Pivotal Study for the FLAIR Endovascular Stent Graft

NCT00678249 | Completed Results DMC

• 2 other identifiers: IMP-9809P060002
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

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.

Conditions

Stenoses

Keywords

Hemodialysis; Vascular Prosthesis; stenoses; grafts

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With Treatment Area Primary Patency (TAPP)

  TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.

  6 month follow-up

Secondary Outcomes (8)

• Total Number of Adverse Events

  6 month Follow-Up

• Percent of Participants With Successful Delivery of the Device

  Index Procedure

• Percent of Participants With Procedural Success

  Index Procedure

• Percent of Participants With TAPP

  2 month Follow-Up

• Percent of Participants With Access Circuit Primary Patency (ACPP)

  6 month Follow-Up

Study Arms (3)

FLAIR

EXPERIMENTAL

Primary PTA followed by placement of the FLAIR Endovascular Stent Graft

Device: FLAIR Endovascular Stent Graft

PTA Only

ACTIVE COMPARATOR

Percutaneous Transluminal Angioplasty

Procedure: PTA

FLAIR Roll-in Participants

EXPERIMENTAL

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.

Device: FLAIR Endovascular Stent Graft

Interventions

FLAIR Endovascular Stent Graft DEVICE

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

Also known as: Flair, Stent Graft

FLAIR

PTA PROCEDURE

Percutaneous Transluminal Angioplasty

Also known as: Flair, Stent Graft

PTA Only

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

New York Presbyterian Hospital/Columbia

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 20147715 DERIVED

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: John Reviere, Director, Clinical Affairs
• Organization: Bard Peripheral Vascular, Inc.

john.reviere@crbard.com

480-303-2644

Study Officials

• David Ciavarella, MD

  C. R. Bard

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 13, 2008
• First Posted: May 15, 2008
• Study Start: January 1, 2001
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: May 11, 2011
• Results First Posted: May 9, 2011

Record last verified: 2011-05

Locations

US (1)