Artegraft Versus Propaten Dialysis Grafts

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

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.

Study Overview

• Status: Terminated
• Conditions: Renal Failure; ESRD
• Intervention / Treatment: Device: Artegraft; Device: Propaten

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97232
      • Kaiser Permanente Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Artegraft; Surgical placement of graft for hemodialysis access
Active Comparator: 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.	Device: Propaten; Surgical placement of graft for hemodialysis access

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Earl Schuman, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: March 27, 2014
• First Posted (Estimate): March 28, 2014

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: ABCA-001