Evaluation of STARgraft AV for Hemodialysis Access

NACompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

April 2, 2019

Primary Completion Date

October 17, 2020

Study Completion Date

May 11, 2021

Conditions
End Stage Renal Disease
Interventions
DEVICE

STARgraft AV

Implant of STARgraft AV shunt in the upper arm and subsequent use for hemodialysis access. After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions. Periodic evaluations of blood flow by ultrasound imaging will be made over the study period. Established standards of care will be followed as needed to maintain dialysis function.

DEVICE

ePTFE AV graft (control)

Implant of standard ePTFE AV shunt as a control in the upper arm and subsequent use for hemodialysis access. After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions. Periodic evaluations of blood flow by ultrasound imaging will be made over the study period. Established standards of care will be followed as needed to maintain dialysis function.

Trial Locations (1)

Unknown

Italian Hospital, Asunción

Sponsors
All Listed Sponsors
lead

Healionics Corporation

INDUSTRY