Expired Study
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New York, New York 10032


Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT00678249


Primary Contact:

Study Director
David Ciavarella, MD
C. R. Bard


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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