Airway Bypass - Safety and Feasibility Study

Exclusion Criteria29

• Patient has clinically significant sputum production.
• Patient has a change in FEV1 \>20% post-bronchodilator.
• Patient has a history of recurrent clinically significant respiratory infection, defined as with more than 3 hospital stays in the past 12 months.
• Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure \>50mmHg and/or evidenced by echocardiogram.
• Patient has an inability to walk less than 140 meters (150 yards) or greater than 450 meters in 6 minutes.
• Patient has evidence of any other disease that may compromise survival such as lung cancer, renal failure, any other investigator identified diseases.
• Patient has an inability to tolerate bronchoscopy under anesthesia.
• Any contraindication to bronchoscopy procedure, including but not limited to:
• Untreatable life-threatening arrhythmias
• Inability to adequately oxygenate the patient during the procedure
• Acute respiratory failure with hypercapnia
• Myocardial infarction within 6 months
• Previously diagnosed high-grade tracheal obstruction
• Uncorrectable coagulopathy
• Patient has clinically significant bronchiectasis.
• Patient has giant bullae \>1/3 lung volume.
• Patient has had previous LVR surgery, lung transplant or lobectomy, or still has ELVR devices or other device to treat COPD in either lung.
• Patient has been involved in other clinical studies within 30 days prior to this study.
• Patient is taking \>20mg prednisone (or similar steroid) daily.
• Patient on antiplatelet agent (e.g., clopidogrel) or anticoagulant therapy (e.g., heparin or coumadin) or has not been weaned off prior to procedure.
• Patient has any other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes.
• A known allergy to nitinol.
• Patient with uncontrolled diabetes as well as overweight patient (BMI \>35 kg/m2).
• Cancer needing chemotherapy in the past two years.
• Patient with pleural effusion and/or pneumothorax.
• Patient with a disease history of asthma, cystic fibrosis, interstitial lung disease (ILD), active tuberculosis.
• Patient with exacerbation of chronic obstructive pulmonary disease (COPD) within the last year which defined as: An acute event with the need of antibiotic treatment or hospitalization.
• Subject has severe gas exchange abnormalities as defined by: PaCO2 \>55 mmHg, PaO2 \<45 mmHg on room air.
• Patient with acute ischemic heart disease, with proven pulmonary hypertension (SPAP \>45 mmHg) in echocardiography and/or need for double platelet aggregation inhibition.