Multi-Site STARgraft (10401) Trial

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).

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Renal Disease (ESRD)
• Intervention / Treatment: Device: STARgraft (10401); Device: Gore Propaten

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Colombia
  • Cali, Colombia
    • Clinica Farallones
    • Contact: Jaime Velez, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. 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.
2. The patient is currently on hemodialysis or intended to begin hemodialysis within 60 days following placement of the device.
3. Adult patients, 18 years or older.
4. Patient has given informed consent to participate in the trial.
5. Stated willingness to comply with all trial procedures and availability for the duration of the trial.
6. Able to effectively communicate with trial personnel.
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 (PD) 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 (HIT).
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.
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: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STARgraft (10401)	Device: STARgraft (10401); Device: STARgraft (10401) Surgical implantation of STARgraft (10401) for Hemodialysis in the upper forearm.
Active Comparator: Gore Propaten	Device: Gore Propaten; Device: Gore Propaten Surgical implantation of Gore Propaten for Hemodialysis in the upper forearm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months

Collaborators and Investigators

• Sponsor: Healionics Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hemodialysis; Vascular access; Arteriovenous graft
• 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: 00635

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