Clinical Trial

Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma

Completed Phase 2/3
View on ClinicalTrials.gov →
Summary
This study evaluates the use of the Acellular Tissue Engineered Vessel (ATEV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be an extremity cohort and an torso cohort. All subjects will be implanted with an ATEV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.
Protocol Amendment History 5 changes
critical Trial completed 2026-07-30
critical Primary endpoint(s) modified 2026-07-30
notable Trial sites reduced: 32 -> 29 locations 2026-07-30
notable Primary completion moved earlier: 2027-09-01 -> 2023-09-19 2026-07-30
minor Completion moved earlier: 2027-09-01 -> 2026-05-15 2026-07-30
Trial Details
NCT Number NCT03005418
Lead Sponsor Humacyte, Inc.
Collaborators: Atlantic Research Group, U.S. Army Medical Research and Development Command
Conditions Trauma, Vascular System Injury
Enrollment 72 participants
Start Date 2018-09-01
Primary Completion 2023-09-19 (estimated)
Study Completion 2026-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-29