Overview
A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.
Description
IAB-2 is an open-label (unblinded), multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from severe COPD/emphysema. There is no control group or comparator. The study will be conducted at as many as twelve sites in the United States and three sites outside of the US, in the Netherlands, Germany and Brazil.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 1\. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment..
2\. 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.
5\. Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention.
6\. Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening.
7\. Clinically significant mucus production or chronic bronchitis. 8. Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening.
9\. Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR).
10\. Clinically significant bronchiectasis. 11. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days.
12\. 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.
13\. 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.
16\. 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.
21\. 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.
23\. 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.
