Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Intervention: Human Acellular Vessel (HAV)
Intervention description: Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when
      surgically implanted into a leg to improve blood flow in patients with peripheral arterial
      disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with disabling symptomatic peripheral arterial disease

               1. Rutherford stage 4 or 5 who require femoro-popliteal bypass surgery or

               2. Rutherford stage 3 with severe claudication (less than 50 yards AND causing
                  severe impairment of ability to work or undertake social activities)

          2. Ankle - brachial index ≤ 0.6 in the study leg

          3. Patient has failed adequate medical therapy which included

               1. Exercise program

               2. Smoking cessation therapy

               3. Control of diabetes, hypertension and dyslipidemias

               4. Antiplatelet therapy

          4. 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

          5. Preoperative imaging shows at least one below knee vessel patent to the ankle with
             good runoff

          6. Proximal HAV anastomosis is expected to be to the common femoral artery below the
             inguinal ligament or to the superficial femoral artery

          7. Distal anastomosis is expected to be to the popliteal artery above the knee

          8. 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

          9. 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

         10. Aged 18 to 85 years old, inclusive

         11. Hemoglobin ≥ 10g/dL and platelet count ≥ 100,000/mm3 at screening

         12. Other hematological and biochemical parameters within a range considered acceptable
             for the administration of general anesthesia at screening

         13. Adequate liver function, defined as serum bilirubin ≤ 1.5 mg/dL; and INR ≤ 1.5 at
             screening

         14. Able to communicate meaningfully with investigative staff, competent to give written
             informed consent, and able to comply with entire study procedures

         15. Life expectancy of at least 1 year

        Exclusion Criteria:

          1. Leg at high risk of amputation (SVS WIfI stage 4)

          2. Recent clinically significant trauma to the leg receiving the HAV

          3. Severe active infection (SVS foot infection grade 3) in the leg receiving the HAV

          4. Distal anastomosis planned to a below knee artery

          5. 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

          6. Stroke within six (6) months prior to study entry (Day 1)

          7. Chronic renal disease such that multiple administrations of contrast agents may pose
             an increased risk of nephrotoxicity (eGFR<45mL/min)

          8. Uncontrolled diabetes (HbA1c >10% at screening)

          9. Treatment with any investigational drug or device within 60 days prior to study entry
             (Day 1)

         10. Cancer that is being actively treated with a cytotoxic agent

         11. AIDS / HIV infection

         12. Documented hypercoagulable state or history as defined as either:

               1. a biochemical diagnosis (e.g. Factor V Leiden, Protein C deficiency, etc.) - OR -

               2. 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

         13. Spontaneous or unexplained bleeding diathesis clinically documented within the last 5
             years or a biochemical diagnosis (e.g. von Willebrand disease, etc.).

         14. Ongoing treatment with vitamin K antagonists or oral direct thrombin inhibitors or
             factor Xa inhibitors (e.g. dabigatran, apixaban or rivaroxaban )

         15. Previous arterial bypass surgery (autologous vein or synthetic graft) in the operative
             leg

         16. Stenosis of >50% of the inflow aortoiliac system ipsilateral to the index leg. Any
             such stenosis must be corrected with angioplasty with or without stenting prior to, or
             at the time of, HAV implantation

         17. Active autoimmune disease - symptomatic or requiring ongoing drug therapy

         18. Active local or systemic infection (WBC > 15,000/mm3)

         19. Known serious allergy to aspirin

         20. Any other condition which in the judgment of the investigator would preclude adequate
             evaluation of the safety and efficacy of the Humacyte Human Acellular Vessel (HAV)

         21. Previous exposure to HAV

         22. Employees of the sponsor or patients who are employees or relatives of the
             investigator

         23. Pregnant women or women planning to become pregnant (Women of child bearing potential,
             WOCBP, must use adequate contraception [hormonal or barrier method of birth control;
             abstinence] for the duration of study participation; WOCBP defined as not sterile or
             not > 1 year postmenopausal.)