Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
Trial Parameters
Eligibility Fast-Check
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Brief 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 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. Willingness of the patient to adhere to institutional standard of care follow-up. 4. Informed Consent Form (ICF) is signed by the patient. 5. The patient is currently on hemodialysis or intended to begin hemodialysis immediately following placement of the GORE® ACUSEAL Vascular Graft device or up to 30 days following placement of the device. 6. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. Exclusion Criteria: 1. The patient currently has a known or suspected systemic infection. 2. The patient is pregnant or breastfeeding. 3. The patient had a separate interventional or surgical vascular procedure within the study limb within 30 days prior to treatment