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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P180002 / PAS001 |
| Date Original Protocol Accepted |
09/25/2018
|
| Date Current Protocol Accepted |
01/28/2019
|
| Study Name |
LIBERATE Extension Study
|
| Device Name |
Zephyr Endobronchial Valve System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Descriptive
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a multi-center, prospective, single-arm cohort study to evaluate long-term safety and long-term effectiveness in the continued follow-up of the premarket cohort for the LIBERATE Pivotal Trial.
|
| Study Population |
Subjects who were previously implanted with the Zephyr Endobronchial Valve System and participated in the LIBERATE Pivotal Trial i.e. initial cohort and crossover subjects.
|
| Sample Size |
Approximately 142 subjects are available for extended follow-up
|
| Key Study Endpoints |
Effectiveness Endpoint: FEV1
Safety Endpoint: Evaluation of adverse events, summarized by seriousness, severity, and relatedness.
|
| Follow-up Visits and Length of Follow-up |
Follow-up is planned for five years from the date of implant procedure
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
190
|
| Actual Number of Sites Enrolled |
22
|
| Patient Follow-up Rate |
The present report is based on the final study data export, performed on April 27, 2023. A total of 93 subjects in the Zephyr EBV group
and 33 subjects in the Crossover group had completed their 2-year follow-up; 79 subjects in the Zephyr EBV group and 25 subjects in
the Crossover group had completed their 3-year follow-up; 56 subjects in the Zephyr EBV group and 16 subjects in the Crossover
group had completed their 4-year follow-up; 52 subjects in the Zephyr EBV group and 15 subjects
|
| Final Safety Findings |
In the Zephyr EBV group, the most frequently occurring respiratory
AEs continue to be COPD exacerbations across Years 2, 3, 4 and 5,
followed by pneumonia in 5.5% to 11.5% of subjects, and
respiratory failure in 1.8% to 11.5% of subjects across Years 2, 3, 4,
and 5.
The nature and frequency of respiratory adverse events during posttreatment
Year 4 and 5 do not suggest any unique pattern for study
subjects and are anticipated in this population. There have been no
unanticipated adverse events to date.
|
| Final Effect Findings |
The improvement in lung function as assessed by FEV1 that was
observed at 4-year post-procedure after treatment with the Zephyr
EBV is similar at 5-years. The change from Baseline to 4-years postprocedure
in FEV1 is an increase of 17.67% with 36.4% of the
subjects achieving an improvement of equal to or greater than 15%.
Improvement in FEV1 is similar in subjects at 5-year post-procedure
with an increase of 13.45% from baseline with 30% of subjects
achieving an improvement of equal to or greater than 15%.
|
| Study Strengths & Weaknesses |
Strengths: Multicenter and international study allowed accrual of
diverse patient population.
Weaknesses: The absolute change in FEV1 in the EBV cohort did
not meet the MCID for FEV1 change in years 2,3, and 5 after
treatment. The primary study endpoint of FEV1 % change was not
met in years 2, 3, and 5 after treatment. And the crossover subjects
did not meet the MCID for Absolute Change in FEV1 or the Primary
Endpoint of FEV1 Percent Change in any of the years after
treatment.
|
| Recommendations for Labeling Changes |
Include the following items: study design and protocol; table of
“Post-Bronchodilator FEV1: Changes from Baseline to Follow-up
for EBV Group (Completed Cases)” from the PAS final report; a
statement that the absolute change in FEV1 in the EBV cohort did
not meet the MCID for FEV1 change in years 2,3, and 5 after
treatment; A statement that the Primary Study Endpoint of FEV1
percent change was not met in years 2, 3, and 5; and a statement that
the crossover subjects did not meet the MCID for Absolute Change
in FEV1 or the Primary Endpoint of FEV1 Percent Change in any of
the years after treatment
|
