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

Primary Purpose

End Stage Renal Disease, Hemolysis, Arteriovenous Graft

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expanded polytetrafluoroethylene Graft
Bovine Carotid Artery Graft
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Hemodialysis, Arteriovenous, Graft, polytetrafluoroethylene, Bovine

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Expanded polytetrafluoroethylene (ePTFE)

Bovine carotid Artery Graft

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).
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.
Percentage of Patients With Secondary Graft Patency
Secondary patency is defined as the interval from graft placement to graft failure.
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)
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).
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.
Percentage of Patients With Secondary Graft Patency
Secondary patency is defined as the interval from graft placement to graft failure.
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)

Secondary Outcome Measures

Incidence of Pseudoaneurysms Formation at the Access Site
Incidence of Pseudoaneurysms Formation at the Access Site
Incidence of Pseudoaneurysms Formation at the Access Site
Incidence of Pseudoaneurysms Formation at the Access Site
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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

Full Information

First Posted
September 18, 2017
Last Updated
May 13, 2019
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03300024
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Funding ended
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
February 12, 2018 (Actual)
Study Completion Date
February 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hemolysis, Arteriovenous Graft
Keywords
Hemodialysis, Arteriovenous, Graft, polytetrafluoroethylene, Bovine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Outcomes Assessor
Masking Description
The study will not be blinded because patient side blinding is expected to have minimal to no effect, while physician side blinding is impractical; and difficult to achieve due to the primary surgeon being the one usually who follows up on any intervention or treatment.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expanded polytetrafluoroethylene (ePTFE)
Arm Type
Active Comparator
Arm 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.
Arm Title
Bovine carotid Artery Graft
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Expanded polytetrafluoroethylene Graft
Other Intervention Name(s)
Synthetic Graft
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Bovine Carotid Artery Graft
Other Intervention Name(s)
Biological Graft
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients With Primary Graft Patency
Description
Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
Time Frame
One year after Graft Placement
Title
Percentage of Patients With Primary-Assisted Graft Patency
Description
Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
Time Frame
One year after Graft Placement
Title
Percentage of Patients With Secondary Graft Patency
Description
Secondary patency is defined as the interval from graft placement to graft failure.
Time Frame
One year after Graft Placement
Title
Percentage of Patients With Functional Patency
Description
Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)
Time Frame
One year after Graft Placement
Title
Percentage of Patients With Primary Graft Patency
Description
Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
Time Frame
Two years after Graft Placement
Title
Percentage of Patients With Primary-Assisted Graft Patency
Description
Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
Time Frame
Two years after Graft Placement
Title
Percentage of Patients With Secondary Graft Patency
Description
Secondary patency is defined as the interval from graft placement to graft failure.
Time Frame
Two years after Graft Placement
Title
Percentage of Patients With Functional Patency
Description
Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)
Time Frame
Two years after Graft Placement
Secondary Outcome Measure Information:
Title
Incidence of Pseudoaneurysms Formation at the Access Site
Time Frame
At 6 months after Graft Placement
Title
Incidence of Pseudoaneurysms Formation at the Access Site
Time Frame
At 12 months after Graft Placement
Title
Incidence of Pseudoaneurysms Formation at the Access Site
Time Frame
At 18 months after Graft Placement
Title
Incidence of Pseudoaneurysms Formation at the Access Site
Time Frame
At 24 months after Graft Placement
Title
Percentage of Patients With Surgical Site Infection
Description
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Time Frame
At 6 months after Graft Placement
Title
Percentage of Patients With Surgical Site Infection
Description
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Time Frame
At 12 months after Graft Placement
Title
Percentage of Patients With Surgical Site Infection
Description
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Time Frame
At 18 months after Graft Placement
Title
Percentage of Patients With Surgical Site Infection
Description
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Time Frame
At 24 months after Graft Placement
Title
Steal Syndrome
Description
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.
Time Frame
At 6 months after Graft Placement
Title
Steal Syndrome
Description
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.
Time Frame
At 12 months after Graft Placement
Title
Steal Syndrome
Description
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.
Time Frame
At 18 months after Graft Placement
Title
Steal Syndrome
Description
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.
Time Frame
At 24 months after Graft Placement
Title
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
Description
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
Time Frame
At 6 months after Graft Placement
Title
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
Description
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
Time Frame
At 12 months after Graft Placement
Title
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
Description
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
Time Frame
At 18 months after Graft Placement
Title
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
Description
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
Time Frame
At 24 months after Graft Placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Reifsnyder, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
29567027
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.
Results Reference
derived

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

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