Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-28 @ 1:03 PM
Study NCT ID:
NCT05567757
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2022-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)
Sponsor:
Vascudyne, Inc.
Organization:
Study Overview
Official Title:
Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: