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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P120009 / PAS001 |
| Date Original Protocol Accepted |
08/16/2013
|
| Date Current Protocol Accepted |
12/16/2016
|
| Study Name |
Nit-Occlud PDA PAS
|
| Device Name |
NIT-OCCLUD PDA
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a controlled, prospective, single-arm, multi-center (up to 20 sites) study. Enrolled subjects will be followed at 2, 12, and
24 months (2 years) post implant.
|
| Study Population |
Patients age 6 months to 21 years weighing > 5kg with an angiographically confirmed PDA with a minimum diameter < 4 mm.
|
| Sample Size |
A total of 180 subjects will be enrolled to ensure 150 subjects treated with the device will be available at 24 months post-procedure.
|
| Key Study Endpoints |
The primary safety endpoint is the serious device and/or procedure related
adverse event rate at 60 months post-procedure.
The primary effectiveness endpoint is the rate of complete closure of the ductus arteriosus as assessed by absence of residual flow at 5 years follow-up by by transthoracic echocardiogram with 2-D color of color flow mapping and pulse wave Doppler (ECHO).
|
| Follow-up Visits and Length of Follow-up |
5 years
Clinical assessments at 2, 12, 24, 36, 48, and 60 months
Echocardiography at 2, 12, 36, and 60 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
The study enrolled a total of 184 subjects from 11 study sites, 180 subjects were implanted with
the device.
|
| Actual Number of Sites Enrolled |
The study enrolled a total of 184 subjects from 11 study sites, 180 subjects were implanted with
the device.
|
| Patient Follow-up Rate |
155/163 (95.1%) completed the 24-month visit
9/9 (100%) completed the 36-month visit per protocol
8/8 (100%) completed the 48-month visit per protocol
6/6 (100%) completed the 60-month visit per protocol
|
| Final Safety Findings |
The primary safety endpoint was to demonstrate the 24-month serious device-related adverse
event rate was no worse than the objective performance criterion (OPC) of 1%. The secondary
safety endpoint was to demonstrate that the rate of device-related adverse events reported
through 24 months post procedure was no worse than 6% (OPC rate of 3% plus an added 3%
margin).
A total of 130 adverse events were reported. Of those, 18 were either adjudicated as serious by
the CEC (n=17) or categorized as serious by the investigator (n=1). Of the 18 SAEs, 2 were
adjudicated as device-related. Additionally, six (6) device-related AEs were reported.
Two (2) late-onset AEs were reported to occur >12 months post-procedure and adjudicated as
device-related by the CEC. All other device- or procedure-related events occurred within one day of
the implant procedure.
For the primary safety endpoint, there were 2 serious device related adverse events reported
through 24 months post implant attempt such events, yielding an event rate of 1.1%. The 2-sided
95% CI is 0.13% to 3.9% and the one-sided CI upper bound = 3.4%. For the secondary safety
endpoint, there were 6 device related AEs in leass than 1 year post-procedure, yielding an event
rate of 3.3% and a one-sided CI upper bound of 6.5%.
|
| Final Effect Findings |
The primary effectiveness endpoint was to demonstrate the 12-month complete closure
rate for the device was no worse than the OPC of 85%. The primary effectiveness endpoint was
calculated as the proportion of subjects with complete closure of the PDA as assessed by absence
of residual flow at the Month 12 follow-up visit. The core lab reports 97.5% (157/161) of subjects
had no (n=152) or trivial (n=5) residual leak at Month 12. The binomial confidence interval around
this rate is 93.8% to 99.3%.
|
| Study Strengths & Weaknesses |
A strength of this study is that it evaluates the continued safety and effectiveness of the device in
the post-approval phase.
A weakness of this study is that it is a single-arm (non-randomized) study.
|
| Recommendations for Labeling Changes |
A labeling change is recommended to add the long-term safety and effectiveness results from these studies.
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