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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737620
First Posted: August 19, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr David Shemesh, Shaare Zedek Medical Center
  Purpose
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.

Condition Intervention Phase
Hemodialysis Fistula Thrombosis Procedure: Prosthetic AV graft implantation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis

Resource links provided by NLM:


Further study details as provided by Dr David Shemesh, Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Patency of AV fistula [ Time Frame: Study period ]

Enrollment: 160
Study Start Date: March 2008
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: propaten graft Procedure: Prosthetic AV graft implantation
Surgical arteriovenous fistula creation with standard or propaten graft
Active Comparator: Standard graft Procedure: Prosthetic AV graft implantation
Surgical arteriovenous fistula creation with standard or propaten graft

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737620


Locations
Israel
Shaare Zedek Medical Center, Jerusalem
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr David Shemesh, Dr, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00737620     History of Changes
Other Study ID Numbers: 11111
First Submitted: August 17, 2008
First Posted: August 19, 2008
Last Update Posted: October 12, 2017
Last Verified: December 2011

Keywords provided by Dr David Shemesh, Shaare Zedek Medical Center:
Renal Failure, End Stage
Blood Vessel Grafting
Hemodialysis
Surgical Arteriovenous Shunt

Additional relevant MeSH terms:
Thrombosis
Fistula
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action