STARgraft (10401) Pilot

Inclusion criteria

• Adult patients, 18 years or older.
• Patient has given informed consent to participate in the trial.
• Stated willingness to comply with all trial procedures and availability for the duration of the trial.
• Able to effectively communicate with trial personnel.
• Indicated patient population (end stage renal disease).
• Candidate for a new AV graft placed in the upper arm and judged to need dialysis within 2 months. Patient may have a failed access at a different anatomical location.
• Life expectancy judged to be at least 2 years with consideration of patient frailty.
• Axillary vein approximately 7 mm in diameter or greater.
• Brachial artery approximately 4 mm in diameter or greater.
• Acceptable cardiac risk level (cardiac output ≥ 3.5 l/min, pulmonary artery pressure ≤ 50 mmHg, and ejection fraction ≥ 40%).
• Systolic blood pressure equal to or greater than 120 mmHg.
• Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram.

Exclusion criteria

• Unable or unlikely to comply with trial protocol and/or follow-up.
• Pregnancy.
• Previous history of Peritoneal Dialysis treatment within the last 2 months
• Central venous catheter located on same side as intended implant location.
• Clinical morbid obesity (BMI > 40).
• Anatomical limitations, including issues discovered intraoperatively during vessel exposure.
• Immunodeficiency syndrome.
• History of hypercoagulation or bleeding disorders.
• Elevated platelet count > 1 million per microliter of blood.
• History of heparin-induced thrombocytopenia syndrome
• Medically confirmed stenosis or compromised valves in the veins downstream of the implant site.
• Inadequate arterial flow or pressure proximal to the implant site.
• Currently participating in another investigational drug or device trial which may clinically interfere with any endpoints of this trial.
• Fever greater than 38°C.
• Known allergic reaction to silicone, or untreatable allergy to imaging contrast materials.
• Confirmed or suspected bacterial, viral or parasitic infection within 8 weeks prior to graft implant, or ongoing symptoms.
• Uncontrolled or poorly controlled diabetes.
• History or evidence of severe cardiac disease.
• Any other condition which, in the judgment of the Investigator, would preclude adequate evaluation or impact patient safety or trial conduct.