A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema

Prior treatment

• Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include: immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency;
• Use of morphine derivatives within 4 weeks prior to screening;

Other illness

• History of heart and/or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, thoracic surgery with removal of lung tissue and endobronchial lung volume reduction (via valves, coils, stents, etc.);
• Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist;
• Any conditions assessed by investigator that make patients inappropriate for enrolment.

Lab values

• Contraindications to bronchoscopy, such as:
  • Prior myocardial infarction within 1 month, unstable myocardial ischaemia, ejection fraction (EF) ≤ 40%; Active haemoptysis; Coagulation disorders; Malignant cardiac arrhythmia, severe pulmonary hypertension, extreme systemic failure, etc;
• Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.);

Other

• Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit;
• Recent COPD exacerbation in preceding 6 weeks;
• Severe emphysema in both the upper and lower lobes of the contralateral lungs, defined as %LAA-950 assessed by HRCT as a percentage of whole lung lobe volume \> 40%;
• Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe;
• Pregnant or breastfeeding;
• Current enrollment in any other investigational study which has not completed requisite follow-up;

• Age≥18 years old;
• Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT;
• Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study;
• 15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%);
• 6MWD \>140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test)
• mMRC score≥2;
• Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2\>50 mmHg on room air;
• Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment.