Table 2.
The ELEVATE trial exclusion criteria
| − Meets any of the contraindications listed in the instructions for use |
| − Primary diagnosis of asthma |
| − Two or more exacerbations of chronic obstructive pulmonary disease (COPD) in the prior year, or 1 or more COPD exacerbations in the prior 3 months with indication for hospitalization assessment according to GOLD 2017 recommendations |
| − Predominant small-airway disease defined as significant bronchiectasis with sputum production (>2 tablespoons daily) or significant bronchial wall thickening per high-resolution CT |
| − Percent low attenuation area <20% in the most damaged lobe of either lung |
| − CT imaging consistent with active pulmonary infection, significant interstitial disease, or pleural disease (predominant bulla >8 cm or 1/3 hemithorax), or severe bullous or predominant paraseptal emphysema pattern |
| − Lung pathology of nodule not proven stable or benign |
| − Radiographic confirmation of atelectasis or other scarring/fibrosis in areas of intended coil implantation |
| − Use of >10 mg/day prednisolone or equivalent dosage of a different corticosteroid |
| − Severe pulmonary hypertension (right ventricular systolic pressure >50 mm Hg or other signs of pulmonary hypertension with right ventricular dysfunction) |
| − Severe hypercapnia (PaCO2 >55 mm Hg on room air) and/or severe hypoxemia (PaO2 <45 mm Hg on room air, high altitude criterion: PaO2 <30 mm Hg) |
| − Previous lung volume reduction (LVR) surgery, lung transplantation, lobectomy, LVR devices, or other device to treat COPD in either lung |
| − Diagnosed with α1-antitrypsin deficiency |
| − Diffusing capacity of the lung for CO <20% |
| − Significant, recent, or unstable cardiac disease defined as severe heart failure (left ventricular ejection fraction <45% despite optimal medical management), unstable cardiac arrhythmia, or coronary artery disease (angina on activity), or ischemic event in the past 6 months |
| − Body mass index >30 |
GOLD, Global Strategy for the Diagnosis, Management, and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017.