Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

NCT06190717 | Recruiting DMC FDA Device

• 1 other identifier: MAFASA-2023
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Diabetes; End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  Freedom from the following through 6 months as adjudicated by the CEC: 1. Clinically significant misplacement or migration of the EchoMark implant. 2. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention. 3. Infection of tissues surrounding the EchoMark implant requiring IV/ 4. Complication requiring explantation of the EchoMark implant.

  6 months

• Primary Effectiveness Endpoint

  Time to clinical maturation

  6 months

Secondary Outcomes (9)

• Difference between EchoSure and Duplex Flow Measurements

  6 Months

• EchoSure Depth Comparison

  6 Months

• EchoSure Diameter Comparison

  6 Months

• EchoMark/EchoSure System Technical Success

  4 Months

• CVC Removal

  6 Months

Other Outcomes (16)

• Hierarchical Composite 1

  6 Months

• Hierarchical Composite 2

  6 Months

• Hierarchical Composite 3

  6 Months

Study Arms (2)

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

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.

Diagnostic Arm

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sonavex, Inc.: lead

Study Sites (21)

Trinity Research Group

Dothan, Alabama, 36301, United States

RECRUITING

Southwest Kidney Institute

Phoenix, Arizona, 85004, United States

RECRUITING

AKDHC Medical Research Services

Phoenix, Arizona, 85012, United States

RECRUITING

AKDHC Center Tucson

Tucson, Arizona, 85754, United States

RECRUITING

Orlando Health Heart and Vascular Institute

Orlando, Florida, 32806, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Kansas Nephrology Research Institute

Wichita, Kansas, 67214, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MSU Health Care Heart and Vascular

Lansing, Michigan, 48910, United States

RECRUITING

Capital Medical Center

Pennington, New Jersey, 08534, United States

RECRUITING

Northwell Health

New Hyde Park, New York, 11042, United States

RECRUITING

Atrium Health

Concord, North Carolina, 28025, United States

RECRUITING

Prisma Health

Greenville, South Carolina, 29605, United States

RECRUITING

Medical University of South Carolina Health Orangeburg

Orangeburg, South Carolina, 29118, United States

RECRUITING

Galen Medical Group

Chattanooga, Tennessee, 37421, United States

RECRUITING

Fresenius Vascular Care Memphis MSO

Memphis, Tennessee, 38115, United States

TERMINATED

Baylor Scott & White Heart and Vascular Hospital

Dallas, Texas, 75226, United States

RECRUITING

Aqua Research Institute Llc

Houston, Texas, 77058, United States

RECRUITING

HealthQare Associates

Arlington, Virginia, 22201, United States

RECRUITING

Physicians Care of Virginia

Roanoke, Virginia, 24014, United States

RECRUITING

Sentara Health

Virginia Beach, Virginia, 23454, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Kidney Failure, Chronic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Katy Feeny

CONTACT

443-862-2024; kfeeny@sonavex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: February 21, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)