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Artegraft Versus Propaten Dialysis Grafts

Primary Purpose

ESRD, Renal Failure

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Artegraft
Propaten
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ESRD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaiser Permanente Northwest

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Artegraft

Propaten

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 13, 2013
Last Updated
May 3, 2019
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT02099344
Brief Title
Artegraft Versus Propaten Dialysis Grafts
Official Title
A Prospective, Randomized Study of the Artegraft vs Propaten Vascular Grafts for Renal Failure Patients Requiring Dialysis Access
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ESRD, Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized to either Combination product- device/biologic Artegraft® or Gore® Propaten®.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artegraft
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Propaten
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Artegraft
Intervention Description
Surgical placement of graft for hemodialysis access
Intervention Type
Device
Intervention Name(s)
Propaten
Intervention Description
Surgical placement of graft for hemodialysis access
Primary Outcome Measure Information:
Title
Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Examine Incidence of Complications in Patients Receiving the Artegraft Bovine Graft vs. Gore Propaten Graft
Description
Complication incidence will be collected from the time of access creation until the graft fails and is abandoned.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Earl Schuman, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Artegraft Versus Propaten Dialysis Grafts

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