This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients
with stenoses at the venous anastomosis of a synthetic AV access graft.
A total of 227 patients were treated at 16 U.S. investigational sites to evaluate the safety
and effectiveness of the FLAIR™ Endovascular Stent Graft. This study compared the FLAIR™
Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous
anastomosis of a synthetic AV access graft.
- Male or female patients between 18 to 90 years of age whose hemodialysis access was a
synthetic AV access graft located in an arm.
- Angiographic evidence of one or more stenoses, 7 cm or less in length and greater
than or equal to 50%, at the graft-vein anastomosis of a synthetic AV access graft.
The entire lesion must have been located within 7 cm of the anastomosis such that
approximately 1 cm of the IMPRA/Bard Device must have extended into non-diseased vein
and approximately 1 cm, but no more than 2 cm, of the IMPRA/Bard Device will be
extended into non-diseased AV graft.
- Clinical evidence of a hemodynamically significant stenosis.
- Percutaneous endovascular therapy for the identified lesion was the best treatment
choice in the opinion of the investigator.
- Patients must have been able to understand and provide informed consent.
- Patients whose synthetic AV access grafts had been implanted greater than 30 days and
had undergone 1 or more successful hemodialysis sessions.
- During primary balloon angioplasty, full expansion of an appropriately sized
angioplasty balloon, in the operator's judgment, must have been achieved.
- 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
- 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.