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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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FLAIR Endovascular Grafts

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Study Status Completed
Application Number P060002 / PAS001
Date Current Protocol Accepted 03/13/2008
Study Name FLAIR Endovascular Grafts
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective randomized study. One arm will receive balloon angioplasty of the target lesion only, and the other arm will receive balloon angioplasty plus the FLAIR Endovascular Stent Graft (referred to as the FLAIR group).
Study Population Description Patients with hemodynamically significant stenosis (>50%) with clinical evidence of graft dysfunction (without thrombotic occlusion) at the synthetic arteriovenous access graft anastomosis, who have a life expectancy of at least 25 months at enrollment, who meet administrative requirements for participation in the study, are at least 18 years old, whose target lesion meets appropriate anatomic criteria, and who are not characterized by any of the study's exclusion criteria.
Sample Size 270 subjects, 30 sites
Data Collection Primary endpoints includ: 1) access Circuit Primary Patency (ACPP - defined as the interval following the index procedure until the next access thrombosis or reintervention; it ends with a reintervention anywhere within the access circuit.); 2) Patency Function (IPF - defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis at 12 months follow-up); 3) number of device and/or procedure related adverse events; Secondary endpoints include:: 1) Number of reinterventions until graft abandonment or through 12 months post-index procedure, 2) Postintervention Assisted Primary Patency, 3) Postintervention Secondary Patency, 4) Procedure Success, and 5) Incidence of major device-related adverse events through 30 days post index procedure.
Follow-up Visits and Length of Follow-up Subject follow-up will occur at 30 days and 6, 12 and 24 months. Follow-up will occur by telephone at 30 days, 6 months and 24 months. It will occur by office visit/review of dialysis records at 12 months. The following will be assessed at follow-up: arteriovenous graft status, repeat interventions to the access circuit and treatment area, and device and/or procedure related adverse events.
Interim or Final Data Summary
Actual Number of Patients Enrolled 270
Actual Number of Sites Enrolled 35
Patient Follow-up Rate 98%
Final Safety Findings Subjects with device- or procedure-related AEs at 12 months: Control group ¡V 6%; FLAIR group ¡V 27%

Subjects with device- or procedure-related AEs at 24 months: Control group ¡V 6%; FLAIR group ¡V 33%

Final Effect Findings Primary endpoint # 1: Access Circuit Primary Patency (ACPP)

Time period ACPP for PTA ACPP for FLAIR

12 months 0.110 [95% CI = 0.05-0.17] 0.240 [95% CI = 0.17-0.32]

24 months 0.055 [95% CI = 0.01-0.10] 0.095 [95% CI =0.03-0.16]

p value = .007 (comparison of PTA with FLAIR), showing superiority of FLAIR at 12 months

Primary endpoint # 2: Index of Patency Function (IPF)

Time period IPF for PTA IPF for FLAIR

(months per intervention) (months per intervention)

12 months 4.4 +/- 3.5 5.2 +/- 4.1

24 months 5.3 +/- 5.2 7.1 +/- 7.0

p value for comparison of PTA with FLAIR at 12 months is .009, showing non-inferiority (7 days)

for FLAIR compared with PTA.

Study Strengths & Weaknesses Strengths:

¿Þ Excellent follow-up (98%)

¿Þ Prospective cohort study

¿Þ Randomization to control vs. subject group


¿Þ Some measures of safety were found to be inferior in the subject compared with the control group. A post-hoc analysis was required in order to cast some doubt on the significance of those findings.

Recommendations for Labeling Changes Yes: Update label with primary safety and effectiveness endpoints

FLAIR Endovascular Grafts Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 07/22/2008 07/21/2008 On Time
2 year report 07/23/2009 07/23/2009 On Time
3 year report 07/22/2010 07/22/2010 On Time
4 year report 07/22/2011 07/19/2011 On Time
5 year report 07/21/2012 09/28/2012 Overdue/Received
6 year report-final 07/22/2013 09/16/2013 Overdue/Received

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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