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NCT05873959 Clinical Trial

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

Trauma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05873959
Other study ID # CLN-PRO-V017
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 31, 2023
Est. completion date May 2024

Study information
Verified date February 2024
Source Humacyte, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 17
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• HAV implantation
HAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury.

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

Sponsors (1)
Lead Sponsor Collaborator
Humacyte, Inc.

Country where clinical trial is conducted

Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of the HAV To determine the rate of adverse events after impanation up to 12 months
Primary Primary patency of the HAV after implantation To determine the rate of HAV primary patency at 30 days after implantation 30 days
Secondary Frequency of Adverse Events of Special Interest (AESIs) 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
Secondary HAV durability To determine the time frame when the HAV has not been removed, replaced, or ligated. up to 12 months
Secondary Rate of affected limb salvage/amputation after implantation To determine the rate of affected limb salvage/amputation after HAV implantation up to 12 months
Secondary Patency of the HAV after implantation To determine the rate of HAV patency (primary, primary assisted, and secondary) after implantation up to 12 months
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