Clinical trial NCT03300024: Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
Official title: A Prospective Randomized Study of Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Disease
Hemolysis
Arteriovenous Graft
Keywords: Hemodialysis
Arteriovenous
Graft
polytetrafluoroethylene
Bovine
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will undergo surgery as per standard of care and receive the randomized graft in compliance to National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for Arteriovenous graft creation. Surgeries will be elective in nature. The grafts will be placed either in the arm (brachial artery-axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) based on anatomic suitability
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Patients With Primary Graft Patency
timeFrame: One year after Graft Placement
measure: Percentage of Patients With Primary-Assisted Graft Patency
timeFrame: One year after Graft Placement
measure: Percentage of Patients With Secondary Graft Patency
timeFrame: One year after Graft Placement
measure: Percentage of Patients With Functional Patency
timeFrame: One year after Graft Placement
measure: Percentage of Patients With Primary Graft Patency
timeFrame: Two years after Graft Placement
measure: Percentage of Patients With Primary-Assisted Graft Patency
timeFrame: Two years after Graft Placement
measure: Percentage of Patients With Secondary Graft Patency
timeFrame: Two years after Graft Placement
measure: Percentage of Patients With Functional Patency
timeFrame: Two years after Graft Placement
Secondary outcomes:
measure: Incidence of Pseudoaneurysms Formation at the Access Site
timeFrame: At 6 months after Graft Placement
measure: Incidence of Pseudoaneurysms Formation at the Access Site
timeFrame: At 12 months after Graft Placement
measure: Incidence of Pseudoaneurysms Formation at the Access Site
timeFrame: At 18 months after Graft Placement
measure: Incidence of Pseudoaneurysms Formation at the Access Site
timeFrame: At 24 months after Graft Placement
measure: Percentage of Patients With Surgical Site Infection
timeFrame: At 6 months after Graft Placement
measure: Percentage of Patients With Surgical Site Infection
timeFrame: At 12 months after Graft Placement
measure: Percentage of Patients With Surgical Site Infection
timeFrame: At 18 months after Graft Placement
measure: Percentage of Patients With Surgical Site Infection
timeFrame: At 24 months after Graft Placement
measure: Steal Syndrome
timeFrame: At 6 months after Graft Placement
measure: Steal Syndrome
timeFrame: At 12 months after Graft Placement
measure: Steal Syndrome
timeFrame: At 18 months after Graft Placement
measure: Steal Syndrome
timeFrame: At 24 months after Graft Placement
measure: Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
timeFrame: At 6 months after Graft Placement
measure: Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
timeFrame: At 12 months after Graft Placement
measure: Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
timeFrame: At 18 months after Graft Placement
measure: Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
timeFrame: At 24 months after Graft Placement
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Thomas Reifsnyder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dakour Aridi H, Arhuidese I, Scudder M, Reifsnyder T, Malas MB. A prospective randomized study of bovine carotid artery biologic graft and expanded polytetrafluoroethylene for permanent hemodialysis access. J Vasc Surg. 2018 May;67(5):1606-1612.e4. doi: 10.1016/j.jvs.2017.12.058. Epub 2018 Mar 19.