Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access

A Prospective Randomized Study of Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access

The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.

Arteriovenous grafts (AVG) remain reliable substitutes for permanent hemodialysis access in scenarios that preclude the placement of arteriovenous fistulae. There is scarcity of evidence to support the current preference of synthetic conduits over biologic grafts in clinical practice. Advances in the design of AVG's warrant contemporary comparisons between synthetic and biologic AVG options. This is especially important as biologic conduits may confer an advantage by virtue of their inherent similarity to the native human vasculature.

The overall goal of this project is to compare one and two year patency (functional, primary, primary assisted and secondary), complication rates and re-intervention rates between BCA and standard ePTFE grafts. The investigators hypothesize that vascular patient who will receive the BCA graft will have improved patency as well as lower complication and re-intervention rates compared to the standard ePTFE graft.

Inclusion Criteria:

• Patients at least 18 years of age
• Have End Stage Renal Disease and are undergoing Arterio-Venous-Graft surgery
• Not Eligible to receive an Arterio-Venous-Fistula
• Provided written informed consent
• Agreed to return for all required clinical follow up for the study

Exclusion Criteria:

• Eligible to receive an Arterio-Venous-Fistula
• Known allergic reaction or history of intolerance to any ePTFE or BCA components
• Local infection at AVG placement site at the time of surgery
• Patients with a bleeding disorder or who refuse blood transfusion
• Patients with an active malignancy
• Life expectancy less than 1 year
• Pregnant women or those planning on becoming pregnant for the duration of the study