Multi-Site STARgraft (10401) Trial

Prior treatment

• Previous history of peritoneal dialysis (PD) treatment within the last 2 months
• Central venous catheter located on same side as intended implant location.
• 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.
• Confirmed or suspected bacterial, viral or parasitic infection within 8 weeks prior to graft implant, or ongoing symptoms.

Other illness

• Immunodeficiency syndrome.
• History of hypercoagulation or bleeding disorders.
• History of heparin-induced thrombocytopenia syndrome (HIT).
• Known allergic reaction to silicone.
• 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.

Lab values

• Elevated platelet count \> 1 million per microliter of blood.

Other

• Unable or unlikely to comply with trial protocol and/or follow-up.
• Pregnancy.
• Clinical morbid obesity (BMI \> 40).
• Anatomical limitations, including issues discovered intraoperatively during vessel exposure.
• Fever greater than 38°C.

• The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease (ESRD) and intends to use the Vascular Graft device for arteriovenous (AV) access.
• The patient is currently on hemodialysis or intended to begin hemodialysis within 60 days following placement of the device.
• 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.
• 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.