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

CLN-PRO-V017

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.

2023-05-31

2024-05-01

2024-05-01

Active (not recruiting)

17

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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 17, 'type': 'ACTUAL'}}

2024-02-05