Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorSonavex, Inc.
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
EchoMark/EchoSure
DeviceSubjects 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/SurgerySubjects 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.
Treatment groups
304 Participants
are divided into 2 treatment groupsGroup A: Diagnostic ArmExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months2
Primary Effectiveness Endpoint
Time to clinical maturation
Time frame
6 monthsSecondary outcomes
1
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.
Time frame
6 Months2
EchoSure Depth Comparison
Difference between EchoSure and CoreLab measurements of depth for assessment of measurement agreement in the diagnostic arm.
Time frame
6 Months3
EchoSure Diameter Comparison
Difference between EchoSure and CoreLab measurement of diameter for assessment of measurement agreement in the diagnostic arm.
Time frame
6 Months4
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.
Time frame
4 MonthsOther outcomes
1
Hierarchical Composite 1
Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Fistula creation success.
Time frame
6 Months2
Hierarchical Composite 2
Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Alive through 180 days.
Time frame
6 Months3
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)
Time frame
6 Months4
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.
Time frame
6 MonthsSponsors and contacts
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Source ClinicalTrials.gov