Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Diabetes Clinical Trial

— MAFASA  

Official title:

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190717
• Other study ID #: MAFASA-2023
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: March 2024
• Source: Sonavex, Inc.
• Contact: Katy Feeny
• Phone: 443-862-2024
• Email: kfeeny[@]sonavex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Diabetes
• End Stage Renal Disease
• Fistula
• Kidney Failure, Chronic

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Trinity Research Group	Dothan	Alabama
United States	Fresenius Vascular Care Memphis MSO	Memphis	Tennessee
United States	Southwest Kidney Institute	Phoenix	Arizona
United States	Physicians Care of Virginia	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Sonavex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hierarchical Composite 1	Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Fistula creation success.	6 Months
Other	Hierarchical Composite 2	Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Alive through 180 days.	6 Months
Other	Hierarchical Composite 3	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)	6 Months
Other	Hierarchical Composite 4	Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Earlier time to AV fistula Clinical Maturation with 180 days.	6 Months
Other	Comparison of Composite and Stratified MAE Rates	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 Months and 12 Months
Other	Comparision of Implant and Procedure Related Adverse Events	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.	6 Months and 12 Months
Other	Clinical Maturation	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.	3 Months, 4 Months, 5 Months, and 6 Months
Other	Cannulation Complication Rates	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.	12 Months
Other	Time to Clinical Maturation for Procedure and Device Related Events	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.	6 Months
Other	Primary Functional Patency	Primary functional patency at 6 months (as adjudicated by the CEC) defined as freedom from intervention on the AVF after maturation.	6 Months
Other	Secondary Function Patency	Secondary functional patency at 6 months (as adjudicated by the CEC) is defined as freedom from abandonment of the AVF after maturation.	6 Months
Other	Time to Clinical Maturation	Time to Clinical Maturation (as adjudicated by the CEC) defined as the time from initial fistula creation to Clinical Maturation.	6 Months
Other	Time to Clinical Maturation for Each Fistula	Time to Clinical Maturation (as adjudicated by the CEC) for each new fistula defined as the time from new fistula creation to Clinical Maturation.	6 Months
Other	Technical Success Cannulation Scans	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.	4 Months
Other	EchoSure Diameter and Depth Comparison in Cannulation Zone	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.	6 Months
Other	Intervention to Assist Maturation Rate	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.	6 Months
Primary	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	Primary Effectiveness Endpoint	Time to clinical maturation	6 months
Secondary	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
Secondary	EchoSure Depth Comparison	Difference between EchoSure and CoreLab measurements of depth for assessment of measurement agreement in the diagnostic arm.	6 Months
Secondary	EchoSure Diameter Comparison	Difference between EchoSure and CoreLab measurement of diameter for assessment of measurement agreement in the diagnostic arm.	6 Months
Secondary	EchoMark/EchoSure System Technical Success	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.	4 Months
Secondary	CVC Removal	Time to CVC removal by subject group	6 Months
Secondary	Rate of Hospitalization	Rate of hospitalization(s) by subject group from baseline to Clinical Maturation.	6 Months
Secondary	AV Fistula Maturation Rate	Percent of AVFs created that mature by 180 days by subject group.	6 Months
Secondary	Total Cost of Care	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.	6 Months
Secondary	Freedom from Events through 30 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.	30 Days and 90 Days