End Stage Renal Disease
Conditions
Keywords
Hemodialysis, Vascular Access, Arterio-Venous Grafts (AVG)
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: 1. 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. 2. Verify safety of the STARgraft-2 multilayer construction in extended dialysis vascular access use. It is intended to enroll 25 subjects in this study.
Interventions
DEVICEImplant of STARgraft-2 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.
Sponsors
Healionics Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, \> 18 years or age. 2. Patient has given informed consent to participate in the trial. 3. Stated willingness to comply with all study procedures and availability for the duration of the study. 4. Able to effectively communicate with study personnel. 5. Candidate for a new arterio-venous graft placed in the upper arm. 6. Life expectancy judged to be at least 2 years. 7. Axillary vein of greater than or equal to 7 mm in diameter. 8. Brachial artery of greater than or equal to 4 mm in diameter. 9. Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, Ejection Fraction ≥ 40%) 10. Systolic blood pressure equal to or greater than 120 mmHg. 11. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram.
Exclusion criteria
1. Unable or unlikely to comply with trial protocol and/or follow-up. 2. Pregnancy. 3. Clinically morbid obesity. 4. Anatomical limitations. 5. Immunodeficiency syndrome. 6. History of bacterial infection within 8 weeks prior to graft implantation. 7. History of hypercoagulation or bleeding disorders. 8. Elevated platelet count \> 1 million per microliter of blood. 9. History of heparin-induced thrombocytopenia syndrome (HIT). 10. Medically confirmed stenosis of the veins downstream of the implant site. 11. Inadequate arterial flow or pressure proximal to the implant site. 12. Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial. 13. Fever greater than 38° C. 14. Prior allergic reaction to silicone. 15. Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Unassisted Patency | 6 months post implantation. | Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Unassisted Patency | 1, 2, 4, 9 and 12 months post implantation | Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency. |
| Assisted Primary Patency | 1, 2, 4, 6, 9 and 12 months post implantation | Percentage of subjects retaining patency after one or more interventions so long as patency was not lost at any point. |
| Secondary Patency (Cumulative Patency) | 1, 2, 4, 6, 9 and 12 months post implantation | Percentage of subjects without loss of access at the original implant site. |
| Graft Related Infections | 1, 2, 4, 6, 9 and 12 months post implantation | Frequency and severity of infections related to graft placement and use for dialysis access. |
| Safety Outcomes | 1, 2, 4, 6, 9 and 12 months post implantation | Frequency and Severity of Adverse Events resulting from graft implantation and use for hemodialysis access. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood Flow Rates in Grafts | 2 weeks and 1, 2, 4, 6, 9, 12 months post implantation. | Ultrasound measurements of flow rates (ml/minute) to detect patency trends with time after implantation |
| Peak Systolic Velocity (PSV) Ratio | 2 weeks and 1, 2, 4, 6, 9, 12 months post implantation | Ultrasound measurement of PSV (The ratio of flow velocity at the venous anastomosis to that at a point 2cm upstream in the graft) |
Countries
Paraguay
Outcome results
None listed