Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Vascular Access, Hemodialysis Access, End Stage Renal Disease, Kidney Failure, Hemodialysis, Arteriovenous Graft, AVG, Cannulation, Quick Sealing dialysis graft Read More

Inclusion Criteria:

• Patients with ESRD who are not, or who are no longer, candidates for creation of an autologous AV fistula and therefore need placement of an AV graft to start or maintain hemodialysis therapy;
• Age 18 to 80 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);
• For patients NOT on Coumadin / warfarin, international normalized ratio (INR) ≤1.5;
• Able and willing to give informed consent;
• Anticipated life expectancy of at least 1 year.

Additional inclusion criteria on Day 0 (intraoperative):

• Both vessels have been exposed and are deemed appropriate for implantation implantation (i.e. based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow and is safely clampable (i.e. artery has lack of significant calcification); and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).

Exclusion Criteria:

• History or evidence of severe cardiac disease (New York Heart Association [NYHA] Functional Class III or IV), myocardial infarction within 6 months prior to enrollment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina;
• Diabetes with a hemoglobin A1c (HbA1c) > 10%
• For upper arm straight configuration, 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;
• In the opinion of the investigator, baseline hypotension, or history of frequent hypotensive episodes during dialysis that puts the patient at increased risk of graft thrombosis;
• In the opinion of the investigator, uncontrolled hypertension;
• Baseline hemoglobin <8 g/dL;
• Baseline platelet count <100,000 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);
• 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 state;
• 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