COPD emphysema
Conditions
Interventions
 
1) Stage 1 will address the closure of the lobar fissure gaps (or collateral 
air channels) to block collateral ventilation with the AeriSeal System
2) Stage 2 will include successfully converted subjects (CV+ to CV- conversion 
in Stage 1). Converted CV- target lobes will follow standard of care and 
receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform 
bronchoscopic lung volume reduction (BLVR). 
Sponsors
Pulmonx Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 12 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 within 3 months of the ICF signature date with the following findings at -910 Hounsfield Units: a. At least one (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 one 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 >= 150 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 infections, including COVID-19, consistent with local recommendation or policy. 14. Subject is on optimal medical management for more than one 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.
Exclusion criteria
Exclusion criteria: 1. Subject has prior lung volume reduction surgery, lobectomy or pneumonectomy, lung transplantation, airway stent placement, pleurodesis, or BLVR of any type, except BLVR using Zephyr Valve with < 50% TLVR at 6 months, followed by valve removal > 6 months prior to ICF signature date. 2. Subject has visible radiological abnormality on HRCT scan such as pulmonary nodule greater than 0.8 cm in diameter (does not apply, if present for 2 years or more without increase in size or if deemed benign by biopsy) or active pulmonary infection (e.g., unexplained parenchymal infiltrate, significant interstitial lung disease or significant pleural disease). 3. Post-COVID-19 pathology on CT, including ground glass opacities with or without consolidation, adjacent pleura thickening, interlobular septal thickening, or air bronchograms. 4. Large bullae encompassing greater than 1/3 of the total lung. 5.Subject had 3 or more COPD exacerbations requiring hospitalization within 12 monthspreceding theICFsignature date or a COPD exacerbation requiring hospitalization within 8 weeks of the ICF signature date. Subjects may be re-considered for future enrollment. 6.Subject has asthma as their primary diagnosis. 7.Subject has chronic bronchitis(defined as greaterthan 4 tablespoons of sputum production perday) as their primary diagnosis. 8.Subject has clinically significant bronchiectasis. 9.Subjectswithevidence of active respiratory infectionshould be considered forenrollmentonlyafter satisfactory resolution. 10.Subject requires invasive ventilatory support. Note: The use of Continuous Positive Airway Pressure (CPAP) or BiPAP devices for sleepapnea is permitted. 11.Subject has severe gas exchangeabnormalities as defined by any one of the following tests,conducted at rest, on room air, as tolerated. •PaCO2>= 50 mm Hg (7.3 kPa) •PaO2 < 45 mm Hg (6.0 kPa) 12.Subject has pulmonary hypertension, defined as mean pulmonary systolic pressure > 45 mmHg. 13.Subject has known documented alpha-1 antitrypsin deficiency. 14.Subject has clinically significant hematological disorder. 15.Subject has recent significant unplanned or unexplained weight loss or other relevantcomorbidities considered by the investigator to be potentially confounding or limiting to thesubject*s participation in the study. 16.Subject has non-atrial arrhythmias or conduction abnormalities on EKG. 17.Subjecthashigh cardiac risk after undergoing cardiac risk assessmentin accordance withpublished guidelines (Fleisher 2007)or hasischemic heart disease, congestive heart failure,cerebrovascular disease (stroke or TIAwithin 6 months of the ICF signature date),or serumcreatinine > 2.0 mg/dL (177 µmol/L). 18.Subject has uncontrolled exercise induced syncope. 19.Subject has evidence of severe diseasewhich in the judgment of theinvestigator may compromise the anticipated treatmenteffect or the subject*s survivalfortheduration ofatleast 12 months. 20.Subject has any other condition that theinvestigator believes would interfere with the intent ofthe study or would make participation not in thebest interest of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of study subjects that successfully convert from CV+ in the treated lobe to having little to no collateral ventilation (CV-) by Chartis at 45 days post-AeriSeal treatment (index or repeat, if performed). | — |
Secondary
| Measure | Time frame |
|---|---|
| The following endpoints will be assessed in Converters (subjects that successfully converted from CV+ status to CV-) from Baseline to Month 6 after placement of Zephyr Valve: • Post-bronchodilator FEV1: percentage of subjects achieving a >= 12% increase • RV: percentage of subjects achieving a >= 310 mL decrease • TLVR by HRCT: percentage of subjects achieving a >= 350 mL decrease • SGRQ total score: percentage of subjects achieving a >= 4-point decrease Additional endpoints The following endpoints will be assessed in all subjects from Baseline to the timepoint indicated. • Post-bronchodilator FEV1: absolute, percent and percent predicted change (Month 3, 6, 12, 24), percentage of subjects achieving a >= 12% increase (Month 3, 12, 24) • RV: absolute and percent change (Month 3, 6, 12, 24) and percentage of subjects achieving a >= 310 mL decrease (Month 3, 12, 24) • TLVR by HRCT: absolute change (Day 45, Month 6, 12), percentage of subjects achieving a >= 350mL decrease (Day 45, Month 12), and percentage of subjects achieving a >= 50% decrease (Day 45, Month 6, 12) • RV/TLC ratio: absolute change (Month 3, 6, 12, 24) • FVC: absolute and percent change (Month 3, 6, 12, 24) • DLCO: absolute and percent predicted change (Month 6, 12) • CAT score: absolute change and percentage of subjects achieving a >= 2-point decrease (Month 3, 6, 12) • mMRC score: absolute change and percentage of subjects achieving a >=1-point decrease (Month 3, 6, 12) • SGRQ total score: absolute change (Month 3, 6, 12) and percentage of subjects achieving a >= 4-point decrease (Month 3, 12) • 6MWT: percentage of subjects achieving a >= 26 m increase in 6MWD (Month 6, 12) | — |
Countries
Australia, Austria, Denmark, France, Germany, Italy, Netherlands, United Kingdom, United States
Contacts
Public ContactRM Ryan
Pulmonx Corporation
Outcome results
None listed