Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis

Prior treatment

• Subjects who are optimal candidates for radiocephalic AVF as indicated by meeting ALL of the following criteria:
  • No previous failed AVF.
  • Cephalic vein diameter on ultrasound of more than 3.5mm.
  • Radial artery diameter on ultrasound of more than 3mm.
  • Vein depth of less than 0.5cm from the skin.
  • Normal Allen's test indicating that ulnar artery flow to the hand is sufficient.
  • No calcification in the wall of the distal radial artery.
  • Sufficient length of the proposed fistula outflow vein to provide an adequate (at least 6 cm) cannulation segment.
  • No evidence of iatrogenic injury to target artery or vein.
• Known or suspected central vein stenosis or obstruction on the side of planned SA creation, unless corrected prior to randomization.
• Planned AVF creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices).
• Treatment with any investigational drug or device within 60 days prior to study entry (Day 0) or ongoing participation in a clinical trial of an investigational product.
• Cancer that is actively being treated with a cytotoxic agent.
• Anticipated renal transplant within 6 months.
• Venous outflow from SA cannot be located more centrally than the venous outflow of any previous failed access in that extremity.
• Previous enrollment in this study or any other study with HAV.

Other illness

• History or evidence of severe peripheral arterial disease in the extremity selected for implant.
• Bleeding diathesis.
• Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
  • Low dose glucocorticoid therapy (e.g. 5-10mg prednisone \[Deltason\]) is acceptable.
  • High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
  • Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
  • The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
  • tacrolimus or FK506 \[Prograf\]
  • mycophenolate mofetil \[Cellcept\],
  • cyclosporine \[Sandimmune or Gengraf\]
  • sirolimus \[Rapamune\] (this only includes systemically administered, drug eluting stents are acceptable)
• History of heparin-induced thrombocytopenia.
• Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy.
• Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA.

Lab values

• Uncontrolled diabetes;
  • HbA1c \>10% (at Screening).
• Active local or systemic infection (white blood cells \[WBC\] \> 15,000 cells/mm3 at Screening). If the infection resolves, the subject must be at least one week post resolution of that infection before SA creation.

Other

• Planned AVF creation that requires more than one stage to complete. (e.g. basilic vein transposition AVF performed in 2 stages).
• Documented hyper-coagulable state.
• Pregnant women, or women intending to become pregnant during the course of the trial.
• Employees of Humacyte and employees or relatives of an investigator.

• Subjects with end-stage renal disease (ESRD), receiving HD via DC and are suitable for the creation of an AVF or implantation of AVG for HD access.
• Subjects who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least the first 6 months after SA creation.
• Subjects aged at least 18 years at Screening.
• Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight or looped HAV in either the forearm or upper arm.
• Hemoglobin ≥8 g/dL and platelet count ≥100,000 /mm3.
• International Normalized Ratio (INR) ≤ 1.5.
• Female subjects must be either:
  • Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening).
  • Or, of childbearing potential, in which case:
  • Must have a negative urine or serum pregnancy test at Screening, and ii. Must agree to use at least one form of the following birth control methods for the duration of the study:
  • Established use of oral, injectable or implanted hormonal methods of contraception.
  • Placement of an intrauterine device or intrauterine system.
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.
• Subject, or legal representative, able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits.
• Life expectancy of at least 2 years.