Clinical trial NCT00678249: Pivotal Study for the FLAIR Endovascular Stent Graft
Official title: A Prospective, Multi-Center, Randomized Evaluation of an IMPRA/Bard ePTFE Encapsulated Carbon Lined Nitinol Endoluminal Device for AV Access Graft Stenoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenoses
Keywords: Hemodialysis
Vascular Prosthesis
stenoses
grafts
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Percent of Participants With Treatment Area Primary Patency (TAPP)
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Total Number of Adverse Events
timeFrame: 6 month Follow-Up
measure: Percent of Participants With Successful Delivery of the Device
timeFrame: Index Procedure
measure: Percent of Participants With Procedural Success
timeFrame: Index Procedure
measure: Percent of Participants With TAPP
timeFrame: 2 month Follow-Up
measure: Percent of Participants With Access Circuit Primary Patency (ACPP)
timeFrame: 6 month Follow-Up
measure: Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)
timeFrame: 6 month Follow-Up
measure: Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)
timeFrame: 6 month Follow-Up
measure: Percent of Participants With Binary Restenosis
timeFrame: 6 month Follow-Up
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia
state: New York
Study officials:
affiliation: C. R. Bard
name: David Ciavarella, MD
role: STUDY_DIRECTOR
References:
citation: Haskal ZJ, Trerotola S, Dolmatch B, Schuman E, Altman S, Mietling S, Berman S, McLennan G, Trimmer C, Ross J, Vesely T. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med. 2010 Feb 11;362(6):494-503. doi: 10.1056/NEJMoa0902045.