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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:
Information provided by (Responsible Party):
Dr David Shemesh, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00737620
First received: August 17, 2008
Last updated: October 29, 2012
Last verified: December 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Patency of AV fistula [ Time Frame: Study period ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737620

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

No publications provided

Responsible Party: Dr David Shemesh, Dr, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00737620     History of Changes
Other Study ID Numbers: 11111
Study First Received: August 17, 2008
Last Updated: October 29, 2012
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Fistula
Thrombosis
Pathological Conditions, Anatomical
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013