OCS Lung System EXPAND II Trial

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

Detailed Description
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Inclusion At least one of the following: Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or Expected cross-clamp time > 6 hours for the second lung; or Donor after Cardiac Death (DCD donor); or Donor age ≥ 55 years old

Official Title
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Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation

Conditions
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Lung Transplantation

Intervention / Treatment
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* Device: OCS Lung Preservation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female primary double lung transplant candidate Age ≥ 18 years old Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information Exclusion Criteria: Prior solid organ or bone marrow transplant Single lung recipient Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis Participant in any other clinical or investigational trials/programs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: OCS Lung System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCS<br>OCS Lung Preservation | Device: OCS Lung Preservation<br>* OCS Lung Preservation<br>* Other names: OCS Lung Transplant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Survival | Patient survival at Day-30 post-transplantation and at initial hospital discharge post-transplantation, whichever occurs later. | 30 days post transplantation | 
| Donor Lung Utilization Rate | Donor lung utilization rate, defined as the number of donated lungs instrumented on OCS™ that meet inclusion/exclusion criteria for the trial and acceptance criteria for transplantation after OCS™ Lung assessment divided by the total eligible donor lungs instrumented on the OCS™ Lung System. | Immediately at Transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Graft Dysfunction Grade 3 | Incidence of Primary Graft Dysfunction Grade 3 on post-operative day 3 | within 72 hours pos-transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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portable ex-vivo lung perfusion, breathing lung transplant, portable OCS Lung System