INSPIRE Continuation Post-Approval Study
- Conditions
- Bronchiolitis Obliterans
- Interventions
- Device: OCS Lung System
- Registration Number
- NCT03868904
- Lead Sponsor
- TransMedics
- Brief Summary
To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- Participant in TransMedics OCS Lung System INSPIRE trial
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description OCS Lung INSPIRE Trial OCS Lung System -
- Primary Outcome Measures
Name Time Method Brochiolitis Obliterans Syndrome (BOS) -free survival 5 years post transplant BOS-free survival
- Secondary Outcome Measures
Name Time Method Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's) 5 years Freedom from BOS
Survival 5 years Survival post transplant
Trial Locations
- Locations (17)
St. Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
University of Leuven Hospital
🇧🇪Leuven, Belgium
N.H.C Hospital Civil
🇫🇷Strasbourg, France
Papworth Hospital
🇬🇧Cambridge, United Kingdom
Hannover Medical School
🇩🇪Hannover, Germany
Hospital Universitario Puerta De Hierro
🇪🇸Madrid, Spain
German Heart Institute Berlin
🇩🇪Berlin, Germany
University of Padua
🇮🇹Padua, Italy
Harefield Hospital
🇬🇧Middlesex, United Kingdom
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada