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

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ClinicalTrials.gov Identifier: NCT03300024
Recruitment Status : Terminated (Funding ended)
First Posted : October 3, 2017
Results First Posted : May 14, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Hemolysis Arteriovenous Graft Device: Expanded polytetrafluoroethylene Graft Device: Bovine Carotid Artery Graft Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (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.
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study of Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : February 12, 2018
Actual Study Completion Date : February 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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 Name: 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 Name: Biological Graft




Primary Outcome Measures :
  1. Percentage of Patients With Primary Graft Patency [ Time Frame: One year after Graft Placement ]
    Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).

  2. Percentage of Patients With Primary-Assisted Graft Patency [ Time Frame: One year after Graft Placement ]
    Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.

  3. Percentage of Patients With Secondary Graft Patency [ Time Frame: One year after Graft Placement ]
    Secondary patency is defined as the interval from graft placement to graft failure.

  4. Percentage of Patients With Functional Patency [ Time Frame: One year 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)

  5. 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).

  6. 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.

  7. 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.

  8. 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 Outcome Measures :
  1. Incidence of Pseudoaneurysms Formation at the Access Site [ Time Frame: At 6 months after Graft Placement ]
  2. Incidence of Pseudoaneurysms Formation at the Access Site [ Time Frame: At 12 months after Graft Placement ]
  3. Incidence of Pseudoaneurysms Formation at the Access Site [ Time Frame: At 18 months after Graft Placement ]
  4. Incidence of Pseudoaneurysms Formation at the Access Site [ Time Frame: At 24 months after Graft Placement ]
  5. Percentage of Patients With Surgical Site Infection [ Time Frame: At 6 months after Graft Placement ]
    The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.

  6. Percentage of Patients With Surgical Site Infection [ Time Frame: At 12 months after Graft Placement ]
    The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.

  7. Percentage of Patients With Surgical Site Infection [ Time Frame: At 18 months after Graft Placement ]
    The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.

  8. Percentage of Patients With Surgical Site Infection [ Time Frame: At 24 months after Graft Placement ]
    The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.

  9. Steal Syndrome [ Time Frame: At 6 months after Graft Placement ]
    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.

  10. Steal Syndrome [ Time Frame: At 12 months after Graft Placement ]
    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.

  11. Steal Syndrome [ Time Frame: At 18 months after Graft Placement ]
    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.

  12. Steal Syndrome [ Time Frame: At 24 months after Graft Placement ]
    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.

  13. Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft [ Time Frame: At 6 months after Graft Placement ]
    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

  14. Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft [ Time Frame: At 12 months after Graft Placement ]
    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

  15. Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft [ Time Frame: At 18 months after Graft Placement ]
    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

  16. Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft [ Time Frame: At 24 months after Graft Placement ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300024


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Thomas Reifsnyder, MD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Informed Consent Form  [PDF] October 27, 2015

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03300024    
Other Study ID Numbers: IRB00069002
First Posted: October 3, 2017    Key Record Dates
Results First Posted: May 14, 2019
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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
Keywords provided by Johns Hopkins University:
Hemodialysis
Arteriovenous
Graft
polytetrafluoroethylene
Bovine
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Hemolysis
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Pathologic Processes