End Stage Kidney Disease (ESRD)NCT07555717
STARgraft (10401) Pilot
A study testing STARgraft (10401) in people with End Stage Kidney Disease (ESRD), 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 (10401) hemodialysis access graft. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease (ESRD)
- What is being tested?
- STARgraft (10401)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteParaguay
- Study dates
- 29 Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patients, 18 years or older.
- Patient has given informed consent to participate in the trial.
- Stated willingness to comply with all trial procedures and availability for the duration of the trial.
- Able to effectively communicate with trial personnel.
- Indicated patient population (end stage renal disease).
- 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.
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- Life expectancy judged to be at least 2 years with consideration of patient frailty.
- Axillary vein approximately 7 mm in diameter or greater.
- Brachial artery approximately 4 mm in diameter or greater.
- Acceptable cardiac risk level (cardiac output ≥ 3.5 l/min, pulmonary artery pressure ≤ 50 mmHg, and 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.
- Previous history of Peritoneal Dialysis treatment within the last 2 months
- Central venous catheter located on same side as intended implant location.
- Clinical morbid obesity (BMI > 40).
- Anatomical limitations, including issues discovered intraoperatively during vessel exposure.
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- Immunodeficiency syndrome.
- History of hypercoagulation or bleeding disorders.
- Elevated platelet count > 1 million per microliter of blood.
- History of heparin-induced thrombocytopenia syndrome
- Medically confirmed stenosis or compromised valves in the veins downstream of the implant site.
- Inadequate arterial flow or pressure proximal to the implant site.
- Currently participating in another investigational drug or device trial which may clinically interfere with any endpoints of this trial.
- Fever greater than 38°C.
- Known allergic reaction to silicone, or untreatable allergy to imaging contrast materials.
- Confirmed or suspected bacterial, viral or parasitic infection within 8 weeks prior to graft implant, or ongoing symptoms.
- Uncontrolled or poorly controlled diabetes.
- History or evidence of severe cardiac disease.
- Any other condition which, in the judgment of the Investigator, would preclude adequate evaluation or impact patient safety or trial conduct.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: STARgraft Vascular Graft 10401 for Hemodialysis Access Pilot
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.
- Conditions
- End Stage Kidney Disease (ESRD)
- Being tested
- STARgraft (10401)
- 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.
STARgraft (10401)Device
Participants will be implanted with 6mm diameter STARgraft (10401) grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.
| Study group | Role | What they receive |
|---|---|---|
| STARgraft (10401) | Experimental | Not described Receives: Device: STARgraft (10401) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness - Primary unassisted patency
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.
Measured: 6 months
Safety - Serious Device Related Adverse Events
Incidence of serious device-related adverse events.
Measured: 6 months
Secondary outcomes (5)
Primary unassisted patency
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.
Measured: 12, 18, 24 and 36 months
Assisted primary patency
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).
Measured: 6, 12, 18, 24 and 36 months
Incidence of graft infections
Measured: 6, 12, 18, 24 and 36 months
Incidence of serious device-related adverse events
Measured: 12, 18, 24 and 36 months
Incidence of major events
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
Measured: 6, 12, 18, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start29 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney Disease (ESRD)Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healionics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555717
- Sponsor's protocol ID
- 00590
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STARgraft Vascular Graft 10401 for Hemodialysis Access Pilot
- ClinicalTrials.gov ID
- NCT07555717
- Acronym / sponsor ID
- 00590
- Conditions
- End Stage Kidney Disease (ESRD)
- Keywords
- Hemodialysis, Vascular Access, Arterio-venous Grafts (AVG)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Healionics CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STARgraft (10401) | Experimental | Device: STARgraft (10401) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult patients, 18 years or older.
- Patient has given informed consent to participate in the trial.
- Stated willingness to comply with all trial procedures and availability for the duration of the trial.
- Able to effectively communicate with trial personnel.
- Indicated patient population (end stage renal disease).
Key exclusion criteria (19 listed)
- Unable or unlikely to comply with trial protocol and/or follow-up.
- Pregnancy.
- Previous history of Peritoneal Dialysis treatment within the last 2 months
- Central venous catheter located on same side as intended implant location.
- Clinical morbid obesity (BMI > 40).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STARgraft (10401)Participants will be implanted with 6mm diameter STARgraft (10401) grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access. | Device | STARgraft (10401) |
Primary outcome
Effectiveness - Primary unassisted patency
Time frame: 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
Time frame: 6 months
Incidence of serious device-related adverse events.
5 secondary outcomes
Primary unassisted patency
Time frame: 12, 18, 24 and 36 months
Assisted primary patency
Time frame: 6, 12, 18, 24 and 36 months
Incidence of graft infections
Time frame: 6, 12, 18, 24 and 36 months
Incidence of serious device-related adverse events
Time frame: 12, 18, 24 and 36 months
Incidence of major events
Time frame: 6, 12, 18, 24 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STARgraft (10401) in people with End Stage Kidney Disease (ESRD), run by Healionics Corporation at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashleigh Cooper (206-432-9060, ashleigh@healionics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness - Primary unassisted patency (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.