|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P180002 / PAS002 |
| Date Original Protocol Accepted |
05/03/2019
|
| Date Current Protocol Accepted |
03/25/2023
|
| Study Name |
ZEVR-Zephyr Valve Registry
|
| Device Name |
Zephyr Endobronchial Valve System
|
| Clinical Trial Number(s) |
NCT00129584 NCT01580215 NCT01796392 NCT02022683 NCT02025205
|
| 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 |
Prospective Cohort Study: Multi-center, single-arm, prospective Registry to be conducted at up to 15 clinical sites. Approximately 150 patients with severe emphysema undergoing Zephyr Valve treatment will be enrolled and followed out to 3 years. Assessments will be performed at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure. The Zephyr Valve Registry will be conducted at a minimum of 5, and a maximum of 10 clinical sites. Enrollment is anticipated to be completed over 24 months. A minimum of 20 subjects treated with at least one Zephyr 5.5-LP EBV will be enrolled.
|
| Study Population |
Adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. Concurrent control comparison group.
|
| Sample Size |
150
|
| Key Study Endpoints |
Safety endpoints:
Incidence rate of Pneumothorax at 45-days post-procedure.
Incidence rate of device/procedure related Serious Adverse Events (SAE) including but not limited to COPD exacerbations, pneumonia, hemoptysis, valve expectoration, valve migration and respiratory failure.
Effectiveness endpoints:
Treated Lobar Volume Reduction (TLVR) assessed by HRCT at 45-days.
Forced Expiratory Volume in 1 second (FEV1) at 6-months, 12-months, 24-months and 36-months.
6MWD at 6-months and 12-months.
SGRQ at 6-months and 12-months.
BODE Index at 6-months and 12-months.
Percent of patients with a TLVR of =350mL10,11.
Percent of patients with a TLVR of =563mL12.
Responder rates reported as percent of patients meeting the Minimal Clinically Important Difference (MCID) for each variable at 6-months and 12-months.
- MCID for FEV1: Increase of 10% (Liters)
- MCID for 6MWD: Increase of +25 meters
- MCID for SGRQ: Decrease of 4 points
|
| Follow-up Visits and Length of Follow-up |
36 months
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results: Pneumothorax adverse event rate: 38.9%
Effectiveness Results: The mean reduction in TLV at 45 days was 1161.9 mL and at 12-months was 1166.8 mL representing a percent reduction of 63.40% and 64.96%, respectively.
|
| Actual Number of Patients Enrolled |
162
|
| Actual Number of Sites Enrolled |
12
|
| Patient Follow-up Rate |
1-year post-procedure follow up: 66.7%
|
