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, Inc.17 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Trauma Trauma Injury Trauma, Multiple Trauma Blunt

Interventions

HAV implantationBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (3)

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

Dnipro, Ukraine

Medical Center LLC "CLINIC VERUM EXPERT"

Kyiv, Ukraine

Communal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after E. Pirogov" of the Vinnytsia Regional Council, center of cardiovascular surgery

Vinnytsia, Ukraine

Outcomes

Primary Outcomes

Safety and tolerability of the HAV

To determine the rate of adverse events after impanation

Time frame: up to 12 months

Primary patency of the HAV after implantation

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

Time frame: 30 days

Secondary Outcomes

Frequency of Adverse Events of Special Interest (AESIs)

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.

Time frame: up to 12 months

HAV durability

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

Time frame: up to 12 months

Rate of affected limb salvage/amputation after implantation

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

Time frame: up to 12 months

Patency of the HAV after implantation

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

Time frame: up to 12 months

Data from ClinicalTrials.gov

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