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.
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