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Completed

NCT Number: NCT05873959

An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma

Humacyte provided HAVs as humanitarian aid to Ukraine. This retrospective observational study is designed to collect data from patients in whom the HAVs have already been implanted on a humanitarian basis between June 2022 and May 2023.

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Key information

Conditions

Trauma Accidental Injuries Multiple Trauma Trauma Blunt Trauma Injury Trauma, Multiple Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Municipal Non-Profit Enterprise ""City Clinical Hospital #16" of the Dnipro City Council", Dnipro, Ukraine

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with an HAV implanted to repair or reconstruct an arterial vessel following life- or limb-threatening traumatic vascular injury of an extremity.
  • Aged 18 to 85 years old, inclusive.
  • Patient or legal representative is able, willing, and competent to give informed consent.

Exclusion criteria

  • Employees of the sponsor or patients who are employees or relatives of the investigator.

Treatment and study plan

HAV implantation

Biological

HAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury.

Primary outcomes

  1. Safety and tolerability of the HAV

    Time frame: up to 12 months

    To determine the rate of adverse events after impanation

  2. Primary patency of the HAV after implantation

    Time frame: 30 days

    To determine the rate of HAV primary patency at 30 days after implantation

Secondary outcomes

  1. Frequency of Adverse Events of Special Interest (AESIs)

    Time frame: up to 12 months

    To determine the rate of Adverse Events of Special Interest (AESIs), such as: thrombosis, clinically significant aneurysm or pseudoaneurysm formation, HAV spontaneous rupture, infection of the HAV conduit, and HAV abandonment.

  2. HAV durability

    Time frame: up to 12 months

    To determine the time frame when the HAV has not been removed, replaced, or ligated.

  3. Rate of affected limb salvage/amputation after implantation

    Time frame: up to 12 months

    To determine the rate of affected limb salvage/amputation after HAV implantation

  4. Patency of the HAV after implantation

    Time frame: up to 12 months

    To determine the rate of HAV patency (primary, primary assisted, and secondary) after implantation

Sponsors and collaborators

Lead sponsor

Humacyte, Inc.

Industry

Registry information

Official study title

An Observational Multicenter Study to Evaluate the Safety and Efficacy of Humacyte's Human Acellular Vessel in a Real World Setting for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 24, 2023
Registry last updated
Nov 25, 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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