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
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Trauma
• Trauma
• Trauma Injury
• Trauma, Multiple
• Wounds and Injuries

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

External Links

•   Use of bioengineered human acellular vessels to treat traumatic injuries in the Ukraine-Russia conflict.