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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Trauma, Trauma Injury, Trauma, Multiple, Trauma Blunt

Intervention / Treatment
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* Biological: HAV implantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HAV implantation|HAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury.|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extremities, arterial replacement, arterial reconstruction