Artegraft Versus Propaten Dialysis Grafts

Kaiser Permanente

Status and phase: Terminated; Phase 4

Conditions: Renal Failure; ESRD

Treatments: Device: Artegraft; Device: Propaten

Study type: Interventional

Funder types: Other

Identifiers

NCT02099344

ABCA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Artegraft

Active Comparator group

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.

Treatment:

Device: Artegraft

Propaten

Active Comparator group

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.

Treatment:

Device: Propaten