A Phase 2 Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients with Life or Limb-threatening Vascular Trauma

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Study Overview

This is a prospective, multicenter, multi-cohort (limb and torso), non-randomized study designed to evaluate the safety and tolerability of the Humacyte HAV in vascular trauma patients undergoing surgery for vascular replacement or reconstruction. The University of Pennsylvania will participate as a site by enrolling subjects between the ages of 18 and 85 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 in either the limb or torso cohort. Patients will be implanted with a Humacyte HAV as an interposition replacement or bypass using standard vascular surgical techniques.

  • Study Identifier: 843530

Recruitment Status

Open

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