This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.
This is Stage 1 of a 2 stage protocol, targeting to enroll 60 patients in prospective, single arm, non-randomized, multi-center observational study to record objective data in patients undergoing upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access, in whom the EchoMark is placed at the site of vascular anastomosis. Follow-up visits include EchoSure and duplex imaging.
Study Type
OBSERVATIONAL
Enrollment
17
Each subject will have an EchoMark implanted at the time of arteriovenous fistula creation, and undergo EchoSure and duplex imaging follow-up.
University of Maryland School of Medicine
Baltimore, Maryland, United States
Roanoke Vascular Access Center
Roanoke, Virginia, United States
Performance: Data Collection
Data collection to verify accuracy
Time frame: 24 weeks
Performance Endpoint
Data collection to understand the natural history of flow physiology in AV fistulas and classify the fistula that will fail.
Time frame: 24 Weeks
Safety Endpoint
Number of Subjects with Freedom from Serious Adverse Events (SAEs) during the EchoMark implantation procedure and sub-sequent post-operative period.
Time frame: 24 Weeks
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