A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema - Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study (IMPACT)

Pulmonx International Sàrl0 个研究点目标入组 93 人开始时间: 2015年1月15日最近更新: 2024年8月19日

适应症

试验速览

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•1. Diagnosis of homogeneous emphysema with a heterogeneity index of < 15%
•between target and adjacent lobes
•2. Subjects of both genders of at least 40 years of age 3. Understand and voluntarily sign a patient informed consent form 4. Diagnosis of COPD with a 15 % predicted = FEV1= 45% predicted despite
•optimal medical management 5. TLC > 100% predicted, RV = 200% predicted 6. 6MWT > 150 meters 7. Non-smoker >8weeks prior to signing the Informed Consent 8. CV negative target lobe

•1. Evidence of active pulmonary infection 2. History of more than 3 exacerbations with hospitalizations over the past 12 months 3. Evidence of pulmonary hypertension (sPAP > 45mmHg) 4. Myocardial infarction or other relevant cardiovascular events in the past 6 months 5. Evidence of Alpha 1 antitrypsin deficiency
•6. Evidence of severe bronchiectasis with greater than two tablespoons of sputum production per day7. Prior LVR or LVRS procedure8. Pulmonary nodule requiring follow-up within the target lobe9. > 20% difference in perfusion between left and right lung10. Pregnant or nursing women11. Hypercapnia (paCO2 > 55mmHg)12. Asthma 13. > 25mg Prednisolone (or equivalent) use/days14. Systemic or malignant disease with high probability of mortality within 12 months15. Severe bullous emphysema (> 1/3 of the Hemithorax)

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