Artegraft Versus Propaten Dialysis Grafts

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized Study of the Artegraft vs Propaten Vascular Grafts for Renal Failure Patients Requiring Dialysis Access

Conditions
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ESRD, Renal Failure

Intervention / Treatment
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* Device: Artegraft
* Device: Propaten


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized to either Combination product- device/biologic Artegraft® or Gore® Propaten®.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Artegraft<br>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. | Device: Artegraft<br>* Surgical placement of graft for hemodialysis access<br>|
| Active Comparator: Propaten<br>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. | Device: Propaten<br>* Surgical placement of graft for hemodialysis access<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft | 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. | 12 months | 

Secondary Outcome Measures

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