Artegraft Versus Propaten Dialysis Grafts

Stopped early · Phase 4

Conditions studied: ESRD, Renal Failure

In brief

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.

Key facts

Study ID

NCT02099344

Run by

Kaiser Permanente

People needed

1

Starts

2014-04-01

Expected to finish

2014-11-01

Last updated by the study team

2019-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Kaiser Permanente Northwest — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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