Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 84 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
C Roddy

More Details

Status
Recruiting
Sponsor
Sonavex, Inc.

Study Contact

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