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?
Prospective, randomized, two arm, parallel group, concurrently controlled, open-label, multi-center clinical trial following up to 250 participants to 3 years. Each site will participate in a Roll-In phase prior to participation in the randomized phase of the study. Each site will enroll up to 2 subjects in this phase. Up to 50 subjects may be enrolled into the Roll-In cohort. Up to 200 subjects with bilateral emphysema will be randomized at up to 25 centers in the United States centers and Europe. In the Randomized cohort, subjects will be randomized to either a Treatment or Control group in a 2:1 ratio. * Optimal Medical Management: All subjects (Roll-in and Randomized) will receive optimal medical management tailored to patient needs and per standard of care and as outlined in the 2024 GOLD report. This may include smoking cessation, vaccination, long-acting bronchodilator therapy, corticosteroids (when appropriate), and participation in or maintenance of an exercise program or pulmonary rehabilitation program. * Treatment group: 133 subjects will receive optimal medical management and Apreo Implant placements. Treatment group subjects will undergo a single bronchoscopy with bilateral placement of up to 3 implants per lung in appropriately selected target airways. Appropriate target segments shall be based on segmental and lobar information (i.e. airway dimensional, emphysematous destruction, volumetric information, hetero/homogeneity) provided in the Quantitative CT (QCT) report for each patient. * Control group: 67 subjects will receive optimal medical management. Control group subjects will be allowed the opportunity to cross over and receive the BREATHE treatment after their Month 12 visit and within 15 months from their baseline visit. Subjects will undergo follow-up assessments at Months 1, 3, 6 and 12, and Years 2 and 3 post-procedure (treatment group) or post-randomization (control group). These visits will involve adverse event assessment, questionnaires, pulmonary function testing, and inspiratory/ expiratory CT scans. Control group subjects electing crossover will then have additional follow-ups at 7- and 30-days post procedure, and 6 months post procedure. Control group subjects not electing crossover will be exited from the study after Month 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
The experimental treatment involves placement of up to 6 Apreo BREATHE Airway Scaffolds (up to 3 per lung), in a single procedure using bronchoscopy and fluoroscopy. Treatment group subjects will also receive optimal medical management (OMM).
Subjects will receive optimal medical management tailored to patient needs and per standard of care and as outlined in the 2024 GOLD report. This may include smoking cessation, vaccination, long-acting bronchodilator therapy, corticosteroids (when appropriate), and participation in or maintenance of an exercise program or pulmonary rehabilitation program.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGBanner Health
Gilbert, Arizona, United States
RECRUITINGUniversity of California at Davis
Sacramento, California, United States
RECRUITINGMayo Clinic
Jacksonville, Florida, United States
RECRUITINGOrlando Health
Orlando, Florida, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
RECRUITINGOSF St Francis Medical Center
Peoria, Illinois, United States
RECRUITINGUniversity of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITING...and 9 more locations
Forced Expiratory Volume in 1 second (FEV1) Responder
Defined as a subject who experiences a reduction from baseline in post-bronchodilator FEV1 of ≥12%
Time frame: Month 12
Residual Volume (RV) + St George's Respiratory Questionnaire for COPD (SGRQ-C)
Responder rate
Time frame: Months 3 and 12
St. George's Respiratory Questionnaire for COPD (SGRQ-C) Responder Rate
SGRQ-C total score
Time frame: Months 3, 6, 12 and Years 2, 3
Modified Medical Research Council (mMRC) Responder Rate
mMRC dyspnea score
Time frame: Months 3, 6, 12 and Years 2, 3
COPD Assessment Test (CAT) Responder Rate
CAT Score
Time frame: Months 3, 6, 12 and Years 2, 3
Forced Expiratory Volume in the first second (FEV1) Responder Rate
FEV1
Time frame: Months 3, 6, 12 and Years 2, 3
6-minute walk distance (6MWD)
6MWD
Time frame: Months 3, 6, 12 and Years 2, 3
Ratio of residual volume (RV)/ total lung capacity (TLC) Responder Rate
Ratio RV/TLC
Time frame: Months 3, 6, 12 and Years 2, 3
Residual Volume (RV) Responder Rate
RV
Time frame: Months 3, 6, 12 and Years 2, 3
Forced Vital Capacity (FVC) Responder Rate
FVC
Time frame: Months 3, 6, 12 and Years 2, 3
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