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

Not Applicable

Active, not recruiting

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.

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. Subjects are able to re-consent and remain in follow-up for an additional year.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
EchoMark	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.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	30 Days	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
Primary Feasibility Endpoint	4 Months	Rate of Technical Success defined as the successful implantation of the EchoMark implant. 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	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.

Secondary Outcome Measures

Name	Time	Method

Locations (4): Surgical Specialist of Charlotte
🇺🇸
Charlotte, North Carolina, United States
SKI Vascular Center
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Peoria, Arizona, United States
Trinity Research Group
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Dothan, Alabama, United States
Michgan Vascular Center
🇺🇸
Flint, Michigan, United States