NCT03916731

Evaluation of STARgraft AV for Hemodialysis Access

First in Human Evaluation of STARgraft AV for Hemodialysis Access in Comparison to ePTFE Vascular Grafts

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Healionics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft. The STARgraft has been demonstrated in preclinical studies to have improved resistance to the common failure mode of venous anastomosis stenosis. Performance of the STARgraft AV will be compared against 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: 1. Demonstrate improved primary patency of the investigational STARgraft AV compared to the ePTFE controls over a period of 6 months, with extended results to 1 year. 2. Verify safety of the STARgraft AV multilayer construction in extended vascular access use. It is intended to enroll 25 subjects each for the investigational devices and the controls respectively (50 total) with randomized device allocation at subject presentation for implant surgery.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-02
• Primary completion: 2020-10-17
• Completion: 2021-05-11
• First posted: 2019-04-16
• Last updated: 2024-10-02

Locations

1 site across 1 country: Paraguay

Regulatory

• FDA-regulated device study