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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P180007 / PAS001 |
| Date Original Protocol Accepted |
03/01/2019
|
| Date Current Protocol Accepted |
09/01/2021
|
| Study Name |
EMPROVE Extension Study
|
| Device Name |
Spiration® Valve System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study is designed as continued, prospective, long-term follow up of the EMPROVE pre-market cohorts. The objective is to evaluate the long-term safety and effectiveness of the Spiration Valve System for the treatment of severe emphysema. This will be an observational study for long-term follow-up of the EMPROVE Trial pre-market patient cohort with no planned interventions
|
| Study Population |
All active (enrolled and not withdrawn) subjects continuing long-term (beyond 1 year) follow-up in protocol CPR-03434.
|
| Key Study Endpoints |
Primary Safety:
All serious adverse events and non-serious adverse events related to the device or procedure will be assessed at annual follow-up visits by seriousness, severity, and relatedness.
Effectiveness Observations:
The following effectiveness assessments will be undertaken at annual follow-up visits:
Spirometry
St. George’s Respiratory Questionnaire (SGRQ)
SF-36
COPD Assessment Test (CAT)
Modified Medical Research Council dyspnea scale (mMRC)
Quality of Well Being (QWB) questionnaire
|
| Follow-up Visits and Length of Follow-up |
Control group subjects will be followed annually through 2 years.
Treatment group subjects will be followed annually through 5 years.
a1 antitrypsin deficiency subjects (a separate non-randomized treatment cohort) will be followed annually through 5 years.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
172
|
| Actual Number of Sites Enrolled |
31
|
| Patient Follow-up Rate |
99% for treatment arm at 5 years. 85% for control arm at 2 years.
|
| Final Safety Findings |
Composite safety endpoint: Treatment group = 12.5% at 5 years; Control group = 20% at 2 years.
|
| Final Effect Findings |
Primary endpoint = FEV1 improvement 0.098 liters at 6 months in comparison with the control group. At 2 years the FEV1: Improvement between Treatment and Control groups = 0.085 liters on average (95% BCI: 0.016 – 0.153), with a posterior probability of superiority > 0.9923. At 5 years the FEV1: Improvement is 0.049 liters (0.049 -/+ 0.247).
|
| Study Strengths & Weaknesses |
The sponsor has conducted a randomized controlled multi-center trial with 5-year follow up for treatment arm, but only 2-year follow up for control arm, following the approved protocol. In addition, control subjects were not blinded and were immediately aware of their assignment to the control group upon randomization, and therefore suffered a 15% drop-out rate.
|
| Recommendations for Labeling Changes |
There are no new or unexpected findings in or conclusions drawn from this Final Report which would suggest that a labeling update is necessary.
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