Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease

Exclusion Criteria

• •History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within 6 months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• •Uncontrolled or poorly controlled diabetes; hospitalization for poor glucose control within the previous 6 months is an absolute exclusion criterion
• •History or evidence of severe peripheral vascular disease in the upper limbs
• •Known or suspected central vein obstruction on the side of planned graft implantation
• •Stroke within 6 months of study entry (Day 1)
• •Candidate for renal transplantation
• •Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
• •Treatment with vitamin K-antagonists, factor Xa inhibitors, or direct thrombin inhibitors within the month prior to study entry (Day 1)
• •Female patients who are pregnant, intending to become pregnant, nursing or intending to nurse during the study
• •Female patients of child bearing potential (not surgically sterile or at least 2 years post menopause) who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), eg, implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner
• •History of cancer with active disease or treatment within the previous year
• •Immunodeficiency including AIDS / HIV
• •Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events (thromboses of previous dialysis accesses do not count)
• •Bleeding diathesis
• •Active clinically significant autoimmune disease
• •History of heparin-induced thrombocytopenia
• •Previous PTFE graft in the operative limb unless the HAVG can be placed more proximally than the previous failed graft
• •More than 1 failed PTFE graft in the operative limb
• •Active local or systemic infection (WBC \> 15,000 cells/mm3)
• •Patients receiving a forearm graft with which crosses the elbow
• •Patients receiving an upper arm graft with arterial anastomosis to the axillary artery or venous anastomosis to the axillary vein unless low in the axilla and accessible for ultrasound monitoring and compression
• •Patients receiving a lower extremity AV access
• •Known serious allergy to aspirin
• •Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAVG
• •Previous enrollment in this study
• •Employees of the sponsor or patients who are employees or relatives of the investigator