pivotal study for the flair endovascular stent graft

Conditions: Stenoses

Summary: 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.

Eligibility criteria:
inclusion criteria: * 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. 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.

Keywords: hemodialysis vascular prosthesis stenoses grafts