NCT05567757

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Vascudyne, Inc. · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Arteriovenous conduit implant	Study subjects will be implanted with an arteriovenous shunt for hemodialysis access in the upper extremity

Timeline

• Start date: 2022-10-04
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2022-10-05
• Last updated: 2025-07-03

Locations

1 site across 1 country: Panama

Regulatory

• FDA-regulated drug study