Lung Volume Reduction Coils for Emphysema in Alpha-1 Antitrypsin Deficiency

NCT ID: NCT02273349

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-10-31

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 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.

Conditions

Alpha-1-Antitrypsin Deficiency; Chronic Obstructive Lung Disease; Emphysema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Patients with Alpha-1-Antitrypsin deficiency treated with endoscopic lung volume reduction using Lung Volume Reduction Coils (PneumRx Inc.)

Group Type: EXPERIMENTAL

Lung Volume Reduction Coil (PneumrX Inc.)

Intervention Type: DEVICE

Endoscopic Lung Volume Reduction

Interventions

Lung Volume Reduction Coil (PneumrX Inc.)

Endoscopic Lung Volume Reduction

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient > 18 years of age, diagnosed with AATD emphysema

2. 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).

3. Patient has post- bronchodilator FEV1 less than or equal to 45% predicted

4. Total Lung Capacity > 100%

5. Residual Volume (RV) >175% predicted

6. Patient has stopped smoking for a minimum of 8 weeks prior to entering the study

7. Patient has read, understood and signed the Informed Consent form

8. Patient is willing and able to attend all required follow-up visits

9. Patient is willing and able to undergo bilateral LVRC treatment

10. Patient has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy

Exclusion Criteria

1. Patient has a change in FEV1 > 20% post-bronchodilator.

2. Patients DLCO < 20% predicted

3. Patient has a history of recurrent clinically significant respiratory infection

4. Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure >50mmHg and or evidenced by echocardiogram

5. Patient has an inability to walk >140 meters (150 yards) in 6 minutes

6. Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc.

7. Patient is pregnant or lactating

8. Patient has an inability to tolerate bronchoscopy under moderate sedation or anesthesia

9. Patient has clinically significant bronchiectasis

10. Patient has giant bullae > 1/3 lung volume

11. Patient has had previous LVR surgery, lung transplant or lobectomy

12. Patient has been involved in other pulmonary drug or device studies with 30 days prior to this study

13. Patient is taking > 20mg prednisone (or similar steroid) daily

14. 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

15. Patient has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

16. Patient has severe homogeneous emphysema by CT scan.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Saarland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rigshospitalet, University of Copenhagen

Copenhagen, , Denmark

University Hospital of Saarland

Homburg, Saarland, Germany

Countries

Denmark; Germany

Other Identifiers

PL001-AATD

Identifier Type: -

Identifier Source: org_study_id