A Prospective Randomized Study of Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- End Stage Renal Disease
- Sponsor
- Johns Hopkins University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Percentage of Patients With Primary Graft Patency
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.
Detailed 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.
Investigators
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
Outcomes
Primary Outcomes
Percentage of Patients With Primary Graft Patency
Time Frame: Two years after Graft Placement
Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
Percentage of Patients With Primary-Assisted Graft Patency
Time Frame: Two years after Graft Placement
Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
Percentage of Patients With Secondary Graft Patency
Time Frame: Two years after Graft Placement
Secondary patency is defined as the interval from graft placement to graft failure.
Percentage of Patients With Functional Patency
Time Frame: Two years after Graft Placement
Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)
Secondary Outcomes
- Incidence of Pseudoaneurysms Formation at the Access Site(At 24 months after Graft Placement)
- Percentage of Patients With Surgical Site Infection(At 24 months after Graft Placement)
- Steal Syndrome(At 24 months after Graft Placement)
- Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft(At 24 months after Graft Placement)