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Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts
This study has been terminated.
Sponsored by: LeMaitre Vascular
Information provided by: LeMaitre Vascular
ClinicalTrials.gov Identifier: NCT00131872
  Purpose

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 Intervention Phase
End Stage Renal Disease
Device: Expedial Vascular Access Graft
Phase II

MedlinePlus related topics: Kidney Failure
Drug Information available for: Polytetrafluoroethylene
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment
Official Title: Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts

Further study details as provided by LeMaitre Vascular:

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

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

Estimated Enrollment: 172
Study Start Date: March 2004
Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131872

Locations
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
Vascular Surgery
Bronx, New York, United States, 10461
Montefiore Medical Center
Bronx, New York, United States, 10461
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, South Carolina
South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System
Greenville, South Carolina, United States, 29605
General Surgery
Bamberg, South Carolina, United States, 29003
United States, Texas
Peripheral Vascular Associates
San Antonio, Texas, United States, 78206
Sponsors and Collaborators
LeMaitre Vascular
  More Information

Study ID Numbers: 00168
Study First Received: August 17, 2005
Last Updated: January 24, 2008
ClinicalTrials.gov Identifier: NCT00131872  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009