STRIVE Post-Market Registry Study
Start Date
10/9/2021
Completion Date
10/1/2029
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.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Spiration Valve System (SVS)
Conditions
Locations
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