End Stage Renal DiseaseNCT05729620
Evaluation of STARgraft-3 for Hemodialysis
A study testing Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access in people with End Stage Renal Disease, run by Healionics Corporation at 1 site in Paraguay.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteParaguay
- Study dates
- 29 Nov 2022to Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- End Stage Renal Disease
- Being tested
- Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
- Keywords
- Hemodialysis, Vascular Access, Arterio-Venous Grafts (AVG)
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis accessDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| STARgraft-3 | Experimental | Participants will be implanted with 6mm diameter STARgraft-3 grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access. Receives: Device: Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Unassisted Patency
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
Measured: 6 months post implantation
Secondary outcomes (6)
Primary Unassisted Patency
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
Measured: 1, 2, 4, 9 and 12 months post implantation
Assisted Primary Patency
Percentage of subjects retaining patency after one or more interventions so long as patency was not lost at any point.
Measured: 1, 2, 4, 6, 9, and 12 months post implantation
Secondary Patency (Cumulative Patency)
Percentage of subjects without loss of access at the original implant site.
Measured: 1, 2, 4, 6, 9, and 12 months post implantation
Frequency of Interventions
Frequency of interventions related to graft placement and use for dialysis access.
Measured: 1, 2, 4, 6, 9 and 12 months post implantation
Blood Flow Rates in Grafts
Ultrasound measurements of flow rates (ml/minute) to detect patency trends with time after implantation.
Measured: 2 weeks and 1, 2, 4, 6, 9, and 12 months post implantation
Safety Outcomes
Frequency and severity of Adverse Events resulting from graft implantation and use for hemodialysis access.
Measured: 1, 2, 4, 6, 9, and 12 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start29 Nov 2022
- Primary completion2 Feb 2024
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healionics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Ebner, MD, Principal investigator, Italian Hospital Asuncion Paraguay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729620
- Sponsor's protocol ID
- CIP 00530
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No