Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3 (BREATHE-3)

This is a randomized clinical trial evaluating the safety and efficacy of Apreo BREATHE system in patients with severe emphysema and dyspnea due to hyperinflation despite optimal medical therapy. It is a self expanding nitinol scaffold that tents open target airways and thus providing support to native airways and releasing trapped air, reducing hyperinflation. Patients will be followed for three years, with randomized participants receiving either standard care alone or standard care plus the Apreo implant via bronchoscopy.

Primary End-Point:
  • FEV1 responders, defined as a subject who experiences a reduction from baseline in post-bronchodilator FEV1 of ≥12%
Breathe3a
Key inclusion criteria are:

  • Severe bilateral emphysema with heterogeneity (upper or lower dominance) in at least one lung

  • Significant air trapping (RV ≥180% predicted)

ClinicalTrials.gov Identifier: NCT06891755

For more detailed information on this trial please click the link above to visit ClinicalTrials.gov

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