Artegraft Versus Propaten Dialysis Grafts

NCT02099344 | Terminated Phase 4 Results

• 1 other identifier: ABCA-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

ESRD; Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Examine Incidence of Complications in Patients Receiving the Artegraft Bovine Graft vs. Gore Propaten Graft

  12 months

Study Arms (2)

Artegraft

ACTIVE COMPARATOR

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

Propaten

ACTIVE COMPARATOR

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

Interventions

Artegraft DEVICE

Surgical placement of graft for hemodialysis access

Artegraft

Propaten DEVICE

Surgical placement of graft for hemodialysis access

Propaten

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Northwest

Portland, Oregon, 97232, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Earl Schuman, MD
• Organization: Kaiser Permanente NW

kathleen.ann.arnold@kpchr.org

503-331-6017

Study Officials

• Earl Schuman, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized to either Combination product- device/biologic Artegraft® or Gore® Propaten®.

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: March 28, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 15, 2019
• Results First Posted: July 14, 2016

Record last verified: 2019-05

Locations

US (1)