Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

Prior treatment

• 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).

Other illness

• The patient currently has a known or suspected systemic infection.
• The patient has a known hypercoagulability or bleeding disorder.

Other

• The patient is pregnant or breastfeeding.
• The patient is enrolled in an investigational study.
• The patient has life expectancy less than 2 years.

• 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.