f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Progress Inadequate
Application Number /
Requirement Number
P160013 S002/ PAS002
Date Original Protocol Accepted 05/31/2019
Date Current Protocol Accepted  
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. PAS data will be collected in the TOP Registry, which is an all-comers
registry that includes all U.S. patients who are transplanted with OCSpreserved lungs and all donor lungs that were perfused on the OCS
system (including organ turndowns and conversion to cold storage). Enrolled patients will fall into one of the following categories:
Primary Analysis Population (PAP) will be comprised of the first 266 patients transplanted with OCS-preserved donor lungs initially
deemed unacceptable (DLIDU) who meet the eligibility criteria according to the approved indication for use (IFU)
“All Other Enrolled Patients” will be comprised of patients transplanted with OCS-preserved DLIDU that do not meet the
eligibility criteria according to the approved IFU
The full PAS cohort will be comprised of the PAP and All Other Enrolled Patients.
Patient enrollment in the TOP Registry for DLIDU will continue until 266 PAP for OCS-preserved DLIDU have been completed.
Sample Size This study tests the hypothesis that 12-month patient and graft survival following transplantation with OCS-preserved DLIDU is greater than a
performance goal of 78%, which is based on the OPTN estimate of 85% and a margin of 7% (i.e., 85% - 7% = 78%). A sample size of
266 subjects provides approximately 80% power (with a one-sided alpha level of 0.025) based on the exact method for a single binomial
Key Study Endpoints The primary effectiveness endpoint is 12-month patient and graft survival post double-lung transplant.
Secondary effectiveness endpoints include:
Incidence of PGD grade 3 at T72 hours post-transplantation
Donor lung utilization rate
Incidence of PGD grade 3 within the initial 72 hours posttransplantation
Other study endpoints include:
Number of lung graft-related serious adverse events through the
30 days post-transplant or initial hospital stay (whichever is
longer) consisting of the following SAEs (at most one per type):
o Bronchial anastomotic complications
o 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 for standard criteria donor lungs
Total ischemia and cross-clamp times for 1st and 2nd transplanted lungs
Kaplan-Meier survival estimated at Month 1, 6, 12, 24, 36, 48 and 60
Survival incidence (simple proportion) at Month 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 estimated at Month 12, 24, 36, 48 and 60
Incidence of BOS at Month 12, 24, 36, 48 and 60 (BOS grading will be collected)
Incidence of re-transplantation (graft failure) at Month 12, 24, 36, 48 and 60
Kaplan-Meier transplantation-free survival estimated at Month 12, 24, 36, 48 and 60
In addition, the following OCS Lung System related data will be collected:
OCS™ Lung System preservation and ventilation parameters trends
for all transplanted lungs
Pulmonary artery pressure
o Peak airway pressure
o Vascular resistance
Lung oxygenation capacity - Final PaO2/FiO2 value on OCS System
Incidence of device malfunction during organ preservation of a
donor lung instrumented on OCS System and resulted in the donor
lungs not being used for transplantation (organ loss) or that
resulted in organs being converted to cold storage
• Incidence of and clinical reasons for donor lungs turn-down for
transplantation after OCS preservation
• Incidence of and clinical reasons for donor lungs converted to cold
storage following OCS instrumentation
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)

OCS-LUNG-PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 11/29/2019 11/26/2019 On Time
one year report 06/20/2020 05/22/2020 On Time
18 month report 09/21/2020 09/18/2020 On Time
two year report 03/21/2021 03/18/2021 On Time
30 month report 09/21/2021 09/20/2021 On Time
3 year report 03/21/2022 03/14/2022 On Time
42 month report 09/21/2022 09/15/2022 On Time
4 year report 03/21/2023    
5 year report 03/21/2024    
6 year report 03/21/2025    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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