Phase
Condition
Emphysema
Treatment
Apreo Implant Group
Clinical Study ID
Ages 35-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 < -950Hounsfield units on CT)
Post-bronchodilator ratio of FEV1/FVC < 0.7 at screening
Post-bronchodilator FEV1 percent predicted ≥20% 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 at screening indicates nonsmoker and stopped smoking at least 8weeks before entering the trial and agrees to refrain from smoking for duration ofstudy participation
Participation in a pulmonary rehabilitation program and/or confirmed to have beenengaged or attempted regular physical activity in the 12 months prior to the firstApreo Procedure and agrees to continue or restart regular physical activity for theduration of the study
Fully vaccinated for Covid-19 (up to date per Australian Government Guidelines) andhas current pneumococcus and influenza vaccination (or documented clinicalintolerance)
Cognitively and physically able to provide written informed consent and completeparticipant questionnaires
Exclusion
Exclusion Criteria:
Arterial blood PaCO2 > 60 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa)
DLCO <20% at screening
Steroid therapy of 10 mg prednisolone (prednisone) or more per day
Three or more acute exacerbations of COPD in the past year before enrollment
Two or more hospitalizations for acute exacerbations of COPD or respiratoryinfections in the past year before enrollment
Any acute exacerbation of COPD or respiratory infection less than 4 weeks before thefirst Apreo Procedure
Previous lung volume reduction surgery or lobectomy, segmentectomy or bullectomy,vapor, glue, or other pulmonary device implant
Known history of pulmonary arterial hypertension
Presence of a giant bulla (≥ 30% of hemithorax)
History of excessive dynamic airway collapse of the trachea or main bronchi
History of adult asthma or chronic bronchitis
Presence of suspicious pulmonary nodule/infiltrate that requires additionalfollow-up, diagnostics or treatment
Unequivocal and symptomatic bronchiectasis
Unequivocal lung cancer or other current cancer diagnosis except non-metastasizedbasal cell skin cancer
Uncontrolled hypertension (blood pressure that is inadequately treated or resistantto treatment) with a systolic > 200 mmHg or diastolic > 110 mmHg at screening orprior to first Apreo Procedure
Uncorrectable coagulopathy or other condition likely to increase risk of peri- orpost- Apreo Procedure bleeding
On anticoagulant or antiplatelet therapy and unable or unwilling to hold for ApreoProcedure
Coronary artery disease with angina
History of myocardial infarction within 6 months
History of a stroke less than 1 year before the first Apreo Procedure
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) ORparticipant with kidney failure (Stage 5 kidney disease)
Mechanical ventilator dependence except participants using nocturnal bi-levelpositive airway pressure (biPAP) or continuous positive airway pressure (CPAP) areallowed if it would not preclude safe implantation of the study device
Pregnant, lactating, or women of childbearing potential who plan to become pregnantwithin the study duration
Known hypersensitivity to nitinol
Significantly immunocompromised, such as organ transplant recipients, those withcongenital immune deficiencies, AIDS, or severe rheumatoid arthritis
Any disease or condition likely to limit survival to less than one year
Concomitant illnesses or medications that may pose a significant increased risk forcomplications following an Apreo Procedure
Currently enrolled in another trial and actively receiving experimental treatment
Any condition in the opinion of the investigator that would interfere with safe andcomplete collection of study data including the safe conduction of bronchoscopyprocedures
Study Design
Study Description
Connect with a study center
Macquarie University Hospital
Macquarie, New South Wales 2109
AustraliaSite Not Available
Royal Melbourne Hospital
Parkville, Victoria 3050
AustraliaSite Not Available
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