|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060002 / PAS001 |
| Date Original Protocol Accepted |
03/13/2008
|
| Date Current Protocol Accepted |
03/13/2008
|
| Study Name |
FLAIR Endovascular Grafts
|
| Device Name |
FLAIR ENDOVASCULAR STENT GRAFT
|
| 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 Objectives |
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 |
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
|
| Key Study Endpoints |
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
Weakness:
¿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
|
