NCT02099344

Artegraft Versus Propaten Dialysis Grafts

A Prospective, Randomized Study of the Artegraft vs Propaten Vascular Grafts for Renal Failure Patients Requiring Dialysis Access

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Artegraft	Surgical placement of graft for hemodialysis access
DEVICE	Propaten	Surgical placement of graft for hemodialysis access

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-03-28
• Last updated: 2019-05-15
• Results posted: 2016-07-14

Locations

1 site across 1 country: United States