STRIVE Post-Market Registry Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spiration Valve System (SVS).
- Who it may be relevant to
- Registry conditions: Emphysema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema
Overview
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.
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.
Interventions
- Device Spiration Valve System (SVS)
Spiration 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
Primary outcome measures
- Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure [Time frame: 12 months]
- Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure [Time frame: 36 months]
Secondary outcome measures (2)
- 45-day pneumothorax rate [Time frame: 45 days]
- Survival rate over 24 months [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 16 centers
- Dignity Health St. Joseph's Hospital and Medical Center — Phoenix
- El Camino, Taft Center for Clinical Research — Mountain View
- University of Miami — Coral Gables
- Northwestern University, Division of Pulmonary and Critical Care Medicine — Chicago
- University of Chicago — Chicago
- LSU Health Shreveport — Shreveport
- University of Maryland — Baltimore
- Beth Israel Decaconess — Boston
- … and 8 more centers
Identifiers
NCT: NCT04302272 · CPR-05644