STRIVE Post-Market Registry Study
ConditionEmphysema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOlympus Corporation of the Americas
About this trial
This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
Subjects must understand and voluntarily sign an informed consent form.
Disqualifiers
Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
Subjects who have incomplete screening or baseline data.
Trial population
Adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Spiration Valve System (SVS)
DeviceSpiration Valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation. The Spiration Valve is loaded in the deployment catheter, then passed through the channel of a flexible bronchoscope and deployed at the intended target location. The SVS device is designed to relieve the symptoms of shortness of breath and hyperinflation associated with severe emphysema without surgery.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure
The primary safety endpoint will be the incidence of device-related and procedure-related pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure.
Time frame
12 months2
Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure
An additional analysis will present the rate (per patient-year) of TAEsSI.
Time frame
36 monthsSecondary outcomes
1
45-day pneumothorax rate
45-day pneumothorax rate, defined as pneumothorax requiring surgical intervention, or prolonged air leak \> 7 days defined as the time from chest tube insertion to the time the air leak is not present.
Time frame
45 days2
Survival rate over 24 months
Survival rate over 24 months compared to the EMPROVE study control cohort
Time frame
24 monthsOther outcomes
1
Targeted lobe volume reduction (TLVR)
Target lobe volume reduction (TLVR) determined from quantitative High-Resolution Computed Tomography (HRCT) at 6 months
Time frame
6 months2
Hyperinflation
It will be measured by the ratio of residual volume to total lung capacity (RV/TLC) using plethysmography from baseline
Time frame
6 and 12 months3
Forced expiratory volume in 1 second (FEV1)
Relative (percentage) change from baseline at 6, 12, 24 and 36 months
Time frame
6, 12, 24 and 36 months4
Modified Medical Research Council (mMRC) change
Modified Medical Research Council (mMRC) change from baseline at 6, 12, 24 and 36 months
Time frame
6, 12, 24 and 36 monthsSponsors and contacts
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Source ClinicalTrials.gov