Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emp… (NCT05949645) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema
Austria, Netherlands, United Kingdom30 participantsStarted 2023-08-15
Plain-language summary
The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants at up to 5 study centers located in Europe and the United Kingdom. The main questions this clinical trial aim to answer are: Is it safe? Does it work?
Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed in each lung during the procedure(s). Participants will be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the procedure(s).
Who can participate
Age range35 Years – 80 Years
SexALL
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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 \< -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
Exclusion criteria
✕. Arterial blood on room air: PaCO2 \> 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa)
. Steroid therapy of 10 mg prednisolone (prednisone) or more per day
✕. Two or more hospitalizations for acute exacerbations of COPD or respiratory infections in the past year before enrollment
✕. 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
✕. Known or suspected history of pulmonary arterial hypertension with a PASP \> 50 mmHg on echocardiogram or mPAP \> 25 mmHg on a right heart catheterization
✕. Presence of a giant bulla (≥ 30% of hemithorax)