Evaluating GORE® ACUSEAL Vascular Graft for Dialysis Access

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety and performance of the GORE® ACUSEAL Vascular Graft in patients with End Stage Renal Disease (ESRD) requiring hemodialysis access. Participants will be implanted with the graft and followed for 24 months to monitor for device-related infections and the graft's secondary patency. The study is non-interventional and will gather real-world evidence from multiple centers across Europe. A total of 72 subjects will be enrolled, with each site limited to 25 participants.

Why it matters

Who can join: the full rules

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 with the GORE® ACUSEAL Vascular Graft device.
4. The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous stenosis.
5. The patient is currently taking maintenance corticosteroids and immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (\> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide.
6. The patient has a known hypercoagulability or bleeding disorder.
7. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to Heparin.
8. The patient is enrolled in an investigational study.
9. The patient has been previously enrolled in this registry.
10. The patient is currently being considered for a live donor kidney transplant (living donor either related or unrelated to patient).
11. The patient has life expectancy less than 2 years.

Where it's running

• 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 Terminated

Study contacts

• Principal investigator: Matteo Tozzi — University of Insubria (Italy)
• Study coordinator: Elisabetta Ferro
• Email: eferro@wlgore.com
• Phone: +39 3486244749

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.