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

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.


Locations(4)

Evangelisches Klinikum Bethel (EvKB)

Bielefeld, Germany

Ev. DiakonissenKrankenhaus Leipzigemeinnützige

Leipzig, Germany

ASST-Settelaghi Ospedale di Circolo e Fondazione Macchi

Varese, Italy

North Bristol NHS Trust Southmead Hospital

Bristol, England, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05846581


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