STRIVE Post-Market Registry Study
The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema
1 other identifier
observational
150
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedStudy Start
First participant enrolled
October 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
April 24, 2026
April 1, 2026
5.1 years
February 24, 2020
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
12 months
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.
36 months
Secondary Outcomes (2)
45-day pneumothorax rate
45 days
Survival rate over 24 months
24 months
Other Outcomes (8)
Targeted lobe volume reduction (TLVR)
6 months
Hyperinflation
6 and 12 months
Forced expiratory volume in 1 second (FEV1)
6, 12, 24 and 36 months
- +5 more other outcomes
Interventions
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 severe emphysema without surgery.
Eligibility Criteria
Adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
El Camino, Taft Center for Clinical Research
Mountain View, California, 94040, United States
University of Miami
Coral Gables, Florida, 33146, United States
Northwestern University, Division of Pulmonary and Critical Care Medicine
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
LSU Health Shreveport
Shreveport, Louisiana, 71130, United States
Beth Israel Decaconess
Boston, Massachusetts, 02215, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39501, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75204, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerard Criner, MD
Temple University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2020
First Posted
March 10, 2020
Study Start
October 9, 2021
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
October 1, 2029
Last Updated
April 24, 2026
Record last verified: 2026-04