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NCT Number: NCT06190717

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.

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Key information

Conditions

Diabetes Chronic Disease Diabetes Mellitus Disease Attributes End Stage Renal Disease Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trinity Research Group, Dothan, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard of care

Procedure

Subjects are assessed using standard of care per KDOQI guidelines, which includes a physical exam at the 2-week follow-up visit and at the 4-6-week follow-up visit. All follow-up visits will include an assessment of adverse events and medical history review to include all interventions, cannulation attempts, and laboratory results. If evaluation yields an abnormal finding, subjects will undergo a Duplex ultrasound assessment and treatment under the institution's standard of care. 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.

Primary outcomes

  1. Primary Safety Endpoint

    Time frame: 6 months

    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.

  2. Primary Effectiveness Endpoint

    Time frame: 6 months

    Time to clinical maturation

Secondary outcomes

  1. Difference between EchoSure and Duplex Flow Measurements

    Time frame: 6 Months

    Difference between log10-transformed EchoSure and Duplex flow measurements of blood flow for assessment of measurement agreement in the diagnostic arm.

  2. EchoSure Depth Comparison

    Time frame: 6 Months

    Difference between EchoSure and CoreLab measurements of depth for assessment of measurement agreement in the diagnostic arm.

  3. EchoSure Diameter Comparison

    Time frame: 6 Months

    Difference between EchoSure and CoreLab measurement of diameter for assessment of measurement agreement in the diagnostic arm.

  4. EchoMark/EchoSure System Technical Success

    Time frame: 4 Months

    Technical Success defined as the successful implantation of the EchoMark implant and the ability to complete each scan to determine the blood flow, diameter, and depth measurements at the EchoMark using the EchoSure diagnostic ultrasound system from baseline to Clinical Maturation, fistula failure, or 4 months, whichever is sooner.

  5. CVC Removal

    Time frame: 6 Months

    Time to CVC removal by subject group

  6. Rate of Hospitalization

    Time frame: 6 Months

    Rate of hospitalization(s) by subject group from baseline to Clinical Maturation.

  7. AV Fistula Maturation Rate

    Time frame: 6 Months

    Percent of AVFs created that mature by 180 days by subject group.

  8. Total Cost of Care

    Time frame: 6 Months

    Total cost of care, defined by National average Medicare payment rate (facility and professional fees) for procedures and care provided to subject by subject group from baseline to Clinical Maturation.

  9. Freedom from Events through 30 and 90 Days

    Time frame: 30 Days and 90 Days

    Freedom from the following through 30 and 90 days from the baseline procedure 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 antibiotic treatment.
    • Complication requiring explantation of the EchoMark implant.

Other outcomes

  1. Hierarchical Composite 1

    Time frame: 6 Months

    Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of:

    Fistula creation success.

  2. Hierarchical Composite 2

    Time frame: 6 Months

    Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of:

    Alive through 180 days.

  3. Hierarchical Composite 3

    Time frame: 6 Months

    Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of:

    Freedom from SAE with 180 days (severity as a tie-breaker for SAEs with matching adverse event term)

  4. Hierarchical Composite 4

    Time frame: 6 Months

    Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of:

    Earlier time to AV fistula Clinical Maturation with 180 days.

  5. Comparison of Composite and Stratified MAE Rates

    Time frame: 6 Months and 12 Months

    Comparison of composite and stratified MAE rates for both subject groups at 6 months and end of study. MAEs are adjudicated by the CEC and defined as any of the following:

    • Clinically significant misplacement or migration of the EchoMark implant.
    • Vessel or tissue injury caused by the EchoMark implant procedure or the implant over time, requiring surgical intervention.
    • Complication requiring explantation of the EchoMark implant.
    • Clinically significant surgical complications (seroma, edema, hematoma, bleeding), excluding expected resorption response visible as hypoechoic region on B-mode ultrasound.
    • Infection requiring IV antibiotic treatment. Pseudoaneurysm.
    • Thrombosis of the AVF circuit that requires an intervention (surgical or endovascular).
    • Steal Syndrome.

  6. Comparision of Implant and Procedure Related Adverse Events

    Time frame: 6 Months and 12 Months

    Comparison of all stratified implant and procedure related AE (as adjudicated by the CEC) rates between subject groups at 6 months and end of study.

  7. Clinical Maturation

    Time frame: 3 Months, 4 Months, 5 Months, and 6 Months

    Percent of subjects that have reached Clinical Maturation (as adjudicated by the CEC) for each subject group at 90 days, 120 day, 150 days, and 180 days.

  8. Cannulation Complication Rates

    Time frame: 12 Months

    Comparison of composite and stratified cannulation complication (as adjudicated by the CEC) rates between subject groups for the following AEs:

    • Infection due to cannulation.
    • Thrombosis due to hematoma.
    • Any other AE determined by the CEC to be cannulation related.

  9. Time to Clinical Maturation for Procedure and Device Related Events

    Time frame: 6 Months

    Distribution of time to Clinical Maturation for both groups for each of the following procedure and device related categories presented as violin/box plots:

    • Clinically significant misplacement or migration of the EchoMark implant.
    • Vessel or tissue injury caused by the EchoMark implant procedure or the implant over time, requiring surgical intervention.
    • Clinically significant surgical complications (seroma, edema, hematoma, bleeding), excluding expected resorption response visible as hypoechoic region on B-mode ultrasound.
    • Infection requiring IV antibiotic treatment.
    • Pseudoaneurysm.
    • Thrombosis of AVF circuit requiring an intervention (surgical or endovascular).
    • Steal Syndrome.
    • No SAE.

  10. Primary Functional Patency

    Time frame: 6 Months

    Primary functional patency at 6 months (as adjudicated by the CEC) defined as freedom from intervention on the AVF after maturation.

  11. Secondary Function Patency

    Time frame: 6 Months

    Secondary functional patency at 6 months (as adjudicated by the CEC) is defined as freedom from abandonment of the AVF after maturation.

  12. Time to Clinical Maturation

    Time frame: 6 Months

    Time to Clinical Maturation (as adjudicated by the CEC) defined as the time from initial fistula creation to Clinical Maturation.

  13. Time to Clinical Maturation for Each Fistula

    Time frame: 6 Months

    Time to Clinical Maturation (as adjudicated by the CEC) for each new fistula defined as the time from new fistula creation to Clinical Maturation.

  14. Technical Success Cannulation Scans

    Time frame: 4 Months

    Rate of cannulation zone technical success rate defined as the ability to complete each scan to determine the diameter, and depth measurements at the proximal, mid, and distal segments of the fistula using the EchoSure diagnostic ultrasound system from the 2-week follow-up to Clinical Maturation, or 4 months, whichever is sooner.

  15. EchoSure Diameter and Depth Comparison in Cannulation Zone

    Time frame: 6 Months

    Agreement of EchoSure diameter and depth results from the cannulation zone at the 6-week follow-up compared to the CoreLab measured diameter and depth results in the DIAG arm.

  16. Intervention to Assist Maturation Rate

    Time frame: 6 Months

    Surgical or Endovascular Interventions to Assist Maturation defined as the difference between groups in the proportion of subjects with surgical or endovascular interventions to assist maturation.

Study contacts

Contact information is provided by the study sponsor or research team.

Katy Feeny

CONTACT

[email protected]

443-862-2024

Sponsors and collaborators

Lead sponsor

Sonavex, Inc.

Industry

Registry information

Acronym: MAFASA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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