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

NCT ID: NCT03300024

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2018-02-12

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.

Conditions

End Stage Renal Disease; Hemolysis; Arteriovenous Graft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Expanded polytetrafluoroethylene Graft

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Bovine Carotid Artery Graft

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Synthetic Graft; Biological 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Reifsnyder, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29567027 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00069002

Identifier Type: -

Identifier Source: org_study_id