End Stage Renal Disease (ESRD)NCT07557862
Multi-Site STARgraft (10401) Trial
A study testing STARgraft (10401) and Gore Propaten in people with End Stage Renal Disease (ESRD), run by Healionics Corporation at 7 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- What is being tested?
- STARgraft (10401) and Gore Propaten
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2026to Jun 2029
- 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
- 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.
- The patient is currently on hemodialysis or intended to begin hemodialysis within 60 days following placement of the device.
- 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.
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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 (PD) 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 (HIT).
- 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.
- 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
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Brazil5 sites
Afya Hospital Dia, Brasília.
Brasília
Thiago Barrosso, MD
Hospital Baía Sul
Florianópolis
Cristiano Bortoluzzi, MD
Royal Portuguese Beneficent Hospital in Pernambuco
Recife
Douglas Cavalcanti, MD
Pedro Ernesto University Hospital
Rio de Janeiro
Leonardo Harduin, MD
Hospital Ana Nery
Salvador
Leonardo Cortizo, MD
Colombia2 sites
Clinica Farallones
Cali
Jaime Velez, MD
Medellín Clinic - El Poblado
Medellín
Luis Cadavid, MD
About this study
Official title: Multi-Site Randomized Controlled Trial of STARgraft (10401) Vascular Graft for Hemodialysis Access
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).
- Conditions
- End Stage Renal Disease (ESRD)
- Being tested
- STARgraft (10401), Gore Propaten
- Keywords
- Vascular access, Arteriovenous graft, Hemodialysis
- 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
Device: STARgraft (10401) Surgical implantation of STARgraft (10401) for Hemodialysis in the upper forearm.
Gore PropatenDevice
Device: Gore Propaten Surgical implantation of Gore Propaten for Hemodialysis in the upper forearm.
| Study group | Role | What they receive |
|---|---|---|
| STARgraft (10401) | Experimental | Not described Receives: Device: STARgraft (10401) |
| Gore Propaten | Active comparator | Not described Receives: Device: Gore Propaten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Subjects with Major Adverse Event
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.
Measured: 6 months
Effectiveness: Primary Unassisted Patency
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2029 (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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 111 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
- NCT07557862
- Sponsor's protocol ID
- 00635
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Site Randomized Controlled Trial of STARgraft (10401) Vascular Graft for Hemodialysis Access
- ClinicalTrials.gov ID
- NCT07557862
- Acronym / sponsor ID
- 00635
- Conditions
- End Stage Renal Disease (ESRD)
- Keywords
- Vascular access, Arteriovenous graft, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Healionics CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 30 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 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STARgraft (10401) | Experimental | Device: STARgraft (10401) |
| Gore Propaten | Active comparator | Device: Gore Propaten |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- The patient is currently on hemodialysis or intended to begin hemodialysis within 60 days following placement of the device.
- 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.
Key exclusion criteria (19 listed)
- Unable or unlikely to comply with trial protocol and/or follow-up.
- Pregnancy.
- Previous history of peritoneal dialysis (PD) 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)Device: STARgraft (10401) Surgical implantation of STARgraft (10401) for Hemodialysis in the upper forearm. | Device | STARgraft (10401) |
| Gore PropatenDevice: Gore Propaten Surgical implantation of Gore Propaten for Hemodialysis in the upper forearm. | Device | Gore Propaten |
Primary outcome
Safety: Subjects with Major Adverse Event
Time frame: 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
Time frame: 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.
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 13 Aug 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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STARgraft (10401) and Gore Propaten in people with End Stage Renal Disease (ESRD), run by Healionics Corporation at 7 sites in 2 countries.
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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Brazil, Colombia. 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?
Safety: Subjects with Major Adverse Event (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 13 Aug 2026.