Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status (CONVERT)

Launched by PULMONX CORPORATION · Sep 16, 2020

Keywords

ClinConnect Summary

Severe emphysema subjects will be consented using an Ethics Committee approved Informed Consent Form (ICF) for baseline evaluations. Subjects with ≥ 50% lobar emphysema destruction (evaluated quantitatively by using percentage lung volume occupied by low-attenuation regions/voxels) and identified as potentially having collateral ventilation, with fissure completeness ≥ 80% from the Quantitative Computed Tomography (QCT) report (CV status later to be confirmed by Chartis assessment at Visit 2) will undergo additional QCT assessment for the feasibility of directing AeriSeal to the appropriate...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is willing and able to provide Informed Consent and to participate in the study.
• • 2. Subject is ≥ 40 and ≤ 75 years of age at the time Informed Consent signature.
• • 3. Subject has at least one lobe with ≥ 50% emphysema destruction (at -910 HU) as determined by QCT.
• • 4. Subject has a diagnosis of homogenous or heterogeneous emphysema, confirmed by HRCT scan. Heterogeneous emphysema defined as ≥ 15% difference (at -910 HU) in emphysema destruction score of adjacent lobes by HRCT.
• • 5. Subject has a gap in the interlobar fissure that corresponds to one or more segments as determined by QCT.
• • 6. Subject has clinically significant dyspnea with a mMRC Dyspnea score ≥ 2.
• • 7. Subject has a Six-Minute Walk Distance ≥ 250 meters.
• • 8. Subject has post-bronchodilator FEV1 ≥ 15% predicted and ≤ 50% predicted.
• • 9. Subject has post-bronchodilator Total Lung Capacity ≥ 100% predicted.
• • 10. Subject has post-bronchodilator Residual Volume ≥ 150% predicted if heterogeneous emphysema and ≥ 200% predicted if homogeneous emphysema.
• • 11. Subject has stopped smoking for at least eight (8) weeks prior to Screening visit as confirmed by carboxyhemoglobin or cotinine levels.
• • 12. Subject has received preventive vaccinations against potential respiratory infections consistent with local recommendations or policy.
• Exclusion Criteria:
• • 1. Subject has severe bullous emphysema where bulla is ≥ 1/3 of the total lung volume.
• • 2. Subject has had prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior ipsilateral pleurodesis, or prior endobronchial lung volume reduction therapy of any type.
• • 3. Subject has evidence of active respiratory infection.
• • 4. Subject has an ongoing COPD exacerbation or bronchospasm.
• 5. Subject has a known allergy to the device components:
• • 1. Polyether block amide - PEBAX®
• • 2. Polyvinyl Alcohol
• • 3. Glutaraldehyde
• • 4. Nitinol (nickel-titanium) or its constituent metals (nickel or titanium)
• • 5. Silicone
• • 6. Subject requires invasive ventilatory support (NOTE: The use of continuous Positive Airway Pressure (CPAP) and BiPAP devices for Sleep Apnea is permitted).
• • 7. Subject has post-bronchodilator Diffusion Capacity (DLCO) \< 20% predicted.
• • 8. Subject cannot tolerate corticosteroids or relevant antibiotics.
• • 9. Subject has other relevant comorbidities as judged by the Investigator or is deconditioned and cannot tolerate the stress of post-treatment inflammatory response.
• • 10. Subject has had three (3) or more COPD exacerbations requiring hospitalization during the year prior to Informed Consent signature.
• 11. Subject has severe gas exchange abnormalities as defined by any one of the following (test conducted at rest on room air as tolerated, or on up to 4 L/min supplemental O2):
• • 1. PaCO2 ≥ 55 mm Hg (7.3 kPa)
• • 2. PaO2 \< 45 mm Hg (6.0 kPa)
• • 3. SpO2 \< 90%
• • 12. Subject has uncontrolled pulmonary hypertension, defined as peak pulmonary systolic pressure \> 45 mm Hg on echocardiogram or right heart catheterization.
• • 13. Subject use of systemic steroids \> 20 mg/day prednisolone or equivalent within 4 weeks of Informed Consent signature.
• • 14. Subject use of immunosuppressive agents within four (4) weeks of Informed Consent signature.
• • 15. Subject whose use heparins and oral anticoagulants (e.g., warfarin, dicumarol) cannot be discontinued according to local pre-procedural protocols. Note: antiplatelet drugs including aspirin and clopidogrel are permitted.
• 16. Subject's CT scan indicates the presence of any the following radiologic abnormalities:
• • 1. Pulmonary nodule on CT scan greater than 0.8 cm in diameter (Does not apply if present for one (1) year or more without increase in size or if proven benign by biopsy).
• • 2. Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate.
• • 3. Significant interstitial lung disease.
• • 4. Significant pleural disease.
• • 17. Subject's baseline EKG indicates non-atrial arrhythmias or conduction abnormalities.
• • 18. Subject has high cardiac risk after undergoing cardiac risk assessment in accordance with published guidelines or ischemic heart disease, congestive heart failure, renal failure, or cerebrovascular disease.
• • 19. Subject has clinically significant asthma (reversible airway obstruction), chronic bronchitis, or bronchiectasis.
• • 20. Subject has allergy or sensitivity to medications required to safely perform bronchoscopy under conscious sedation or general anesthesia.
• • 21. Subject participated in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to Screening visit. Subjects being followed as part of a long-term surveillance of a non-pulmonary study that has reached its primary endpoint are eligible for participation in this study.
• • 22. Subject has Body Mass Index (BMI) \< 18 kg/m2 or \> 35 kg/m2.
• • 23. Subject is a female who is pregnant, breast-feeding, or planning to be pregnant in next 12 months.
• 24. Subject has clinically significant abnormal screening laboratory test results per the Institution specific reference laboratory normal values for the following:
• • 1. White blood cells (total)
• • 2. Hematocrit
• • 3. Platelets
• • 4. Prothrombin time or INR
• • 5. Partial thromboplastin time
• • 6. Positive β-HCG Pregnancy test (if female)
• 25. Subject has evidence of severe disease which in the judgment of the Investigator may compromise survival for the duration of the study (at least 12 months) e.g.:
• • 1. HIV/AIDs
• • 2. Active malignancy
• • 3. Stroke or Transient Ischemic attack (TIA) within 12 months of Screening visit
• • 4. Myocardial infarction within six (6) months of the Screening visit
• • 5. Congestive heart failure within six (6) months of the Screening visit defined as clinical evidence of right or left heart failure or left ventricular ejection fraction \< 45% on echocardiogram
• • 26. Subject has uncontrolled diabetes mellitus.
• • 27. Subject has any other condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject including but not limited to alcoholism, high risk for drug abuse, or noncompliance in returning for follow-up visits.