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

Status: Completed

Conditions: Trauma Blunt; Trauma Injury; Trauma; Trauma, Multiple

Treatments: Biological: HAV implantation

Study type: Observational

Funder types: Industry

Identifiers

NCT05873959

CLN-PRO-V017

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.