Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema (ELEVATE)

Boston Scientific

Status

Completed

Conditions

Emphysema

Treatments

Device: Endobronchial Coils

Study type

Interventional

Funder types

Industry

Identifiers

NCT03360396

BTG-004517-01

Details and patient eligibility

About

This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.

Full 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

Enrollment

120 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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