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.