Pivotal Study for the FLAIR Endovascular Stent Graft

A Prospective, Multi-Center, Randomized Evaluation of an IMPRA/Bard ePTFE Encapsulated Carbon Lined Nitinol Endoluminal Device for AV Access Graft Stenoses

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 Overview

• Status: Completed
• Conditions: Stenoses
• Intervention / Treatment: Device: FLAIR Endovascular Stent Graft; Device: FLAIR Endovascular Stent Graft; Procedure: PTA

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.

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital/Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Stent Graft; Flair; 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: Stent Graft; Flair
Active Comparator: PTA Only; Percutaneous Transluminal Angioplasty	Procedure: PTA; Percutaneous Transluminal Angioplasty; Other Names: Stent Graft; Flair
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 balloon angioplasty followed by placement of the FLAIR Endovascular Stent Graft; Other Names: Stent Graft; Flair; 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: Stent Graft; Flair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Adverse Events	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.	6 month Follow-Up
Percent of Participants With Successful Delivery of the Device	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.	Index Procedure
Percent of Participants With Procedural Success	Procedural Success was defined as anatomic success (<30% residual stenosis) and at least one indicator of hemodynamic or clinical success	Index Procedure
Percent of Participants With 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.	2 month Follow-Up
Percent of Participants With Access Circuit Primary Patency (ACPP)	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.	6 month Follow-Up
Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)	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.	6 month Follow-Up
Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)	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.	6 month Follow-Up
Percent of Participants With Binary Restenosis	Binary restenosis defined as lesions with greater than or equal to 50% diameter stenosis of the treatment area (calculated by a core lab).	6 month Follow-Up

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Study Director: David Ciavarella, MD, C. R. Bard

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): June 1, 2004
• Study Completion (Actual): June 1, 2004

Study Registration Dates

• First Submitted: May 13, 2008
• First Submitted That Met QC Criteria: May 14, 2008
• First Posted (Estimate): May 15, 2008

Study Record Updates

• Last Update Posted (Estimate): May 11, 2011
• Last Update Submitted That Met QC Criteria: May 10, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Hemodialysis; grafts; Vascular Prosthesis; stenoses
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: IMP-9809; P060002 (Other Identifier: Food and Drug Administration)