Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

Recruiting Observational Study
Chronic Kidney Diseases End Stage Renal Disease on Dialysis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
72 (estimated)
Sponsor
W.L.Gore & Associates · Industry
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About This Trial
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 in…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease and intends to use GORE® ACUSEAL Vascular Graft device for arteriovenous (AV) access. 2. Age ≥18 years at time of Informed Consent Form (ICF) signature. 3…
Contacts

Elisabetta Ferro

+39 3486244749

eferro@wlgore.com

CONTACT