STARgraft (10401) Pilot

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.

Study Overview

• Status: Recruiting
• Conditions: End Stage Kidney Disease (ESRD)
• Intervention / Treatment: Device: STARgraft (10401)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashleigh Cooper; Phone Number: 206-432-9060; Email: ashleigh@healionics.com

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Recruiting
    • Italian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patients, 18 years or older.
2. Patient has given informed consent to participate in the trial.
3. Stated willingness to comply with all trial procedures and availability for the duration of the trial.
4. Able to effectively communicate with trial personnel.
5. Indicated patient population (end stage renal disease).
6. 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.
7. Life expectancy judged to be at least 2 years with consideration of patient frailty.
8. Axillary vein approximately 7 mm in diameter or greater.
9. Brachial artery approximately 4 mm in diameter or greater.
10. Acceptable cardiac risk level (cardiac output ≥ 3.5 l/min, pulmonary artery pressure ≤ 50 mmHg, and ejection fraction ≥ 40%).
11. Systolic blood pressure equal to or greater than 120 mmHg.
12. 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. Previous history of Peritoneal Dialysis treatment within the last 2 months
4. Central venous catheter located on same side as intended implant location.
5. Clinical morbid obesity (BMI > 40).
6. Anatomical limitations, including issues discovered intraoperatively during vessel exposure.
7. Immunodeficiency syndrome.
8. History of hypercoagulation or bleeding disorders.
9. Elevated platelet count > 1 million per microliter of blood.
10. History of heparin-induced thrombocytopenia syndrome
11. Medically confirmed stenosis or compromised valves in the veins downstream of the implant site.
12. Inadequate arterial flow or pressure proximal to the implant site.
13. Currently participating in another investigational drug or device trial which may clinically interfere with any endpoints of this trial.
14. Fever greater than 38°C.
15. Known allergic reaction to silicone, or untreatable allergy to imaging contrast materials.
16. Confirmed or suspected bacterial, viral or parasitic infection within 8 weeks prior to graft implant, or ongoing symptoms.
17. Uncontrolled or poorly controlled diabetes.
18. History or evidence of severe cardiac disease.
19. Any other condition which, in the judgment of the Investigator, would preclude adequate evaluation or impact patient safety or trial conduct.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STARgraft (10401)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
Safety - Serious Device Related Adverse Events	Incidence of serious device-related adverse events.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	6, 12, 18, 24 and 36 months
Incidence of graft infections		6, 12, 18, 24 and 36 months
Incidence of serious device-related adverse events		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	6, 12, 18, 24 and 36 months

Other Outcome Measures

Outcome Measure	Time Frame
Flow rate in graft (ultrasound)	6, 12, 18, 24 and 36 months
Peak Systolic Velocity Ratio at venous anastomosis (ultrasound)	6, 12, 18, 24 and 36 months
Pulsatility index (ultrasound) in graft and in outflow vein	6, 12, 18, 24 and 36 months

Collaborators and Investigators

• Sponsor: Healionics Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hemodialysis; Vascular Access; Arterio-venous Grafts (AVG)
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic
• Other Study ID Numbers: 00590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes