An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma

November 21, 2024 updated by: Humacyte, Inc.

An Observational Multicenter Study to Evaluate the Safety and Efficacy of Humacyte's Human Acellular Vessel in a Real World Setting for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma

Humacyte provided HAVs as humanitarian aid to Ukraine. This retrospective observational study is designed to collect data from patients in whom the HAVs have already been implanted on a humanitarian basis between June 2022 and May 2023.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

17

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Dnipro, Ukraine
        • Municipal Non-Profit Enterprise ""City Clinical Hospital #16" of the Dnipro City Council"
      • Kyiv, Ukraine
        • Medical Center LLC "CLINIC VERUM EXPERT"
      • Vinnytsia, Ukraine
        • Communal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after E. Pirogov" of the Vinnytsia Regional Council, center of cardiovascular surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with vascular trauma in the extremities who required arterial replacement or reconstruction and in whom the HAVs have been already implanted on a humanitarian basis between June 2022 and May 2023.

Description

Inclusion Criteria:

  • Patients with an HAV implanted to repair or reconstruct an arterial vessel following life- or limb-threatening traumatic vascular injury of an extremity.
  • Aged 18 to 85 years old, inclusive.
  • Patient or legal representative is able, willing, and competent to give informed consent.

Exclusion Criteria:

• Employees of the sponsor or patients who are employees or relatives of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of the HAV
Time Frame: up to 12 months
To determine the rate of adverse events after impanation
up to 12 months
Primary patency of the HAV after implantation
Time Frame: 30 days
To determine the rate of HAV primary patency at 30 days after implantation
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Adverse Events of Special Interest (AESIs)
Time Frame: up to 12 months
To determine the rate of Adverse Events of Special Interest (AESIs), such as: thrombosis, clinically significant aneurysm or pseudoaneurysm formation, HAV spontaneous rupture, infection of the HAV conduit, and HAV abandonment.
up to 12 months
HAV durability
Time Frame: up to 12 months
To determine the time frame when the HAV has not been removed, replaced, or ligated.
up to 12 months
Rate of affected limb salvage/amputation after implantation
Time Frame: up to 12 months
To determine the rate of affected limb salvage/amputation after HAV implantation
up to 12 months
Patency of the HAV after implantation
Time Frame: up to 12 months
To determine the rate of HAV patency (primary, primary assisted, and secondary) after implantation
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humacyte, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

May 26, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-PRO-V017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trauma

Clinical Trials on HAV implantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe