark implanted at the time of AVF creation. The subject will return every 2 weeks for a follow-up assessment to include an EchoSure scan until fistula maturation and/or permanent access use is achieved. The EchoSure scans are to be reviewed by the investigator(s) or delegated study staff and aid in the determination when a further assessment, including a physical exam, is required to determine cannulation clearance or if an intervention(s) may be required to prevent failure of fistula maturation. All physical exams will include assessing the fistula for bruit and thrill. The subject's medical history will be reviewed at each visit and will include all interventions, cannulation attempts, and adverse event reporting.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Safety Endpoint	Freedom from the following through 6 months as adjudicated by the CEC: Clinically significant misplacement or migration of the EchoMark implant. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention. Infection of tissues surrounding the EchoMark implant requiring IV/ Complication requiring explantation of the EchoMark implant.	6 months
Primary Effectiveness Endpoint	Time to clinical maturation	6 months

Secondary Outcomes

Measure	Description	Time Frame
Difference between EchoSure and Duplex Flow Measurements	Difference between log10-transformed EchoSure and Duplex flow measurements of blood flow for assessment of measurement agreement in the diagnostic arm.	6 Months
EchoSure Depth Comparison

Other Outcomes

Measure	Description	Time Frame
Hierarchical Composite 1	Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Fistula creation success.	6 Months
Hierarchical Composite 2	Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Alive through 180 days.

Eligibility Module

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.

ID	Term
D003920	Diabetes Mellitus
D007676	Kidney Failure, Chronic

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation