|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160013 / PAS001 |
| Study Name |
INSPIRE Continuation PAS
|
| Device Name |
Organ Care System (OCS™) Lung System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
External Registry
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Two-arm observational study – continued follow-up of subjects enrolled in the INSPIRE trial
|
| Study Population |
All U.S. patients enrolled in the INSPIRE trial in the UNOS database and all OUS patients in INSPIRE who consent to participation
|
| Sample Size |
A total of 349 patients were enrolled in the INSPIRE trial (mITT population). The sponsor has committed to aproaching all these patients to participate in the study and give Informed Consent. Additionally, the UNOS database will be queried to obtain endpoint data on all US INSPIRE patients in an anonymized fashion by arm.
|
| Key Study Endpoints |
BOS-free survival (freedom from BOS and mortality) through 5 years post-transplantation
|
| Follow-up Visits and Length of Follow-up |
Subjects will be followed for 5 years post-transplant. Interim post-approval reports will be submitted at 6, 12, 18, 24, and 36 months after PMA approval.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
349 patients from the INSPIRE randomized trial
|
| Actual Number of Sites Enrolled |
17 sites
|
| Patient Follow-up Rate |
5-year follow-up rate: 99% (218/221)
|
| Final Safety Findings |
There were 118 deaths and 14 re-transplantation over 5 years post initial lung transplant
|
| Final Effect Findings |
5-year BOS-free survival (BOS grade 1, 2, 3, or ungradeable) was similar in the OCS and SOC treatment arms (PP population: 53% OCS vs. 49% SOC, p-value=0.50; mITT population: 52% OCS vs. 49% SOC, p-value=0.57).
5-year patient survival was similar in the OCS and SOC treatment arms (PP population: 68% OCS vs. 65% SOC, p-value=0.84; mITT population: 67% OCS vs. 64% SOC, p-value=0.98).
5-year freedom from BOS (grade 1, 2, 3, or ungradeable) was similar in the OCS and SOC treatment arms (PP population: 67% OCS vs. 65% SOC, p-value=0.49; mITT population: 68% OCS vs. 65% SOC, p-value=0.35).
|
| Study Strengths & Weaknesses |
Despite the acceptable number of patients and sites for a clinical study of this type and a high 5-year follow-up rate of 99%, it is concerning that the majority of participants were treated at a small number of sites. Of the 221 PAS patients, 124 patients (56%) were treated at 3 sites [Hanover (n=52); UCLA (n=47); and Leuven (n=25)]. This raises the concern that results of the overall trial may be driven by finding at these particular sites, thus limiting the generalizeability of the study findings to lung transplant patients at large. The PAS results need to be replicated in larger studies using real world evidence.
|
| Recommendations for Labeling Changes |
Yes
|
