INSPIRE Continuation Post-Approval Study
OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS
1 other identifier
observational
220
9 countries
17
Brief Summary
To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Typical duration for all trials
17 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
March 7, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedStudy Start
First participant enrolled
June 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2021
CompletedApril 7, 2022
November 1, 2021
2.3 years
March 7, 2019
April 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Brochiolitis Obliterans Syndrome (BOS) -free survival
BOS-free survival
5 years post transplant
Secondary Outcomes (2)
Survival
5 years
Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's)
5 years
Study Arms (1)
OCS Lung INSPIRE Trial
Interventions
No active interventions are part of this study. This study will collect long-term survival and BOS data in subjects who were part of the INSPIRE trial.
Eligibility Criteria
Patients who participated in TransMedics OCS Lung System INSPIRE Trial
You may qualify if:
- Participant in TransMedics OCS Lung System INSPIRE trial
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TransMedicslead
Study Sites (17)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
University of California at San Francisco
San Francisco, California, 94143, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
University of Leuven Hospital
Leuven, 3000, Belgium
University of Alberta
Edmonton, Alberta, T6G 2C8, Canada
N.H.C Hospital Civil
Strasbourg, 67091, France
German Heart Institute Berlin
Berlin, D-13353, Germany
Hannover Medical School
Hanover, D-300625, Germany
University of Padua
Padua, 35128, Italy
Hospital Universitario Puerta De Hierro
Madrid, 25222, Spain
Papworth Hospital
Cambridge, CB23 3RE, United Kingdom
Harefield Hospital
Middlesex, UB9 6JH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2019
First Posted
March 11, 2019
Study Start
June 30, 2019
Primary Completion
October 12, 2021
Study Completion
October 12, 2021
Last Updated
April 7, 2022
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share