Status:
WITHDRAWN
Lung Volume Reduction Coils for Emphysema in Alpha-1 Antitrypsin Deficiency
Lead Sponsor:
University Hospital, Saarland
Conditions:
Alpha-1-Antitrypsin Deficiency
Chronic Obstructive Lung Disease
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
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 hyp...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02273349
Start Date
October 1 2014
End Date
October 1 2015
Last Update
May 2 2017
Active Locations (2)
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1
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, DK-2100
2
University Hospital of Saarland
Homburg, Saarland, Germany, 66421