Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial (MAFASA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT06190717

Recruitment Status : Recruiting

First Posted : January 5, 2024

Last Update Posted : May 8, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Sonavex, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes End Stage Renal Disease	Device: EchoMark/EchoSure Procedure: Standard of Care	Not Applicable

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	304 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Actual Study Start Date :	February 21, 2024
Estimated Primary Completion Date :	February 1, 2025
Estimated Study Completion Date :	February 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Diagnostic Arm 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 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.
Active Comparator: Standard of Care 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 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.

Arm

Intervention/treatment

Experimental: Diagnostic Arm

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

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.

Active Comparator: Standard of Care

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

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.

Outcome Measures

Primary Outcome Measures :

Primary Safety Endpoint [ Time Frame: 6 months ]
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.
Primary Effectiveness Endpoint [ Time Frame: 6 months ]
Time to clinical maturation

Secondary Outcome Measures :

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.
EchoSure Depth Comparison [ Time Frame: 6 Months ]
Difference between EchoSure and CoreLab measurements of depth for assessment of measurement agreement in the diagnostic arm.
EchoSure Diameter Comparison [ Time Frame: 6 Months ]
Difference between EchoSure and CoreLab measurement of diameter for assessment of measurement agreement in the diagnostic arm.
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.
CVC Removal [ Time Frame: 6 Months ]
Time to CVC removal by subject group
Rate of Hospitalization [ Time Frame: 6 Months ]
Rate of hospitalization(s) by subject group from baseline to Clinical Maturation.
AV Fistula Maturation Rate [ Time Frame: 6 Months ]
Percent of AVFs created that mature by 180 days by subject group.
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.
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:
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 antibiotic treatment.
4. Complication requiring explantation of the EchoMark implant.

Other Outcome Measures:

Hierarchical Composite 1 [ Time Frame: 6 Months ]
Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of:

Fistula creation success.
Hierarchical Composite 2 [ Time Frame: 6 Months ]
Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of:

Alive through 180 days.
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)
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.
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:
1. Clinically significant misplacement or migration of the EchoMark implant.
2. Vessel or tissue injury caused by the EchoMark implant procedure or the implant over time, requiring surgical intervention.
3. Complication requiring explantation of the EchoMark implant.
4. Clinically significant surgical complications (seroma, edema, hematoma, bleeding), excluding expected resorption response visible as hypoechoic region on B-mode ultrasound.
5. Infection requiring IV antibiotic treatment. Pseudoaneurysm.
6. Thrombosis of the AVF circuit that requires an intervention (surgical or endovascular).
7. Steal Syndrome.
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.
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.
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:
1. Infection due to cannulation.
2. Thrombosis due to hematoma.
3. Any other AE determined by the CEC to be cannulation related.
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:
1. Clinically significant misplacement or migration of the EchoMark implant.
2. Vessel or tissue injury caused by the EchoMark implant procedure or the implant over time, requiring surgical intervention.
3. Clinically significant surgical complications (seroma, edema, hematoma, bleeding), excluding expected resorption response visible as hypoechoic region on B-mode ultrasound.
4. Infection requiring IV antibiotic treatment.
5. Pseudoaneurysm.
6. Thrombosis of AVF circuit requiring an intervention (surgical or endovascular).
7. Steal Syndrome.
8. No SAE.
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.
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.
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.
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.
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.
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.
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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 84 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06190717

Contacts

Layout table for location contacts

Contact: Katy Feeny	443-862-2024	kfeeny@sonavex.com

Locations

Layout table for location information

United States, Alabama
Trinity Research Group	Recruiting
Dothan, Alabama, United States, 36301
Contact: E Ivey
Principal Investigator: Jason Beaver, MD
United States, Arizona
Southwest Kidney Institute	Recruiting
Phoenix, Arizona, United States, 85004
Contact: J Rodriguez
Principal Investigator: Umar Waheed, MD
United States, Tennessee
Fresenius Vascular Care Memphis MSO	Recruiting
Memphis, Tennessee, United States, 38115
Contact: M Sanford
Principal Investigator: Eric Gardner, MD
United States, Virginia
Physicians Care of Virginia	Recruiting
Roanoke, Virginia, United States, 24014
Contact: A Johnson
Principal Investigator: Ryan Evans, MD

Sponsors and Collaborators

Sonavex, Inc.

More Information

Layout table for additonal information

Responsible Party:	Sonavex, Inc.
ClinicalTrials.gov Identifier:	NCT06190717
Other Study ID Numbers:	MAFASA-2023
First Posted:	January 5, 2024 Key Record Dates
Last Update Posted:	May 8, 2024
Last Verified:	March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	Yes
Device Product Not Approved or Cleared by U.S. FDA:	Yes

Additional relevant MeSH terms:

Layout table for MeSH terms

Kidney Failure, Chronic Arteriovenous Fistula Fistula Kidney Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Pathological Conditions, Anatomical Renal Insufficiency, Chronic	Renal Insufficiency Chronic Disease Disease Attributes Pathologic Processes Arteriovenous Malformations Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Fistula Vascular Diseases Congenital Abnormalities

To Top