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Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene (ePTFE) for Permanent Hemodialysis Access

This study has been completed.
Sponsor:
Collaborator:
Artegraft, Inc.
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01021839
First received: November 18, 2009
Last updated: November 25, 2009
Last verified: November 2009
History of Changes
  Purpose

The investigators did a randomized control trial comparing bovine carotid artery grafts with ePTFE grafts for patients that need hemodialysis access. The goal of the study was to determine differences in primary and assisted patency rates and frequency of complications between these two types of grafts. The investigators' hypothesis was that bovine carotid artery grafts more closely mimic autologous tissue and therefore, would provide better patency and fewer complications.


Condition Intervention
Kidney Failure
Renal Dialysis
 Procedure: Grafts placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bovine Carotid Artery Graft Revisited: A Prospective, Randomized Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Primary and Assisted Patency [ Time Frame: 6, 12, 18, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patients were monitored for the following complications: thrombosis of the graft; graft infection; pseudoaneurysm formation; steal syndrome. [ Time Frame: 6,12,18 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: April 2006
Study Completion Date: June 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bovine Carotid Artery Graft Procedure: Grafts placement
Graft placement (upper or lower extremity); surgical or radiographic revision as needed.
Other Name: Artegraft
Active Comparator: Expanded Polytetrafluoroethylene Grafts Procedure: Grafts placement
Graft placement (upper or lower extremity); surgical or radiographic revision as needed.
Other Name: Artegraft

Detailed Description:

Objective: To understand how bovine carotid artery (BCA) grafts compare to cuffed polytetrafluoroethylene (ePTFE) grafts as conduits for hemodialysis access in terms of patency and complications.

Background: Many hemodialysis patients do not have adequate anatomy for native arteriovenous fistulas. In these patients, synthetic conduits remain the only option for permanent hemodialysis access. We sought to compare the standard cuffed ePTFE with bovine carotid artery grafts as this has not been undertaken since the 1970's.

Methods: Following Institutional Review Board approval, a prospective, randomized controlled trial was conducted enrolling 29 patients in the BCA group and 28 patients in the ePTFE group. Univariate and multivariate analysis was undertaken to understand factors that affect complications. Patency rates were calculated using the Kaplan-Meyer method.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic kidney disease stage 4 or 5, in need of hemodialysis access

Exclusion Criteria:

  • Surgically suitable for a native arteriovenous fistula
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021839

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Artegraft, Inc.
Investigators
Principal Investigator: Tatsuo Kawai, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Tatsuo Kawai, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01021839     History of Changes
Other Study ID Numbers: 2006p-000081
Study First Received: November 18, 2009
Last Updated: November 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
renal dialysis
bioprosthesis
arteriovenous shunt
surgical

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013