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

Completed

• Conditions: Trauma; Trauma Injury; Trauma Blunt; Trauma, Multiple

• Registration Number: NCT05873959
• Lead Sponsor: Humacyte, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-24
• Primary Completion: 2023-05-26
• Study Completion: 2024-01-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of the HAV	up to 12 months	To determine the rate of adverse events after impanation
Primary patency of the HAV after implantation	30 days	To determine the rate of HAV primary patency at 30 days after implantation

Secondary Outcome Measures

Name	Time	Method
HAV durability	up to 12 months	To determine the time frame when the HAV has not been removed, replaced, or ligated.
Rate of affected limb salvage/amputation after implantation	up to 12 months	To determine the rate of affected limb salvage/amputation after HAV implantation
Patency of the HAV after implantation	up to 12 months	To determine the rate of HAV patency (primary, primary assisted, and secondary) after implantation
Frequency of Adverse Events of Special Interest (AESIs)	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.

Trial Locations

Locations (3)

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, Ukraine