Back to resultsComparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene (ePTFE) for Permanent Hemodialysis Access
Primary Purpose
Kidney Failure, Renal Dialysis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Grafts placement
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure focused on measuring renal dialysis, bioprosthesis, arteriovenous shunt, surgical
Eligibility Criteria
Inclusion Criteria:
- Chronic kidney disease stage 4 or 5, in need of hemodialysis access
Exclusion Criteria:
- Surgically suitable for a native arteriovenous fistula
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bovine Carotid Artery Graft
Expanded Polytetrafluoroethylene Grafts
Arm Description
Outcomes
Primary Outcome Measures
Primary and Assisted Patency
Secondary Outcome Measures
patients were monitored for the following complications: thrombosis of the graft; graft infection; pseudoaneurysm formation; steal syndrome.
Full Information
NCT ID
NCT01021839
First Posted
November 18, 2009
Last Updated
November 25, 2009
Sponsor
Massachusetts General Hospital
Collaborators
Artegraft, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01021839
Brief Title
Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene (ePTFE) for Permanent Hemodialysis Access
Official Title
Bovine Carotid Artery Graft Revisited: A Prospective, Randomized Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Artegraft, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Renal Dialysis
Keywords
renal dialysis, bioprosthesis, arteriovenous shunt, surgical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bovine Carotid Artery Graft
Arm Type
Active Comparator
Arm Title
Expanded Polytetrafluoroethylene Grafts
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Grafts placement
Other Intervention Name(s)
Artegraft
Intervention Description
Graft placement (upper or lower extremity); surgical or radiographic revision as needed.
Primary Outcome Measure Information:
Title
Primary and Assisted Patency
Time Frame
6, 12, 18, 24 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic kidney disease stage 4 or 5, in need of hemodialysis access
Exclusion Criteria:
Surgically suitable for a native arteriovenous fistula
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatsuo Kawai, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene (ePTFE) for Permanent Hemodialysis Access
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