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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P180007 / PAS002 |
| Date Original Protocol Accepted |
05/21/2019
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| Date Current Protocol Accepted |
09/22/2023
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| Study Name |
SVS [STRIVE] Post-Market Registry Study
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| Device Name |
Spiration® Valve System
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| Clinical Trial Number(s) |
NCT01812447
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| 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.
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| Study Population |
The population will be comprised of subjects with severe emphysema and evidence of low collateral ventilation, such as fissure integrity.
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| Sample Size |
150 subjects at a minimum of 10 sites and up to 40 sites.
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| 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
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| 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.
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| Interim or Final Data Summary |
| Interim Results |
Safety Results
As only 38/150 (25%) subjects have been enrolled to date, no clinical conclusions can be drawn about device safety or effectiveness.
Effectiveness Results
As only 38/150 (25%) subjects have been enrolled to date, no clinical conclusions can be drawn about device safety or effectiveness.
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| Actual Number of Patients Enrolled |
38
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| Actual Number of Sites Enrolled |
13
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| Patient Follow-up Rate |
87%
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| Study Strengths & Weaknesses |
1.) This is a registry study and is thus subject to the limitations identified by Levine and Julian: patients are not randomly allocated to the intervention for registries, patients follow-up is more active and standardized for randomized trials, missing or incomplete data may represent a greater source of bias for registries, and the registry enrollment is less supervised compared with randomized trials. (Levine MN, Julian JA. Registries that show efficacy: good, but not good enough. J Clin Oncol. 2008;26:5316–5319.)
2.) Registry study strengths include: Extrapolation possible because of the representativeness of the sample cohort - Non-biased in terms of independence, if validated (contrary to claims data) - Real world representation: no artificial population - Covering treatment reality (real world data); population based collection possible - Suitable for quality improvement matters - Collection of large set of data; detectability of rare events or risk - Non-homogeneous patient population and variation in treatment considered (European Journal of Vascular and Endovascular Surgery)
3.) This study is “designed to assess 36-month safety and effectiveness” of the subject device. With only 25% enrollment to date and limited follow-up timepoints, the data provided for this study is not mature enough to draw conclusions.
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