Evaluation of STARgraft-2 for Hemodialysis Access

NCT04783779 | Completed FDA Device

• 1 other identifier: CIP 00480 A
• Study Type: interventional
• Target: 24
• 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-2 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection. This study is an extension from a prior First in Human (FIH) study (NCT03916731) with the STARgraft AV investigational device. That study also included control implants of commercially available standard ePTFE grafts approved for the same use. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to:

1. 1.Evaluate the performance of the investigational STARgraft-2 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year.
2. 2.Verify safety of the STARgraft-2 multilayer construction in extended dialysis vascular access use.

Conditions

End Stage Renal Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Primary Unassisted Patency

  Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.

  6 months post implantation.

Secondary Outcomes (5)

• Primary Unassisted Patency

  1, 2, 4, 9 and 12 months post implantation

• Assisted Primary Patency

  1, 2, 4, 6, 9 and 12 months post implantation

• Secondary Patency (Cumulative Patency)

  1, 2, 4, 6, 9 and 12 months post implantation

• Graft Related Infections

  1, 2, 4, 6, 9 and 12 months post implantation

• Safety Outcomes

  1, 2, 4, 6, 9 and 12 months post implantation

Other Outcomes (2)

• Blood Flow Rates in Grafts

  2 weeks and 1, 2, 4, 6, 9, 12 months post implantation.

• Peak Systolic Velocity (PSV) Ratio

  2 weeks and 1, 2, 4, 6, 9, 12 months post implantation

Study Arms (1)

STARgraft-2

EXPERIMENTAL

Participants will be implanted with 6mm diameter STARgraft-2 grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.

Device: Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access

Interventions

Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access DEVICE

After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions. Periodic evaluations of blood flow by ultrasound imaging will be made over the study period. Established standards of care will be followed as needed to maintain dialysis function.

STARgraft-2

Eligibility Criteria

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

You may qualify if:

• Male or female, \> 18 years or age.
• Patient has given informed consent to participate in the trial.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Able to effectively communicate with study personnel.
• Candidate for a new arterio-venous graft placed in the upper arm.
• Life expectancy judged to be at least 2 years.
• Axillary vein of greater than or equal to 7 mm in diameter.
• Brachial artery of greater than or equal to 4 mm in diameter.
• Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, 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.
• Clinically morbid obesity.
• Anatomical limitations.
• Immunodeficiency syndrome.
• History of bacterial infection within 8 weeks prior to graft implantation.
• 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 of the veins downstream of the implant site.
• Inadequate arterial flow or pressure proximal to the implant site.
• Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial.
• Fever greater than 38° C.
• Prior allergic reaction to silicone.
• Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms

Sponsors & Collaborators

• Healionics Corporation: lead

Study Sites (1)

Italian Hospital

Asunción, Paraguay

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

Study Officials

• Adrian Ebner, MD

  Italian Hospital Asuncion Paraguay

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: All participants are implanted with the investigational grafts at a single site under consistent conditions. Study follow up examinations are performed at the same site. Routine dialysis procedures over the study period are performed at the participants established clinic.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: February 16, 2021
• Primary Completion: June 1, 2022
• Study Completion: October 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)