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

NCT01021839 | Completed

• 1 other identifier: 2006p-000081
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure; Renal Dialysis

Keywords

renal dialysis; bioprosthesis; arteriovenous shunt; surgical

Outcome Measures

Primary Outcomes (1)

• Primary and Assisted Patency

  6, 12, 18, 24 months

Secondary Outcomes (1)

• patients were monitored for the following complications: thrombosis of the graft; graft infection; pseudoaneurysm formation; steal syndrome.

  6,12,18 and 24 months

Study Arms (2)

Bovine Carotid Artery Graft

ACTIVE COMPARATOR

Procedure: Grafts placement

Expanded Polytetrafluoroethylene Grafts

ACTIVE COMPARATOR

Procedure: Grafts placement

Interventions

Grafts placement PROCEDURE

Graft placement (upper or lower extremity); surgical or radiographic revision as needed.

Also known as: Artegraft

Bovine Carotid Artery Graft; Expanded Polytetrafluoroethylene Grafts

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Surgically suitable for a native arteriovenous fistula

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Artegraft, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tatsuo Kawai, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 30, 2009
• Study Start: April 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 30, 2009

Record last verified: 2009-11

Locations

US (1)