FLAIR™ Delivery System Study

Inclusion Criteria: * The subject is either a male or non-pregnant female ≥ 18 years old. * The subject has been properly informed about the study per IRB requirements, and has signed and dated the IRB-approved ICF. * The subject is willing to comply with the protocol requirements and can be contacted by telephone. * The subject has a synthetic AV access graft located in an arm that has been implanted for \> 30 days and has undergone at least one successful dialysis session prior to the index procedure. * Angiographic evidence indicates that the subject has a stenosis of \>50% located at the graft-vein anastomosis of the subject's synthetic AV access graft. * The target lesion is estimated to be ≤ 7 cm in length by angiography prior to performance of any interventional procedures. * The entire target lesion is located within 7 cm of the graft-vein anastomosis, as verified by angiography, such that approximately 1 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased vein and approximately 1 cm but no more than 2 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased AV graft. * Graft diameter at the deployment site is between 5 mm and 8 mm, as verified by angiography. * Full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, can be achieved during primary angioplasty. Exclusion Criteria: * The subject has a life expectancy of \< 6 months. * The presence of a previously placed stent and/or stent graft located in the treatment area. The treatment area is defined as the entire target lesion and 1 cm of landing zone into both non-diseased AV graft and non-diseased vein. * The subject has an infected AV access graft or other infection. * The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft be deployed fully across the elbow joint. * The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft cross an angle (between the outflow vein and synthetic AV access graft) that is \> 90 degrees. * The subject has an uncorrected blood coagulation disorder. * The subject has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated. * Subject is currently enrolled or scheduled to be enrolled in other investigations that conflict with follow-up testing or confounds data in this trial. * The subject has a known hypersensitivity to nickel-titanium.