Evaluation of STARgraft-2 for Hemodialysis Access

Study Overview
=================
Brief Summary
-----------------
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 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 a prior First in Human (FIH) study (NCT03916731) with the STARgraft AV investigational device. That 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-2 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. Verify safety of the STARgraft-2 multilayer construction in extended dialysis vascular access use. It is intended to enroll 25 subjects in this study.

Official Title
-----------------
Evaluation of STARgraft-2 for Hemodialysis Access

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Device: Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, > 18 years or age. Patient has given informed consent to participate in the trial. Stated willingness to comply with all study procedures and availability for the duration of the study. Able to effectively communicate with study personnel. Candidate for a new arterio-venous graft placed in the upper arm. Life expectancy judged to be at least 2 years. Axillary vein of greater than or equal to 7 mm in diameter. Brachial artery of greater than or equal to 4 mm in diameter. Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, Ejection Fraction ≥ 40%) Systolic blood pressure equal to or greater than 120 mmHg. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram. Exclusion Criteria: Unable or unlikely to comply with trial protocol and/or follow-up. Pregnancy. Clinically morbid obesity. Anatomical limitations. Immunodeficiency syndrome. History of bacterial infection within 8 weeks prior to graft implantation. History of hypercoagulation or bleeding disorders. Elevated platelet count > 1 million per microliter of blood. History of heparin-induced thrombocytopenia syndrome (HIT). Medically confirmed stenosis of the veins downstream of the implant site. Inadequate arterial flow or pressure proximal to the implant site. Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial. Fever greater than 38° C. Prior allergic reaction to silicone. Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants are implanted with the investigational grafts at a single site under consistent conditions. Study follow up examinations are performed at the same site. Routine dialysis procedures over the study period are performed at the participants established clinic.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STARgraft-2<br>Participants will be implanted with 6mm diameter STARgraft-2 grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access. | Device: Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Unassisted Patency | Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency. | 6 months post implantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Unassisted Patency | Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency. | 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. | 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. | 1, 2, 4, 6, 9 and 12 months post implantation | 
| Graft Related Infections | Frequency and severity of infections related to graft placement and use for dialysis access. | 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. | 1, 2, 4, 6, 9 and 12 months post implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Vascular Access, Arterio-Venous Grafts (AVG)