Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts
Phase 2
Terminated
- Conditions
- End Stage Renal Disease
- Registration Number
- NCT00131872
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 172
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary or assisted primary patency at 1 year
- Secondary Outcome Measures
Name Time Method Overall adverse event rate Time to first access Secondary patency Time to hemostasis following needle withdrawal after dialysis
Trial Locations
- Locations (8)
Vascular Surgery Associates
🇺🇸Baton Rouge, Louisiana, United States
General Surgery
🇺🇸Bamberg, South Carolina, United States
South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Vascular and General Surgery
🇺🇸Miami, Florida, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Peripheral Vascular Associates
🇺🇸San Antonio, Texas, United States
Vascular Surgery
🇺🇸Bronx, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States