OCS™ Lung TOP Registry For Donor Lungs for Transplantation

NCT03639025 | Active Not Recruiting DMC FDA Device

• 1 other identifier: OCS-LUN-PAS01
• Study Type: observational
• Target: 458
• Locations: 1 country
• Sites: 18

Brief Summary

Single-arm, prospective, multi-center, post-approval U.S. registry

Conditions

Lung Transplantation

Outcome Measures

Primary Outcomes (1)

• 12-month patient and graft survival post double-lung transplant

  Primary Effectiveness Endpoint

  12 months

Secondary Outcomes (5)

• Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs

  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)

  0, 24, 48 and 72 hours

• Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation

  72 hours

• Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate

  1 hour

• Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation

  Within 72 hours post-transplantation

Other Outcomes (9)

• Standard Criteria Lungs - Incidence of PGD3 at T72 hours

  72 hours

• Total ischemia and cross-clamp times for 1st and 2nd transplanted lungs

  2 hours

• Kaplan-Meier patient survival estimated at Month 1, 6, 12, 24, 36, 48 and 60

  1,6,12,24,36,48,60 months

Study Arms (3)

Standard Donor Lungs Primary Analysis Population

Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.

Device: OCS Lung System

Donor Lungs Initially Unacceptable Primary Analysis Pop.

Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.

Device: OCS Lung System

All Other Enrolled Patients

All OCS Lung transplanted patients that do not meet any of the above analysis populations.

Device: OCS Lung System

Interventions

OCS Lung System DEVICE

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.

All Other Enrolled Patients; Donor Lungs Initially Unacceptable Primary Analysis Pop.; Standard Donor Lungs Primary Analysis Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• TransMedics: lead

Study Sites (18)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins

Baltimore, Maryland, 21218, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States

Location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: December 10, 2018
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2029
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (18)