Humacyte in Vascular Trauma (Vascular Graft, Damaged Vessels) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about a new study vascular graft that can be surgically put into your arm, leg or torso to repair a damaged vessel and re-establish blood flow.

What is the Condition Being Studied?

Vascular Graft, Damaged Vessels

Who Can Participate in the Study?

-18 to 85 years old
-Have had traumatic injury to an arterial vessel in the arm, leg, or torso
-Patient or relative is able to give informed consent

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Have the study graft called the Human Acellular Vessel (HAV) placed in you to re-establish blood flow to the injured area.
-Complete follow-up visits so you and your HAV can be checked
-Complete follow-up phone calls after a year in the study (every 3 months for up to 3 years after surgery)
-Come into the office for study visits once in year 2 and in year 3

Study Details

Full Title
A Phase 2 Study for the Evaluation of Safety and Efficacy of Humacyte?s Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients with Life or Limb-threatening Vascular Trauma
Principal Investigator
Protocol Number
IRB: PRO00107030
NCT: NCT03005418
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698