Multi-Site STARgraft (10401) Trial

NCT07557862 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 00635
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

End Stage Renal Disease (ESRD)

Keywords

Vascular access; Arteriovenous graft; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

STARgraft (10401)

EXPERIMENTAL

Device: STARgraft (10401)

Gore Propaten

ACTIVE COMPARATOR

Device: Gore Propaten

Interventions

STARgraft (10401) DEVICE

Device: STARgraft (10401) Surgical implantation of STARgraft (10401) for Hemodialysis in the upper forearm.

STARgraft (10401)

Gore Propaten DEVICE

Device: Gore Propaten Surgical implantation of Gore Propaten for Hemodialysis in the upper forearm.

Gore Propaten

Eligibility Criteria

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

You may qualify if:

• 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.
• 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 (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.
• 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.

Sponsors & Collaborators

• Healionics Corporation: lead

Study Sites (1)

Clinica Farallones

Cali, Colombia

Location

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CO (1)