RecruitingNCT05846581

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

Sponsor

W.L.Gore & Associates

Enrollment

72 participants

Start Date

Jan 12, 2024

Study Type

OBSERVATIONAL

Conditions

Chronic Kidney Diseases End Stage Renal Disease on Dialysis

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking outcomes for patients who receive a specific type of synthetic blood vessel graft (the GORE ACUSEAL Vascular Graft) used to create dialysis access — the connection point where a dialysis machine connects to your bloodstream. The goal is to collect real-world data on how well this graft performs. **You may be eligible if...** - You have end-stage kidney disease and need a new dialysis access point created in your arm - Your doctor has chosen to use the GORE ACUSEAL graft for your procedure - You are 18 or older - You are willing to participate and attend follow-up visits **You may NOT be eligible if...** - You already have an existing functional dialysis access (unless it has failed) - You have a condition that would prevent graft placement (like severe blood vessel disease in both arms) - You are not expected to live long enough to complete the follow-up period - You are already enrolled in a conflicting clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGORE® 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.