Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

Inclusion Criteria:

1. The patient requires the creation of vascular access for hemodialysis secondary to adiagnosis of End-Stage Renal Disease and intends to use GORE® ACUSEAL Vascular Graftdevice 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 hemodialysisimmediately 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 thestudy limb within 30 days prior to treatment with the GORE® ACUSEAL Vascular Graftdevice.

4. The patient had a previous documented (via imaging technique) and unsuccessfullytreated ipsilateral central venous stenosis.

5. The patient is currently taking maintenance corticosteroids and immunosuppressantmedication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (> 10mg), 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 (livingdonor either related or unrelated to patient).

11. The patient has life expectancy less than 2 years.