About this trial
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?
Eligibility criteria
Qualifiers
1. 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.
Disqualifiers
Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
Subject has a steroid-dependent condition requiring (e.g. ≥10 mg oral corticosteroid per day).
Subject has bilateral lobar emphysematous destruction scores of >70% percent of voxels with <-950 Hounsfield units on thin slice inspiratory CT, as determined by the CT core lab.
Subject has arterial or capillary blood on room air: PaCO2 > 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa).
Trial design
Treatments tested in this trial
- Apreo BREATHE Airway Scaffold
- Optimal Medical Management (OMM)