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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Arteriovenous Fistula, Kidney Diseases

Intervention / Treatment
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* Device: EchoMark


Participation Criteria
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Eligibility Criteria
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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 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EchoMark<br>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<br>* The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.<br>|

What is the study measuring?
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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 |