NL-OMON41236已完成不适用
A Multi-center, Prospective, Randomized, Controlled Single Arm Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema. - IMPACT-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •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 day
- •7. Prior LVR or LVRS procedure
- •8. Pulmonary nodule requiring follow-up within the target lobe
- •9. > 20% difference in perfusion between left and right lung
- •10. Pregnant or nursing women
- •11. Hypercapnia (paCO2 > 55mmHg)
- •12. Asthma
- •13. > 25mg Aprednislon (or equivalent) use/days
- •14. Systemic or malignant disease with high probability of mortality within 12 months
- •15. Severe bullous emphysema
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