Status:
COMPLETED
Evaluation of STARgraft-2 for Hemodialysis Access
Lead Sponsor:
Healionics Corporation
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 pre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04783779
Start Date
February 16 2021
End Date
October 31 2023
Last Update
February 28 2024
Active Locations (1)
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1
Italian Hospital
Asunción, Paraguay