Artegraft Versus Propaten Dialysis Grafts

Phase 4

Terminated

Brief Summary: Compare Artegraft and Propaten grafts for use in dialysis access to see if one performs better than the other. How long each one lasts until a complication arises or until the graft is no longer used will be compared.

The study hypothesis is that the Artegraft, being an actual blood vessel, will work better than the manufactured Propaten graft.

Detailed Description: Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care. Patients will be assessed at 2-3 weeks post-operatively and again at 6 and 12 months for flow characteristics, dialysis adequacy and graft associated complications such as stenosis, infection and thrombosis. Data on urea reduction ratio (URR), kinetic modeling (Kt/V), and access flow (QB) will be collected at 3, 6, 9 and 12 months via phone call to the hemodialysis center in order to evaluate patency and function.

Access complications (stenosis, thrombosis, infection) will be treated per our standard protocol. These data will be recorded and then primary, assisted primary and secondary patency rates will be calculated and the graft arms compared using life table analysis.

Recruitment & Eligibility

Inclusion Criteria

> 18 years of age
Candidate for hemodialysis
Not a candidate for native AV fistula
In need of a new AV graft in the upper arm location
Artery and vein > 3mm.
Medically stable and have a life expectancy of ≥ 12 months
The patient or legal guardian understands the study and is willing to comply with the requirements.

Exclusion Criteria

< 18 years of age
Current history or within 6 months of IV drug abuse
Chronic hypotension (<100 mm systolic pressure) not responsive to treatment
Pregnant or lactating
Known hypercoagulable state
Requires only a revision of an existing graft
Receiving artery or vein is less than 3 mm in diameter at the time of implantation
Known axillary/subclavian occlusion or stenosis that has not been treated
Known or suspected systemic infection
Heparin sensitivity (known HIT)
Enrolled in another investigational study.
Subject has more than 1 graft in target limb.

Arm && Interventions

Group	Intervention	Description
Artegraft	Artegraft	Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Propaten	Propaten	Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.

Primary Outcome Measures

Name	Time	Method
Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft	12 months	The primary outcome will be determined by Kaplan-Meier life table analysis. Patency determination will be from access creation until the first occlusion of the graft.

Secondary Outcome Measures

Name	Time	Method
Examine Incidence of Complications in Patients Receiving the Artegraft Bovine Graft vs. Gore Propaten Graft	12 months	Complication incidence will be collected from the time of access creation until the graft fails and is abandoned.