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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
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.
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.
Italian Hospital
Asunción, Paraguay
Primary Unassisted Patency
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
Time frame: 12 months post implantation.
Primary Unassisted Patency
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
Time frame: 1, 2, 4, 9 and 12 months post implantation
Assisted Primary Patency
Percentage of subjects retaining patency after one or more interventions so long as patency was not lost at any point.
Time frame: 1, 2, 4, 6, 9 and 12 months post implantation
Secondary Patency (Cumulative Patency)
Percentage of subjects without loss of access at the original implant site.
Time frame: 1, 2, 4, 6, 9 and 12 months post implantation
Graft Related Infections
Frequency of infections related to graft placement and use for dialysis access.
Time frame: 1, 2, 4, 6, 9 and 12 months post implantation
Safety Outcomes
Frequency and Severity of Adverse Events resulting from graft implantation and use for hemodialysis access.
Time frame: 1, 2, 4, 6, 9 and 12 months post implantation
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