NCT05846581

Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

Observational Prospective Post-Market Clinical Follow-Up (PMCF) Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 72 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a European, Observational, Non-Interventional, Prospective, Non-Randomized, Single Arm, Multicenter, PMCF Registry to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. There is no comparator device. The aim of study is to obtain real-world observational evidence about the use of the device. The AVG 22-09 registry consists of End-Stage Renal Disease (ESRD) patients who require hemodialysis access through Vascular Graft per the evaluating physician. A total of 72 subjects will be implanted in this registry with a limit of 25 subjects implanted per site. The registry has been designed with standard eligibility criteria to enroll subjects for which the registry device is intended to treat. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted. All patients must provide informed consent prior to any registry related procedures being performed and the patient is considered enrolled when informed consent is obtained. The primary objective is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft in hemodialysis access for the treatment of Chronic Kidney Disease (CKD) in patients with End Stage Renal Disease (ESRD). All patients who sign an informed consent will be considered enrolled and at the completion of study participation, subjects will be advised by their respective clinical centers on the appropriate follow up regimen to be followed but it is expected that the each implanted subject will be evaluated through hospital discharge and return for follow-up visits per site standard of care. Each enrolled and implanted subject will be followed for 24 months.

Conditions

• Chronic Kidney Diseases
• End Stage Renal Disease on Dialysis

Interventions

Type	Name	Description
DEVICE	GORE® ACUSEAL Vascular Graft	The device placement will be performed according to each participating site's standard practice. No specific procedures are required by the protocol. At the time of the GORE® ACUSEAL Vascular Grafts implantation, procedural and adverse event information will be collected.

Timeline

• Start date: 2024-01-12
• Primary completion: 2027-10-27
• Completion: 2027-10-27
• First posted: 2023-05-06
• Last updated: 2025-07-09

Locations

5 sites across 3 countries: Germany, Italy, United Kingdom

Regulatory

• FDA-regulated device study