Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

Inclusion Criteria:\> 1. Patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. \> \>\> 2. Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. \> \>\> 3. The patient must be able to have the vascular access graft placed in an upper extremity. \> \>\> 4. The patient is 18 years of age or older. \> \>\> 5. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. \> \>\> 6. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. \> \>\> 7. The patient or his/her legal guardian is willing to provide informed consent. \> \>\> \> \>\> \> \>\> Exclusion Criteria:\> \>\> <!-- --> 1. The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.\> \>\> 2. The patient currently has a known or suspected systemic infection.\> \>\> 3. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\> \>\> 4. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. \> \>\> 5. The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.\> \>\> 6. The patient is enrolled in another investigational study.\> \>\> 7. The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\> \>\> 8. Study device is intended to be used temporarily.\> \>\> 9. The patient has had \>2 previous arteriovenous accesses in treatment arm.\> \>\> 10. Patient is taking Aggrenox®.\> \>\> 11. The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.\> \>\> 12. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(\>10 mg), cyclosporine, tacrolimus or cyclophosphamide.\> \>\> 13. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\> \>\> 14. Life expectancy is less than 12 months.\> \>\> 15. The patient is pregnant.\> \>\> 16. The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).