Pivotal Study for the FLAIR Endovascular Stent Graft

Exclusion Criteria

• •Concomitant disease (e.g., terminal cancer) or other medical condition that was likely to result in death of the patient within 6 months of the time of implantation.
• •Stenoses that had a corresponding thrombosis treated within 7 days.
• •The presence of a second lesion in the access circuit less than or equal to 3 cm from the edges of the primary lesion that was treated within 30 days or that was greater than or equal to 30%. Access circuit was defined as the area from the AV access graft arterial anastomosis to the superior vena cava-right atrial junction.
• •The presence of a second lesion in the access circuit greater than 3 cm from the edges of the primary lesion that was greater than or equal to 30%. Second lesions that were greater than or equal to 30% must have been treated prior to patient inclusion to reduce the percent stenosis to less than 30%.
• •Patients who were unwilling or unable to return for follow-up visits or patients with whom follow-up visits may have been unreliable.
• •Patients who had a stent placed at the target lesion site.
• •Patients with a blood coagulative disorder or sepsis.
• •Patients in which the IMPRA/Bard Device would have been required to cross an angle (between the inflow vein and synthetic AV access graft) that was greater than 90 degrees.
• •Patients in which the IMPRA/Bard Device would have been required to be deployed fully across the elbow joint, which is identified radiographically by a combination of the humeroulnar joint and the humeroradial joint.
• •Patients with a contraindication to the use of contrast media.
• •Patients whose AV access graft was infected.
• •Patients who were currently or were scheduled to enroll in other investigations that conflicted with follow-up testing or confounds data in this trial.
• •Procedural use of another investigational device.
• •Patients who were pregnant.