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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Diseases; Arteriovenous Fistula
• Intervention / Treatment: Device: EchoMark

Detailed Description

This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to evaluate the feasibility and safety of the EchoMark and the EchoSure in subjects undergoing new upper arm autologous arteriovenous fistula creation who require hemodialysis. All subjects will provide informed consent prior to undergoing any study procedures. The study will consists of multiple follow-up visits during the 52 week duration.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katy Feeny; Phone Number: 443-862-2024; Email: kfeeny@sonavex.com

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Trinity Research Group
  • Arizona
    • Peoria, Arizona, United States, 85381
      • SKI Vascular Center
  • Michigan
    • Flint, Michigan, United States, 48507
      • Michgan Vascular Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Surgical Specialist of Charlotte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent
2. Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
3. Subject is willing and capable of complying with all required follow-up visits
4. 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
5. Subject has an estimated life expectancy > 18 months
6. Subject is ambulatory (cane or walker are acceptable)
7. Subjects presenting for upper arm autologous arteriovenous fistula creation
8. Vein diameter > 2.5 mm at the antecubital fossa via imaging
9. Artery diameter > 3 mm via imaging
10. Subject is not participating in another investigational clinical trial that has not met its primary endpoint. Participation in a post-market registry is acceptable.

Exclusion Criteria:

1. Subjects receiving a forearm fistula.
2. Subject has history of Steal Syndrome.
3. Subject who is immunocompromised or immunosuppressed.
4. Subject has had three previous failed AV fistulae for hemodialysis access
5. Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.
6. Known or suspected active infection on the day of the index procedure.
7. 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
8. Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count <50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access
9. Subjects with active malignancy
10. Subjects with a history of poor compliance with the dialysis protocol
11. Subjects with a known or suspected allergy to any of the device materials
12. Subjects with an existing fistula or graft
13. Subjects who are pregnant, plan to become pregnant, or are breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EchoMark; 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.	Device: EchoMark; The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 and the 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.	6 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of EchoSure and duplex measurements of flow	Only duplex images that pass the CoreLab quality control check will be included in the assessment.	6 Months
Comparison of EchoSure and duplex measurements of diameter	Only duplex images that pass the CoreLab quality control check will be included in the assessment.	6 Months
Comparison of EchoSure and duplex measurements of depth	Only duplex images that pass the CoreLab quality control check will be included in the assessment.	6 Months
Time to radiographic maturation	defined as the number of days from baseline procedure to date of radiographic maturation (date of ultrasound imaging, as adjudicated by the CEC). Radiographic maturation is defined as a fistula with volume flow of 500mL/min and 5mm diameter.	12 Months
Time to clinical maturation	defined as the number of days from baseline procedure to date of clinical maturation. Clinical maturation is defined as 75% of dialysis sessions with successful 2 needle cannulation. Date of clinical maturation is defined as first date of the 4-week window when clinical maturation is achieved.	12 Months
Radiographic maturation success rate	defined as the percentage of subjects that achieve radiographic maturation (as determined by the physician and adjudicated by the CEC) by end of study. Radiographic maturation is defined as a fistula with 500mL/min and 5mm diameter.	12 Months
Clinical maturation success rate	defined as the percentage of subjects that achieve clinical maturation by end of study. Date of clinical maturation is defined as first date of the 4-week window when clinical maturation is achieved.	12 Months
6-month patency rate	defined by the status (yes/no) of an arteriovenous dialysis access with detectable blood flow through and beyond the anastomosis shown by either an imaging modality or physical examination (presence of a palpable thrill or audible bruit along some point of the arteriovenous dialysis access beyond the arteriovenous anastomosis).	6 Months
12-month patency rate	defined by the status (yes/no) of an arteriovenous dialysis access with detectable blood flow through and beyond the anastomosis shown by either an imaging modality or physical examination (presence of a palpable thrill or audible bruit along some point of the arteriovenous dialysis access beyond the arteriovenous anastomosis).	12 Months
Occurrence of events occurring within 30 days of implantation that require reinterventions (open or endovascular), hospitalizations, or prolongation of existing hospitalization.		30 Days
Occurrence of reported reduction of blood flow that prevents the ability to cannulate or requires further assessment and/or intervention from baseline procedure to 12 months.		12 Months
Occurrence of the reported inability to cannulate fistula beginning once the fistula is deemed radiographically and clinically mature to 12 months.		12 Months
Occurrence of the development of steal syndrome from baseline to 12 months.		12 Months
Occurrence of bleeding requiring surgical intervention (including PRBC transfusion) from baseline to 12 months.		12 Months
Occurrence of infiltration requiring procedural intervention from baseline to 12 months.		12 Months
Occurrence of hematoma requiring procedural intervention from baseline to 12 months.		12 Months
Occurrence of the inability to use the EchoSure component of the system from baseline to 4 months	Due to: Migration of the EchoMark device; Early resorption of the EchoMark device as defined as breakdown of the EchoMark shape prior to 4 months from index procedure.	4 Months
Occurrence of pain related to the study devices from baseline to 12 months		12 Months
Occurrence of infection (not limited to infection requiring implant explanation) from baseline to 12 months		12 Months
Occurrence of infection confirmed by either implant explanation or purulent fluid on pathologic assessment during incision and drainage beginning at baseline to 12 months		12 Months
Composite of new major device related adverse events (MAEs) at 12 months post EchoMark LP implantation, as adjudicated by the Clinical Events Committee (CEC).	The proportion of subjects with device success and free from device- and/or procedure related SAEs (per CEC adjudication) at 12 months. The summaries for each individual safety data point will also be provided, including: Device or procedure-related death; Device related infection; Device related interventions; Device related hospitalizations; Fistula failure; Fistula rupture; Aneurysm	12 Months

Collaborators and Investigators

• Sponsor: Sonavex, Inc.
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Actual): June 20, 2023
• Study Completion (Estimated): June 6, 2025

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: IDE-F1-2021; R44HL147423 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No