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

Sponsor

University Hospital, Saarland (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02273349

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alpha-1-Antitrypsin Deficiency Chronic Obstructive Lung Disease Emphysema	Device: Lung Volume Reduction Coil (PneumrX Inc.)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema in Alpha-1 Antitrypsin Deficient Patients

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2015

Anticipated Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Patients with Alpha-1-Antitrypsin deficiency treated with endoscopic lung volume reduction using Lung Volume Reduction Coils (PneumRx Inc.)	Device: Lung Volume Reduction Coil (PneumrX Inc.) Endoscopic Lung Volume Reduction

Arm

Intervention/Treatment

Experimental: Treatment

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

Device: Lung Volume Reduction Coil (PneumrX Inc.)

Endoscopic Lung Volume Reduction

Outcome Measures

Primary Outcome Measures

symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) compared to the 6 months Follow-up Visit [6 months]
Quality of Life

Secondary Outcome Measures

Percent change in FEV1 from Baseline (Pre-Treatment Visit) [6 and 12 months]
Lung function
Decrease in the Residual Volume and the RV/TLC ratio [6 and 12 months]
Lung function
Improvement in the 6 minute walk distance [6 and 12 months]
6MWT
Changes in mMRC Dyspnoe Scale [6 and 12 months]
mMRC

Other Outcome Measures

Number and type of device-related and procedure-related serious adverse events (SAE) attributed to the use of RePneu LVRC [up to 6 months]
SAE device and procedure related

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.