Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

Inclusion Criteria: 1. be ≥ 18 years of age; 2. if female of childbearing potential, provide evidence of a negative pregnancy test within 3 days prior to graft placement (Day -3 to Day 0); 3. be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the upper extremity; 4. have an outflow vein of greater than or equal to 3 mm in diameter; 5. be able to effectively communicate with study personnel; 6. be considered by the physician to be available for subsequent visits; 7. be willing to comply with all aspects of the treatment and evaluation schedule over a 52 week duration; 8. allow representatives of the sponsor, designated CRO, Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records; 9. sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures; 10. must agree to participate in protocol 014-VWAV07, a safety study to run consecutively for an additional 4 years or until Post-Market Approval (PMA), whichever is longer; and 11. have the Lifespan® ePTFE Vascular Graft successfully implanted. Exclusion Criteria: 1. pregnant, breast-feeding, or female of childbearing potential who do not agree to remain abstinent or to use a contraceptive method during the study period. Non-childbearing potential is defined as either post-menopausal (amenorrheic for at least 1 year) or surgically sterile. Surgically sterile is defined as tubal ligation or the absence of the uterus and/or ovaries; 2. male of childbearing potential, who does not agree to remain abstinent or to use contraception to prevent fathering a child during the course of the study. Non-childbearing potential is defined as vasectomy or bilateral orchiectomy; 3. a central venous stenosis on the ipsilateral side is documented; 4. a hypercoagulable state is documented; 5. life expectancy is less than one year; 6. an organ transplant is expected within 6 months of test or control product (study products) placement; 7. hypersensitivity to any component of the study products or procedural materials or medications is known; 8. concurrently involved in another investigational study; 9. a study product being investigated by others has been received within 30 days prior to randomization in this trial; 10. the study product being studied in this trial has previously been received; 11. uncontrolled hypertension with systolic BP \>200mmHg or diastolic BP \>115mmHg is present at screening; 12. currently receiving chemotherapy or radiation therapy; or 13. placement of a new end-to-end arteriovenous anastomosis graft is required.