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This is a prospective, multicenter randomized trial of lung transplant recipients transplanted with either a DBD or DCD donor lungs. The DENOVO Trial will enroll a total of 300 patients in the OCS arm and 150 patients in the SCS arm. The primary endpoint will be patient & graft survival and freedom of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS Lung | Experimental |
| |
| Static Cold Storage | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCS Lung System | Device | Donor lungs preserved on OCS Lung System |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day patient and graft survival with freedom from PGD3 | The primary endpoint is 30-day patient and graft survival with freedom from PGD 3 within the initial 72-hours (T0-T72). | 30-days post-transplant |
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Donor Inclusion/Exclusion Criteria
Inclusion Criteria:
Exclusion Criteria:
- Severe traumatic donor lung injury with air and/or blood leak (as seen on radiological studies, bronchial examinations or final visual physical assessment in donor's chest or back table).
Recipient Inclusion/Exclusion:
Inclusion Criteria:
Exclusion:
- Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia Church | Contact | 978-289-3546 | jdeane@transmedics.com | |
| Kelly Jork | Contact | 978-494-3918 | kjork@transmedics.com |
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| Static Cold Storage |
| Other |
Donor Lungs preserved on Static Cold Storage |
|