Use of ABI-007 for the Prevention of Vascular Access Graft Failure in Patients Undergoing Hemodialysis

Exclusion Criteria

• •Use of a stent at the time of current angioplasty or at any previous time in the index lesion.
• •No perforation at the time of current angioplasty.
• •Thrombosed graft for more than 7 days.
• •Patient has the following blood counts at baseline:
• •Absolute neutrophil count (ANC) \< 2.0\*10\^9/L;
• •platelets \< 100\*10\^9/L;
• •Hemoglobin (Hgb) \< 9 g/dL.
• •Patient has the following blood chemistry levels at baseline:
• •Aspartate transaminase (AST or SGOT), alanine transaminase (ALT or SGPT) \> 2.5x upper limit of normal range (ULN);
• •total bilirubin ≥ upper limit of normal (ULN);
• •Unable to give informed consent, or for whom informed consent cannot be obtained from a legal guardian.
• •Women who are pregnant and women of child bearing potential who do not use adequate contraception.
• •2 procedures of percutaneous or surgical intervention on the PTFE graft within the previous 90 days.
• •Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational trial.
• •Patient has a life expectancy of less than 6 months.
• •Intended kidney transplant within 6 months of enrollment in the study
• •Any significant medical condition which in the investigators opinion may interfere with the patients optimal participation in the study.
• •Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
• •Patient has a history of allergy or hypersensitivity to the study drug.
• •Documented hypercoagulable state requiring anti-coagulation (protein S, protein C, antiphospholipid; anticoagulation on an empiric basis for graft thromboses in not a contradiction).
• •Patient is human immunodeficiency virus (HIV) positive.
• •Patient is currently receiving other chemotherapy drug(s).