|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P160013 S002/ PAS002 |
| Date Original Protocol Accepted |
05/31/2019
|
| Date Current Protocol Accepted |
06/28/2023
|
| Study Name |
OCS-LUNG-PAS
|
| Device Name |
Organ Care System (OCS™) Lung System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a single-arm, prospective, multi-center post-approval U.S. registry study on double lung transplant recipients whose donor lungs were
preserved on the OCS™ Lung System. This all-comers registry is designed to evaluate short- and long-term safety and effectiveness of the OCS™
Lung System for lung transplantation in a real-world setting.
|
| Study Population |
This is a single-arm study on double lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System.
|
| Sample Size |
Enrollment of the SCDL Primary Analysis Population will continue until 266 eligible DLIDU Primary Analysis Population Recipients have been enrolled.
|
| Key Study Endpoints |
The primary effectiveness endpoint is 12-month patient and graft survival post double-lung transplant.
Secondary effectiveness endpoints include:
Standard Criteria Donor Lungs:
¿ Total ischemic time for OCS™-preserved lungs
¿ Incidence of Primary Graft Dysfunction (PGD) grade 3 within the
initial 72 hours post-transplantation (T0, T24, T48, and T72 hours)
Donor Lungs Initially Deemed Unacceptable for Procurement and
Transplantation:
¿ Incidence of PGD grade 3 at T72 hours post-transplantation
¿ Donor lung utilization rate
¿ Incidence of PGD grade 3 within the initial 72 hours post transplantation
Other Endpoints:
For Both SCDLU and DLIDU:
¿ Number of lung graft-related serious adverse events (SAEs)
through 30 days post-transplant or through initial transplant
surgical admission if longer than 30 days, per subject, consisting of
the following SAEs (at most one per type):
¿ Bronchial anastomotic complications
¿ Major pulmonary-related infection
¿ Survival incidence (simple proportion) at 30 days
¿ Survival incidence (simple proportion) at initial transplant surgery
hospital discharge, if longer than 30 days
¿ Incidence of PGD3 at T72 hours
Total ischemia and cross-clamp times for 1st and 2nd transplanted
lungs
¿ Kaplan-Meier patient survival estimated at Month 1, 6, 12, 24, 36, 48 and 60
¿ Kaplan-Meier BOS-free survival estimated at Month 12, 24, 36, 48 and 60
¿ Kaplan-Meier Freedom from BOS and grading estimated at Month 12, 24, 36, 48 and 60
¿ Kaplan-Meier graft survival (freedom from re-transplantation/graft failure) estimated at Month 12, 24, 36, 48 and 60
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Total of 235 subjects including 65 SCDL-PAP and 117 DLIDU-PAP
|
| Actual Number of Sites Enrolled |
18
|
| Patient Follow-up Rate |
78% (173 of 223 CEC-adjudicated subjects)
|
