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

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

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

Study Overview

• Status: Completed
• Conditions: Emphysema
• Intervention / Treatment: Device: Endobronchial Coils

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria
    • Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie
• France
  • Grenoble, France
    • CHU Grenoble
  • Montpellier, France
    • CHU Montpellier
  • Nice, France, CS 51069
    • Centre Hospitalier Universitaire de Nice
  • Paris, France
    • Hôpital Bichat
  • Reims, France, 51092
    • CHU de Reims - Hôpital Maison Blanche
  • Strasbourg, France, 67091
    • Nouvel Hopital Civil
• Germany
  • Berlin, Germany
    • Charite Berlin - Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie
  • Berlin, Germany
    • Gemeinschaftskrankenhaus Havelhöhe GmbH
  • Bonn, Germany
    • Universitätsklinkum Bonn
  • Essen, Germany
    • Ruhrlandklinik Essen
  • Heidelberg, Germany
    • Thoraxklinik
  • Hemer, Germany
    • Lungenklinik
  • Immenhausen, Germany, 34376
    • Lungenfachklinik Immenhausen
  • Immenstädt, Germany
    • Klinikverbund Kempten-Oberallgäu
  • Stuttgart, Germany
    • Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
• Italy
  • Firenze, Italy
    • Ospedale Careggi
• Netherlands
  • Groningen, Netherlands, 3150-3610536
    • University Medical Center Groningen
• United Kingdom
  • London, United Kingdom
    • Royal Brompton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endobronchial Coils; Treatment with PneumRx Endobronchial Coil System	Device: Endobronchial Coils; Endobronchial Coil implants
No Intervention: Control; Medically-managed control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in FEV1 at 6 Months	Percent change in FEV1	6 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Analyses Post Primary Endpoint	Descriptive statistics will summarize effectiveness endpoints at 12 and 36 months for all coil treated subjects in France.	12 and 36 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: PneumRx, Inc.
• Investigators: Principal Investigator: Felix Herth, MD,, University Hospital Heidelberg; Principal Investigator: Arschang Valipour, MD,FCCP,PhD, Nord-Klinik Floridsdorf

Publications and helpful links

General Publications

• Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: severe heterogeneous emphysema; severe homogeneous emphysema
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: BTG-004517-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes