Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae

NCT04896476 | Active Not Recruiting Results DMC FDA Device

• 2 other identifiers: IDE-F1-2021R44HL147423
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.

Conditions

Kidney Diseases; Arteriovenous Fistula

Outcome Measures

Primary Outcomes (3)

• Primary Safety Endpoint

  Composite of new major device related adverse events (MAEs) at 30 days post EchoMark implantation, as adjudicated by the Clinical Events Committee (CEC) including: * Device or procedure-related death * Device related infection * Device related interventions * Device related hospitalizations * Fistula failure * Fistula rupture * Aneurysm

  30 Days

• Primary Feasibility Endpoint

  Rate of Technical Success defined as the successful implantation of the EchoMark implant. Technical success will be assessed from baseline to 4 months.

  4 Months

• Rate of Technical Success Defined as the Successful Ability to Determine Blood Flow, Diameter, and Depth Measurements Using the EchoSure Diagnostic Ultrasound System. Technical Success Will be Assessed From Baseline to 4 Months.

  Rate of Technical Success defined as the successful ability to determine blood flow, diameter, and depth measurements using the EchoSure diagnostic ultrasound system. Technical success will be assessed from baseline to 4 months.

  4 Months

Other Outcomes (22)

• Comparison of EchoSure and Duplex Measurements Using Percentages

  6 Months

• Comparison of EchoSure and Duplex Measurements of Diameter

  6 Months

• Comparison of EchoSure and Duplex Measurements of Depth

  6 Months

Study Arms (1)

EchoMark/EchoSure

EXPERIMENTAL

All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. The follow-up EchoSure scans will be conducted by the designated EchoSure user without the investigator and without the sonographer/RVT conducting the Duplex exam in the room, either during the routine work-up prior to the surgeon seeing the patient or after. The EchoSure results for flow, and vessel depth and diameter are shown as numerical values on the screen of the EchoSure device.

Device: EchoMark / EchoSure

Interventions

EchoMark / EchoSure DEVICE

The EchoMark is to be secured a minimum of 3 cm away from the anastomosis. The follow-up EchoSure scans will be conducted by the designated EchoSure user without the investigator and without the sonographer/RVT conducting the Duplex exam in the room, either during the routine work-up prior to the surgeon seeing the patient or after. The EchoSure results for flow, and vessel depth and diameter are shown as numerical values on the screen of the EchoSure device.

EchoMark/EchoSure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 subject'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)
• Subjects presenting for upper arm autologous arteriovenous fistula creation
• Vein diameter \> 2.5 mm at the antecubital fossa via imaging
• Artery diameter \> 3 mm via imaging
• Subject is not participating in another investigational clinical trial that has not met its primary endpoint. Participation in a post-market registry is acceptable.

You may not qualify if:

• Subjects receiving a forearm fistula.
• 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 pregnant, plan to become pregnant, or are breastfeeding.

Sponsors & Collaborators

• Sonavex, Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Trinity Research Group

Dothan, Alabama, 36301, United States

Location

SKI Vascular Center

Peoria, Arizona, 85381, United States

Location

Michgan Vascular Center

Flint, Michigan, 48507, United States

Location

Surgical Specialist of Charlotte

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Katy Feeny, Director of Clinical Affairs
• Organization: Sonavex

KFEENY@SONAVEX.COM

443-862-2024

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 21, 2021
• Study Start: January 21, 2022
• Primary Completion: October 24, 2023
• Study Completion: June 6, 2025
• Last Updated: February 18, 2025
• Results First Posted: February 18, 2025

Record last verified: 2024-12

Locations

US (4)