Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?
⁃ Subject is at least 40, but not older than 84, years of age.
• Subject has body mass index (BMI) of between 18 and 32, inclusive.
• Subject has completed a documented pulmonary rehabilitation program within 12 months prior to Baseline.
• Subject has mMRC score ≥ 2.
• Subject can walk ≥100 meters in 6 minutes.
• Subject has ≥25% emphysema destruction score in each lung as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the CT core lab.
• Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score (-910HU) as determined by the CT core lab.
• Subject has bilateral heterogenous emphysema and pre-procedure post-bronchodilator RV ≥ 180% predicted, or one lung with homogenous emphysema and pre-procedure postbronchodilator RV ≥ 200% predicted.
• Subject has pre-procedure post-bronchodilator FEV1/ FVC \< 0.70.
⁃ Subject has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥15% and ≤45%.
⁃ Subject has pre-procedure post-bronchodilator RV/TLC ≥ 0.55.
⁃ Subject has pre-procedure DLCO ≥ 20%.
⁃ Subject has been receiving optimal medical management tailored to subject needs for 2 months prior to enrollment.
⁃ Subject has not actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 4 months, and agrees to smoking cessation during the study.
‣ 56\. Subject has received preventative vaccinations (or documented clinical intolerance) against potential respiratory infections, including pneumococcus, influenza, RSV (subjects \>60 yrs. old) and Covid-19, consistent with local recommendations or policy.
‣ 16\. In the opinion of the Primary investigator, subject can undergo bronchoscopy under general anesthesia and is able to adhere to the study follow-up schedule.
‣ 17\. Subject has provided written informed consent.