Follows patients on dialysis who receive a GORE ACUSEAL vascular graft
Studies safety and how well the GORE ACUSEAL graft works in adults with kidney failure.
Plain-language title generated from the registry record
Registry title: Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
Key facts
- Where
- Varese, ItalySee the site
Where in Italy
- Asst Settelaghi, Ospedale Di Circolo E Fondazione MacchiVarese, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- W.L.Gore & Associates
- Trial code
- NCT05846581
- Record updated
- 13 August 2026
- Original description
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:Read full original descriptionShow less
Observational Prospective Post-Market Clinical Follow-Up (PMCF) Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
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.
Inclusion: 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; Age ≥18 years at time of Informed Consent Form (ICF) signature; Willingness of the patient to adhere to institutional standard of care follow-up; Informed Consent Form (ICF) is signed by the patient; 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; The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
Exclusion: The patient had a separate interventional or surgical vascular procedure within the study limb within 30 days prior to treatment with the GORE® ACUSEAL Vascular Graft device; The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous stenosis; The patient is currently taking maintenance corticosteroids and immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide; The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to Heparin; The patient has been previously enrolled in this registry; The patient is currently being considered for a live donor kidney transplant (living donor either related or unrelated to patient); The patient currently has a known or suspected systemic infection; The patient has a known hypercoagulability or bleeding disorder; The patient is pregnant or breastfeeding; The patient is enrolled in an investigational study; The patient has life expectancy less than 2 years.