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Evaluation of STARgraft-3 for Hemodialysis
Sponsor: Healionics Corporation
Summary
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection. This study is an extension from prior studies with STARgraft AV (NCT03916731) and STARgraft-2 (NCT04783779) investigational devices. A previous study also included control implants of commercially available standard ePTFE grafts approved for the same use. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to evaluate the performance of the investigational STARgraft-3 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year. Estimated enrollment is 15 subjects in this study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2022-11-29
Completion Date
2027-07
Last Updated
2026-04-27
Healthy Volunteers
No
Conditions
Interventions
Implant of STARgraft-3 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.
Locations (1)
Italian Hospital
Asunción, Paraguay