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Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)

End Stage Renal Disease Clinical Trial

Official title:
Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)

Clinical Trial Summary

Prospective, nonrandomized, single-arm, single-center, open-label, initial safety study in subjects requiring hemodialysis. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and weeks 12, 26. Extended follow up on patent conduits only at weeks 52 and 104.

Clinical Trial Description

Twenty (20) patients with end-stage kidney disease (ESKD), who are poor candidates for an autogenous fistula creation and either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation will be implanted with a TRUE AVC as an arteriovenous conduit in the upper extremity. Study subjects will be evaluated for implant safety and patency at 26 weeks. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and weeks 12, 26. Extended follow up on patent conduits only at weeks 52 and 104. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05567757
Study type Interventional
Source Vascudyne, Inc.
Contact Mark Stenoien
Phone +7632031032
Email mstenoien@vascudyne.com
Status Recruiting
Phase Phase 1/Phase 2
Start date October 4, 2022
Completion date December 30, 2024
View Details
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