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

This study has been terminated.
Sponsor:
Information provided by:
LeMaitre Vascular
ClinicalTrials.gov Identifier:
NCT00131872
First received: August 17, 2005
Last updated: January 24, 2008
Last verified: November 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
  More Information

No publications provided

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

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

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

ClinicalTrials.gov processed this record on July 28, 2014