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

NCT00737620 | Completed Phase 4

• 1 other identifier: 11111
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Fistula Thrombosis

Keywords

Renal Failure, End Stage; Blood Vessel Grafting; Hemodialysis; Surgical Arteriovenous Shunt

Outcome Measures

Primary Outcomes (1)

• Patency of AV fistula

  Study period

Study Arms (2)

propaten graft

ACTIVE COMPARATOR

Procedure: Prosthetic AV graft implantation

Standard graft

ACTIVE COMPARATOR

Procedure: Prosthetic AV graft implantation

Interventions

Prosthetic AV graft implantation PROCEDURE

Surgical arteriovenous fistula creation with standard or propaten graft

Standard graft; propaten graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Anticoagulation therapy

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center, Jerusalem

Jerusalem, Israel

Location

Related Publications (1)

• Shemesh D, Goldin I, Hijazi J, Zaghal I, Berelowitz D, Verstandig A, Olsha O. A prospective randomized study of heparin-bonded graft (Propaten) versus standard graft in prosthetic arteriovenous access. J Vasc Surg. 2015 Jul;62(1):115-22. doi: 10.1016/j.jvs.2015.01.056. Epub 2015 Mar 12.

  PMID: 25770987 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 17, 2008
• First Posted: August 19, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2011
• Last Updated: October 30, 2012

Record last verified: 2011-12

Locations

IL (1)