Artegraft Versus Propaten Dialysis Grafts

NCT ID: NCT02099344

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-11-30

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.

Conditions

ESRD; Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Artegraft

Intervention Type: DEVICE

Surgical placement of graft for hemodialysis access

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.

Group Type: ACTIVE_COMPARATOR

Propaten

Intervention Type: DEVICE

Surgical placement of graft for hemodialysis access

Interventions

Artegraft

Surgical placement of graft for hemodialysis access

Intervention Type: DEVICE

Propaten

Surgical placement of graft for hemodialysis access

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Earl Schuman, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Northwest

Portland, Oregon, United States

Countries

United States

Other Identifiers

ABCA-001

Identifier Type: -

Identifier Source: org_study_id