Clinical Trial

Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

Study acronym: AVG22-09
Recruiting
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Summary
The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are: * Safety: Freedom from device-related infection adverse events at 24 months from device implant * Performance: Secondary patency at 24 months from device implant. Participants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2023-04-26; most recent amendment 2025-07-08.
Status change: Not Yet Recruiting → Recruiting 2023-10-27
Trial Details
NCT Number NCT05846581
Lead Sponsor W.L.Gore & Associates
Conditions Chronic Kidney Diseases, End Stage Renal Disease on Dialysis
Enrollment 72 participants
Start Date 2024-01-12
Primary Completion 2027-10-27 (estimated)
Study Completion 2027-10-27 (estimated)
Updated on ClinicalTrials.gov 2026-08-13