A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease

The InnAVasc Arteriovenous Graft (IG) is intended for use in ESRD hemodialysis (HD) patients who require HD and whose next most appropriate access is an arteriovenous graft (AVG), also including those who may require an immediate cannulation AVG.

Patients with ESRD who require HD and are suitable for an AVG for HD access will be eligible for inclusion in the study. Subjects will be implanted with an InnAVasc Arteriovenous Graft (IG) in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a "straight" (soft "C") configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop). Placing the graft across the elbow will be prohibited. Subjects must be able to be on antiplatelet therapy per the discretion of their physician (e.g., aspirin, clopidogrel, etc.).

Inclusion criteria

Pre-Operative Inclusion Criteria:

Patients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study:

• Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;
• Age 18 to 90 years old, inclusive;
• Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);
• Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition);
• Able and willing to give informed consent;
• Anticipated life expectancy of at least 1 year.

Intra-Operative Inclusion Criteria:

Both vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).

Pre-Operative Exclusion Criteria:

Patients will be excluded from the study at screening if they exhibit any of the following exclusion criteria:

• History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may preclude participation in and completion of the study;
• Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);
• For upper arm straight configuration, an antecubital fossa crease to axillary crease distance < 18 cm;
• History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access);
• Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;
• Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis;
• Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness);
• Baseline hemoglobin <7 g/dL;
• Baseline platelet count <50,000 or >500,000 cells/mm3;
• Documented history of stroke within 6 months prior to enrollment;
• Treatment with any investigational drug or device within 30 days prior to enrollment;
• Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy or permanent sterilization);
• History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin;
• Immunodeficiency including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable;
• Documented or suspected hypercoagulable condition;
• Bleeding diathesis, other than that associated with ESRD;
• Documented history of heparin-induced thrombocytopenia (HIT);
• Active local or systemic infection as documented from the medical history or bloodwork/blood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation;
• Scheduled renal transplant within 6 months;
• Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the IG;
• Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.