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

NCT02887859 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-04-18

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Human Acellular Vessel (HAV)

Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques

Sponsors & Collaborators

  • Atlantic Research Group

    collaborator OTHER

  • Humacyte, Inc.

    lead INDUSTRY

Principal Investigators

  • Shamik Shamik, MD · Humacyte, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-20
Primary Completion
2020-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02887859 on ClinicalTrials.gov