Clinical trial NCT06190717: Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Official title: Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
End Stage Renal Disease
Lead sponsor: Sonavex, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 6 months
measure: Primary Effectiveness Endpoint
timeFrame: 6 months
Secondary outcomes:
measure: Difference between EchoSure and Duplex Flow Measurements
timeFrame: 6 Months
measure: EchoSure Depth Comparison
timeFrame: 6 Months
measure: EchoSure Diameter Comparison
timeFrame: 6 Months
measure: EchoMark/EchoSure System Technical Success
timeFrame: 4 Months
measure: CVC Removal
timeFrame: 6 Months
measure: Rate of Hospitalization
timeFrame: 6 Months
measure: AV Fistula Maturation Rate
timeFrame: 6 Months
measure: Total Cost of Care
timeFrame: 6 Months
measure: Freedom from Events through 30 and 90 Days
timeFrame: 30 Days and 90 Days
Other outcomes:
measure: Hierarchical Composite 1
timeFrame: 6 Months
measure: Hierarchical Composite 2
timeFrame: 6 Months
measure: Hierarchical Composite 3
timeFrame: 6 Months
measure: Hierarchical Composite 4
timeFrame: 6 Months
measure: Comparison of Composite and Stratified MAE Rates
timeFrame: 6 Months and 12 Months
measure: Comparision of Implant and Procedure Related Adverse Events
timeFrame: 6 Months and 12 Months
measure: Clinical Maturation
timeFrame: 3 Months, 4 Months, 5 Months, and 6 Months
measure: Cannulation Complication Rates
timeFrame: 12 Months
measure: Time to Clinical Maturation for Procedure and Device Related Events
timeFrame: 6 Months
measure: Primary Functional Patency
timeFrame: 6 Months
measure: Secondary Function Patency
timeFrame: 6 Months
measure: Time to Clinical Maturation
timeFrame: 6 Months
measure: Time to Clinical Maturation for Each Fistula
timeFrame: 6 Months
measure: Technical Success Cannulation Scans
timeFrame: 4 Months
measure: EchoSure Diameter and Depth Comparison in Cannulation Zone
timeFrame: 6 Months
measure: Intervention to Assist Maturation Rate
timeFrame: 6 Months
Locations:
city: Dothan
country: United States
facility: Trinity Research Group
state: Alabama
city: Phoenix
country: United States
facility: Southwest Kidney Institute
state: Arizona
city: Orlando
country: United States
facility: Orlando Health Heart and Vascular Institute
state: Florida
city: Pennington
country: United States
facility: Capital Medical Center
state: New Jersey
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Concord
country: United States
facility: Atrium Health
state: North Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Orangeburg
country: United States
facility: Medical University of South Carolina Health Orangeburg
state: South Carolina
city: Memphis
country: United States
facility: Fresenius Vascular Care Memphis MSO
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: Aqua Research Institute Llc
state: Texas
city: Roanoke
country: United States
facility: Physicians Care of Virginia
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Health
state: Virginia
Study officials:
References: