Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts

January 24, 2008 updated by: LeMaitre Vascular

Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts

The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

172

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33125
        • Vascular and General Surgery
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Vascular Surgery Associates
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Bronx, New York, United States, 10461
        • Vascular Surgery
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • South Carolina
      • Bamberg, South Carolina, United States, 29003
        • General surgery
      • Greenville, South Carolina, United States, 29605
        • South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System
    • Texas
      • San Antonio, Texas, United States, 78206
        • Peripheral Vascular Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has chronic renal failure and requires vascular access for hemodialysis
  • Patient has given informed consent to participate in the trial and is willing to comply with the study protocol
  • Patient is male or female, 18 years of age or older
  • The vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm)
  • Patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center
  • Patient has a vein 4 mm or larger to which the graft can be anastomosed

Exclusion Criteria:

  • Patient is unable to comply with the study follow-up
  • Patient has a known sensitivity to polyurethane or porcine heparin
  • Patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available
  • Patient has an immunodeficiency syndrome
  • Patient has a prior history of bacterial infection within 8 weeks of implantation of graft
  • Patient has a severe coagulation disorder
  • Patient has an elevated platelet count of greater than 1 million
  • Patient has a history of heparin-induced thrombocytopenia syndrome (HIT)
  • Patient is pregnant
  • Patient has a fever greater than 100 degrees Fahrenheit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary or assisted primary patency at 1 year

Secondary Outcome Measures

Outcome Measure
Secondary patency
Overall adverse event rate
Time to first access
Time to hemostasis following needle withdrawal after dialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LeMaitre Vascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

August 17, 2005

First Submitted That Met QC Criteria

August 18, 2005

First Posted (Estimate)

August 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 29, 2008

Last Update Submitted That Met QC Criteria

January 24, 2008

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00168

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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