CONVERT-II (CONVERT-II)
Brief description of study
This is a prospective, open-label, multi-center, single-arm study enrolling subjects with severe heterogeneous emphysema and collateral ventilation in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe.
Detailed description of study
Purpose: This study is intended to evaluate the safety and effectiveness of the AeriSeal System to block open air channels causing collateral ventilation to enable bronchoscopic lung volume reduction (BLVR) with Zephyr Valve in participants with severe emphysema.
Investigational Devices: The AeriSeal System is used to deliver a polymer foam to block open-air channels in diseased regions of the lung causing collateral ventilation. The AeriSeal System has obtained a CE mark in the European Union, but it is an experimental device in the USA. This means that the AeriSeal System is being evaluated to see if it is safe and effective. It is not approved by the United States Food and Drug Administration (FDA). The study device is only available in the USA on an experimental basis as part of a clinical study.
The Zephyr Valve is a small, one-way valve that allows the trapped air in diseased regions of the lung to be exhaled and prevent more air from becoming trapped inside. This reduces lung hyperinflation and improves breathing mechanics. Zephyr Valve received CE mark and FDA approval after it was proven safe and effective in several randomized (like the flip of a coin) controlled studies.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 40 years - 80 years
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Gender: All
Subjects are eligible for the study if they meet all the following inclusion criteria:
1. Subject is willing and able to provide informed consent and to participate in the study.
2. Subject is aged ≥ 40 and ≤ 80 years at the time of the ICF signature date.
3. Subject has completed a documented pulmonary rehabilitation (in clinic or home-based)
program within 6 months prior to Baseline.
4. Subject has stopped smoking for at least 8 weeks prior to the ICF signature date as confirmed
by carboxyhemoglobin or cotinine levels.
5. Subject has an HRCT from the screening institution within 3 months of the ICF signature
date with the following findings at -910 Hounsfield Units:
a. At least 1 lobe with segmental emphysema destruction score ≥ 50%.
b. 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.
c. LUL, LLL, RUL, RLL, or RUL+RML are targets for valve intervention.
d. Subject has a gap in the interlobar fissure that corresponds to 1 or more segments and the
fissure(s) contacting the target lobe is ≥ 80% complete per QCT report.
e. Subject has 98% of the fissure gap confined to a maximum of 3 segments within the
target lobe per Fissure Targeting Report (FTR).
6. Subject has 6MWD ≥ 250 m and ≤ 450 m.
7. Subject has clinically significant dyspnea with an mMRC score of ≥ 2.
8. Subject has post-bronchodilation FEV1 ≥ 15% predicted and ≤ 45% predicted.
9. Subject has an FEV1/FVC ratio of < 0.7.
10. Subject has post-bronchodilation TLC, measured by body plethysmography, ≥ 100%
predicted.
11. Subject has post-bronchodilation RV ≥ 175% predicted, measured by body plethysmography.
12. Subject has post-bronchodilation DLCO ≥ 20% predicted.
13. Subject has received preventative vaccinations against potential respiratory infection
including COVID-19, consistent with local recommendation or policy.
14. Subject is on optimal medical management for more than 1 month prior to the ICF signature
date.
15. Subject has collateral ventilation (CV+) as confirmed per the Chartis assessment prior to the
AeriSeal Index Procedure.
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