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

A Phase 2/3 Study for the Evaluation of Safety and Efficacy of Humacyte's ATEV for Vascular Replacement or Reconstruction in Patients With Life or Limb-threatening Vascular Trauma

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.

This is a prospective, multicenter, multi cohort, non-randomized phase 2/3 study in adult patients with life or limb threatening vascular trauma which requires surgical repair.

There will be an extremity cohort and a torso cohort. The extremity cohort will include patients who require repair of a vessel contained to the upper or lower extremity. The torso cohort includes patients who require repair of vessels within the thorax (excluding the heart), abdomen, and retroperitoneum. Subjects will be implanted with an ATEV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.

The active study duration for each study participant will be 36 months from implantation or until ATEV failure/ removal/ death, if earlier. Follow up after month 12 will involve the capture of information on assessments performed at "standard of care" routine clinic visits or by telephone follow up with the patient or his/her physician with physical exam and ultrasound at month 24 and month 36.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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