Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema
- Conditions
- Emphysema
- Interventions
- Device: Endobronchial Coils
- Registration Number
- NCT03360396
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.
- Detailed Description
This will be a prospective, multicenter, randomized, controlled study comparing outcomes between the Endobronchial Coil and Control Groups. Subjects will be block randomized in a Treatment to Control ratio of 2:1. The randomization will be stratified by site and homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the Treatment and Control Groups
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Read, understood and signed the Informed Consent form
- Meets indications for use per the IFU
- Bilateral heterogeneous and/or homogeneous emphysema
- Post bronchodilator 15% predicted ≤ Forced Expiratory Volume in 1 second (FEV1) ≤ 45% predicted
- Post bronchodilator Residual Volume (RV) ≥ 200% predicted
- Post bronchodilator Total Lung Capacity (TLC) >100% pred.
- Post bronchodilator RV/TLC > 55%
- Dyspnea related to hyperinflation scored ≥ 2 on modified Medical Research Council (mMRC) dyspnea scale despite optimal medical management
- Receiving optimal drug therapy and medical management according to clinical practice.
- Performing regular physical activity, at least 2 times per week
- Stopped smoking as confirmed by carboxyhemoglobin (CoHB)
- 100m ≤ 6 minute walk distance (6MWD) ≤ 450m
- Deemed eligible per Eligibility Review Committee (ERC)
- if treated in France, subject must be entitled to French social security.
- Known sensitivity to drugs required for performing bronchoscopy or in whom bronchoscopic procedures are contraindicated
- Evidence of active infection in the lungs
- Hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent metals
- Clinical significant pulmonary fibrosis
- Clinically significant, generalized bronchiectasis
- Clinically significant bleeding disorders
- Patient taking immunosuppressive drugs other than steroids (e.g., for the treatment of cancer, rheumatoid arthritis, autoimmune disease, or prevention of tissue or organ rejection).
- Primary diagnosis of asthma
- Two (2) or more COPD exacerbations in the prior year, or 1 or more COPD exacerbations in the prior 3 months with indication for hospitalization assessment, according to GOLD 2017 recommendations .
- Predominant small airways disease defined as significant bronchiectasis with sputum production (> 2 tablespoons daily) or significant bronchial wall thickening per High Resolution Computed Tomography (HRCT)
- Percent Low Attenuation Area (%LAA) < 20% in the most damaged lobe of either lung.
- Computed Tomography (CT) Imaging consistent with active pulmonary infection, significant interstitial disease or pleural disease
- Severe bullous disease (defined by bulla > 8cm or 1/3 of lung volume, or single bullous defect >8 cm) or predominant paraseptal emphysema [defined by numerous large (>1cm) paraseptal defects in the target lobe comprising of >5% of total lung volume].
- Lung pathology of nodule not proven stable or benign
- Radiographic confirmation of atelectasis or other scarring/fibrosis in areas of intended Coil implant
- Use of more than 20 mg/day prednisolone or equivalent dosage of a different corticosteroid
- Severe pulmonary hypertension (Right Ventricular Systolic Pressure (RVSP) > 50 mm Hg or other signs of Pulmonary Hypertension (PHT) with right ventricular dysfunction)
- Severe hypercapnia (PaCO2 > 55 mmHg on room air) and/or severe hypoxemia (PaO2 < 45mm Hg on room air, High altitude criterion: PaO2 < 30 mm Hg)
- Previous Lung Volume Reduction (LVR) surgery, lung transplantation, lobectomy, LVR devices or other device to treat COPD in either lung.
- Diagnosed with alpha-1 antitrypsin deficiency
- Diffusion Capacity of the lungs for Carbon Monoxide (DLCO) < 20 %
- Significant, recent or unstable cardiac disease defined as severe heart failure (Left Ventricular Ejection Fraction (LVEF) < 45% despite optimal medical management), unstable cardiac arrhythmia or coronary artery disease (angina on activity), or ischemic event in the past 6 months.
- Body Mass Index (BMI) > 30
- Participation in any other clinical Study.
- Subject is pregnant or lactating, or plan to become pregnant within the study timeframe.
- If treated in France, Subject is a "personnel vulnerable" as defined by French Regulation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endobronchial Coils Endobronchial Coils Treatment with PneumRx Endobronchial Coil System
- Primary Outcome Measures
Name Time Method Absolute Change in SGRQ Score at 6 Months 6 months Change in SGRQ score - St. George Respiratory Questionnaire from 0 to 100, higher score indicating more limitations (worse), increase in score indicating worse outcome, decrease in score indicating improvement
Percent Change in FEV1 at 6 Months 6 months Percent change in FEV1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
CHU Grenoble
🇫🇷Grenoble, France
Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie
🇦🇹Wien, Austria
Centre Hospitalier Universitaire de Nice
🇫🇷Nice, France
CHU de Reims - Hopital Maison Blanche
🇫🇷Reims, France
Charite Berlin - Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie
🇩🇪Berlin, Germany
Universitätsklinkum Bonn
🇩🇪Bonn, Germany
Ruhrlandklinik Essen
🇩🇪Essen, Germany
Thoraxklinik
🇩🇪Heidelberg, Germany
Lungenklinik
🇩🇪Hemer, Germany
Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
🇩🇪Stuttgart, Germany
Lungenfachklinik Immenhausen
🇩🇪Immenhausen, Germany
Klinikverbund Kempten-Oberallgäu
🇩🇪Immenstädt, Germany
CHU Montpellier
🇫🇷Montpellier, France
Hôpital Bichat
🇫🇷Paris, France
Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Ospedale Careggi
🇮🇹Firenze, Italy
Gemeinschaftskrankenhaus Havelhöhe GmbH
🇩🇪Berlin, Germany
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Royal Brompton Hospital
🇬🇧London, United Kingdom