End Stage Renal Disease (ESRD)
Conditions
Keywords
Vascular access, Arteriovenous graft, Hemodialysis
Brief summary
This is a multi-site, single-blind with parallel group, randomized controlled trial of Healionics STARgraft (10401) vascular graft for hemodialysis access compared with a market-leading commercially available ePTFE vascular graft (Gore Propaten Vascular Graft).
Interventions
DEVICESTARgraft (10401)
Device: STARgraft (10401) Surgical implantation of STARgraft (10401) for Hemodialysis in the upper forearm.
DEVICEGore Propaten
Device: Gore Propaten Surgical implantation of Gore Propaten for Hemodialysis in the upper forearm.
Sponsors
Healionics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease (ESRD) and intends to use the Vascular Graft device for arteriovenous (AV) access. 2. The patient is currently on hemodialysis or intended to begin hemodialysis within 60 days following placement of the device. 3. Adult patients, 18 years or older. 4. Patient has given informed consent to participate in the trial. 5. Stated willingness to comply with all trial procedures and availability for the duration of the trial. 6. Able to effectively communicate with trial personnel. 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 (PD) 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 (HIT). 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. 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 |
|---|---|---|
| Safety: Subjects with Major Adverse Event | 6 months | Percent of subjects with major adverse event, defined as adverse events resulting from graft implantation or use for dialysis; and requiring surgical or endovascular intervention, or impacting or delaying graft use. |
| Effectiveness: Primary Unassisted Patency | 6 months | Measured as the percentage of patients retaining PUP at the timepoint. Loss of primary unassisted patency is defined as use of any intervention to maintain full function of the permanent access: angioplasty, surgery of any type (such as for an pseudoaneurysm), thrombectomy or thrombolysis, or creation of an entirely new access. |
Countries
Brazil, Colombia
Contacts
CONTACTAshleigh Cooper
Outcome results
None listed