Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD

Inclusion Criteria

• Patients with disabling symptomatic peripheral arterial disease
• Rutherford stage 4 or 5 who require femoro-popliteal bypass surgery or
• Rutherford stage 3 with severe claudication (less than 50 yards AND causing severe impairment of ability to work or undertake social activities)
• Ankle - brachial index ≤ 0.6 in the study leg
• Patient has failed adequate medical therapy which included
• Exercise program
• Smoking cessation therapy
• Control of diabetes, hypertension and dyslipidemias
• Antiplatelet therapy
• Preoperative angiography or CT angiography shows superficial femoral artery occlusion AND required Humacyte Human Acellular Vessel (HAV) length of ≤ 38cm. This imaging may have been conducted up to 6 months prior to study entry provided that the patient's symptoms have remained stable since that time
• Preoperative imaging shows at least one below knee vessel patent to the ankle with good runoff
• Proximal HAV anastomosis is expected to be to the common femoral artery below the inguinal ligament or to the superficial femoral artery
• Distal anastomosis is expected to be to the popliteal artery above the knee
• Femoral artery occlusion is not considered suitable for endovascular treatment; e.g. long segment chronic total occlusion, previous failed stent or stent graft in the superficial femoral artery, previous failed endovascular treatment where the lesion could not be crossed
• Autologous vein graft is not feasible in the judgment of the treating surgeon; e.g. because all suitable veins have been used previously for coronary or peripheral bypass, or pre-operative vein mapping shows inadequate length or quality of vein to complete the planned bypass
• Aged 18 to 85 years old, inclusive
• Hemoglobin ≥ 10g/dL and platelet count ≥ 100,000/mm3 at screening
• Other hematological and biochemical parameters within a range considered acceptable for the administration of general anesthesia at screening
• Adequate liver function, defined as serum bilirubin ≤ 1.5 mg/dL; and INR ≤ 1.5 at screening
• Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able to comply with entire study procedures
• Life expectancy of at least 1 year

Exclusion Criteria

• Leg at high risk of amputation (SVS WIfI stage 4)
• Recent clinically significant trauma to the leg receiving the HAV
• Severe active infection (SVS foot infection grade 3) in the leg receiving the HAV
• Distal anastomosis planned to a below knee artery
• History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• Stroke within six (6) months prior to study entry (Day 1)
• Chronic renal disease such that multiple administrations of contrast agents may pose an increased risk of nephrotoxicity (eGFR 10% at screening)
• Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
• Cancer that is being actively treated with a cytotoxic agent
• AIDS / HIV infection
• Documented hypercoagulable state or history as defined as either:
• a biochemical diagnosis (e.g. Factor V Leiden, Protein C deficiency, etc.) - OR -
• a clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g. DVT, PE, etc.) within the previous 5 years
• Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g. von Willebrand disease, etc.).
• Ongoing treatment with vitamin K antagonists or oral direct thrombin inhibitors or factor Xa inhibitors (e.g. dabigatran, apixaban or rivaroxaban )
• Previous arterial bypass surgery (autologous vein or synthetic graft) in the operative leg
• Stenosis of >50% of the inflow aortoiliac system ipsilateral to the index leg. Any such ste