A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema
Phase: NA
Conditions: Emphysema
Sponsor: Boston Scientific Corporation

A RandomizEd ControLed Study of PnEumRx Endobronchial Coil System Versus Standard-of-Care 
Medical MAnagement in the Treatment of Subjects with Severe Emphysema (ELEVATE) 
 
NCT03360396 
 
Effective Date of Initial Version: 10 January 2018 
Effective Date of Final Version: 04 September 2020  

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Protocol Number:
BTG-004517-01-FR
Protocol Name:
A RandomizEd ControlLed Study of PnEumRx Endobronchial Coil 
System Versus Standard-of-Care Medical MAnagement in the 
Treatment of Subjects with Severe Emphysema (ELEVATE)
Global Sponsor:
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, MA 01752, USA
Global Principal 
Investigator(s):
Felix Herth, M.D. 
Professor of Medicine
Head, Department of Internal Medicine, Pulmonary and Critical Care 
Medicine
Thoraxklinik at Heidelberg University Hospital 
Amalienstr. 5
69126 Heidelberg
Arschang Valipour, M.D.; FCCP; PhD; Assistant Professor Head, 
Department of Respiratory and Critical Care Medicine
Krankenhaus Nord-Klinik Floridsdorf 
Brünner Straße 68
1210 Vienna, Austria
Sponsor Medical Expert
Thomas Bowman, M.D.
300 Boston Scientific Way
Marlborough, MA 01752, USA
+1 (508) 683-6580
Study Device
PneumRx Endobronchial Coil System 
With CE Mark
Protocol ver.7.0 Approval 
Date:
See Header
Protocol Amendment ver. 
Approval Date:
N/A
This document is the confidential property of the Sponsor. No part of it may be transmitted, reproduced, 
published, or used by other persons without prior written permission.
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This protocol contains confidential information for use by the Investigators and their designated representatives 
participating in this clinical investigation. The protocol should be held confidential and maintained in a secure 
location.
Do not copy or distribute without written permission from Boston Scientific Corporation.
TABLE 1: Protocol Revision History
VERSION 
NUMBER
AMENDMENT 
APPROVAL 
DATE
BRIEF DESCRIPTION OF CHANGES
Ver. 1
10-Jan-2018
Original Release
Ver. 2
26-Apr-2018
Changes and clarifications as per ANSM feedback
Ver. 3
09-May-2018
Addition of mandatory Pregnancy Test as per ANSM request
Ver. 4
29-May-2018
Adaptations according to new IFU Version J
Ver. 5
05-Mar-2020
Reduced scope as per ANSM alignment
Ver. 6
4Aug2020
x
Change in sponsorship to Boston Scientific
Corporation (BSC)
x
Updates to Safety Section 7 to align with the ISO 
14155 & MEDDEV 27.3 Event Definitions and BSC 
Event Reporting Requirements
Ver. 7
See Header
x
Updates per ANSM Feedback
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PROTOCOL APPROVAL & RELEASE 
SIGNATURE PAGE
Protocol Number:
BTG-004517-01-FR
Protocol Name:
A RandomizEd ControlLed Study of PnEumRx Endobronchial Coil System Versus
Standard-of-Care Medical MAnagement in the Treatment of Subjects with Severe
Emphysema (ELEVATE)
Protocol Version:
Ver. 7
Protocol Approval Date:
See Header
The above-referenced protocol was reviewed and approved for release by the following:
Approver
Printed
Name
Signature
Date (DD/MMM/YYYY)
Principal
Investigator
Sponsor: Senior
Manager Clinical 
Development
Sponsor: 
Statistician
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GLOBAL PRINCIPAL INVESTIGATOR 
SIGNATURE
Protocol Number:
BTG-004517-01-FR
Protocol Name:
A RandomizEd ControlLed Study of PnEumRx Endobronchial Coil
System Versus Standard-of-Care Medical MAnagement in the
Treatment of Subjects with Severe Emphysema (ELEVATE)
Protocol Version:
Ver. 7
Protocol Approval Date:
See Header
The Global Principal Investigator (undersigned) hereby declares that he/she has read this protocol and agrees
to its contents.
The undersigned confirms that the trial will be conducted and documented in accordance with the Declaration of
Helsinki, the protocol, standards ISO 14155:2011 E, Clinical investigation of medical devices for human subjects –
Good Clinical Practice, applicable laws and regulatory requirements specified in the protocol, and the stipulations 
of the clinical trial agreement.
Investigator Name (please print):  
                                            
Investigator Signature:
Date (DD/MMM/YYYY):
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COUNTRY COORDINATING 
INVESTIGATOR SIGNATURE
Protocol Number:
BTG-004517-01-FR
Protocol Name:
A RandomizEd ControlLed Study of PnEumRx Endobronchial Coil
System Versus Standard-of-Care Medical MAnagement in the
Treatment of Subjects with Severe Emphysema (ELEVATE)
Protocol Version:
Ver. 7
Protocol Approval Date:
See Header
The Country Coordinating Investigator (undersigned) hereby declares that he/she has read this protocol and 
agrees to its content.
The undersigned confirms that the trial will be conducted and documented in accordance with the Declaration 
of Helsinki, the protocol, ISO 14155:2011 E, Clinical investigation of medical devices for human subjects –
Good Clinical Practice, applicable laws and regulatory requirements specified in the protocol, and the 
stipulations of the clinical trial agreement.
Investigator Name (please print):  
Investigator Signature:
Date (DD/MMM/YYYY):
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INVESTIGATOR PROTOCOL REVIEW 
STATEMENT
Protocol Number:
BTG-004517-01-FR
Protocol Name:
A RandomizEd ControlLed Study of PnEumRx Endobronchial Coil
System Versus Standard-of-Care Medical MAnagement in the
Treatment of Subjects with Severe Emphysema (ELEVATE)
Protocol Version:
Ver. 7
Protocol Approval Date:
See Header
The site Principal Investigator (undersigned) hereby declares that he/she has read this protocol and agrees to its
contents.
The undersigned confirms that the trial will be conducted and documented in accordance with the Declaration of 
Helsinki, the protocol, ISO 14155:2011 E, Clinical investigation of medical devices for  human  subjects  – Good 
Clinical Practice, applicable laws and regulatory requirements specified in the protocol, and the stipulations of the 
clinical trial agreement.
By written consent to this protocol, the investigator agrees to the above and to fully co-operate with  all monitoring 
and audits in relation to this trial by allowing  direct  access  to all  documentation, including source data, by authorized 
individuals representing Boston Scientific Corporation, IEC/IRBs and/or by regulatory authorities.
Investigator Name (please print):  
Investigator Signature:
Date (DD/MMM/YYYY):
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Table of Contents
Table of Contents 
PROTOCOL APPROVAL & RELEASE SIGNATURE PAGE ....................................................................................3 
GLOBAL PRINCIPAL INVESTIGATOR SIGNATURE ...............................................................................................4 
1 
SCHEDULE OF VISITS..........................................................................................................................19 
2 
BACKGROUND.......................................................................................................................................21 
2.1 
Disease Background.................................................................................................................21 
2.2 
General Description of Investigative Agent(s)/Device ...........................................................22 
2.3 
Summary of Prior Clinical Experience with the Coil System..................................................23 
3 
TRIAL OBJECTIVE(S) ...........................................................................................................................24 
3.1 
Trial Objectives..........................................................................................................................24 
3.2 
Trial Design................................................................................................................................24 
3.3 
Randomization...........................................................................................................................24 
3.4 
Primary Endpoint (s) ................................................................................................................24 
4 
SUBJECT SELECTION..........................................................................................................................25 
4.1 
Patient Population .....................................................................................................................25 
4.2 
Subject Selection ......................................................................................................................25 
4.3 
Subject Crossover ....................................................................................................................27 
4.4 
Subject Withdrawal ...................................................................................................................27 
5 
TREATMENT OF SUBJECTS ................................................................................................................28 
5.1 Coil System......................................................................................................................................28 
6 
MEASUREMENTS AND EVALUATIONS................................................................................................31 
6.1 
Treatment Group Assignment .................................................................................................31 
6.2 
Pulmonary Function Central Laboratory................................................................................31 
6.3 
Central Imaging Review............................................................................................................31 
6.4 
Time and EventSchedule..........................................................................................................31 
6.5 
Trial Evaluations and Procedures............................................................................................34 
7 
ADVERSE EVENTS ................................................................................................................................37 
7.1 
Adverse Event Definitions........................................................................................................37 
7.2 
Recording Adverse Events (AE) ..............................................................................................38 
7.3 
Recording and Reporting Device Deficiencies.......................................................................39 
7.4 
Device and Procedure Causality Assessment........................................................................39 
7.5 
Submitting Expedited Safety Reports .....................................................................................39 
7.6 
Periodic Safety Reporting.........................................................................................................39 
7.7 
Expected Adverse Events.........................................................................................................39 
8 
STATISTICAL CONSIDERATIONS..........................................................................................................40 
8.1 
Trial Design and Determination of Sample Size .....................................................................40 
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8.2 
Statistical Analysis....................................................................................................................41 
8.3 
Analysis Populations and Sub-Groups...................................................................................41 
8.4 
Baseline and Demographic Characteristics ...........................................................................41 
8.5 
Efficacy Analyses......................................................................................................................41 
8.6 
Safety Analyses.........................................................................................................................42 
9 
DATA MANAGEMENT............................................................................................................................42 
10LEGAL//ETHICS AND ADMINISTRATIVE PROCEDURES..........................................................................43 
10.1 
Good Clinical Practice/Regulatory Compliance .....................................................................43 
10.2 
Trial Site and Investigator Qualification..................................................................................43 
10.3 
Institutional Review Board (IRB)/Independent Ethics Committees (IEC) .............................45 
10.4 
Informed Consent – Ethical Compliance .................................................................................45 
10.5 
Subject Privacy and Confidentiality.........................................................................................46 
10.6 
Trial Monitoring..........................................................................................................................46 
10.7 
Modification of the Protocol......................................................................................................47 
10.8 
Suspension or Termination of Trial..........................................................................................47 
10.9 
Departure from Protocol ..........................................................................................................47 
10.10 Potential Risks to Subjects......................................................................................................47 
10.11 Potential Benefits to Subjects and Society.............................................................................47 
10.12 Financial Considerations .........................................................................................................48 
10.13 Recording, Access to and Retention of SourceData .............................................................48 
10.14 Electronic Case Report Forms..................................................................................................49 
10.15 Publications................................................................................................................................49 
10.16 Audit/Inspections ......................................................................................................................49 
11 
BIBLIOGRAPHY.....................................................................................................................................50 
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TABLE 2: TERMS, ACRONYMS, ABBREVIATIONS
The following abbreviations and specialist terms are used in this protocol.
6MWD
6 Minute Walk Distance
6MWT
6 Minute Walk Test
ABG
Arterial Blood Gases
AE
Adverse Event
ANSM
Agence Nationale de Sécurité du Médicament et des produits de 
santé
ATS
American Thoracic Society
BG
Blood Gas
BMI
Body Mass Index
BP
Blood Pressure
CAIRS
Coil Associated Inflammatory Response Syndrome
CAO
Coil Associated Opacity
CAT
COPD Assessment Test
CI
Confidence Interval
CO2
Carbon Dioxide
CoHB
Carboxyhemoglobin
COPD
Chronic Obstructive Pulmonary Disease
CPP
Comité de Protection des Personnes
CT
Computed Tomography
CV
Curriculum Vitae
DLCO
Diffusion Capacity for the Lungs for Carbon Monoxide
DSMB
Data Safety Monitoring Board
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
EQ-5D
EuroQol-5 Dimensions quality of life questionnaire
ERC
Eligibility Review Committee
ERS
European Respiratory Society
eTMF
Electronic Trial Master File
EU
European Union
FDA
Food and Drug Administration
FEV1
Forced Expiratory Volume in 1 second
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GCP
Good Clinical Practice
Hg(mm Hg)
Mercury (millimeters of Mercury)
HR
Heart Rate
HRCT
High Resolution Computed Tomography
HU
Hounsfield Unit
ICF
Informed Consent Form
IEC
Independent Ethics Committee
IFU
Instructions for Use
IRB
Institutional Review Board
ITT
Intent-to-Treat
LAA
Low Attenuation Area
LoVRexp
Mean Expiratory Lobar Volume
LVEF
Left Ventricular Ejection Fraction
LVR
Lung Volume Reduction
LVRS
Lung Volume Reduction Surgery
MCID
Minimum Clinical Important Difference
MCMC
Markov chain Monte Carlo
MedDRA
Medical Dictionary for Regulatory Activities
mMRC
Modified Medical Research Council
OUS
Outside United States
PA
Posterior anterior
PaCO2
Partial Pressure of Carbon Dioxide in Arterial Blood
PaO2
Partial Pressure of Oxygen in Arterial Blood
PFT
Pulmonary Function Testing
PHT
Pulmonary Hypertension
PI
Principal Investigator
PP
Per Protocol
QCT
Quantitative Computed Tomography
QOL
Quality of Life
RV
Residual Volume
RVSP
Right Ventricular Systolic Pressure
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
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SDV
Source Data Verification
SGRQ
Saint George’s Respiratory Questionnaire
SoC
Standard of Care
SOC
System Organ Class
SOI
Study Operations Instructions
SOP
Standard Operating Procedure
SD
Standard Deviation
T
Temperature
TLC
Total Lung Capacity
Tx
Treatment
UADE
Unanticipated Adverse Device Effect
US
United States
USADE
Unanticipated Serious Adverse Device Effect
VC
Vital Capacity
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PROTOCOL SYNOPSIS
Reference
BTG-004517-01-FR
Title:
A RandomizEd ControlLed Study of PnEumRx Endobronchial Coil
System Versus Standard-of-Care Medical MAnagement in the  Treatment 
of Subjects with Severe Emphysema (ELEVATE)
Sponsor:
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, MA 01752, USA
Timelines and duration:
Study Duration: All Subjects randomized to Treatment will be followed 
for 36 months post initial treatment. Subjects randomized to Control will 
be eligible to crossover and receive treatment as soon as possible. 
Crossover subjects will then be followed for 36 months post initial 
treatment. Control subjects who choose not to crossover will exit the 
study immediately.
Expected Enrollment Start:  Early 2018 
Estimated Study Completion: First half 2023
METHOD
Design:
Prospective, multicenter, open label, randomized (2:1), controlled study 
comparing outcomes in subjects treated with the PneumRx 
Endobronchial Coil System (Coil) to a medically-managed control group. 
The medically-managed control group will be eligible to crossover after 6
months.
Population:
The population studied included severe emphysema patients indicated for 
Coil treatment per the approved,  CE marked Instructions  for  Use (IFU), 
who met the following inclusion criteria and  did not  meet any  of the 
exclusion criteria.
Inclusion Criteria:
1.
Read, understood and signed the Informed Consent form
2.
Meets indications for use per the IFU
3.
Bilateral heterogeneous and/or homogeneous emphysema
4.
15% predicted 3RVWbronchodilator Forced Expiratory Volume in 1
second (FEV1) 45% predicted
5.
Post bronchodilator Residual Volume (RV) 200% predicted
6.
Post bronchodilator Total Lung Capacity (TLC) >100% pred.
7.
Post bronchodilator RV/TLC >55%
8.
Dyspnea related to hyperinflation VFRUHGon modified Medical 
Research Council (mMRC) dyspnea scale despite optimal medical 
management
9.
Receiving optimal drug therapy and medical management according 
to clinical practice.
10. Performing regular physical activity, at least 2 times per week 
1
1 The World Health Organization defines physical activity as any bodily movement produced by skeletal muscles that 
requires energy expenditure – including activities undertaken while working, playing, carrying out household chores,
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11. Stopped smoking as confirmed by carboxyhemoglobin(CoHB)
12. 100m minute walk distance (6MWD)  450m
13. Deemed eligible per Eligibility Review Committee (ERC)
14. If treated in France, Subject must be entitled to French social 
security.
Exclusion Criteria:
1.
Known sensitivity to drugs required for performing bronchoscopy or in 
whom bronchoscopic procedures are contraindicated
2.
Evidence of active infection in the lungs
3.
Hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent 
metals
4.
Clinically significant pulmonary fibrosis
5.
Clinically significant, generalized bronchiectasis
6.
Clinically significant bleeding disorders
7.
Patient taking immunosuppressive drugs other than steroids (e.g., for 
the treatment of cancer, rheumatoid arthritis, autoimmune disease, or 
prevention of tissue or organrejection).
8.
Primary diagnosis of asthma
9.
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 
recommendations2.
10. 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)
11. Percent Low Attenuation Area (%LAA) < 20% in the mostdamaged
lobe of either lung.
12. Computed Tomography (CT) Imaging consistent with active 
pulmonary infection, significant interstitial disease or pleural disease
13. Severe bullous disease (defined by bulla > 1/3 of lung volume, or 
single bullous defect > 8cm) or significant paraseptal emphysema 
[defined by numerous large (>1cm) paraseptal defects in the target 
lobe comprising >5% of total lung volume]. Lung pathology of nodule 
not proven stable or benign
14. Radiographic confirmation of atelectasis or other scarring/fibrosis in 
areas of intended Coil implant
15. Use of more than 20 mg/day prednisone (or equivalent dosage of a
similar steroid) daily
16. Severe pulmonary hypertension (Right Ventricular Systolic Pressure
(RVSP) > 50 mm Hg (preferably measured by right heart 
catheterization) or other signs of Pulmonary Hypertension (PHT) with
travelling, and engaging in recreational pursuits. For those with limited mobility, this should be done at least 2 days per 
week.
2 Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung
Disease (GOLD) 2017
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right  ventricular dysfunction)
17. 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)
18. Previous Lung Volume Reduction (LVR) surgery, lung 
transplantation, lobectomy, LVR devices or other device to treat 
COPD in either lung.
19. Diagnosed with alpha-1 antitrypsin deficiency
20. Diffusion Capacity of the Lungs for Carbon Monoxide (DLCO)< 20 %
21. 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.
22. Body Mass Index (BMI) > 30
23. Participation in any other clinical study.
24. Subject is pregnant or lactating, or plan to become pregnant within 
the study timeframe.
25. If treated in France, Subject is a “personne vulnerable” as defined by 
French regulation
Eligibility Review
Committee:
Final eligibility was be confirmed by an expert panel of experienced 
interventionalists, the Eligibility Review Committee (ERC), prior to
randomization.
Participating sites:
Up to 30 centers across Europe were invited to participate. Sites were
selected based on their experience with the Coil System, expertise in
interventional bronchoscopy and operational and multidisciplinary 
resource availability.
Visits and Assessments:
Baseline Visit:
After obtaining Subject consent, the Subject’s eligibility for Treatment was 
evaluated. Relevant medical history, medications, comorbidities, previous  
treatments of emphysema, physical activity  / rehabilitation status, and 
baseline characteristics were collected and entered into the Electronic 
Data Capture (EDC) system. Pulmonary Function Test (PFT), pregnancy 
test, imaging (HRCT scan inspiratory and  expiratory,), exercise testing (6 
Minute Walk Test – 6MWT), dyspnea assessment (mMRC), quality of life 
(QoL) assessment (St Georges Respiratory Questionnaire (SGRQ), 
COPD Assessment Test (CAT), EuroQol-5 Dimensions QoL 
questionnaire (EQ-5D), and blood gases (BG) were collected. Eligibility 
was reviewed by the ERC, and if deemed eligible, subject was
randomized.
Procedure Visits:
Subjects will undergo the Coil treatment. One lung will be treated per 
procedure, with procedures separated by approximately 2 months. Lobar 
targeting will be based on quantitative CT (QCT) densitometry analysis
and Coils will be placed in the lobe with the higher LAA as measured in 
Hounsfield units (HU) at a -950 HU threshold.
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Procedure data, chest X-ray data, adverse event data, pregnancy test, 
and medications will be collected and entered into the EDC system.
Each center’s principal investigator (PI), or one primary implanter, will 
perform all coil treatments in ELEVATE. If necessary, a secondary 
implanter will also be trained as a back-up.
Follow-up Visits:
Follow-up visits should be conducted per the schedule below. Study 
specific follow-up visits should take place during exacerbation free 
periods defined as 30 days with symptoms within normal day-to-day 
variability.
12- and 36-month study follow-up visits will include:
-
PFT
-
AE review
-
Medications
-
Inspiratory and expiratory HRCT
Definition of visit windows:
Patients should have visits scheduled during exacerbation-free periods, 
defined as 30 days with symptoms within normal day to day variability.
Treatment/Control Group Subjects:
Visit:                                      Visit Window:
Baseline                                 Eligibility, Inclusion
Randomization                      
Treatment 1
Treatment 2                           2 months +/- 4 weeks post 1st treatment
12 months post Treatment 1 12 months +/- 4 weeks post 1st treatment
36 months post Treatment 1 36 months +/- 4 weeks post 1st treatment
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Device:
PneumRx Endobronchial Coil System (Coil)
Treatment:
The Coil System is a CE-marked implantable device that is indicated for use 
in patients with homogeneous and/or heterogeneous severe emphysema to 
improve quality of life, lung function, and exercise capacity.
The Coil System consists of sterile Endobronchial Coils which come in 3 
different sizes (100 mm, 125 mm, and 150mm) and a sterile, disposable, 
single-procedure Delivery System consisting of a Cartridge, Catheter, 
Guidewire and Forceps.
The Coil System is designed for bilateral treatment using a therapeutic 
bronchoscope with a 2.8 mm working channel and fluoroscopy for 
visualization beyond the bronchoscope.
Post-treatment pulmonary rehabilitation or exercise program is strongly 
encouraged.
Primary Objectives:
The objective of the study is to prospectively confirm the safety and 
effectiveness profile of Coil treatment in consideration of the findings of 
previous Randomized Controlled Trials.
Co-Primary Effectiveness Endpoints:
x
Percent change in FEV1from baseline to 6 months and
x
Change in SGRQ from baseline to 6 months
Management of Adverse
Events
Safety information will be collected on an ongoing basis throughout the study 
as participating centers become aware that an adverse event has occurred. 
Serious Adverse Events (SAE) and specific respiratory Adverse Events 
(AE) of interest will be recorded on the AE form in the EDC system by the 
investigator or authorized designee.
Event, date of onset, severity, 
seriousness, duration, and relationship to the procedure/device will be 
recorded. All AEs will be followed until they are adequately resolved or 
stabilized or study completion/ termination, whichever comes first.
An AE or suspected adverse reaction is considered "serious" if, in the
view of either the investigator or sponsor, it results in any of the following 
outcomes:
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Death,
Led to serious deterioration in the health of the subject that either 
resulted in
A life threatening illness or injury, or
A permanent impairment of a body structure or a body function, or
In-patient or prolonged hospitalization,or
Medical or surgical intervention to prevent life-threatening illness or injury 
or permanent impairment to a body structure or a body function
Led to fetal distress, fetal death or a congenital anomaly/birth defect.
Information on Specific Respiratory Events of interest will be collected 
and analyzed via event specific case report forms. These events of 
interest include:
x
COPD exacerbation
x
Hemoptysis
x
Pneumothorax
x
Lower Respiratory Tract Infection/Pneumonia
x
Tissue Reaction, Localized (a.k.a. Coil Associated Inflammatory 
Response Syndrome (CAIRS), also called Coil Associated 
Opacity (CAO) in the IFU)
Statistical Analyses:
The co-primary effectiveness endpoint will be analyzed on the intent-to-treat 
(ITT) population through the 6-month visit, using descriptive statistics to 
summarize results separately for treatment and control groups. No 
comparative inferential statistics will be conducted.
Safety analyses will be conducted on the safety population defined as 
those subjects who enter the bronchoscopy suit for the initial Coil 
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procedure. AE and SAEs will be summarized by Treatment group based 
on MedDRA codes. Incidence
rates through
6 months will be 
summarized for treatment and control groups. Events will also be
summarized by relevant, discrete time periods including the Treatment 
recovery period (30 days from either treatment).
Descriptive statistics will summarize percent change in FEV1 as well as 
AEs and SAEs at 12 and 36 months follow-up for all coil treated 
subjects.
RESULTS
Number of subjects to be
analyzed
A total of 120 Subjects were randomized in a 2:1 ratio of Treatment to 
Control, respectively (80 Treatment group subjects, 40 Control group 
subjects).
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Duration of the follow-up
Subjects will continue in the study through 36 months from first Coil 
implant. If Control subjects don’t participate to crossover, they will exit the 
study immediately.
The trial will be conducted and documented in accordance with the Declaration of Helsinki, the protocol, ISO 
14155:2011 E, Clinical investigation of medical devices for human subjects – Good Clinical Practice, 
applicable laws and regulatory requirements specified in the protocol, and the stipulations of the clinical trial 
agreement.
1 SCHEDULE OF VISITS
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Treatment/Control Group Subjects:
Procedure /
Assessment
Baseline
Randomization
Treatment
(Tx) 1*
Treatment
(Tx) 2+++
12 Month
post 
initial 
treatment 
Follow-Up
Visit***
36 
Months 
post 
initial 
treatment 
Follow-Up
Visit***
Informed
Consent
X
Baseline
Assessment1
X
Randomization
X
X
Procedure
Treatment
X
X
X
Medications
X
X
X
X
X
AEs
X
X
X
X
PFTs including
Lung volumes and 
Spirometry
X
X
X
6MWT
X
QOL (SGRQ,
mMRC, CAT, 
EQ5D)
X
HRCT
(inspiratory and 
Expiratory)
X
X
X
Chest X-Ray
X
X2
X2
Pregnancy test
X
X
X
1Includes demographics, medical history, physical exam, vitals, echocardiogram, and additional pre -treatment evaluations 
(e.g. blood panel, blood gas).
2At procedure visits, a Chest X-Ray or a still fluoroscopic image will be performed immediately post procedure. A second chest X-Ray
should be done before discharge, a minimum of 4 hours following the firstchest X-Ray.
*No more than 45 days post baseline visit
+++ 2 months ±4 weeks post initial coil treatment
*** ±4 week
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2 BACKGROUND
2.1 Disease Background
Emphysema is a chronic respiratory disease with an estimated global prevalence of 1.8% (Halbert, 2006). 
Emphysema is characterized by gradual destruction and disappearance of alveolar walls. This results in 
reduction in the elastic recoil pressure of the lungs, and allows the smaller airways to collapse prematurely 
during exhalation, resulting in hyperinflation, air trapping, and diaphragmatic flattening with decreased 
diaphragmatic efficiency. This hyperinflation worsens with rapid breathing associated with exercise. These 
effects are believed to be a primary contributor to the dyspnea experienced by emphysema  patients 
(O’Donnell, 2006). The alveolar wall damage also creates large nonfunctional air pockets or  bullae  that 
become physiologic dead space in the thorax, preventing healthier portions of the lung from expanding and
contracting normally. Patients with advanced emphysema also frequently demonstrate collateral  ventilation  
both within the affected lobes and even across lobar fissures. As the  disease  progresses,  emphysema 
patients  develop  progressive increases in Residual Volume (RV) and Total Lung Capacity (TLC) which lead   
to dyspnea. Eventually patients also develop hypoxemic due to progressive loss of  alveolar  capillary  
membrane surface area. Hypoxemia and deconditioning contribute to muscle weakness and fatigue. The 
crippling effects of end-stage emphysema include severe dyspnea, severe limitation  of  activities, recurrent 
lung infections, and ultimately respiratory failure, which can result in death.
There are several treatments available for emphysema including
medications, physical therapy, 
supplemental oxygen, endobronchial valve procedure, and surgery. Smoking cessation is important in the 
treatment of emphysema to limit the rate of progression of the disease. Emphysema can also be treated 
with inhaled bronchodilators, inhaled corticosteroids, anticholinergics, theophylline, phosphodiesterase-4
inhibitors and supplemental oxygen. Emphysema patients are prone to exacerbations, usually due to 
respiratory infections, which are usually treated with antibiotics and/or systemic corticosteroids and 
frequently require
emergency room visits and/or hospitalizations. Emphysema patients may undergo 
pulmonary rehabilitation exercises and training. There are also two surgical procedures available for 
treatment of severe emphysema: lung transplantation and lung volume reduction surgery (LVRS). Lung 
transplantation  is a seldom used option because of the limited availability of donor lungs, low transplantation 
priority for  emphysema patients relative to other rapidly fatal pulmonary diseases, and because of the 
advanced age of most emphysema patients. LVRS is major surgery that carries the risk of morbidity and
mortality. Recently, less invasive bronchoscopic approaches have been developed and several approaches
are being actively investigated in human clinical trials in Europe and the US.
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2.2 General Description of Investigative Agent(s)/Device
The Coil System is designed to compress the areas of lung parenchyma most damaged by emphysema 
to allow more normal tissue to expand (Figure 1).
Figure 1 - Diagram of the Lung Volume Reduction Procedure Using Coils
The Coil has been designed to treat the specific patho-physiologic  challenges  of  the  emphysema  disease 
state. Emphysema is characterized by loss of the lung's natural elastic recoil which causes unsupported airways 
to collapse during exhalation. This, in turn, causes air trapping and  increased lung  volume,  which makes 
breathing difficult. The Coil is intended to compress lung parenchyma,  create  tissue  tension,  and restore radial 
support, thereby tethering open the airways  to  reduce  airway  collapse and  air  trapping.  The Coils also 
compress diseased tissue to reduce hyperinflation and  shift preferential  filling  from  diseased tissue to healthy 
tissue. Exhalation is facilitated, as re-tensioned lung tissue helps to maintain airwaypatency.
Because the Coil acts by a simple mechanical action of tissue tensioning and compression, the desired effects 
are achieved without collateral ventilation interfering with treatment outcome. The Coil is deployed using a
minimally invasive approach through a bronchoscope and requires no incision. The Coil is designed to treat 
emphysema patients regardless of their disease distribution; it is suitable  for  patients  with  homogeneous 
and/or heterogeneous (either upper lobe predominant disease or lower lobe predominant) emphysema.
The Coil System has been shown to improve QoL, exercise capacity, and pulmonary function in patients with 
emphysema (Sciurba et al., 2016; Slebos et al., 2015; Deslée et al., 2016; Shah et al., 2013).
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2.3 Summary of Prior Clinical Experience with the Coil System
The Coil System received the CE mark on October 8, 2010 and has been commercially available in select 
European countries since that time. Over 7,000 Coil procedures have been completed in Europe and other 
markets where the Coil System is commercially available. Additionally, the Coil System has  been studied in over 
2,000 subjects across 8 clinical studies in the EU and North America, including a US pivotal randomized 
controlled study conducted to support future FDA approval.
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3 TRIAL OBJECTIVE(S)
3.1 Trial Objectives
3.1.1 Primary Objectives
The primary objective of the ELEVATE study is to prospectively confirm the safety and effectiveness profile of 
Coils for the treatment of severe emphysema in consideration of the findings of previous randomized controlled 
trials.
3.1.2 SecondaryObjectives
Secondary objectives are determination of responder rates to clinical endpoints and mean change in 
physiologic endpoints.
3.2 Trial Design
This is a prospective, multicenter, open label, randomized (2:1), controlled study comparing outcomes  in 
subjects treated with the Coil System (Treatment) to a medically-managed  control group  (Control).  Control 
group patients will be eligible for treatment with Coils (Crossover) 6 months after entry into the study.
The study is anticipated to begin enrollment  early 2018.  All  subjects  randomized to Treatment will be followed  
for 36 months post initial treatment. Subjects randomized to Control will be eligible for crossover as soon as 
possible. Crossover subjects will then be followed for 36 months post initial treatment. The anticipated last 
patient visit is expected in first half of 2023. If Control subjects choose not to crossover to treatment, they will 
exit the study immediately.
The data
in this
study, including
Subject characteristics, outcome measures (e.g., health-related QOL, 
pulmonary function, exercise capacity), and safety (SAEs and specific respiratory AEs of interest), will be 
collected via the use of an electronic data capture (EDC) system on electronic Case Report Forms (eCRFs).
No biological samples will be taken other than blood draws taken at screening, and no biological samples will  
be stored for the study.
3.3 Randomization
A total of 120 subjects were randomized in a 2:1 ratio  of Treatment to Control respectively (80 Treatment group 
subjects, 40 Control group subjects) across up to 30 sites.
3.4 Primary Endpoint (s)
The Co-Primary Effectiveness Endpoint for the study is:
x
Percent change in FEV1from baseline to 6 months
x
Change in St. George’s Respiratory Questionnaire (SGRQ) from baseline to 6 months.
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4 SUBJECT SELECTION
4.1 Patient Population
Severe emphysema patients indicated for Coil System treatment per the approved, CE marked IFU who meet 
the study inclusion and exclusion criteria, will be eligible to participate in the study.
4.2 Subject Selection
Recruitment will come from centers across Europe experienced in Coil System treatment and interventional 
bronchoscopy procedures that have affiliated physicians who have successfully completed the  PneumRx Training 
program. The Coil procedure will be performed only at hospitals that have met the site qualification requirements for 
use of the Coil System as defined in the Coil training program  and  the  study  protocol. Additional qualification 
requirements include the ability to conduct the study per the approved protocol and demonstrated conduct of PFT, 
6MWT, SGRQ, mMRC Dyspnea Scale testing in accordance with American Thoracic Society (ATS)/European 
Respiratory Society (ERS) standards.
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Up to 30 centers across Europe will be invited to participate. Sites  will  be selected based on their  experience with 
Coil technology, expertise in interventional bronchoscopy and operational and multidisciplinary resource availability.
Each center’s PI, or a primary implanter, will perform all Coil treatments in the study if possible. If necessary, a 
secondary implanter will be trained as a back-up for situations in which the primary implanter is unavailable.
Pregnancy test need to be performed for females of child-bearing potential prior to radiographic procedures at 
baseline and implant procedures.
4.2.1 Inclusion Criteria
The study population will include all subjects who have met the inclusion criteria:
1.
Read, understood and signed the Informed Consent form
2.
Meets indications for use per the IFU
3.
Bilateral heterogeneous and/or homogeneous emphysema
4.
15% predicted 3RVWbronchodilator Forced Expiratory Volume in 1 second (FEV1) 45% predicted
5.
Post bronchodilator Residual Volume (RV) 200%predicted
6.
Post bronchodilator Total Lung Capacity (TLC) >100%predicted
7.
Post bronchodilator RV/TLC > 55%
8.
Dyspnea on modified Medical Research Council (mMRC) dyspnea scale despite optimal medical 
management
9.
Receiving optimal drug therapy and medical management according to clinical practice.
10. Performing regular physical activity, at least 2 times per week 3
11. Stopped smoking as confirmed by carboxyhemoglobin (CoHB)
12. 100m minute walk GLVWDQFH0:' 450m
13. Deemed eligible per Eligibility Review Committee (ERC)
14. If treated in France, Subject must be entitled to French social security
4.2.2 ExclusionCriteria
The study population will not include any subjects who have met any of the exclusion criteria.
1.
Known sensitivity to drugs required for performing bronchoscopy or in whom bronchoscopic procedures 
are contraindicated
2.
Evidence of active infection in the lungs
3.
Hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent metals
4.
Clinically significant pulmonary fibrosis
5.
Clinically significant, generalized bronchiectasis
6.
Clinically significant bleeding disorders
7.
Patient taking immunosuppressive drugs other than steroids (e.g., for the treatment of cancer, 
rheumatic arthritis, autoimmune disease, or prevention of tissue or organ rejection).
8.
Primary diagnosis of asthma
9.
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 recommendations45.
3 The World Health Organization defines physical activity as any bodily movement produced by skeletal muscles that requires ene rgy expenditure –
including activities undertaken w hile w orking, playing, carrying out household chores, travelling, and engaging in recreational pursuits. For those w ith 
limited mobility, this should be done at least 2 days per w eek.
4 Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018
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10. 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)
11. Percent Low Attenuation Area (%LAA) < 20% in the most damaged lobe of either lung.
12. Computed Tomography (CT) Imaging consistent with active pulmonary infection, significant interstitial 
disease or pleural disease
13. Severe bullous disease (defined by bulla > 1/3 of lung volume, or single bullous defect > 8cm) or
significant paraseptal emphysema [defined by numerous large (>1cm) paraseptal defects in the target 
lobe comprising >5% of total lung volume].
14. , or Lung pathology of nodule not proven stable or benign Radiographic confirmation of atelectasis or other 
scarring/fibrosis in areas of intended Coil implant
15. Use of more than 20 mg/day prednisone (or equivalent dosage of a similar steroid) daily
16. Severe pulmonary hypertension (Right Ventricular Systolic Pressure (RVSP) > 50 mm Hg (preferably 
measured by right heart catheterization) or other signs of Pulmonary Hypertension (PHT) with right 
ventricular dysfunction)
17. 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)
18. Previous Lung Volume Reduction (LVR) surgery, lung transplantation, lobectomy, LVR devices or other 
device to treat COPD in either lung.
19. Diagnosed with alpha-1 antitrypsin deficiency
20. Diffusion Capacity of the Lungs for Carbon Monoxide (DLCO) < 20 %
21. 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
22. Body Mass Index (BMI) > 30.
23. Participation in any other clinical study.
24. Subject is pregnant  or lactating,  or plan to become pregnant  within the study timeframe.
25. If  treated  in France, Subject is a “personne vulnerable”  as defined  by French regulation.
4.3 Subject Crossover
Control group Subjects will be eligible for crossover to Treatment as soon as possible. Control subjects will 
be eligible for crossover if they still meet all inclusion and exclusion criteria, and if the patient is deemed to
benefit from the Coil treatment by the investigator, based on best medical judgment. Crossover subjects will 
continue in the study through 36 months from first Coil implant. If Control subjects do not crossover to 
treatment, they will exit the study immediately.
4.4 Subject Withdrawal
Subjects are free to withdraw from the study at any time and will be withdrawn if they inform their PI that they 
no longer wish to participate or if they become lost to follow-up. The investigator may withdraw a subject at 
any time for safety or non-compliance with the protocol. Subject’s Withdrawal will be recorded in the EDC 
system along with the relevant reason(s) for study exit (lost to follow-up, withdrawn by investigator, or 
withdrawn by subject). Data collected prior to the subject’s withdrawal will remain part of the study record, 
unless country specific data protection regulations prohibit it.
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5 TREATMENT OF SUBJECTS
5.1 Coil System
5.1.1 Pre-implantPatientCare
Procedural planning should be performed in accordance with the IFU. Prior to the first treatment, HRCT for 
assessment of the degree of emphysematous lung tissue should be used to identify the lung lobes most 
appropriate for treatment.
5.1.2 Implant Procedure
The Coil is delivered through a standard 2.8 mm Inner Diameter therapeutic bronchoscope. The Coil System is a
two-part system that consists of:
1) Sterile implants (3 sizes: 100 mm, 125 mm, and 150mm)
2) Sterile, disposable, single-use (single-patient) Delivery System consisting of a Cartridge, a Catheter, a
Guidewire and Forceps.
Each Coil implantation procedure must be performed under fluoroscopy in accordance with the IFU. Use of general 
anesthesia or conscious sedation is at the discretion of the bronchoscopist and anesthesiologist. A complete 
treatment includes two treatments: the first side (upper or lower lobe Coil implantation) followed by treatment of the 
contralateral side. Procedures must be staggered (contralateral procedure should be scheduled approximately 2
months after first treatment), such that both lungs are not treated during a single procedure. Lobar targeting for Coil 
implantation will be based on quantitative CT (QCT) densitometry analysis provided by PneumRx, per the PneumRx 
QCT Service.
The Treatment is considered complete after the  contralateral  procedure.  The  investigator  can decide to limit the 
Treatment to one side if there are contraindications preventing the Treatment of the contralateralside.
Each center’s PI, or a primary implanter, will perform all Coil treatments in the study if possible. If necessary, a 
secondary implanter will be trained as a back-up if primary implanter is unavailable.
5.1.3 Post-implantManagement
Prophylactic regimen of medications should be administered according to the IFU and standard of care (SoC).
Per the IFU, a chest X-ray  or  still fluoroscopy  image should be done post-procedure to verify Coil placement  and 
to ensure there is no pneumothorax.  A second, confirmatory chest X-ray should be done before discharge  a 
minimum of 4 hours following the first chest X-ray. The second, confirmatory X-ray must be two views, posterior 
anterior (PA) andLateral.
The Subject  will be counseled on expected side-effects  of  the Coil procedure, including the potential AEs listed  in 
Section 7.7. The Subject will be instructed to contact the treating physician immediately should any of the potential 
AEs be experienced. It is particularly  important  that  Subjects  be  instructed at  discharge to contact their implanting 
physician if they experience symptoms that may be indicative of pneumonia or CAIRS/CAO, to ensure that 
appropriate treatment isdelivered.
Follow-up visits should be conducted per the schedule below. Study specific follow -up visits should take place 
during exacerbation free periods defined as 30 days with symptoms within normal day to day variability.
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Treatment Group Subjects:
Visit
Visit window
Baseline visit
Eligibility, inclusion
Randomization
First coil treatment
No more than 45 days post baseline visit
Second coil treatment
2 months +/- 4 weeks post first procedure
12-month follow-up
12 months +/- 4 weeks post first procedure
36-month follow-up
36 months +/- 4 weeks post first procedure
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Control Group Subjects:
Visit
Visit window
Baseline visit
Eligibility, inclusion
Randomization
First coil treatment
Second coil treatment
2 months +/- 4 weeks post first procedure
12-month follow-up
12 months +/- 4 weeks post first procedure
36-month follow-up
36 months +/- 4 weeks post first procedure
5.1.4 Duration of Treatmentand Follow up
All Subjects randomized to Treatment will be followed for 36 months  post  initial  treatment.  Subjects randomized to
Control will be allowed immediate treatment and will be followed for 36 months post initial treatment. If Control Subjects 
do not crossover to treatment, they will exit the study immediately.
5.1.5 ConcomitantTherapies or Interventions
Both Treatment and Control Subjects will be given SoC treatment for subjects with GOLD III or IV emphysema, defined 
as proven optimal medical care for stable COPD, either as presented in the GOLD guidelines (Global Initiative for Chronic 
Obstructive Lung  Disease: Global  strategy for the diagnosis, management,  and prevention of chronic obstructive 
pulmonary disease [Updated 2017])7or per national or local standards.
As recommended by the GOLD guidelines, each Subject will continue  maintenance  bronchodilator  therapy, which 
will include an inhaled long-acting beta-agonist, inhaled anticholinergic, or both. These drugs may also
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be combined with theophylline and/or inhaled corticosteroids at the discretion of the treating physician. The physician 
will be allowed to adjust the subject’s pharmacological regimen as needed during the course of the study to manage 
variations in the subject’s condition (e.g., COPD exacerbations). However,  the  Subject’s medical regimen should 
be optimized at the pre-Treatment Visit, prior to completing the baseline 6MWT and PFTs. Changes in medications 
or dosages will be recorded in the eCRF.
Pulmonary rehabilitation and maintenance therapy is recommended by the GOLD guidelines. Subjects may 
participate in pulmonary rehabilitation and maintenance therapy  throughout  their  participation  in  the  study. Post 
treatment pulmonary rehabilitation or a regular exercise program is strongly encouraged.
6 MEASUREMENTS AND EVALUATIONS
6.1 Treatment Group Assignment
A total of  120 Subjects  were randomized in a 2:1 Treatment  to Control ratio (80 Treatment  group Subjects,  40
Control group Subjects). 
Randomization will occur after ERC review of Subject data entered into the EDC. Site will be notified when 
randomization can occur after ERC review.
6.2 Pulmonary Function Central Laboratory
A PFT Core lab will provide oversight of PFT tests.  This will include training of sites, certification of assessors  and 
review of Baseline and 6 month PFT data to ensure valid measurements meeting the standards defined by ATS/ERS 
(Miller et al., 2005; Wagner et al., 2005; McIntyre et al., 2005, Miller et al., 2005).
6.3 Central Imaging Review
Quantitative assessment of baseline CT imaging will follow the PneumRx QCT process. Minimum scan criteria 
should be met as defined by the PneumRx QCT service. Sites will upload or send CD or other digital media of HRCT 
scan to PneumRx QCT service. PneumRx will provide site with a lung  densitometry  report  that  will report on the 
heterogeneity of emphysema, lobar volumes, and the degree of destruction (%LAA) for each lobe which should be 
used to determine the lobe of each lung to treat with Coils.
6.4 Time and EventSchedule
The eCRFs will be completed by the PI (or an authorized member of the investigator’s staff) at the participating site 
and entered into the EDC database per the event schedule described below.  The PI will attest  that  all  entries in 
the EDC are accurate.
6.4.1 Baseline Visit
After the Subject provides informed consent, the Subject will be evaluated to ensure they are appropriate 
candidates for use of the Coil System. Eligibility to enroll in the study is assessed as described in Section 4.2.
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The following evaluations will be performed as part of the Baseline visit.
x
Informed Consent
x
Demographic Information
x
Medical history information, including comorbidities, smoking status, previous treatments of emphysema 
and baseline characteristics, physical activity, rehabilitation status
x
Medications
x
Pulmonary Function Test (PFT)
x
Six Minute Walk Test(6MWT)
x
Modified Medical Research Council mMRC dyspnea scale will be completed.
x
QoL assessments: SGRQ, CAT, and EQ5Dwill be completed
x
Blood gas, including CoHB for smoking cessation confirmation
x
Blood test including cardiac panel with BNP test and other biomarker, if available
x
Pregnancy test for females of child-bearing potential prior to radiographic procedures
x
Echocardiogram
x
Vital signs
x
Inspiratory and expiratory HRCT (Note: a HRCT scan (inspiratory and expiratory) performed within 6
months prior to baseline may be used if it was acquired per the PneumRx QCT service protocol.)
x
Chest X-Ray.
6.4.2 Procedure/ImplantVisit
Enrolled Subjects randomized to the either arm will undergo the Coil Treatment in accordance with the approved 
(CE Mark) IFU.  Procedure visits will include 2 sessions: treatment procedure for  one lung,  followed  by treatment 
procedure for the contralateral side lung, which should be scheduled approximately 2 months following the initial
procedure.
The following evaluations will be performed for each procedure visit:
x
Pregnancy test for females of child bearing-potential prior to radiographic procedures
x
Treatment date
x
Duration of bronchoscopy procedure
x
Duration of fluoroscopy
x
Duration of hospital stay
x
Lung lobe and location treated
x
Number and size of implanted Coils
x
Procedural SAEs (see Section 7)
x
Device malfunctions
x
Prophylactic medications (antibiotics, steroids – including dosage and start/stopdates)
x
Fluoroscopy image immediately post procedure – should be captured in eCRF
x
Chest X-ray (PA and Lateral) before discharge at least 4 hours following the fluoroscopy image
6.4.3 Follow-Up Visits
Follow-up office visits will be conducted at 12, and 36 months post first Endobronchial Coil treatment for both 
Treatment group subjects and Crossover subjects..
Follow-up visits should be conducted per the schedule below. Study specific follow-up visits should take place 
during exacerbation free periods defined as 30 days with symptoms within normal day to day variability.
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12- and 36-month study follow-up visits will include:
-
PFT
-
AE review
-
Medications
-
Inspiratory and expiratory HRCT
6.4.4 Patientcompletion or early withdrawal
Subjects who receive the Treatment procedure complete the study 36 months  after the  initial  implant  procedure or 
when they choose to withdraw from the study, if  earlier  than  36 months post-procedure. In the event of a continuing 
SAE related to the Coil system, the subject will be asked to return for  follow-up until the  SAE has resolved or is deemed 
to be continuing indefinitely. Control subjects who  do not  crossover  to treatment will exit the study immediately.
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6.4.5 Data Collection
Informed consent, baseline assessments, procedure data, adverse event data, medications, and effectiveness 
measures will be collected and entered into the EDC system. The eCRFs will be completed by the PI (or an 
authorized member of the investigator’s staff) at the participating site and entered into the EDC database. All entries 
into the EDC system will be in English.
PIs will be provided a process for  assigning  a de-identified  number  to the  Subject  and will be asked to keep any 
study paperwork in a secure private  area. Electronic  audits  will be in place to help ensure that data entered is within 
reasonable limits. This also allows the site to be queried  regarding inappropriate  data.  The study will also be
monitored by Boston Scientific Corporation and/or their designees for the duration of the study to ensure accurate 
collection of data and compliance.
6.5 Trial Evaluations and Procedures
6.5.1 Informed ConsentProcess
All Subjects must sign an ICF approved by the relevant IEC to be enrolled in the study.
The PI or delegate will review  the treatment  plans  with the Subject,  and the Subject  will have an opportunity  ask 
questions  about  trial procedures, the required visit schedule, risks  and benefits  of the study treatments,  and 
alternative treatment options  prior  to signature.  The Subject  will receive a copy of  the signed ICF  to keep for their
records.
Subjects will be informed of any revisions of the ICF and any revisions must be signed and kept in the Subject 
study file.
Acquisition of the informed consent or any revisions should be documented in the Subject’s medical record and 
the ICF signed and dated by the individual who conducted the informed consent discussion.
6.5.2 Demographics
The following demographic data will be obtained: date of birth, gender, race, ethnicity, weight and height.
6.5.3 MedicalHistory
Medical history, including existing comorbidities deemed clinically significant (e.g., respiratory, pulmonary, 
cardiovascular, renal, liver, cerebral vascular, vascular, and psychiatric conditions and diseases) will be 
collected by the investigator.
Diagnosis and medical history for emphysema will be recorded separately, and will include at minimum the number 
of years since the subject was diagnosed with emphysema, characteristics of the emphysema, treatment history, 
and history of hospitalization events due to emphysema.
Smoking status and physical activity will be captured.
6.5.4 Vital Signs, Blood panel and Echocardiogram
Assessments of blood panel at baseline will follow routine standards (Haemoglobin, Hematocrit (HCT), White Blood
Cells, Platelet count, Prothrombin time, Eosinophil leucocytes, INR, Sodium, Potassium, Chloride,
Glucose, Total Protein, Albumin, Blood Urea Nitrogen, Creatinine, Cardiac panel including BNP-test and other 
biomarker if available).
Assessment of pulmonary hypertension and left ventricular ejection fraction will be performed at baseline and 
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documented in the CRF.
Pregnancy test need to be performed for females of child-bearing potential prior to radiographic procedures at 
baseline and implant procedures.
6.5.5 Pulmonary FunctionTest
PFT will include  post  bronchodilator  Spirometry, Lung plethysmography, and DLCOsb at Baseline and Follow- up
Visits. Baseline Visit should also include pre bronchodilator spirometry to  assess  bronchodilator  reversibility. 
Tests should be conducted per ATS/ERS standards and will be assessed by an independent, 3rd  party vendor for 
adherence to these standards to ensure consistency and quality of data collection at baseline.
6.5.6 Six Minute WalkTest
6MWT will be conducted by a qualified individual according to ATS/ERS Guidelines as specified in the 
schedule of visits.
6.5.7 Medication and Prior TreatmentHistory
The use of concurrent respiratory, cardiac, anticoagulant, antibiotic,  and  steroid  medications  (medications taken 
within 30 days of screening and during the conduct of  the trial)  will be recorded and entered in to the EDC.
6.5.8 Eligibility Review Committee
Data from subjects who have signed the ICF and are considered by the treating physician to be eligible  to receive 
the Coil treatment as part of  the trial,  should be submitted to the ERC for final assessment of eligibility  for the
study. The ERC will review the data in accordance with the procedures agreed to in the ERC Charter.
The ERC will consist of a minimum of 5 interventionalists. The purpose of the ERC is to provide peer-review from 
interventionalists who are extremely knowledgeable in the procedure and patient selection to  confirm eligibility and 
suitability of subjects selected for participation in the ELEVATE  trial. The ERC  shall provide the final decision 
with regard to enrollment.
Data that will be provided to the ERC for review include PFT, medical history, and HRCT with QCT data. Two
(2) of  the 5 ERC  members  will be selected via random number generation.  A member may decline to evaluate 
a subject file; in this case another member will be randomly selected. If 2 members agree to either approve or deny 
enrollment, that decision will be final.  If the 2 members disagree, then a third, randomly selected member will 
independently review the case to determine eligibility. ERC members  will document the reason for denial if  the 
subject is not deemed not  eligible  for  the study.  The process  will be blinded, such that a member receiving a
request for review will not  know  how  others have voted. An ERC member cannot review his /her own subject, in 
which case another ERC member will be randomly selected to review the data.
The determination of study eligibility will be recorded on the relevant eCRF.
6.5.9 Expert Radiology Review
All baseline CT scans will be reviewed by expert Radiologists in accordance with the  ELEVATE  Radiology  
Review Manual. An eCRF providing a detailed pulmonary radiologic assessment will be completed by one of 3
independent radiologists for each subject. The report from  the expert  Radiologist  will be reviewed  by the ERC as 
part of the subject eligibility assessment.
6.5.10
Randomization/EnrollmentEvent
If a Subject is deemed eligible to participate in the trial, the Subject is assigned the next sequential Randomization 
Assignment via the study EDC. Randomization will be determined using assignment by a computer-generated 
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randomization scheme. Upon randomization/enrollment, each Subject will be assigned a unique numeric Subject 
identity code.
A total of 120 Subjects were randomized in a  2:1  ratio  Treatment  to Control  respectively (80  Treatment group 
subjects, 40 Control group subjects). 
6.5.11
Implant ProcedureRecord
Details on the Coil treatment procedures performed on study Subjects will be recorded in the relevant eCRF. 
Procedure data collected and entered into the EDC system will include:
x
Treatment date
x
Duration of bronchoscopy procedure
x
Duration of fluoroscopy
x
Duration of hospital stay
x
Lung lobe and location treated
x
Number and size of implanted Coils
x
Procedural SAEs (see Section 7)
x
Device malfunctions
x
Prophylactic medications (antibiotics, steroids – including dosage and start/stop dates)
6.5.12
Coil Removal
Coil removal following implantation (defined as removal of a Coil after termination of the Coil implantation procedure) 
must be medically indicated and performed in accordance with the IFU. Each occurrence of post - procedure Coil 
removal will be recorded as an SAE in the appropriate eCRF. Recommendations regarding Coil removal will be 
provided to the study site as part of the Study Operational Instructions (SOI). To perform bronchoscopic Coil removal 
subsequent to the implantation procedure, you must have a therapeutic bronchoscope with a minimum 2.0mm inner 
diameter working channel and a 65cm maximum working length.
6.5.13
Quality of Life
QoL instruments suitable for Subjects being treated for emphysema (i.e., SGRQ, CAT, EQ5D, and mMRC) will 
be administered at study visits as specified in the schedule of visits.
6.5.14
Imaging
Chest X-rays (PA and lateral) will be performed at  Baseline and post-procedure in accordance with the IFU. These 
will be documented in the appropriate eCRF, subject-identifying information redacted, and submitted to Boston 
Scientific Corporation upon request.
HRCT will be performed at the Baseline Visit and 12 and 36 month Follow-up Visits. HRCT will include both  
inspiratory and  expiratory scans  completed per  the recommendations  provided as part of the PneumRx QCT
service.
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7 ADVERSE EVENTS
7.1 Adverse Event Definitions
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in a study subject, user or other  persons  whether  or  not  related to the 
investigational medical device.
Adverse experience will be considered synonymous with the term AE and vice versa.
7.1.1
Definitions of SAE/SADE/USADE/DeviceDeficiency
Serious Adverse Event (SAE)
An SAE is any untoward medical occurrence that:
x
results in death;
x
Led to serious deterioration in the health of the subject , that either resulted in
o
A life-threatening illness or injury, or
o
A permanent impairment of a body structure or a body function, or
o
In-patient or prolonged hospitalization,or
o
Medical or surgical intervention to prevent life-threatening illness or injury or  permanent impairment 
to a body structure or a body function
x
Led to fetal distress, fetal death or a congenital anomaly/birth defect.
Serious Adverse Device Effect (SADE)
An SADE is an adverse effect that has resulted in any of the consequences characteristic of a serious adverse
event.
Unanticipated Serious Adverse Device Effect (USADE)
A USADE is a serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report
Device Deficiency
A device deficiency is an inadequacy of a medical device with respect  to  its  identity,  quality,  durability, reliability, 
safety or performance. Device deficiencies include malfunctions, use errors and inadequate labeling.
A device malfunction is the failure of a medical device to perform in accordance with its intended purpose when 
used in accordance with the instructions for use.
:
SAE  information will be collected throughout the study. SAEs will be recorded on the eCRF by the investigator or  
authorized  designee.  Event,  date  of onset, duration, serious/non-serious, anticipated/not anticipated, severity,
relationship to the procedure/device, outcome, and action taken will be recorded. Additional information on  specific 
events may be requested in the eCRFs. All events must be recorded in English. Any source documentation required 
to investigate SAEs for reporting must be translated to English.
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NOTE: A planned hospitalization for a pre-existing condition, or a procedure required by the clinical protocol, 
without a serious deterioration in health, is not considered to be a SAE.
An anticipated SAE is any SAE, the nature or severity of which is identified  in the IFU. Any other device related SAE 
will be considered an unanticipated adverse device effect (USADE).
All SAEs that are determined to be related to the device or procedure will be evaluated for reportability in accordance 
with MEDDEV 2.7/3 revision 3. The investigator
will be responsible for submitting source documentation to
PneumRx in order to document the investigation for the event.
7.2 Recording Adverse Events (AE)
Subjects will be required to report AEs of interest. At each study visit, site staff will ask general, open-ended, non-
directed questions to obtain information about  AEs.  If  the subject is unable to attend a trial visit,  AEs  can be
collected by telephone contact. At any time during the study,  the Subject may volunteer  information that meets the 
definition of an AE.
The investigator should record all SAEs and specific Respiratory AEs  of  interest  in the eCRFs.  Below is a list  of 
specific Respiratory AEs of interest that should be recorded:
x
COPD Exacerbation
x
Hemoptysis
x
Pneumothorax
x
Lower Respiratory Tract Infection/Pneumonia
x
Tissue Reaction, Localized (a.k.a. Coil Associated Inflammatory response syndrome  (CAIRs),  also called 
Coil Associated Opacity (CAO) in the IFU)
Investigators will obtain all the information required to complete  the  AE  form.  Where possible,  a diagnosis, rather 
than a list of signs or symptoms, should be recorded. Any medical management of an event and the resolution of an 
event must be recorded in source documentation and on the appropriate eCRF using medical terminology according 
to sponsor instructions.
For each SAE and specific respiratory AEs of interest, the following information will be recorded at a minimum:
x
AE term
x
Serious/non-serious
x
Severity
x
Action taken
x
Relationship to Coil System
x
Expected/Unexpected
x
Date and time of onset
x
Date and time of resolution
Was the subject withdrawn from the study due to the AE
Any SAE experienced by a subject will be followed until the SAE has resolved to the PI’s or sub-investigator's 
satisfaction or is considered stable. If  a problem still exists, then the PI or sub-investigator at his/her discretion will 
ask the subject to come back to the clinic for further evaluation. SAEs should be managed as discussed in Section
7.5.
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7.3 Recording and Reporting Device Deficiencies
All device deficiencies must be reported to BSC within 24 hours of becoming aware of the event. The report 
should be submitted in English with all available information. Devices should be returned to Boston Scientific 
Corporation via the standard commercial method.
7.4 Device and Procedure Causality Assessment
The PI or sub-investigator must indicate whether he/she believes the SAE is unrelated, possibly related (reasonable 
possibility that the investigational device and/or procedure caused the SAE)  or  probably related  to the medical device 
or procedure.
7.5 Submitting Expedited Safety Reports
All SAEs and UADEs (defined above)  must be reported to the sponsor via EDC  within 24 hours  of  learning of  the 
event. Any supporting source documents required to investigate the SAE or  USADE  must be provided as soon as 
possible to PneumRx.
The sponsor must  promptly inform  the Independent  Ethics  Committee (IEC), both CPP and ANSM in France,  of
all USADEs and SAEs as  required per  site IEC  requirements. These events will be reported by the sponsor, as 
appropriate, to the regulatory authorities according to relevant  jurisdictional m edical device regulations. As  the Coil 
System is a CE marked and commercially available device  in  the  EU,  Medical  Device  Vigilance System reporting 
requirements are applicable to adverse incidents reported through this study.
7.6 Periodic Safety Reporting
Periodic annual safety reports will be submitted to the ANSM and will be communicated across all study 
centers.
7.7 Expected Adverse Events
AEs reported through clinical studies and post-market  vigilance (in the EU and OUS regions) are detailed in the IFU. 
AEs which may be observed with endobronchial devices, systems for placement of these devices, and related 
procedures (including diagnostics and bronchoscopy procedures) and use of the Coil System include, but are not
limited to, the events shown below. These events may vary in frequency and severity.
x
Allergic Reaction
x
Emphysema, 
Subcutaneous
x
Pneumonia*
x
Aspiration
x
Hemoptysis, including Severe
Hemoptysis
x
Pneumonitis
x
Bleeding or 
Hemorrhage
x
Hoarseness
x
Pneumothorax
x
Bronchial Blood Clot
x
Hypertension
x
Procedure-Related 
Complication (e.g.,
fever, spasm)
x
Bronchial Ulceration
x
Hypotension
x
Pulmonary Embolism
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x
Bronchospasm
x
Infection
x
Respiratory Distress
x
Cardiac Arrhythmias
x
Inflammation
x
Respiratory Failure
x
COPD Exacerbation
x
Lung Abscess
x
Respiratory Tract 
Infection
x
Cough
x
Pain
x
Sedation – Related 
Complications (e.g., 
nausea, vomiting, 
headache)
x
Death
x
Painful Respiration
x
Sepsis
x
Device Dislocation
x
Pleural Effusion
x
Tissue Reaction, 
Localized (a.k.a 
CAIRs/CAO)
x
Dyspnea
x
Pleural Fistula
x
Tissue Trauma, 
Procedural (e.g., tissue 
perforation, dissection)
*A recognized, non-infectious localized tissue reaction, also termed Coil Associated Inflammatory response 
syndrome (CAIRs), also called Coil Associated Opacity (CAO) in the IFU, may occur in the area of implanted coils 
and is typically diagnosed on imaging (chest X-ray or CT scan). This is believed to be an inflammatory response 
that presents with pneumonia-like symptoms, including chest or pleuritic pain/discomfort, increased dyspnea, 
fatigue, and/or haze or infiltrates on chest X-ray, and may be difficult to distinguish from pneumonia. While some 
degree of CAIRs/CAO has been observed in clinical trials up to 2 months following the Coil procedure, many of 
these events are asymptomatic or symptomatically mild, resolve with limited intervention, and do not develop into 
serious adverse events (SAEs).  However, CAIRs/CAO can become severe and require prompt and specific 
intervention. Thus, subjects are advised to contact their treating physician immediately for follow-up if they 
experience pneumonia-like symptoms.
Note: Additional interventional procedures may be necessary if subjects experience some of these potential 
AE(s) following Coil treatment.
8 STATISTICAL CONSIDERATIONS
8.1 Trial Design and Determination of Sample Size
A total of 120 Subjects were randomized in a 2:1 ratio  of  Treatment  to Control respectively (80 treatment group 
subjects, 40 Control group subjects). 
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8.2 Statistical Analysis
The statistical analysis plan (SAP) will be a separate document and will be updated as required, in association with 
any protocol amendments. The plan will include detailed descriptions of analysis methods, tables, listings  and figures 
and will describe statistical programming considerations.
8.3 Analysis Populations and Sub-Groups
Intent to Treat Population (ITT) – All randomized Subjects, regardless of whether or not treatment was 
attempted.
Per Protocol Population (PP) - All randomized Subjects without major protocol deviations (see Section 10.9). 
Safety Population - All randomized Subjects who enter the bronchoscopy suite for the initial Coil procedure.
8.4 Baseline and Demographic Characteristics
Descriptive statistics will be used to summarize Subject demographics and baseline characteristics.
8.5 Efficacy Analyses
All effectiveness analyses will be analyzed on the ITT population through the 6-month visit, using descriptive statistics 
to summarize results separately for treatment and control groups. No comparative inferential statistics will be 
conducted. In addition, descriptive statistics will summarize percent change in FEV1 from baseline to 12 and 36
months for all coil treated subjects. Baseline will be defined as the last measurement taken prior to coil treatment.
Descriptive statistics will summarize effectiveness endpoints at 12, 24 and 36 months follow-up.
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8.6 Safety Analyses
Safety analyses will be conducted on the safety population defined as those Subjects who enter the bronchoscopy 
suite for the initial Coil procedure.  AE and SAEs  will be summarized by treatment  group based on MedDRA codes. 
Incidence rates through 6 months will be  summarized for treatment and control groups. For coil treated subjects, 
events will also be summarized by relevant, discrete time periods including the Treatment recovery period (30 days
from either treatment), as well as through the 12- and 36-month follow-up periods.
9
DATA MANAGEMENT
Data from the study will be collected via EDC. Clinical data will be sent in a secured validated format to Boston 
Scientific Corporation on an ongoing basis.
Data will be entered in the eCRFs at the  study site.  Trained  study personnel  will be responsible for entering data 
on the observations, tests and assessments specified in the protocol into the eCRF system  and according to the 
eCRF instructions. The eCRF instructions will also provide the study site with data entry instructions. Risk-based 
monitoring of investigational site(s) will be conducted. Data entered in the  eCRF  will  be immediately saved to a 
central database and changes tracked to provide an audit trail. When data have been entered, reviewed, edited and
Source Data Verification (SDV) performed as specified per  the  clinical  monitoring plan, the investigator will be 
required to sign the eCRF electronically as per the agreed upon project process, and data will be locked to prevent 
further  editing. A copy of the eCRF will be archived at the study site  at the end of the study.
Data verification and data validation checks will be performed by Boston Scientific Corporation Data Management or 
designee utilizing electronic edit checks comprised of validated computer programs and manual data review. Any 
data discrepancies will be referred back to the investigator. After the database has been declared clean it will be  
locked, and editing in the database will only be allowed with the proper documentation.
After database lock, data will be extracted to SAS® (SAS Institute,  Inc.,  Cary, NC, USA)  for  analysis as defined  in 
the SAP.
AEs will be coded according to the version of MedDRA agreed upon by Boston Scientific Corporation.
Electronic data checks for accuracy will be built into the EDC system. Data analyses will be performed and
reviewed in an aggregate and de-identified fashion. These reviews will aid in continued refinement of the data
collection process and analysis. Access to de-identified data will be provided to Boston Scientific Corporation .
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10LEGAL//ETHICS AND ADMINISTRATIVE PROCEDURES
10.1
Good Clinical Practice/Regulatory Compliance
The procedures set out in the this protocol, pertaining to the conduct, evaluation,  and documentation of  this study, 
are designed to ensure that the sponsor and investigators abide by ISO 14155:2011 E, Clinical investigation of 
medical devices
for human subjects – Good Clinical Practice, applicable state and local regulations; and the 
standard operating procedures (SOPs) of Boston Scientific Corporation, and its designee(s).
It is the PI’s responsibility to ensure that adequate  time and  appropriate  resources  are  available at the study site 
prior to making a commitment to participate in this study. The PI should also be able to estimate or demonstrate the 
potential for recruiting the required number of suitable subjects within the agreed upon recruitment period. The PI will 
maintain a list of appropriately qualified personnel to whom the PI has delegated significant study-related tasks.
10.2
Trial Site and Investigator Qualification
This study will be performed by qualified investigators at up to 30 sites across Europe.
All participating study sites will be reviewed by the study sponsor to verify that they are able to meet the requirements 
of the study. Each participating institution must have an established IRB/IEC and clinical protocol review process that 
is compliant with ISO  I4155,  ensuring  the  clinical protocol  can be adequately  evaluated and approved at the 
institutional level.
10.2.1
InvestigatorCV
The investigator will provide the sponsor or designee with his/her signed Curriculum Vitae (CV), as well as 
those of any sub-investigator or staff personnel with significant study responsibilities.
10.2.2
Statement ofInvestigator
The investigator will be required to sign and date a Statement of Investigator form  provided by the sponsor for  the 
original and each subsequent amendment of the protocol and return the original signed document to the sponsor. A 
copy of the signed form will be given to the investigator for his/her files.
10.2.3
Financialdisclosure
Financial disclosure statements will be completed for the investigator and all sub-investigators to disclose potential 
conflicts of interest (ISO 14155). The investigator is responsible for ensuring completed and signed financial 
disclosure forms are submitted to the sponsor or designee. A copy of the form(s) will be given to the investigator 
for their files. Financial disclosure  information  will  be  collected  by the sponsor before the s tart of the study and 
maintained for one year after study completion.
10.2.4
InvestigatorRecruitment
All investigators will be specialists in interventional bronchoscopy or will be experienced thoracic surgeons who are 
experienced with the Coil procedure. Potential  investigators  will  be  recruited and approved by Boston Scientific
Corporation. Once the investigator is approved, the investigators will obtain approval from their IEC.
One physician at each site will agree to act as the PI. Each center’s  PI,  or  one primary implanter, will perform all 
coil treatments in the study. Additional physicians at each site may also participate as sub-investigators; however,
coil implantations for ELEVATE (treatment and crossover) will be performed by  one primary implanter if possible. 
If necessary, a secondary implanter will be trained as a back-up should scheduling or logistical issues arise.
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10.2.5
InvestigatorTraining
Physician-investigators who wish to participate in this study must satisfactorily complete a training program
conducted and documented by Boston Scientific Corporation. Training includes  proper  Subject  selection,  implant  
procedure  as well as training on the protocol. Investigators will conduct the study under  all applicable regulatory 
requirements. All participating PIs will be asked to sign a sponsor-generated Investigator’s  Agreement  (as provided 
in contract), as well as  any  required  institution-specific  Investigator’s  Agreement.  All  participating study 
investigators must provide recent certification of GCPtraining.
10.2.6
Responsibilities
10.2.6.1
Sponsor Responsibilities
The sponsor of this study is Boston Scientific Corporation. The sponsor is committed to:
x
Protecting the rights, health, safety and welfare of study Subjects by the review of IEC approvals and 
verification of the Subject informed consent process.
x
Informing the clinical investigator of any new information that may affect the health, safety or welfare of the 
Subjects, or which may influence their decision to continue participating in the study.
x
Periodically reviewing the data to ensure that the investigator is in compliance with the protocol and the 
investigator’s agreement.
x
Providing the investigator with the study protocol and access to the EDC system and trial eCRFs.
x
Selection and approval of investigators to participate in this trial.
x
Maintaining a system of study documentation associated with the trial and corresponding sites and 
investigators.
x
Providing training on key elements of the protocol, including Subject inclusion/exclusion criteria, EDC 
system, and what constitutesFollow-up.
x
Oversight of the  Eligibility  Review Committee
x
Review eCRFs to ensure completeness and accuracy of study data. Sites will be asked to resolve 
discrepancies via the EDC system.
x
Acting as a resource for questions after training for the duration of the trial.
10.2.6.2
Responsibilities of the Principal Investigator
The PI will affirm by his/her signature on the Investigator's Agreement that he/she will fulfill his/her 
responsibilities relative to the study. The PI will be responsible for:
x
Ensuring that all Subjects entering the study conform to the Subject inclusion criteria and that  no exclusion 
criteria apply.
x
Obtaining IEC approval from the respective institution to perform the procedure, prior to enrolling any Subjects 
in the study. The informed consent document to be used will also be submitted by the investigator to the  
IEC  for  approval  prior  to initiation of the investigator’s  participation in the study. The  PI is also responsible 
for providing any other additional documentation relevant  to the study as required  by the IEC for their 
complete review. Written assurance of IEC approval of the study  plan and the informed consent document 
must be provided to Boston Scientific Corporation, Inc. prior  to initiation  of  the  study at the site.
x
Obtaining written Informed Consent from each Subject prior to enrollment and verifying that the correct  and 
approved IEC version is used.  The signed ICF  will be maintained in the Subject’s  medical record, and a
copy of the signed ICF will become an integral part of each case report file retained by the investigator. A
copy of the signed ICF shall be given to the Subject who signed the ICF.
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x
The investigator will review, correct as needed, and sign off on the accuracy and completeness  of  the data 
entered in the EDC system. Original laboratory reports, procedure notes, etc. are to be retained by the 
investigator, and the resulting data shall be entered onto the appropriate eCRFs.
x
The investigator will report all  SAEs,  USADEs,  and  device deficiencies  to the sponsor via EDC within 24 
hours of learning of the event.
10.2.7
Site qualifications
The Institution must have appropriately qualified  investigators  and  clinical / administrative support staff in place  to
adequately conduct the study in compliance with the relevant guidelines and regulations (see Section  10.1)  and to 
treat emphysema with Coils.
10.3
Institutional Review Board (IRB)/Independent Ethics 
Committees (IEC)
10.3.1
Institutionalapproval of the protocol
It is the responsibility of the PI to submit this protocol, the informed  consent document (approved  by the sponsor 
or designee), relevant supporting information and all  types  of Subject recruitment information to the IEC for review 
and approval prior to site initiation.  A copy of the written approval of  the protocol and ICF  must  be received by the 
sponsor or designee prior to the recruitment of Subjects at the site.
Prior to implementing changes in the study, the sponsor and IEC must also approve any revised  ICF  documents 
and amendments to the protocol with documentation of the approvals submitted to the sponsor or designee. The 
approval document should clearly state the study reference, date of review and actions taken.
The investigator, will be responsible for keeping the IEC apprised of the progress of the trial, any changes to the 
protocol, deviations from the protocol and SAES or USADEs.
10.4
Informed Consent – Ethical Compliance
It is the responsibility of the investigator  to obtain  written Informed  Consent from  Subjects  prior  to the conduct of 
any trial procedures. All consent documentation must in accordance with applicable regulations  and GCP. Each 
Subject or the subject’s legally  authorized  representative  is  requested  to sign the ICF after the subject  has
received and read the written information and received an explanation  of  the  study,  including  but  not limited to: 
the objectives, treatment plan, potential benefits and risk,  inconveniences,  alternative  treatment  options and the 
Subject’s rights and responsibilities. The Subject has the right to  decline  participation  or withdraw from the study 
at any time for any reason without fear of retribution. A copy of the informed consent documentation (Consent Form 
or Subject Information and Consent Form, as applicable) must be given to the Subject or the Subject’s legally 
authorized representative. If applicable, it will be  provided  in  a certified  translation of the Subject’s local language.
Acquisition of the informed consent should be documented in the Subject’s  medical record and the ICF should  be 
signed and personally dated by the Subject and the individual who conducted the informed consent discussion. 
Signed consent forms must remain in each Subject’s study file and must be available  for  verification by Study 
Monitors at any time.
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Each investigator will provide the sponsor with a copy of the IEC approved consent forms and a copy of the IRB/IEC 
written approval, prior to the start of the trial. Additionally, if  the  IEC  required  modification  of  the  sample Subject 
Information and Consent  document  provided  by the sponsor, the documentation  supporting this requirement must 
be provided to the sponsor.
The sponsor reserves  the right  to delay initiation of the trial at a site where the ICFs do not meet the standards  of 
applicable regulations and international GCP standards/guidelines.
10.5
Subject Privacy and Confidentiality
The sponsor and investigator affirm and uphold the principle for the Subject’s  right  to protection  against invasion 
of privacy. Throughout this study, all data collected and analyzed by the sponsor or designee will be treated 
confidentially and identified by an identification number.
To verify compliance with the protocol, the sponsor will require the investigator to permit its designee access to the 
Subject’s primary medical record to review those portions that directly concern this study (including but not limited 
to laboratory test results, radiology images, and hospital and outpatient records).
As part of required content of the informed consent, the Subject must be informed that his/her records will be 
reviewed by the sponsor, sponsor representative and/or a representative of the appropriate  regulatory agency. The
informed consent or related document  will also state that  patient  privacy will be maintained pursuant  to  both 
European and local regulation.
Should access to such medical records require a waiver or authorization separate from the statement  of informed 
consent, the investigator will obtain such permission in writing from the Subject before the subject is entered in the
trial.
Data collected during this trial may be used to support the development, registration or marketing of the Coil System. 
Collected data may be reviewed by the sponsor and/or its representatives, independent auditors who validate the 
data on behalf of the sponsor, third parties with whom the sponsor may develop, register or market the Coil System, 
national  or  local regulatory authorities  and the IRB/IEC  which granted approval  for  this  study to proceed.
10.6
Trial Monitoring
Monitoring of the study will be detailed in the study monitoring plan  and  will  be  performed  by  qualified  personnel 
from the sponsor or sponsor designee. This trial will  be  Risk-Based  Monitored.  Monitoring  will consist of centralized 
monitoring with an escalation to remote or on-site monitoring if needed.
Centralized monitoring will be conducted to look  for  timely  entry of  data into EDC, completion of  trial visits  within 
windows and valid endpoint measurements. Monitoring can be escalated per the Monitoring Plan.
Remote monitoring can be conducted over the phone or by webcast and will concentrate on correcting issues found 
during centralized monitoring or to request additional  details.  Monitoring  can  be  escalated  to  on-site visits per the 
monitoring plan.
During on-site monitoring visits, the progress of the study will be discussed with the investigator or his/her 
representative. The ICFs will be reviewed for signatures and the eCRFs checked for completeness and accuracy. 
Subject source data must be available for review. The investigator and his/her staff are expected to cooperate with 
the study monitor and be available during at least a portion of the monitoring visit to review the eCRFs and any 
queries/resolutions, answer questions, and provide any missing information.
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The study monitor will record the date of each visit together with a summary of the status and progress of the trial. 
Proposed actions will be confirmed with the investigator in writing.
Telephone and electronic mail contact will  be made with the investigator  and study staff as  necessary during the 
data collection and report writing periods.
10.7
Modification of the Protocol
All amendments to the protocol must be documented in writing, reviewed and approved by the investigator and 
sponsor and submitted to the IEC for approval/positive vote prior to initiation. If the protocol amendment substantially 
alters the trial design or potential risk to the Subject, new written informed  consent  must  be obtained from each 
Subject for continued participation in the trial.
10.8
Suspension or Termination of Trial
BSC reserves the right to terminate the study at any stage but intends to exercise this right only for valid 
scientific or administrative reasons and reasons related to protection of subjects. Investigators, associated 
IRBs/IECs/REBs, and regulatory authorities, as applicable, will be notified in writing in the event of study 
termination. Possible reasons for premature study termination include, but are not limited to, the following:
-
The occurrence of unanticipated adverse device effects that present a significant or unreasonable risk to subjects 
enrolled in the study. 
10.9
Departure from Protocol
No deviation may be made from the protocol except to protect the health and  welfare  of  a study Subject. Further, 
changes to the protocol will be implemented only after an amendment has been agreed to in writing by both the 
investigator and the sponsor, and the protocol amendment is approved by the IEC.
Protocol deviations will be tracked in the EDC, and categorized as follows:
x
Major   protocol deviations
x
Minor   protocol deviations
Major  protocol deviations  are defined  as:
x
Enrollment eligibility criteria deviations
x
Informed consent process was not followed
x
Endpoint assessments not performed tostandards
x
Endpoint testing not performed
x
Procedure not performed in accordance with theIFU
x
SAE not reported per protocol
x
Randomization errors
All other protocol deviations will be classified as minor protocol deviations.
10.10
Potential Risks to Subjects
There are limited risks to Subjects as a result of having their data collected  for  this study.  The  study procedures 
and data being collected are part of routine Subject follow-up or SoC.
10.11
Potential Benefits to Subjects and Society
In the future, patients may benefit from results that lead to a better understanding of the safety  and effectiveness 
of the Coil System in the broader context of other options for treating emphysema. In previous studies of the LVRC, 
many subjects have experienced improvements in lung function, exercise capacity, and quality of life.
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The health care system may benefit from  a better  overall understanding of safety, effectiveness  and costs  of this
procedure.
This study may also help define new standards of care for treatment of emphysema.
10.12
Financial Considerations
10.12.1
SubjectCompensation:
Subjects will not be compensated for their participation in the study. Subject reimbursement for travel may be 
considered.
10.12.2
PhysicianCompensation:
Participating sites will be compensated a reasonable amount,  calculated  to cover the costs  of physician and staff 
time to enter data and administer the study. Compensation will be provided for  timely and  completed eCRFs.
10.13
Recording, Access to and Retention of SourceData
Investigators are required to prepare and maintain adequate source documentation which includes:
x
Documents relative to the Subject medical history that verify eligibility criteria
x
Records covering Subject participation in the trial including basic identification information, results of physical 
examinations and diagnostic tests, original laboratory results (initialed and dated  by investigator), therapy, 
trial treatment administration, concurrent medication information, pathology reports, and visit/consult notes.
All key data must be recorded in the Subject’s source documents including the informed consent acquisition.
The investigator must permit authorized representatives of the sponsor, the regulatory authorities, the IEC, and
auditors to inspect facilities and records relevant to the trial.
The monitor (auditors, IEC or regulatory inspectors) may check the eCRF entries against the  source documents. 
The consent form will include a statement by which the subjects allow the above-named access to source data that 
substantiate information recorded in the eCRFs. These personnel, bound by professional secrecy, will not disclose 
any personal information or personal medical information.
As described in the ICH GCP Guidelines, ‘essential documents’, including eCRFs, source documents, consent 
forms, laboratory test results, device inventory records, should be retained by the investigator until at least two years 
after the last approval of a marketing application in an ICH region or  at  least  two years  have  elapsed  since the 
formal discontinuation of a clinical development of the IP. These documents should be retained for a longer period 
however if required by the applicable regulatory requirements or by  an  agreement  with  the sponsor. The investigator 
must obtain written permission from the sponsor prior to destruction of any trial document.
These records must be made available at reasonable times for inspection and duplication, if required, by a properly
authorized representative of regulatory authorities in accordance with regulatory requirements.
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10.14
Electronic Case Report Forms
The investigator is responsible for maintaining adequate and accurate source documents from which accurate 
information will be transcribed in to eCRFs that have been designed to capture all observations and other data 
pertinent to the clinical investigation. eCRFs should be completed by the investigator or  delegate  as  stated on the 
Delegation of Authority Log.
Overwriting of information or use of liquid correcting fluid is not allowed in source documentation.
Once the study monitor has verified the  contents of the completed eCRF against the source data, queries  may be 
raised if the data are unclear or contradictory. The eCRFs must be reviewed and electronically signed and dated by 
the investigator once all data has been entered and all queries resolved.
10.15
Publications
All manuscripts, abstracts or other modes of  presentation arising from the results of the trial must be reviewed and 
approved in writing by the sponsor, in advance of submission. The review is intended to protect sponsor proprietary 
information existing either at the date of commencement of the trial or generated during the trial. No individual 
investigator may publish results from his/her site until after publication of the primary manuscript describing the full 
trial population.
The detailed obligations regarding the publication of any data, material results or other information that  is generated 
or created in relation to the trial shall be set out in the agreement between the investigator  and sponsor, in 
accordance with the Boston Scientific Corporation PublicationPolicy.
In accordance with recommendations from the International  Committee of  Medical  Journal Editors, the study  will 
be listed in a publicly accessible registry of clinical trials such as clinicaltrials.gov.
10.16
Audit/Inspections
To ensure compliance with relevant regulations, data generated by this trial must  be  available  for inspection upon 
request by representatives of the regulatory authorities,  the sponsor and its  representatives,  and the IEC  for each 
trial site.
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11
BIBLIOGRAPHY
1.
Puhan MA, Chandra D, Mosenifar Z, Ries A, Make B, Hansel NN, Wise RA, Sciurba F, National Emphysema 
Treatment Trial (NETT) Research Group The minimal important difference of exercise tests in severe 
COPD. Eur Respir J.2011;37:784–790.
2.
Jones PW. St. George's Respiratory Questionnaire: MCID. COPD. 2005;2:75–79.
3.
Donohue JF. Minimal clinically important differences in COPD lung function. COPD. 2005;2:111–124.
4.
Hartman JE, Ten Hacken NH, Klooster K, Boezen HM, de Greef MH, Slebos DJ. The minimal important 
difference for residual volume in patients with severe emphysema. Eur Respir J.2012;40:1137–1141.
5.
Mehta, C. R. and Pocock, S. J. (2011), Adaptive increase in sample size when interim results are 
promising: A practical guide with examples. Statist. Med., 30: 3267–3284. doi: 10.1002/sim.4102
6.
Halbert RJ, Natoli JL, Gano A, Badamgarav E, Buist AS, Mannino DM. Global burden of COPD: systemic 
review and meta-analysis. Eur Respir J 2006; 28(3): 523-532.
7.
O'Donnell, DE et al. Effects of fluticasone propionate/salmeterol on lung hyperinflation and exercise 
endurance in COPD. CHEST. 2006;130(3):647-656.
8.
Sciurba et al. Effect of endobronchial coils vs usual care on exercise tolerance in patients with severe 
emphysema: the RENEW randomized clinical trial. JAMA. 2016;315(20):2178-2189.
9.
Slebos et al. Bronchoscopic coil treatment for patients with severe emphysema: a meta-analysis. 
Respiration. 2015;90(2):136-145.
10. Deslée et al. Lung volume reduction coil treatment vs usual care in patients with severe emphysema:
the REVOLENS randomized clinical trial. JAMA. 2016;315(2):175-184.
11. Shah PL, Zoumot Z, Singh S, et al. Endobronchial coils for the treatment of severe emphysema with 
hyperinflation (RESET): a randomised controlled trial. Lancet. Respir. Med.2013;1(3):233–240.
12. Global Initiative for Chronic Obstructive Lung Disease: Global Strategy for the Diagnosis, Management, and 
Prevention of Chronic Obstructive Pulmonary Disease, Updated 2017.
13. Miller MR, et al; ATS/ERS Task Force on Standardization of lung function testing. Standardisation of 
spirometry. Eur Respir J. 2005;26:319-338.
14. Wanger J, et al; ATS/ERS Task Force on Standardisation of lung function testing. Standardisation of
the measurement of lung volumes. Eur Respir J. 2005;26:511-522.
15. McIntyre N, et al. ATS/ERS Task Force on Standardisation of lung function testing.  Standardisation  of the 
single-breath determination of carbon monoxide uptake in the lung. Eur Respir J.2005;26:720-735.
16. Miller, MR, et al:  ATS/ERS Task Force on General considerations  for lung function testing. Eur Respir  J. 
2005;26:153–161.
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