End Stage Kidney Disease (ESRD)
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 (10401) hemodialysis access graft. 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 (10401) compared to the ePTFE controls in a prior study (NCT03916731) and to published results, over a period of 6 months. Additional data out to 36 months post-implantation may be captured.
Interventions
DEVICESTARgraft (10401)
Participants will be implanted with 6mm diameter STARgraft (10401) grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.
Sponsors
Healionics Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients, 18 years or older. 2. Patient has given informed consent to participate in the trial. 3. Stated willingness to comply with all trial procedures and availability for the duration of the trial. 4. Able to effectively communicate with trial personnel. 5. Indicated patient population (end stage renal disease). 6. Candidate for a new AV graft placed in the upper arm and judged to need dialysis within 2 months. Patient may have a failed access at a different anatomical location. 7. Life expectancy judged to be at least 2 years with consideration of patient frailty. 8. Axillary vein approximately 7 mm in diameter or greater. 9. Brachial artery approximately 4 mm in diameter or greater. 10. Acceptable cardiac risk level (cardiac output ≥ 3.5 l/min, pulmonary artery pressure ≤ 50 mmHg, and ejection fraction ≥ 40%). 11. Systolic blood pressure equal to or greater than 120 mmHg. 12. 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. Previous history of Peritoneal Dialysis treatment within the last 2 months 4. Central venous catheter located on same side as intended implant location. 5. Clinical morbid obesity (BMI \> 40). 6. Anatomical limitations, including issues discovered intraoperatively during vessel exposure. 7. Immunodeficiency syndrome. 8. History of hypercoagulation or bleeding disorders. 9. Elevated platelet count \> 1 million per microliter of blood. 10. History of heparin-induced thrombocytopenia syndrome 11. Medically confirmed stenosis or compromised valves in the veins downstream of the implant site. 12. Inadequate arterial flow or pressure proximal to the implant site. 13. Currently participating in another investigational drug or device trial which may clinically interfere with any endpoints of this trial. 14. Fever greater than 38°C. 15. Known allergic reaction to silicone, or untreatable allergy to imaging contrast materials. 16. Confirmed or suspected bacterial, viral or parasitic infection within 8 weeks prior to graft implant, or ongoing symptoms. 17. Uncontrolled or poorly controlled diabetes. 18. History or evidence of severe cardiac disease. 19. Any other condition which, in the judgment of the Investigator, would preclude adequate evaluation or impact patient safety or trial conduct.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness - Primary unassisted patency | 6 months | Primary unassisted patency, defined as the percentage of grafts retaining adequate flow for dialysis without requiring any surgical or endovascular procedure to maintain or re-establish its function. |
| Safety - Serious Device Related Adverse Events | 6 months | Incidence of serious device-related adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary unassisted patency | 12, 18, 24 and 36 months | Primary unassisted patency, defined as the percentage of grafts retaining adequate flow for dialysis without requiring any surgical or endovascular procedure to maintain or re-establish its function. |
| Assisted primary patency | 6, 12, 18, 24 and 36 months | Measured as the percentage of patients retaining assisted primary patency at the timepoints. Assisted primary patency begins when an access requires surgical or endovascular interventions designed to maintain the functionality of a patent access and ends at the first occlusion (thrombosis). |
| Incidence of graft infections | 6, 12, 18, 24 and 36 months | — |
| Incidence of serious device-related adverse events | 12, 18, 24 and 36 months | — |
| Incidence of major events | 6, 12, 18, 24 and 36 months | Defined as adverse events requiring surgical or percutaneous intervention, or adverse events impacting or delaying graft use resulting from graft implant or use of the graft for hemodialysis |
Countries
Paraguay
Contacts
CONTACTAshleigh Cooper
Outcome results
None listed