OCS™ Lung TOP Registry For Donor Lungs for Transplantation (TOP)
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ClinicalTrials.gov Identifier: NCT03639025 |
Recruitment Status :
Recruiting
First Posted : August 20, 2018
Last Update Posted : November 8, 2022
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Condition or disease | Intervention/treatment |
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Lung Transplantation | Device: OCS Lung System |
This is an all-comers registry that will enroll:
- Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
- Consented patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
- All donor lungs that were perfused on OCS Lung System.
Enrolled patients will fall into one of the following three possible analysis categories:
- TOP SCDL PAS Primary Analysis Population: will be comprised of the first 289 eligible/PAS consented recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- TOP DLIDU Primary Analysis Population: Will be comprised of the first 266 eligible/PAS consented recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.
Patient enrollment in the TOP Registry will continue until both the 289 Primary Analysis Population for OCS-preserved standard criteria donor lungs and 266 Primary Analysis Population for OCS-preserved donor lungs initially deemed unacceptable have been completed.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 555 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 5 Years |
Official Title: | The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation |
Actual Study Start Date : | December 10, 2018 |
Estimated Primary Completion Date : | October 2023 |
Estimated Study Completion Date : | October 2028 |

Group/Cohort | Intervention/treatment |
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Standard Donor Lungs Primary Analysis Population
The first 289 eligible/PAS consented recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
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Device: OCS Lung System
The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions:
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Initially Unacceptable Donor Lung Primary Analysis Pop.
The first 266 eligible/PAS consented recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
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Device: OCS Lung System
The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions:
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All Other Enrolled Patients
All OCS Lung transplanted patients that do not meet any of the above analysis populations.
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Device: OCS Lung System
The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions:
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- 12-month patient and graft survival post double-lung transplant [ Time Frame: 12 months ]Primary Effectiveness Endpoint
- Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs [ Time Frame: 2 hours ]Lung ischemic time
- Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours) [ Time Frame: 0, 24, 48 and 72 hours ]Primary Graft Dysfunction
- Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation [ Time Frame: 72 hours ]Primary Graft Dysfunction
- Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate [ Time Frame: 1 hour ]Utilization Rate
- Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation [ Time Frame: Within 72 hours post-transplantation ]Primary Graft Dysfunction
- Standard Criteria Lungs - Incidence of PGD3 at T72 hours [ Time Frame: 72 hours ]Primary Graft Dysfunction
- Total ischemia and cross-clamp times for 1st and 2nd transplanted lungs [ Time Frame: 2 hours ]Ischemic and cross-clamp times
- Kaplan-Meier survival estimated at Month 1, 6, 12, 24, 36, 48 and 60 [ Time Frame: 1,6,12,24,36,48,60 months ]Survival evaluation (K-M)
- Survival incidence at Month 6, 12, 24, 36, 48 and 60 [ Time Frame: 6,12,24,36,48,60 months ]Survival incidence (simple proportion)
- Kaplan-Meier BOS-free survival estimated at Month 12, 24, 36, 48 and 60 [ Time Frame: 12,24,36,48,60 months ]BOS free survival (K-M)
- Kaplan-Meier Freedom from BOS estimated at Month 12, 24, 36, 48 and 60 [ Time Frame: 12,24,36,48,60 months ]Freedom from BOS (K-M)
- Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 12, 24, 36, 48 and 60 [ Time Frame: 12,24,36,48,60 months ]BOS Incidence (simple proportion)
- Incidence of re-transplantation (graft failure) at Month 12, 24, 36, 48 and 60 [ Time Frame: 12,24,36,48,60 months ]Graft failure
- Kaplan-Meier transplantation-free survival estimated at Month 12, 24, 36, 48 and 60 [ Time Frame: 12,24,36,48,60 months ]Graft failure
- Lung graft-related SAEs through 30 days post-transplant or discharge - Bronchial anastomotic complications; Major pulmonary-related infection [ Time Frame: 30 days or hospital discharge (whichever is longer) ]Safety Endpoint
- Survival incidence at 30 days [ Time Frame: 30 days ]Safety Endpoint
- Survival incidence at initial transplant surgery hospital discharge, if longer than 30 days. [ Time Frame: 30 days or hospital discharge (whichever is longer) ]Safety Endpoint

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
This is an all-comers registry that will enroll all:
- Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
- Consented patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
- All donor lungs that were perfused on OCS Lung System.
Enrolled patients will fall into one of the following three possible analysis categories:
- TOP SCDL PAS Primary Analysis Population: will be comprised of the first 289 eligible/PAS consented recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- TOP DLIDU Primary Analysis Population: Will be comprised of the first 266 eligible/PAS consented recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639025
Contact: Julia Deane | 9782893546 | jdeane@transmedics.com | |
Contact: Kausar Qidwai | 9785220984 | kqidwai@transmedics.com |

Responsible Party: | TransMedics |
ClinicalTrials.gov Identifier: | NCT03639025 |
Other Study ID Numbers: |
OCS-LUN-PAS01 |
First Posted: | August 20, 2018 Key Record Dates |
Last Update Posted: | November 8, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |