Device Evaluation: Device Deployment Assessment
Evaluation of the ability to deploy the Apreo Implant in target airways (There is no scale - questions are assessed individually)
Device Evaluation: Device Usability Survey
Evaluate operator device use challenges (There is no scale - questions are assessed individually)
Device Evaluation: Instructions for Use (IFU) Survey
Evaluate operator understanding of instructions for use (There is no scale - questions are assessed individually)
Efficacy Evaluation: Airway Patency at 30 Days
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Efficacy Evaluation: Airway Patency at 3 Months
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Efficacy Evaluation: Airway Patency at 6 Months
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Efficacy Evaluation: Airway Patency at 12 Months
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Efficacy Evaluation: Mucus Assessment at 30 Days
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Efficacy Evaluation: Mucus Assessment at 3 Months
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Efficacy Evaluation: Mucus Assessment at 6 Months
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Efficacy Evaluation: Mucus Assessment at 12 Months
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Efficacy Evaluation: Computed Tomography (CT) Scan at 6 Months
CT evaluation of Apreo Implant diameter
Efficacy Evaluation: CT Scan at 12 Months
CT evaluation of Apreo Implant diameter
Efficacy Evaluation: Forced Expiratory Volume in 1 Second (FEV1) at 1-3 Days
Change in FEV1 between Baseline and 1-3 days post-procedure
Efficacy Evaluation: FEV1 at 30 Days
Change in FEV1 between Baseline and 30 days post-procedure
Efficacy Evaluation: FEV1 at 3 Months
Change in FEV1 between Baseline and 3 months post-procedure
Efficacy Evaluation: FEV1 at 6 Months
Change in FEV1 between Baseline and 6 months post-procedure
Efficacy Evaluation: FEV1 at 12 Months
Change in FEV1 between Baseline and 12 months post-procedure
Efficacy Evaluation: Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) at 6 Months
Change in DLCO between baseline and 6 months post-procedure
Efficacy Evaluation: Residual Volume (RV) at 6 Months
Change in RV between baseline and 6 months as assessed by quantitative CT
Efficacy Evaluation: Residual Volume (RV) at 12 Months
Change in RV between baseline and 12 months as assessed by quantitative CT
Efficacy Evaluation: Arterial Blood Gas (ABG): PaO2 at 6 Months
Change in PaO2 between baseline and 6 months
Efficacy Evaluation: Arterial Blood Gas (ABG): PaCO2 at 6 Months
Change in PaCO2 between baseline and 6 months
Safety: Procedural Complications
Percentage of participants with acute procedural complications within 24 hours of study procedure
Safety: Rate of SAEs
Rate of occurrence of serious adverse events related to the device and/or Apreo procedure through 12 months
Safety: Rate of Adverse Device Effects
Rate of adverse device effects through 12 months post-procedure
Efficacy Evaluation: Forced Expiratory Volume at 1 Second/ Forced Vital Capacity (FEV1/FVC) at 1-3 Days
Change in FEV1/FVC between Baseline and 1-3 days post-procedure
Efficacy Evaluation: FEV1/FVC at 30 Days
Change in FEV1/FVC between Baseline and 30 days post-procedure
Efficacy Evaluation: FEV1/FVC at 3 Months
Change in FEV1/FVC between Baseline and 3 Months post-procedure
Efficacy Evaluation: FEV1/FVC at 6 Months
Change in FEV1/FVC between Baseline and 6 Months post-procedure
Efficacy Evaluation: FEV1/FVC at 12 Months
Change in FEV1/FVC between Baseline and 12 Months post-procedure
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 1-3 Days
Change in RV between Baseline and 1-3 Days
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 30 Days
Change in RV between Baseline and 30 Days
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 3 Months
Change in RV between Baseline and 3 Months
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 6 Months
Change in RV between Baseline and 6 Months
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 12 Months
Change in RV between Baseline and 12 Months
Efficacy Evaluation: Residual Volume/Total Lung Capacity (RV/TLC) at 1-3 Days
Change in RV/TLC between Baseline and 1-3 Days
Efficacy Evaluation: RV/TLC at 30 Days
Change in RV/TLC between Baseline and 30 Days
Efficacy Evaluation: RV/TLC at 3 Months
Change in RV/TLC between Baseline and 3 Months
Efficacy Evaluation: RV/TLC at 6 Months
Change in RV/TLC between Baseline and 6 Months
Efficacy Evaluation: RV/TLC at 12 Months
Change in RV/TLC between Baseline and 12 Months
Efficacy Evaluation: Forced Vital Capacity (FVC) at 1-3 Days
Change in FVC between Baseline and 1-3 Days
Efficacy Evaluation: FVC at 30 Days
Change in FVC between Baseline and 30 Days
Efficacy Evaluation: FVC at 3 Months
Change in FVC between Baseline and 3 Months
Efficacy Evaluation: FVC at 6 Months
Change in FVC between Baseline and 6 Months
Efficacy Evaluation: FVC at 12 Months
Change in FVC between Baseline and 12 Months
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 1-3 Days
Change in 6MWT between Baseline and 1-3 Days
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 30 Days
Change in 6MWT between Baseline and 30 Days
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 3 Months
Change in 6MWT between Baseline and 3 Months
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 6 Months
Change in 6MWT between Baseline and 6 Months
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 12 Months
Change in 6MWT between Baseline and 12 Months
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 1-3 Days
Change in Modified BORG Dyspnea Scale between Baseline and 1-3 Days (scale is 0= no difficulty breathing to 10=maximal difficulty)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 30 Days
Change in Modified BORG Dyspnea Scale between Baseline and 30 Days (scale is 0= no difficulty breathing to 10=maximal difficulty)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 3 Months
Change in Modified BORG Dyspnea Scale between Baseline and 3 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 6 Months
Change in Modified BORG Dyspnea Scale between Baseline and 6 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 12 Months
Change in Modified BORG Dyspnea Scale between Baseline and 12 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
Efficacy Evaluation: COPD Assessment Test (CAT) at 1-3 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Change in CAT between Baseline and 1-3 Days
Efficacy Evaluation: COPD Assessment Test (CAT) at 30 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Change in CAT between Baseline and 30 Days
Efficacy Evaluation: Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) at 3 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Change in CAT between Baseline and 3 Months
Efficacy Evaluation: COPD Assessment Test (CAT) at 6 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Change in CAT between Baseline and 6 Months
Efficacy Evaluation: COPD Assessment Test (CAT) at 12 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Change in CAT between Baseline and 12 Months
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 1-3 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Change in SGRQ-C between Baseline and 1-3 Days
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 30 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Change in SGRQ-C between Baseline and 30 Days
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 3 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Change in SGRQ-C between Baseline and 3 Months
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 6 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Change in SGRQ-C between Baseline and 6 Months
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 12 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Change in SGRQ-C between Baseline and 12 Months
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 1-3 Days
Change in mMRC between Baseline and 1-3 Days
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 30 Days
Change in mMRC between Baseline and 30 Days
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 3 Months
Change in mMRC between Baseline and 3 Months
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 6 Months
Change in mMRC between Baseline and 6 Months
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 12 Months
Change in mMRC between Baseline and 12 Months