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

NCT03300024 | Terminated Results FDA Device

• 1 other identifier: IRB00069002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Hemolysis; Arteriovenous Graft

Keywords

Hemodialysis; Arteriovenous; Graft; polytetrafluoroethylene; Bovine

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (16)

• 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

  At 6 months after Graft Placement

Study Arms (2)

Expanded polytetrafluoroethylene (ePTFE)

ACTIVE COMPARATOR

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

Bovine carotid Artery Graft

EXPERIMENTAL

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

Interventions

Expanded polytetrafluoroethylene Graft DEVICE

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.

Also known as: Synthetic Graft

Expanded polytetrafluoroethylene (ePTFE)

Bovine Carotid Artery Graft DEVICE

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.

Also known as: Biological Graft

Bovine carotid Artery Graft

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• 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.

  PMID: 29567027 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Hemolysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Thomas Reifsnyder
• Organization: Johns Hopkins University

treifsn1@jhmi.edu

410-955-7518

Study Officials

• Thomas Reifsnyder, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: October 3, 2017
• Study Start: February 1, 2015
• Primary Completion: February 12, 2018
• Study Completion: February 12, 2018
• Last Updated: May 21, 2019
• Results First Posted: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)