STARgraft (10401) Pilot

NCT07555717 | Recruiting FDA Device

• 1 other identifier: 00590
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

Hemodialysis; Vascular Access; Arterio-venous Grafts (AVG)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Primary unassisted patency

  12, 18, 24 and 36 months

• Assisted primary patency

  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

  6, 12, 18, 24 and 36 months

Other Outcomes (3)

• 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

Study Arms (1)

STARgraft (10401)

EXPERIMENTAL

Device: STARgraft (10401)

Interventions

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.

STARgraft (10401)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Healionics Corporation: lead

Study Sites (1)

Italian Hospital

Asunción, Paraguay

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ashleigh Cooper

CONTACT

206-432-9060; ashleigh@healionics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 29, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

PA (1)