An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema: The CONVERT II Trial
This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.
• Subject is willing and able to provide informed consent and to participate in the study.
• Subject is aged ≥ 40 and ≤ 80 years at the time of the ICF signature date.
• Subject has completed a documented pulmonary rehabilitation (in clinic or home-based) program within 12 months prior to Baseline.
• Subject has stopped smoking for at least 8 weeks prior to the ICF signature date as confirmed by carboxyhemoglobin or cotinine levels.
• Subject has a recent HRCT meeting the scan parameter requirements and performed within 3 months of the ICF signature date with the following findings at -910 Hounsfield Units:
∙ At least one (1) lobe with segmental emphysema destruction score ≥ 50%.
‣ Subject has heterogenous emphysema, defined as difference in emphysema destruction score of ≥ 15 between the density scores of the target lobe and the ipsilateral non-target lobe(s) per QCT report with % voxel density of \< -910 HU. For non-target lobes that include the RML, calculate the combination of non-target lobes as a single density score using volume-weighted percent.
‣ LUL, LLL, RUL, RLL, or RUL+RML are targets for valve intervention.
‣ Subject has a gap in the interlobar fissure that corresponds to one or more segments and the fissure(s) contacting the target lobe is ≥ 80% complete per QCT report.
‣ Subject has 98% of the fissure gap confined to a maximum of 3 segments within the target lobe per Fissure Targeting Report (FTR).
• Subject has 6MWD ≥ 150 m and ≤ 450 m.
• Subject has clinically significant dyspnea with an mMRC score of ≥ 2.
• Subject has post-bronchodilation FEV1 ≥ 15% predicted and ≤ 45% predicted.
• Subject has an FEV1/FVC ratio of \< 0.7.
⁃ Subject has post-bronchodilation TLC, measured by body plethysmography, ≥ 100% predicted.
⁃ Subject has post-bronchodilation RV ≥ 175% predicted, measured by body plethysmography.
⁃ Subject has post-bronchodilation DLCO ≥ 20% predicted.
⁃ Subject has received preventative vaccinations against potential respiratory infections, including COVID-19, consistent with local recommendation or policy.
⁃ Subject is on optimal medical management for more than one month prior to the ICF signature date.
⁃ Subject has collateral ventilation (CV+) as confirmed per the Chartis assessment prior to the AeriSeal Index Procedure.