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

Shaare Zedek Medical Center

Status and phase

Completed

Phase 4

Conditions

Hemodialysis Fistula Thrombosis

Treatments

Procedure: Prosthetic AV graft implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT00737620

11111 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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