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

Completed · Phase 2/Phase 3

Conditions studied: Trauma, Vascular System Injury

In brief

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.

Key facts

Study ID

NCT03005418

Run by

Humacyte, Inc.

People needed

72

Starts

2018-09-01

Expected to finish

2026-05-15

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction
• Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6 mm Acellular Tissue Engineered Vessel (ATEV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations.
• Autologous vein graft is either not feasible in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit, presence of severe venous insufficiency) or is not desirable because of the urgency of revascularization
• Able to communicate meaningfully with investigative staff, and able to comply with entire study procedures. If the patient is unconscious, then information from a reliable witness indicates that the patient would normally be able to comply with study procedures
• Patient or relative is able, willing and competent to give informed consent
• Life expectancy of at least 1 year

You may not qualify if…

• Mangled Extremity Severity Score (MESS) of ≥ 7
• Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury)
• Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS) > 5 or Injury Severity Score (ISS) >60)
• ATEV may not be used for coronary artery repair
• Known pregnant women
• Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries
• Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the ATEV
• Previous exposure to ATEV
• Known participation in any investigational study within the last 30 days
• Employees of the sponsor or patients who are employees or relatives of the investigator

Where it is running

• Jacob Medical Center at UC San Diego — La Jolla, California, United States
• Keck Hospital of University of Southern California (USC) — Los Angeles, California, United States
• Cedars-Sinai Medical Cener — Los Angeles, California, United States
• UCI Medical Center — Orange, California, United States
• University California, Davis — Sacramento, California, United States
• University of California San Diego (UCSD) Medical Center — San Diego, California, United States
• Ernest E Moore Shock Trauma Center at Denver Health — Denver, Colorado, United States
• UF Health Jacksonville — Jacksonville, Florida, United States
• Jackson South Medical Center — Miami, Florida, United States
• Ryder Trauma Center — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• R Adams Cowley Baltimore Shock Trauma — Baltimore, Maryland, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Louis University (SLU) — St Louis, Missouri, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• Duke University Hospital — Durham, North Carolina, United States
• Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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