Post-Approval Study for the FLAIR Endovascular Stent Graft

Inclusion Criteria: * Subject must be either a male or non-pregnant female greater than or equal to 21 years of age * Subject is willing to comply with the protocol requirements and can be contacted by telephone * Subject has a synthetic AV access graft located in an arm that has been implanted for greater than or equal to 30 days and has undergone at least one successful dialysis session prior to the index procedure * Angiographic evidence (per the institution's standard) is available to indicate that the subject has a stenosis greater than or equal to 50% located at the graft-vein anastomosis of subject's synthetic AV access graft * The target lesion is estimated to be less than or equal to 7 cm in length (by angiography) * 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 the non-diseased AV graft * Full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, can be achieved during primary angioplasty * Graft diameter at the deployment site is between 5 mm and 8 mm as verified by angiography Exclusion Criteria: * The subject has a life expectancy of \< 25 months. * The target lesion has had a corresponding thrombosis treated less than or equal to 7 days prior to the index procedure. * …