OCS™ Lung TOP Registry For Donor Lungs for Transplantation

Study Overview
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Brief Summary
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Single-arm, prospective, multi-center, post-approval U.S. registry

Detailed Description
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This is an all-comers registry that will enroll: Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and 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 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 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 266 eligible DLIDU Primary Analysis Population recipients have been enrolled.

Official Title
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The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation

Conditions
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Lung Transplantation

Intervention / Treatment
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* Device: OCS Lung System


Participation Criteria
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Eligibility Criteria
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This is an all-comers registry that will enroll all: Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and 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 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard Donor Lungs Primary Analysis Population<br>Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System. | Device: OCS Lung System<br>* 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: Reducing ischemic injury through the use of warm, oxygenated blood based perfusion. Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients. Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant.<br>|
| Donor Lungs Initially Unacceptable Primary Analysis Pop.<br>Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System. | Device: OCS Lung System<br>* 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: Reducing ischemic injury through the use of warm, oxygenated blood based perfusion. Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients. Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant.<br>|
| All Other Enrolled Patients<br>All OCS Lung transplanted patients that do not meet any of the above analysis populations. | Device: OCS Lung System<br>* 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: Reducing ischemic injury through the use of warm, oxygenated blood based perfusion. Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients. Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month patient and graft survival post double-lung transplant | Primary Effectiveness Endpoint | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs | Lung ischemic time | 2 hours | 
| Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours) | Primary Graft Dysfunction | 0, 24, 48 and 72 hours | 
| Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation | Primary Graft Dysfunction | 72 hours | 
| Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate | Utilization Rate | 1 hour | 
| Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation | Primary Graft Dysfunction | Within 72 hours post-transplantation |