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

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. Identifier: NCT00131872
Recruitment Status : Terminated
First Posted : August 19, 2005
Last Update Posted : January 29, 2008
Information provided by:
LeMaitre Vascular

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Device: Expedial Vascular Access Graft Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts
Study Start Date : March 2004
Actual Study Completion Date : November 2006

Primary Outcome Measures :
  1. Primary or assisted primary patency at 1 year

Secondary Outcome Measures :
  1. Secondary patency
  2. Overall adverse event rate
  3. Time to first access
  4. Time to hemostasis following needle withdrawal after dialysis

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00131872

United States, Florida
Vascular and General Surgery
Miami, Florida, United States, 33125
United States, Louisiana
Vascular Surgery Associates
Baton Rouge, Louisiana, United States, 70809
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Vascular Surgery
Bronx, New York, United States, 10461
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, South Carolina
General Surgery
Bamberg, South Carolina, United States, 29003
South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Texas
Peripheral Vascular Associates
San Antonio, Texas, United States, 78206
Sponsors and Collaborators
LeMaitre Vascular Identifier: NCT00131872     History of Changes
Other Study ID Numbers: 00168
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: January 29, 2008
Last Verified: November 2006

Keywords provided by LeMaitre Vascular:
vascular access graft
end stage renal disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency