Status:
TERMINATED
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts
Lead Sponsor:
LeMaitre Vascular
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2006
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00131872
Start Date
March 1 2004
End Date
November 1 2006
Last Update
July 8 2024
Active Locations (8)
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1
Vascular and General Surgery
Miami, Florida, United States, 33125
2
Vascular Surgery Associates
Baton Rouge, Louisiana, United States, 70809
3
Montefiore Medical Center
The Bronx, New York, United States, 10461
4
Vascular Surgery
The Bronx, New York, United States, 10461