A Multi Center Study Testing a New Implant for Adults With Severe Emphysema

Laborértékek

• 1. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment..
  • α-1 Antitrypsin deficiency 3. Women of child-bearing potential. 4. More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening.
  • Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention.
  • Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening.
  • Clinically significant mucus production or chronic bronchitis. 8. Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening.
  • Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR).
  • Clinically significant bronchiectasis. 11. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days.
  • Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure >45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 3-months prior to screening visit). Note: the echocardiogram is not a required screening procedure.
  • Suspected malignant pulmonary nodule or other lung cancer. 14. HRCT collected per CT scanning protocol within the last 6-months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:
  • Large bullae encompassing greater than 30% of either lung
  • Insufficient landmarks to evaluate the CT study using the software as it is intended
  • All lobes are less than 25% parenchyma diseased (< -950 HU) 15. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant.
  • TLC < 100% predicted at screening. 17. DLCO < 15% or > 50% of predicted value at screening. 18. PaCO2 > 50 mm Hg at screening. 19. PaO2 < 45 mm Hg in room air at screening. 20. Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) >2.5% at screening.
  • Current diagnosis of substance abuse disorder. 22. Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder.
  • Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.

• Signed Informed Consent.
• Diagnosis of COPD/emphysema.
• At least 22-years of age.
• 18 ≤ BMI ≤ 32.
• 6-minute walk Distance between 100-meters and 400-meters at baseline exam.
• Stable disease with less than 10-mg prednisone (or equivalent) daily
• Non-smoking for 4-months prior to screening interview (including tobacco, vaping, marijuana, etc.).
• FEV1 between 15% and 50% of predicted value at baseline exam.
• FEV1/FVC <70%.
• Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation <-950 HU, as determined by 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 (< -950HU) as determined by CT core lab.
• RV > 175% of predicted value.
• mMRC score ≥ 2.