A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema

Korábbi kezelés

• Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment
• More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening
• Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening
• Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR)

Más betegség

• Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening
• Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure >45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram
• Suspected malignant pulmonary nodule or other lung cancer
• Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
• Current diagnosis of substance abuse disorder.
• 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.

Laborértékek

• Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days

Egyéb

• α-1 Antitrypsin deficiency
• Women of child-bearing potential
• Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention
• Clinically significant mucus production or chronic bronchitis
• Clinically significant bronchiectasis
• 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).
• TLC < 100% predicted at screening
• DLCO < 15% or > 50% of predicted value at screening
• PaCO2 > 50 mm Hg at screening
• PaO2 < 45 mm Hg in room air at screening
• Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) >2.5% at screening.

• Signed Informed Consent
• Diagnosis of COPD/emphysema
• At least 22-years of age
• 18 ≤ BMI ≤ 32
• 6-minute walk Distance of between 100 - and 400 meters
• Stable disease with less than 10-mg prednisone (or equivalent) daily
• Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.).
• FEV1 between 15% and 45% of predicted value at baseline exam
• FEV1/FVC <70%
• Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation less than -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 less than -950 HU, as determined by CT core lab.
• RV > 175% of predicted value.
• mMRC score ≥ 2