|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P180007 / PAS002 |
| Date Original Protocol Accepted |
05/21/2019
|
| Date Current Protocol Accepted |
09/22/2023
|
| Study Name |
SVS [STRIVE] Post-Market Registry Study
|
| Device Name |
Spiration® Valve System
|
| Clinical Trial Number(s) |
NCT01812447
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the PAS registry study registry is to collect safety and effectiveness data in a post-approva1 setting for the Spiration Valve System (SVS). The SVS will be used as intended and in accordance with FDA-approved labeling.
This post-market study is a single-arm, prospective, multi center Registry. It is designed to assess 36-month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of Spiration Valve System therapy for the treatment of severe emphysema in the United States.
|
| Study Population |
The population will be comprised of subjects with severe emphysema and evidence of low collateral ventilation, such as fissure integrity.
|
| Sample Size |
150 subjects at a minimum of 10 sites and up to 40 sites.
|
| Key Study Endpoints |
Primary Safety:
Incidence of pre specified thoracic adverse events of special interest {TAEsSI) through 12 months following the first implantation procedure, including but not limited to acute asthma or bronchospasm; acute exacerbation of COPD, airway injury from valve placement, valve migration, or airway stenosis from a valve, hemoptysis, pneumonia, pneumothorax, and respiratory failure that requires mechanical intervention.
Secondary Safety:
(a) 45-day pneumothorax rate.
(b) Survival rate over 24 months compared to the EMPROVE study control cohort
|
| Follow-up Visits and Length of Follow-up |
All enrolled Subjects who undergo the SVS procedure will be monitored for outcome data from baseline through 3 years post-first implant.
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
As only 99/150 (66%) subjects have been enrolled to date and only 41 have reached 12-month safety timepoint, no conclusions can be drawn about device safety.
Effectiveness Results
As only 99/150 (66%) subjects have been enrolled to date and only 2 have reached 36-month effectiveness timepoint, no conclusions can be drawn about device effectiveness.
|
| Actual Number of Patients Enrolled |
99
|
| Actual Number of Sites Enrolled |
16
|
| Patient Follow-up Rate |
99% (30/99 (40%) of subjects were withdrawn post-procedure.
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