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

Kidney Failure Clinical Trial

Official title:

Bovine Carotid Artery Graft Revisited: A Prospective, Randomized Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021839
• Other study ID #: 2006p-000081
• Status: Completed
• Phase: N/A
• First received: November 18, 2009
• Last updated: November 25, 2009
• Start date: April 2006
• Est. completion date: June 2009

Study information

• Verified date: November 2009
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Surgically suitable for a native arteriovenous fistula

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure
• Renal Dialysis
• Renal Insufficiency

Intervention

Procedure:
• Grafts placement
Graft placement (upper or lower extremity); surgical or radiographic revision as needed.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Artegraft, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary and Assisted Patency		6, 12, 18, 24 months	No
Secondary	patients were monitored for the following complications: thrombosis of the graft; graft infection; pseudoaneurysm formation; steal syndrome.		6,12,18 and 24 months	No