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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05873959

Enrollment

Registered

2023-05-24

Start date

2023-05-01

Completion date

2024-01-15

Last updated

2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma, Trauma Blunt, Trauma Injury, Trauma, Multiple

Keywords

extremities, arterial replacement, arterial reconstruction

Brief summary

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.

Interventions

BIOLOGICALHAV implantation

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

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of the HAV	up to 12 months	To determine the rate of adverse events after impanation
Primary patency of the HAV after implantation	30 days	To determine the rate of HAV primary patency at 30 days after implantation

Secondary

Measure	Time frame	Description
Frequency of Adverse Events of Special Interest (AESIs)	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.
HAV durability	up to 12 months	To determine the time frame when the HAV has not been removed, replaced, or ligated.
Rate of affected limb salvage/amputation after implantation	up to 12 months	To determine the rate of affected limb salvage/amputation after HAV implantation
Patency of the HAV after implantation	up to 12 months	To determine the rate of HAV patency (primary, primary assisted, and secondary) after implantation

Countries

Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026