End Stage Renal Disease
Conditions
Keywords
vascular access graft, hemodialysis, dialysis, end stage renal disease
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.
Interventions
DEVICEExpedial Vascular Access Graft
Sponsors
LeMaitre Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary or assisted primary patency at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary patency | — |
| Overall adverse event rate | — |
| Time to first access | — |
| Time to hemostasis following needle withdrawal after dialysis | — |
Countries
United States
Outcome results
None listed