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Completed

NCT Number: NCT04783779

Evaluation of STARgraft-2 for Hemodialysis Access

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. 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. Verify safety of the STARgraft-2 multilayer construction in extended dialysis vascular access use.

It is intended to enroll 25 subjects in this study.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Italian Hospital

Asunción, Paraguay

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Primary Unassisted Patency

    Time frame: 6 months post implantation.

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

Secondary outcomes

  1. Primary Unassisted Patency

    Time frame: 1, 2, 4, 9 and 12 months post implantation

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

  2. Assisted Primary Patency

    Time frame: 1, 2, 4, 6, 9 and 12 months post implantation

    Percentage of subjects retaining patency after one or more interventions so long as patency was not lost at any point.

  3. Secondary Patency (Cumulative Patency)

    Time frame: 1, 2, 4, 6, 9 and 12 months post implantation

    Percentage of subjects without loss of access at the original implant site.

  4. Graft Related Infections

    Time frame: 1, 2, 4, 6, 9 and 12 months post implantation

    Frequency and severity of infections related to graft placement and use for dialysis access.

  5. Safety Outcomes

    Time frame: 1, 2, 4, 6, 9 and 12 months post implantation

    Frequency and Severity of Adverse Events resulting from graft implantation and use for hemodialysis access.

Other outcomes

  1. Blood Flow Rates in Grafts

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

    Ultrasound measurements of flow rates (ml/minute) to detect patency trends with time after implantation

  2. Peak Systolic Velocity (PSV) Ratio

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

    Ultrasound measurement of PSV (The ratio of flow velocity at the venous anastomosis to that at a point 2cm upstream in the graft)

Sponsors and collaborators

Lead sponsor

Healionics Corporation

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 5, 2021
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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