FLAIR™ Delivery System Study

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
FLAIR Endovascular Stent Graft and Delivery System	FLAIR™ Endovascular Stent Graft	-

Primary Outcome Measures

Name	Time	Method
Technical Success for Delivery	Measured at the time of implantation (Day 0)	defined as deployment of the implant to the intended location, assessed at the time of the index procedure.

Secondary Outcome Measures

Name	Time	Method
Number of Device/Procedure-related Adverse Events(Safety of Delivery)	Index Procedure to 30 days	Device/Procedure-related adverse events from the index procedure through 30 days post procedure