Clinical trial NCT00131872: Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts
Official title: Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: vascular access graft
hemodialysis
dialysis
end stage renal disease
Lead sponsor: LeMaitre Vascular
Sponsor class: INDUSTRY
First posted: 2005-08-19
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Primary or assisted primary patency at 1 year
Secondary outcomes:
measure: Secondary patency
measure: Overall adverse event rate
measure: Time to first access
measure: Time to hemostasis following needle withdrawal after dialysis
Other outcomes:
Locations:
city: Miami
country: United States
facility: Vascular and General Surgery
state: Florida
city: Baton Rouge
country: United States
facility: Vascular Surgery Associates
state: Louisiana
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Bronx
country: United States
facility: Vascular Surgery
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Bamberg
country: United States
facility: General Surgery
state: South Carolina
city: Greenville
country: United States
facility: South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System
state: South Carolina
city: San Antonio
country: United States
facility: Peripheral Vascular Associates
state: Texas
Study officials:
References: