NCT02273349撤回不适用
Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema in Alpha-1 Antitrypsin Deficient Patients
University Hospital, Saarland4 个研究点 分布在 2 个国家开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) compared to the 6 months Follow-up Visit
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused emphysema. The hypothesis is that emphysema in AATD patients shows similar tissue destruction profile was well as symptoms and thus will respond favorably to LVRC treatment, demonstrating improvement in lung function, exercise capacity, and quality of life relative to their baseline status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 18 years of age, diagnosed with AATD emphysema
- •CT scan indicates bilateral heterogeneous or non-severe homogeneous emphysema, with sufficient lung parenchyma for coil deployment, in accordance with manufacturer recommendations (see section 5.2.4.1).
- •Patient has post- bronchodilator FEV1 less than or equal to 45% predicted
- •Total Lung Capacity > 100%
- •Residual Volume (RV) >175% predicted
- •Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
- •Patient has read, understood and signed the Informed Consent form
- •Patient is willing and able to attend all required follow-up visits
- •Patient is willing and able to undergo bilateral LVRC treatment
- •Patient has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy
排除标准
- •Patient has a change in FEV1 > 20% post-bronchodilator.
- •Patients DLCO < 20% predicted
- •Patient has a history of recurrent clinically significant respiratory infection
- •Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure >50mmHg and or evidenced by echocardiogram
- •Patient has an inability to walk >140 meters (150 yards) in 6 minutes
- •Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc.
- •Patient is pregnant or lactating
- •Patient has an inability to tolerate bronchoscopy under moderate sedation or anesthesia
- •Patient has clinically significant bronchiectasis
- •Patient has giant bullae > 1/3 lung volume
- •Patient has had previous LVR surgery, lung transplant or lobectomy
- •Patient has been involved in other pulmonary drug or device studies with 30 days prior to this study
- •Patient is taking > 20mg prednisone (or similar steroid) daily
- •Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as heparin or coumadin) or has not been weaned off prior to procedure
- •Patient has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
- •Patient has severe homogeneous emphysema by CT scan.
结局指标
主要结局
symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) compared to the 6 months Follow-up Visit
时间窗: 6 months
Quality of Life
次要结局
- Changes in mMRC Dyspnoe Scale(6 and 12 months)
- Percent change in FEV1 from Baseline (Pre-Treatment Visit)(6 and 12 months)
- Decrease in the Residual Volume and the RV/TLC ratio(6 and 12 months)
- Improvement in the 6 minute walk distance(6 and 12 months)
研究者
研究点 (4)
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