|
General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P160013 / PAS002 |
Date Original Protocol Accepted |
06/18/2018
|
Date Current Protocol Accepted |
06/28/2023
|
Study Name |
TOP PAS Registry
|
Device Name |
Organ Care System (OCS™) Lung System
|
Clinical Trial Number(s) |
NCT01630434
|
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 |
Primary Safety Endpoint 12-month patient and graft survival post double-lung transplant
Secondary Safety Endpoints 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 |
As of August 23, 2024, 458 subjects have been enrolled and transplanted in the TOP Registry. Eighty-seven (87) SCDL patients and 272 DLIDU patients have been enrolled and adjudicated by CEC. Enrollment is now complete and has been closed.
|
Actual Number of Sites Enrolled |
20
|