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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemodialysis Fistula Thrombosis Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shaare Zedek Medical Center, Jerusalem

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prosthetic AV graft implantation

Procedure

Surgical arteriovenous fistula creation with standard or propaten graft

Primary outcomes

Patency of AV fistula

Time frame: Study period

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2011
First posted: Aug 19, 2008
Registry last updated: Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed