Pivotal Study for the FLAIR Endovascular Stent Graft

This study has been completed.
Sponsor:
Information provided by:
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00678249
First received: May 13, 2008
Last updated: May 10, 2011
Last verified: May 2011
  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.


Condition Intervention
Stenoses
Device: FLAIR Endovascular Stent Graft
Procedure: PTA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Randomized Evaluation of an IMPRA/Bard ePTFE Encapsulated Carbon Lined Nitinol Endoluminal Device for AV Access Graft Stenoses

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Percent of Participants With Treatment Area Primary Patency (TAPP) [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Total Number of Adverse Events [ Time Frame: 6 month Follow-Up ] [ Designated as safety issue: Yes ]
    The safety endpoint was evaluated based on the incidence of adverse events observed within the same time interval. An adverse event was defined as any undesirable clinical occurrence in a patient that (a) is considered possibly or definietly device related by the investigator, (b) involves the access circuit (AV graft arterial anastomosis to the superior vena cava-right atrial junction) or the arm where the access circuit is located or (c) the investigator considers relevant to the objectives of this study. An adverse event could be mild, moderate or severe.

  • Percent of Participants With Successful Delivery of the Device [ Time Frame: Index Procedure ] [ Designated as safety issue: No ]
    The ability to successfully deliver the FLAIR™ Endovascular Stent Graft. Successful delivery is the ability to deliver and seat the implant in the intended location of a stenosed segment of the venous anastomosis region of a synthetic access graft. This attribute is only applicable to the FLAIR and FLAIR Roll-in arms.

  • Percent of Participants With Procedural Success [ Time Frame: Index Procedure ] [ Designated as safety issue: No ]
    Procedural Success was defined as anatomic success (<30% residual stenosis) and at least one indicator of hemodynamic or clinical success

  • Percent of Participants With TAPP [ Time Frame: 2 month Follow-Up ] [ Designated as safety issue: No ]
    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.

  • Percent of Participants With Access Circuit Primary Patency (ACPP) [ Time Frame: 6 month Follow-Up ] [ Designated as safety issue: No ]
    ACCP defined as patency (open to blood flow) following the index study procedure until access thrombosis or an intervention of a lesion anywhere within the access circuit.

  • Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP) [ Time Frame: 6 month Follow-Up ] [ Designated as safety issue: No ]
    ACAPP defined as patency (open to blood flow)following the index study procedure until access thrombosis or a surgical intervention that excludes the treated lesion from the access circuit.

  • Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency) [ Time Frame: 6 month Follow-Up ] [ Designated as safety issue: No ]
    ACCP defined as patency (open to blood flow) following the index study procedure until the access is surgically revised or abandoned because of the inability to treat the original lesion. Multiple treatments for occlusions to restore patency are compatible with ACCP.

  • Percent of Participants With Binary Restenosis [ Time Frame: 6 month Follow-Up ] [ Designated as safety issue: No ]
    Binary restenosis defined as lesions with greater than or equal to 50% diameter stenosis of the treatment area (calculated by a core lab).


Enrollment: 227
Study Start Date: January 2001
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLAIR
Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
Device: FLAIR Endovascular Stent Graft
Primary balloon angioplasty followed by placement of the FLAIR Endovascular Stent Graft
Other Names:
  • Flair
  • Stent Graft
Active Comparator: PTA Only
Percutaneous Transluminal Angioplasty
Procedure: PTA
Percutaneous Transluminal Angioplasty
Other Names:
  • Flair
  • Stent Graft
Experimental: 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.
Device: 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.
Other Names:
  • Flair
  • Stent 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678249

Locations
United States, New York
New York Presbyterian Hospital/Columbia
New York, New York, United States, 10032
Sponsors and Collaborators
C. R. Bard
Investigators
Study Director: David Ciavarella, MD C. R. Bard
  More Information

No publications provided by C. R. Bard

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Reviere, Director, Clinical Affairs, Bard Peripheral Vascular, Inc.
ClinicalTrials.gov Identifier: NCT00678249     History of Changes
Other Study ID Numbers: IMP-9809, P060002
Study First Received: May 13, 2008
Results First Received: February 20, 2009
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
Hemodialysis
Vascular Prosthesis
stenoses
grafts

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 22, 2014