Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
End Stage Renal Disease, Hemolysis, Arteriovenous Graft
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Hemodialysis, Arteriovenous, Graft, polytetrafluoroethylene, Bovine
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Expanded polytetrafluoroethylene (ePTFE)
Bovine carotid Artery Graft
The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.
The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.