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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05729620
Other study ID # CIP 00530
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 29, 2022
Est. completion date July 2024

Study information

Verified date January 2024
Source Healionics Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 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 prior studies with STARgraft AV (NCT03916731) and STARgraft-2 (NCT04783779) investigational devices. A previous 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-3 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. Estimated enrollment is 15 subjects in this study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 21
Est. completion date July 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Implant of STARgraft-3 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.

Locations

Country Name City State
Paraguay Italian Hospital Asunción

Sponsors (1)

Lead Sponsor Collaborator
Healionics Corporation

Country where clinical trial is conducted

Paraguay, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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 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
Secondary Frequency of Interventions Frequency of interventions related to graft placement and use for dialysis access. 1, 2, 4, 6, 9 and 12 months post implantation
Secondary Blood Flow Rates in Grafts Ultrasound measurements of flow rates (ml/minute) to detect patency trends with time after implantation. 2 weeks and 1, 2, 4, 6, 9, and 12 months post implantation
Secondary 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
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