Brief Summary
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.
Brief Title
STRIVE Post-Market Registry Study
Detailed Description
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.
Subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant.
Subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
(661) 645-1007
Central Contact Email
isabel.arcos@olympus.com
Completion Date
Completion Date Type
Estimated
Conditions
Emphysema
Eligibility Criteria
Inclusion Criteria:
1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
2. Subjects must understand and voluntarily sign an informed consent form.
Exclusion Criteria:
1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
3. Subjects who have incomplete screening or baseline data.
1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
2. Subjects must understand and voluntarily sign an informed consent form.
Exclusion Criteria:
1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
3. Subjects who have incomplete screening or baseline data.
Inclusion Criteria
Inclusion Criteria:
1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
2. Subjects must understand and voluntarily sign an informed consent form.
1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
2. Subjects must understand and voluntarily sign an informed consent form.
Gender
All
Gender Based
false
Keywords
Emphysema
Chronic obstructive pulmonary disease (COPD)
Spiration valve system
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04302272
Org Class
Industry
Org Full Name
Olympus Corporation of the Americas
Org Study Id
17
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema
Primary Outcomes
Outcome Description
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.
Outcome Measure
Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure
Outcome Time Frame
12 months
Outcome Description
An additional analysis will present the rate (per patient-year) of TAEsSI.
Outcome Measure
Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure
Outcome Time Frame
36 months
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
45 days
Outcome Measure
45-day pneumothorax rate
Outcome Description
Survival rate over 24 months compared to the EMPROVE study control cohort
Outcome Time Frame
24 months
Outcome Measure
Survival rate over 24 months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study 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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ali Sadoughi
Investigator Email
asadough@montefiore.org
Investigator Phone
718-920-5965