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.

Study Overview

• Status: Terminated
• Conditions: End Stage Renal Disease; Hemolysis; Arteriovenous Graft
• Intervention / Treatment: Device: Expanded polytetrafluoroethylene Graft; Device: Bovine Carotid Artery Graft

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Expanded polytetrafluoroethylene (ePTFE); 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.	Device: Expanded polytetrafluoroethylene Graft; Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.; Other Names: Synthetic Graft
EXPERIMENTAL: Bovine carotid Artery Graft; 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.	Device: Bovine Carotid Artery Graft; Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.; Other Names: Biological Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Primary Graft Patency	Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).	One year after Graft Placement
Percentage of Patients With Primary-Assisted Graft Patency	Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.	One year after Graft Placement
Percentage of Patients With Secondary Graft Patency	Secondary patency is defined as the interval from graft placement to graft failure.	One year after Graft Placement
Percentage of Patients With Functional Patency	Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)	One year after Graft Placement
Percentage of Patients With Primary Graft Patency	Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).	Two years after Graft Placement
Percentage of Patients With Primary-Assisted Graft Patency	Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.	Two years after Graft Placement
Percentage of Patients With Secondary Graft Patency	Secondary patency is defined as the interval from graft placement to graft failure.	Two years after Graft Placement
Percentage of Patients With Functional Patency	Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)	Two years after Graft Placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pseudoaneurysms Formation at the Access Site		At 6 months after Graft Placement
Incidence of Pseudoaneurysms Formation at the Access Site		At 12 months after Graft Placement
Incidence of Pseudoaneurysms Formation at the Access Site		At 18 months after Graft Placement
Incidence of Pseudoaneurysms Formation at the Access Site		At 24 months after Graft Placement
Percentage of Patients With Surgical Site Infection	The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.	At 6 months after Graft Placement
Percentage of Patients With Surgical Site Infection	The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.	At 12 months after Graft Placement
Percentage of Patients With Surgical Site Infection	The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.	At 18 months after Graft Placement
Percentage of Patients With Surgical Site Infection	The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.	At 24 months after Graft Placement
Steal Syndrome	Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.	At 6 months after Graft Placement
Steal Syndrome	Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.	At 12 months after Graft Placement
Steal Syndrome	Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.	At 18 months after Graft Placement
Steal Syndrome	Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.	At 24 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft	At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention	At 6 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft	At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention	At 12 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft	At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention	At 18 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft	At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention	At 24 months after Graft Placement

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Thomas Reifsnyder, MD, Johns Hopkins University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2015
• Primary Completion (ACTUAL): February 12, 2018
• Study Completion (ACTUAL): February 12, 2018

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (ACTUAL): October 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Hemodialysis; Graft; Bovine; Arteriovenous; polytetrafluoroethylene
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hemolysis
• Other Study ID Numbers: IRB00069002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only key study personnel will be responsible for entering and tracking information. At the end of the study period, study coordinators and research fellows will have access to the final trial dataset and will analyse the data. The final results will be communicated to the PI and co-PI's, the sponsors and participants and will be later published in a peer-reviewed scientific journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes