Clinical Trials

Inclusion Criteria:

• ​​​​​​​​​​​​​​Adults with peripheral arterial disease and critical limb ischemia, with no suitable conduits for bypass.
• Aged 18 to 85 years old, inclusive, any gender.
• Clinical diagnosis of vascular occlusion requiring bypass surgery in the form of interposition or bypass graft placement:  
  • Patients with lower limb threatening ischemia;
  • Patients with no other suitable conduit for bypass;
  • Other preoperative imaging and evaluation will follow what is considered standard of care for all patients with limb threatening ischemia.
• Able to communicate meaningfully with investigative staff and comply with study procedures.
• Patient is able, willing, and competent to give informed consent.
• Life expectancy of at least 30 days.​​​​​​​

Exclusion Criteria:

• Scenarios in which vascular reconstruction is not feasible or not advised (investigator judgement).
• Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.
• Treatment with any investigational drug or device within 60 days prior to study entry (Day 0). This will be the day of surgery.
• Pregnant women or women planning to become pregnant (women of childbearing potential [WOCBP] must use contraception [hormonal or barrier method of birth control; abstinence] for duration of study participation; WOCBP defined as not sterile or not > 1 year postmenopausal.
• Known medical condition which would preclude long-term antiplatelet therapy.
• Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the Humacyte HAV.

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.