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

Emphysema Clinical Trial

— ELEVATE  

Official title:

A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360396
• Other study ID #: BTG-004517-01
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: November 22, 2022

Study information

• Verified date: August 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 22, 2022
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Device:
• Endobronchial Coils
Endobronchial Coil implants

Locations

Country	Name	City	State
Austria	Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie	Wien
France	CHU Grenoble	Grenoble
France	CHU Montpellier	Montpellier
France	Centre Hospitalier Universitaire de Nice	Nice
France	Hôpital Bichat	Paris
France	CHU de Reims - Hopital Maison Blanche	Reims
France	Nouvel Hôpital Civil	Strasbourg
Germany	Charite Berlin - Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie	Berlin
Germany	Gemeinschaftskrankenhaus Havelhöhe GmbH	Berlin
Germany	Universitätsklinkum Bonn	Bonn
Germany	Ruhrlandklinik Essen	Essen
Germany	Thoraxklinik	Heidelberg
Germany	Lungenklinik	Hemer
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	Klinikverbund Kempten-Oberallgäu	Immenstädt
Germany	Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH	Stuttgart
Italy	Ospedale Careggi	Firenze
Netherlands	University Medical Center Groningen	Groningen
United Kingdom	Royal Brompton Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	PneumRx, Inc.

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in FEV1 at 6 Months	Percent change in FEV1	6 months
Primary	Absolute Change in SGRQ Score at 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	6 months