Pivotal Study for the FLAIR Endovascular Stent Graft

NCT ID: NCT00678249

Last Updated: 2011-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2004-06-30

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.

Conditions

Stenoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FLAIR

Primary PTA followed by placement of the FLAIR Endovascular Stent Graft

Group Type: EXPERIMENTAL

FLAIR Endovascular Stent Graft

Intervention Type: DEVICE

Primary balloon angioplasty followed by placement of the FLAIR Endovascular Stent Graft

PTA Only

Percutaneous Transluminal Angioplasty

Group Type: ACTIVE_COMPARATOR

PTA

Intervention Type: PROCEDURE

Percutaneous Transluminal Angioplasty

FLAIR Roll-in Participants

Primary Patency followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.

Group Type: EXPERIMENTAL

FLAIR Endovascular Stent Graft

Intervention Type: DEVICE

Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.

Interventions

FLAIR Endovascular Stent Graft

Primary balloon angioplasty followed by placement of the FLAIR Endovascular Stent Graft

Intervention Type: DEVICE

PTA

Percutaneous Transluminal Angioplasty

Intervention Type: PROCEDURE

FLAIR Endovascular Stent Graft

Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.

Intervention Type: DEVICE

Other Intervention Names

Flair; Stent Graft; Flair; Stent Graft; Flair; Stent 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Bard Peripheral Vascular, Inc.

Principal Investigators

David Ciavarella, MD

Role: STUDY_DIRECTOR

C. R. Bard

Locations

New York Presbyterian Hospital/Columbia

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20147715 (View on PubMed)

Other Identifiers

P060002

Identifier Type: OTHER

Identifier Source: secondary_id

IMP-9809

Identifier Type: -

Identifier Source: org_study_id