Condition: Chronic Kidney Diseases · End Stage Renal Disease on Dialysis · Sponsor: W.L.Gore & Associates
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.
This description comes directly from the study's public registry record.
Elisabetta Ferro · +39 3486244749 · eferro@wlgore.com
Always discuss trial participation with your own doctor first.
| Evangelisches Klinikum Bethel (EvKB) | Bielefeld, Germany | Recruiting |
| Ev. DiakonissenKrankenhaus Leipzigemeinnützige | Leipzig, Germany | Recruiting |
| ASST-Settelaghi Ospedale di Circolo e Fondazione Macchi | Varese, Italy | Recruiting |
| North Bristol NHS Trust Southmead Hospital | Bristol, England, United Kingdom | Recruiting |
| King's College Hospital NHS Foundation Trust | London, England, United Kingdom | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT05846581