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

Johns Hopkins University

Status: Terminated

Conditions: Hemolysis; End Stage Renal Disease; Arteriovenous Graft

Treatments: Device: Bovine Carotid Artery Graft; Device: Expanded polytetrafluoroethylene Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT03300024

IRB00069002

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Expanded polytetrafluoroethylene (ePTFE)

Active Comparator group

Description:

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.

Treatment:

Device: Expanded polytetrafluoroethylene Graft

Bovine carotid Artery Graft

Experimental group

Description:

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.

Treatment:

Device: Bovine Carotid Artery Graft