Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema

Korábbi kezelés

• Steroid therapy of 10 mg prednisolone (prednisone) or more per day
• Any acute exacerbation of COPD or respiratory infection less than 4 weeks before the first Apreo Procedure
• Previous lung volume reduction surgery or lobectomy, segmentectomy or bullectomy, vapor, glue, or other pulmonary device implant
• Uncontrolled hypertension (blood pressure that is inadequately treated or resistant to treatment) with a systolic > 200 mmHg or diastolic > 110 mmHg at screening or prior to first Apreo Procedure
• On anticoagulant or antiplatelet therapy and unable or unwilling to hold for Apreo Procedure
• Significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis
• Concomitant illnesses or medications that may pose a significant increased risk for complications following an Apreo Procedure
• Currently enrolled in another trial and actively receiving experimental treatment

Más betegség

• Two or more hospitalizations for acute exacerbations of COPD or respiratory infections in the past year before enrollment
• Known or suspected history of pulmonary arterial hypertension with a PASP > 50 mmHg on echocardiogram or mPAP > 25 mmHg on a right heart catheterization
• History of adult asthma or chronic bronchitis
• Unequivocal lung cancer or other current cancer diagnosis except non-metastasized basal cell skin cancer
• Uncorrectable coagulopathy or other condition likely to increase risk of peri- or post- Apreo Procedure bleeding
• History of myocardial infarction or unstable angina within past 6 months
• History of a stroke less than 1 year before the first Apreo Procedure
• Known hypersensitivity to nitinol
• Any disease or condition likely to limit survival to less than one year
• Any condition in the opinion of the investigator that would interfere with safe and complete collection of study data including the safe conduction of bronchoscopy procedures

Laborértékek

• Clinical history of heart failure with documented LVEF ≤ 40%
• Clinical history of diabetes with a HbA1c > 9.0%
• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 (CKD-EPI) OR participant with kidney failure (Stage 5 kidney disease)

Egyéb

• Arterial blood on room air: PaCO2 > 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa)
• DLCO <20% at screening
• Presence of a giant bulla (≥ 30% of hemithorax)
• Presence of suspicious pulmonary nodule/infiltrate that requires additional follow-up, diagnostics or treatment
• Unequivocal and symptomatic bronchiectasis
• Mechanical ventilator dependence except participants using nocturnal bi-level positive airway pressure (biPAP) or continuous positive airway pressure (CPAP) are allowed if it would not preclude safe implantation of the study device
• Pregnant, lactating, or women of childbearing potential who plan to become pregnant within the study duration

• Age ≥ 35 and ≤ 80 years old
• Computed tomography (CT) scan evidence of homogeneous or heterogeneous emphysema
• At least one target lobe with > 35% destruction (percent of voxels with < -950 Hounsfield units on CT)
• Post-bronchodilator ratio of FEV1/FVC < 0.7 at screening
• Post-bronchodilator FEV1 percent predicted ≥15% and ≤50% of predicted at screening
• Post-bronchodilator RV > 180% predicted
• Post-bronchodilator RV/TLC ≥ 0.55 at screening
• Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4
• Cotinine testing or carboxyhemoglobin at screening indicates nonsmoker and stopped smoking at least 8 weeks before entering the trial and agrees to refrain from smoking for duration of study participation
• Participation in a pulmonary rehabilitation program and/or confirmed to have been engaged or attempted regular physical activity in the 12 months prior to the first Apreo Procedure and agrees to continue or restart regular physical activity for the duration of the study
• Fully vaccinated for Covid-19 (up to date per local government guidelines) and has current pneumococcus and influenza vaccination (or documented clinical intolerance)
• Cognitively and physically able to provide written informed consent and complete participant questionnaires