Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD

Status Completed

Clinical Trial Summary

This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when surgically implanted into a leg to improve blood flow in patients with peripheral arterial disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner.

Clinical Trial Description

This is a prospective, open label, single treatment arm, multicenter phase 2 study to evaluate the safety and efficacy of the HAV in patients with PAD undergoing femoro-popliteal bypass surgery. The primary objective of this study is to evaluate the safety and tolerability of the HAV in these patients and to determine the patency of the Humacyte HAV at 12 months post-implantation. The secondary objectives of this study are to further assess safety in terms of PRA response, and to determine the rates of HAV interventions required to keep the HAV patent. There is no formal hypothesis testing planned; the study involves only a single, open-label treatment group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02887859
Study type	Interventional
Source	Humacyte, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	December 20, 2016
Completion date	December 2023

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