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
NCT05873959 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17
Last updated 2024-11-25
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.
Conditions
- Trauma
- Trauma Injury
- Trauma, Multiple
- Trauma Blunt
Interventions
- BIOLOGICAL
-
HAV implantation
HAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury.
Sponsors & Collaborators
-
Humacyte, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-01
- Primary Completion
- 2023-05-26
- Completion
- 2024-01-15
- FDA Drug
- Yes
Countries
- Ukraine
Study Locations
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