Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis

Phase 4

Completed

• Conditions: Hemodialysis Fistula Thrombosis
• Interventions: Procedure: Prosthetic AV graft implantation

• Registration Number: NCT00737620
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis access will develop stenosis at the venous anastomosis and eventually will fail. Aspirin have been used for many years as a prophylactic drug therapy to prevent thrombosis but good clinical evidence for its benefit is lacking. Many drugs have been used to reduce intimal hyperplasia in animal models. Until recently there has been little success in clinical trials of anti-inflammatory, antiproliferative, antiplatelet, antithrombotic or calcium channel blocking drugs. Recently a major breakthrough was done by GORE when introducing the new heparin bonded PTFE graft by covalent attachment. This trial is planed to assess and compare between the GORE-TEX® PROPATEN vascular graft versus unmodified ePTFE grafts the patency and complication.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-08-17
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-19
• Primary Completion: 2011-11
• Status Verified: 2011-12
• Last Update Submitted: 2012-10-29
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• All the patients who are scheduled for the creation of a new prosthetic access with informed consent will be enrolled in the trial
• Investigators will attempt to enroll a male:female ratio of patients representative of their current patient population

Exclusion Criteria

• Anticoagulation therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propaten graft	Prosthetic AV graft implantation	-
Standard graft	Prosthetic AV graft implantation	-

Primary Outcome Measures

Name	Time	Method
Patency of AV fistula	Study period

Trial Locations

Locations (1)

Shaare Zedek Medical Center, Jerusalem; 🇮🇱 Jerusalem, Israel