A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents
Phase: NA
Conditions: Walled Off Pancreatic Necrosis
Sponsor: Boston Scientific Corporation

AXIOS WON Drainage IDE (E7116) 
 
92153943 Rev/Ver I Protocol 
NCT03525808 
August 16, 2018 
E7116 
 
 
 
 
 
A Multicenter, Single-Arm Study of Endoscopic Ultrasound-Guided Drainage 
of Walled-off Pancreatic Necrosis with Lumen-Apposing Metal Stents 
AXIOS WON Drainage IDE 
NCT03525808 
Protocol 
August 16, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 THESE DOCUMENTS ARE THE PROPERTY OF BOSTON SCIENTIFIC CORP. AND SHALL NOT BE REPRODUCED, DISTRIBUTED, DISCLOSED OR USED FOR 
MANUFACTURE OR SALE OF APPARATUS WITHOUT THE EXPRESS WRITTEN CONSENT OF BOSTON SCIENTIFIC CORP. 

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A Multicenter, Single-Arm Study of Endoscopic Ultrasound-Guided 
Drainage of Walled-off Pancreatic Necrosis with Lumen-Apposing Metal 
Stents  
 
AXIOS WON Drainage IDE (E7116) 
 
Clinical Investigation Plan 
 
 
 
IDE# G170261 
 
 
 
Sponsored By 
 
Boston Scientific Corporation 
100 Boston Scientific Way 
Marlborough, MA 01752-1234 
USA 
 
 
 
 
 
 
 
 
 
 
 
 
 
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. 
 

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Contact Information 
Role 
Contact  
Clinical Contact 
Lina Ginnetti 
Director of Clinical Research 
Boston Scientific Corporation 
100 Boston Scientific Way 
Marlborough, MA 01752-1234 
USA 
Coordinating Principal 
Investigator 
Dr. Barham Abu Dayyeh, MD 
Mayo Clinic 
200 1st St SW 
Rochester, MN 55905 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Original Release: October 6, 2017 
Current Version: August 16, 2018, 2017 
Revision History 
 
Revision 
Number 
Release Date 
Template 
number and 
version 
Section 
Change 
Reason for Change 
92153943, 
Rev/Ver. B 
October 6, 2017 
Template 
90702637 
Rev/Ver 
AH          
4.3 
Changed header to 
Additional 
Endpoints; added 
additional endpoint 
#7 from Synopsis 
Typo 
92153943, 
Rev/Ver. B 
October 6, 2017 
Template 
90702637 
Rev/Ver 
AH          
7.2 
Deleted the Sample 
Size section as it 
already resides 
under Section 7.1 
Typo 
92153943, 
Rev/Ver. B 
October 6, 2017 
Template 
90702637 
Rev/Ver 
AH          
15.1 
Removed Complete 
Distal Migration 
from the last bullet 
and replaced with 
Necrosectomy 
Procedure 
Typo 
92153943, 
Rev/Ver. 
C 
October 10, 
2017 
Template 
90702637 
Rev/Ver 
AH          
7.3 
Sample Size 
relocated within 
Section 7 
Administrative 
92153943, 
Rev/Ver. 
D 
November 1, 
2017 
Template 
90702637 
Rev/Ver 
AH          
7.1  
Added Success 
Criteria 
Per FDA Feedback 
92153943, 
Rev/Ver. 
D 
November 1, 
2017 
Template 
90702637 
Rev/Ver 
AH          
7.2 
Added Success 
Criteria and Table 
7.3 of categorized 
SAEs from recent 
literature 
Per FDA Feedback 
92153943, 
Rev/Ver. E 
November 21, 
2017 
Template 
90702637 
Rev/Ver 
AH          
Synopsis, 
5.2 
Addition of 
exclusion criteria 
#6 
Per FDA Feedback 
92153943, 
Rev/Ver. E 
November 21, 
2017 
Template 
90702637 
Rev/Ver 
AH          
Synopsis, 
6.1, 6.4 
Addition of the 
collection of 
current medication 
Per FDA Feedback 
92153943, 
Rev/Ver. E 
November 21, 
2017 
Template 
90702637 
15.1 
Language added to 
clarify that BSC 
Per FDA Feedback 

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Revision 
Number 
Release Date 
Template 
number and 
version 
Section 
Change 
Reason for Change 
Rev/Ver 
AH          
will be responsible 
for all UADE 
assessments 
92153943, 
Rev/Ver. F 
December 14, 
2017 
Template 
90702637 
Rev/Ver 
AH          
Synopsis, 
5,7 
Changed sample 
size to 40, added  
random-effects 
meta-analysis for 
resolution rates 
and SAE rates, 
modified success 
criteria. Changed 
title of “Safety 
Cohort” to 
“Treated Cohort” 
Per FDA Feedback 
92153943, 
Rev/Ver. 
G 
May 9, 2018 
Template 
90702637 
Rev/Ver AJ   
Synopsis, 
Visit 
Schedule  
Safety 
Endpoint 
6.4, 2.1, 7.2 
Added Imaging 
criteria to Study 
Visits and 
Synopsis; added 
labs to 
screening/pre-op 
visit; removed 
clinical UPNs; 
protocol template 
update, added 
safety endpoint 
assessment to 
synopsis and safety 
endpoint; added 
procedural details 
to stent placement 
visit and synopsis; 
Made changes to 
the primary 
effectiveness 
endpoint 
assessment; Added 
section 7.2 Safety 
Endpoint 
Assessment; added 
SF-12 to 
Appendices  
Per 
Site/Investigator 
Feedback 
92153943, 
Rev/Ver. 
H 
August 15, 2018 
Template 
90702637 
Rev/Ver AJ   
7.4 
Added double 
pigtail plastic 
stents to 
justification of 
pooling  
Per FDA Feedback 

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Revision 
Number 
Release Date 
Template 
number and 
version 
Section 
Change 
Reason for Change 
92153943, 
Rev/Ver. I 
August 16, 2018 
Template 
90702637 
Rev/Ver AJ   
Synopsis, 
6.3, 7.4 
Added Boston 
Scientific 7Fr 
AdvanixTM Biliary 
Stent to Stent 
Placement 
Procedure 
Per FDA Feedback 

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Protocol Synopsis 
 
Full Title 
A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided 
Drainage of Walled-off Pancreatic Necrosis with Lumen-Apposing 
Metal Stents 
Short Title 
AXIOSTM WON Drainage IDE 
Study Objective 
To demonstrate safety and effectiveness of lumen-apposing metal stents 
for resolution of walled off pancreatic necrosis (WONs) in patients with 
WONs with solid component >30% 
Indication(s) for 
Use  
Current cleared indication for use:  The AXIOSTM Stent and 
Electrocautery Enhanced Delivery System is cleared in the U.S. “for use 
to facilitate transgastric or transduodenal endoscopic drainage of 
symptomatic pancreatic pseudocysts ≥ 6cm in size and walled-off 
necrosis ≥ 6cm in size with ≥ 70% fluid content that are adherent to the 
gastric or bowel wall. Once placed, the AXIOSTM Stent functions as an 
access port allowing passage of standard and therapeutic endoscopes to 
facilitate debridement, irrigation and cystoscopy”. Outside the U.S., the 
AXIOSTM Stent and Electrocautery Enhanced Delivery System is 
indicated for use to facilitate transgastric or transduodenal endoscopic 
drainage of a pancreatic pseudocyst or walled-off necrosis with ≥ 70% 
fluid content or to facilitate drainage of the biliary tract. 
Proposed expanded indication for this IDE study:  The AXIOSTM Stent 
and Electrocautery Enhanced Delivery System is intended “for use to 
facilitate transgastric or transduodenal endoscopic drainage of 
symptomatic pancreatic pseudocysts ≥ 6cm in size and walled-off 
necrosis ≥ 6cm in size that are adherent to the gastric or bowel wall.  
Once placed, the AXIOSTM Stent functions as an access port allowing 
passage of standard and therapeutic endoscopes to facilitate debridement, 
irrigation and cystoscopy”.   
Test Device 
AXIOSTM Stent and Electrocautery Enhanced Delivery System 
Test Device Sizes 
10mm, 15mm, and 20mm 
Study Design 
Prospective, single arm, multi-center trial 
Number of 
Subjects 
40 
Number of Sites 
Up to 6 centers 

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Primary 
Endpoints 
Primary Effectiveness Endpoint:  
Resolution of WON with endoscopic drainage defined as radiographic 
decrease of WON size to ≤ 3cm evaluated by CT scan or MRI  
Primary Safety Endpoint:   
AXIOSTM stent related or WON drainage procedure related serious 
adverse events 
Additional 
Endpoints 
1. Reduction of WON-related clinical symptoms.                                       
Note: WON-related symptoms as defined in Inclusion Criteria #4 
2. Technical AXIOSTM stent placement success, defined as placement in 
desired location using endoscopic/EUS techniques per standard of 
practice. 
3. Technical AXIOSTM stent removal success, defined as ability to 
remove the AXIOSTM stent using an endoscopic snare or forceps or 
graspers without AXIOSTM stent removal related serious adverse 
events. 
4. Drainage procedural time: Time elapsed between initial puncture of 
the WON with electrocautery to endoscope retrieval.   
5. Resolution of WON with or without necrosectomy by 6 months post 
AXIOSTM stent removal. 
6. Time to WON resolution using same definition as for primary 
endpoint, namely: 
• Resolution of WON with endoscopic drainage defined as 
radiographic decrease of WON size to ≤ 3cm evaluated by CT 
scan or MRI  
7. Recurrence of WON after initial resolution and up to 6 months post 
AXIOSTM stent removal. 
8. Stent lumen patency, evaluated via imaging or direct visual inspection 
with endoscope, and defined as one or both of the following:  
• Drainage through AXIOSTM stent visualized from the stomach or 
bowel, and/or 
• Visual confirmation  of AXIOSTM stent lumen patency 
9. Fluoroscopy (time) per endoscopic procedure.  
10. Incidence of new organ failure from drainage procedure to WON 
resolution. 
11. Change in Quality of Life score (SF-12 questionnaire) from baseline 
to stent removal and end of study 

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Study Visits and 
Follow-Up 
Schedule 
• Screening/ Pre-op Visit: informed consent, demographics, etiology of 
Acute Pancreatitis (biliary, alcohol, idiopathic or other), onset date of 
AP, WON related symptoms, baseline CT scan or MRI (identification 
of % necrosis and confirmation of absence of pseudoaneurysms inside 
WON), organ failure assessment (Marshal scoring system), severity 
of AP, and Quality of Life (SF-12), labs, current medication 
• Stent Placement Procedure:  
o AXIOSTM stent placement 
Note: Physicians will select the site of the AXIOSTM stent 
placement under endoscopic guidance and choose an access 
location that is free from necrotic debris and intervening blood 
vessels, where the wall between the GI tract and fluid collection is 
10mm or less, and where it is possible to place the AXIOSTM stent 
in a position such that the inner flange (inside WON) has enough 
space to expand.   
o Lavaging of WON and/or breaking up of large chunks of necrosis 
under endoscopic visualization for up to 20 minutes, and/or 
placement of nasocystic drain, or a single 7fr double pigtail plastic 
stent (Boston Scientific 7Fr AdvanixTM Biliary Stent) through the 
AXIOSTM stent  at the discretion of investigator.  
o Stent lumen patency assessment 
o Adverse event/device event assessment 
o Current medication 
o Labs (as needed) 
Note: Labs need to be repeated at this visit ONLY IF they were 
collected more than 3 days before the stent placement procedure.    
 
• WON Resolution Assessment Visit - 7 days (+/-3 days) for inpatients 
and 14 days (+/- 5 days) for outpatients (needed until radiographic 
decrease of WON size to ≤ 3cm): 
o Cross sectional imaging (CT or MRI) to assess reduction in WON 
size.  If reduction in size is deemed insufficient, necrosectomy 
will be initiated 
o Documentation of clinical improvement defined as improvement 
of principal WON-related symptoms 
o Necrosectomy (as needed)  
o Adverse event/device event assessment) 

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o Organ failure assessment (Marshal scoring system) 
o Current medication 
o Labs (as needed) 
• Reintervention/Necrosectomy Visits when needed during AXIOSTM 
stent indwell:  
o Necrosectomy initiated if WON reduction in size is deemed 
insufficient during WON Resolution Assessment Visit. Duration 
of each necrosectomy session is limited to 60 minutes 
o Percutaneous drainage or additional endoscopic drainage may be 
needed if reduction in WON size is insufficient or in cases of 
continued WON related symptoms such as infection/sepsis despite 
necrosectomy. Choice of stent (AXIOSTM or double pigtail plastic 
stent(s)) for repeat endoscopic drainage procedures will be left to 
the discretion of the investigator. The double pigtail plastic 
stent(s) or new AXIOSTM stent may be placed through the tract 
established by the original AXIOSTM stent or in a separate 
location. 
o Stent lumen patency assessment 
o Adverse event/device event assessment 
o Labs (as needed) 
o Imaging (as applicable) 
o Current medication 
• Stent Removal Visit - between 14 days and 60 days of stent 
placement:  
o Stent lumen patency assessment 
o Stent removal after evidence of clinical and radiographic (via CT 
or MRI) resolution of WON 
Note: Removal of stent by 60 days is required if WON is not 
resolved. Patients with unsuccessful or incomplete WON 
resolution by 60 days will proceed to standard of care treatment 
outside of this protocol after removal of the AXIOSTM stent; 
however, the patient outcome will continue to be followed.  
Alternative interventions may include surgery, endoscopic 
drainage with double pigtail plastic stents, percutaneous catheter 
drainage and necrosectomy (video-assisted retroperitoneal 
debridement (VARD), or endoscopic transluminal debridement, or 
open necrosectomy).  

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o Adverse event/device event assessment 
o Organ failure assessment (Marshal scoring system) 
o Quality of Life (SF-12) 
o Current medication 
• 7 Day (+/- 3 days) Post Stent Removal Visit – (office or phone call): 
o Adverse Event assessment 
o Current mediation 
• WON Recurrence Assessment Visit/End of Study - at 6 Months (+/- 
14 days) from stent removal:  
o Recurrence assessment (presence of clinical symptoms and further 
diagnosis per standard of care (e.g. labs and imaging) 
o Adverse Events assessment 
o  Quality of Life (SF-12) 
o Current medication 

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Key Inclusion 
Criteria 
1. Age between 22 and 75 years old 
2. Severe or moderately severe acute necrotizing pancreatitis, defined 
per the 2012 Revised Atlanta Classification [1].  
3. WON resulting from necrotizing pancreatitis per contrast-enhanced 
CT or MRI with the following characteristics, per the 2012 Revised 
Atlanta Classification: [1].  
• Heterogeneous with liquid and non-liquid density with varying 
degrees of loculations (some may appear homogeneous) 
• Well defined wall 
• Location-intrapancreatic and/or extrapancreatic 
4. Infected WON or symptomatic sterile WON 
Note: WON-related symptoms may include: pain, fever, leukocytosis, 
failure to thrive or deterioration of overall heath score, gastric outlet 
obstruction (GOO), weight loss, biliary obstructive symptoms, 
systemic inflammatory response syndrome (SIRS), deteriorating 
organ function, chronic nausea, lethargy, and inability to eat or gain 
weight   
5. Imaging suggestive of greater than 30% necrotic material 
6. WON ≥ 6cm in size 
7. Eligible for endoscopic intervention 
8. Acceptable candidate for endoscopic transluminal drainage 
9. Patient understands the study requirements and the treatment 
procedures and provides written Informed Consent 
10. Patient is willing to comply with all specified follow-up evaluations, 
including willingness to undergo a pre/post imaging study 

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Key Exclusion 
Criteria 
1. Pseudocyst 
2. Cystic neoplasm 
3. Untreated Pseudoaneurysm > 1cm within the WON  
4. More than one WON clearly separated and requiring drainage 
5. WONs that require dual modality interventions (endoscopic and 
percutaneous) from the beginning (i.e. deep paracolic space 
involvement that is inaccessible through the central drainage access)   
6. Prior surgical, interventional radiology or endoscopic procedures for 
the treatment of the WON 
7. Abnormal coagulation: 
• INR > 1.5 and not correctable 
• presence of a bleeding disorder 
• platelets < 50,000/mm3 
8. Intervening gastric varices or unavoidable blood vessels within the 
access tract (visible using endoscopy or endoscopic ultrasound) 
9. WON that poorly approximates the GI lumen (≥1cm away) 
10. Pericolic gutter necrosis 
11. Pelvic necrosis 
12. Prior true anaphylactic reaction to contrast agents, nitinol (nickel 
titanium), silicone or any other materials contacting the patient 
13. Female of childbearing potential with a positive pregnancy test prior 
to the procedure or intends to become pregnant during the study 
14. Currently participating in another investigational drug or device study 
that has not completed the primary endpoint or that clinically 
interferes with the endpoints of this study 
Multiple 
Interventions 
During Index 
Procedure 
Index Procedure: 
Once stent is placed into the WON, dilation of the AXIOSTM stent is 
allowed to expand the stent if needed.  Dilation can be performed to the 
maximal diameter of the AXIOSTM stent. A single, 7 fr double pigtail 
plastic stent (Boston Scientific 7Fr AdvanixTM Biliary Stent) may be 
placed through the AXIOSTM stent at the discretion of the investigator. 
Access to the WON with a forward viewing diagnostic or therapeutic 
upper gastroscope is allowed up to 20 minutes (from time of endoscopic 
access of the WON) to break-up large chunks of necrosis and lavage 
collection at the discrection of the physician.  

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Primary 
Effectiveness 
Endpoint 
Assessment 
Note: Success will be based on the number of WONs resolved, not on the 
number of AXIOSTM Stents required to achieve resolution. 
• If it is determined that the fluid collection is actually two separate 
collections, and each collection is drained via an AXIOSTM stent, then 
each collection will be assessed individually via the drainage success 
criteria of ≤3cm. 
• If it is determined that the fluid collection is a single collection but the 
drainage is inadequate via a single AXIOSTM stent, then the success 
of the AXIOSTM drainage will be assessed as follows: 
o If a second AXIOSTM stent is used at a new drainage site/original 
drainage site and the entire fluid collection is drained to meet the 
success criteria of ≤3cm then the collection will be considered to 
be a single collection drainage success. 
o If a second AXIOSTM stent is used at a new drainage site and the 
entire fluid collection does not drain adequately to meet the 
drainage success criteria of ≤3cm then the fluid drainage of the 
collection will be considered to be a single drainage failure. 
o If a plastic stent is used at a new drainage site and the entire fluid 
collection drains to meet the drainage success criteria of ≤3cm 
then the fluid drainage will be considered indeterminate 
o If a single, 7fr plastic stent is used at the same drainage site, 
through the AXIOSTM stent, and the entire fluid collection drains 
to meet the drainage success criteria of ≤3cm then the fluid 
drainage will be considered a single collection drainage success. 
o If a plastic stent is used at a new drainage site and the entire fluid 
collection does not drain to meet the drainage success criteria of 
≤3cm then the fluid drainage will be considered a single drainage 
failure. 

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Primary Safety 
Endpoint 
Assessment 
The Primary Safety Endpoint is AXIOSTM stent related or WON drainage 
procedure related serious adverse events however if it is determined that 
the patient has an infection, then the primary safety success of the 
AXIOSTM device or the drainage procedure will be assessed as follows: 
• If the patient presents with an infected collection at the initial 
drainage procedure, the infection will be classified as a localized 
infection and will not be considered a stent related or WON 
drainage related serious adverse event 
• If the patient presents with a sterile collection at the initial 
drainage procedure and post-procedurally develops an infected 
collection, the infection will be classified as a localized infection 
and will not be considered a stent related or WON drainage 
related serious adverse event as this is a known consequence of 
any endoscopic drainage procedure, where the access route to the 
collection is through a non-sterile GI lumen and is not a function 
of a particular stent or device  
(Note: If the stent is occluded at the onset of infection, then the 
infection will be attributed to the device. If the stent remains 
unobstructed at the time of infection, then the infection will not be 
attributed to the device.) 
• If the patient presents with a sterile or infected collection at the 
initial drainage procedure and then post-procedurally develops a 
wide-spread infection in the form of sepsis or blood stream 
infection, then the infection will be classified as systemic and will 
be considered a stent related or WON drainage related serious 
adverse event only if the AXIOS stent was clearly and visually 
occluded by solid necrosis at the time of repeat endoscopy. This 
determination will be made by the operating physician at the time 
of endoscopy  
 
 
Statistical Methods  

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Primary 
Effectiveness 
Endpoint – 
Statistical Methods 
As in the original IDE, #G130264, there is no formal statistical 
hypothesis for this study.  The proportion of AXIOS patients with 
reduction of WON size to ≤ 3cm within 60 days from AXIOSTM stent 
placement in the original IDE is 76.7% (23/30) patients. Given that the 
WONs in the proposed IDE will have an estimated necrotic material 
content above 30%, namely larger than in IDE #G130264, a slightly 
lower success rate of 70.0% is expected for this study.  This success 
rate is within the range of reported WON resolution rates in several 
recent publications [2-8] on plastic stent WON drainage, an established 
WON drainage method as described in the ASGE guidelines on 
treatment of pancreatic fluid collections [9].   
Primary 
Effectiveness 
Endpoint – Success 
Criteria 
An observed rate of 67% or higher for the proportion of AXIOSTM 
patients with reduction of WON size to ≤ 3cm within 60 days from 
AXIOSTM stent placement is required for success. 
 
Primary Safety 
Endpoint – 
Statistical Methods 
As in the original IDE, #G130264, there is no formal statistical 
hypothesis for this study.  The proportion of AXIOSTM patients with 
AXIOSTM stent related or WON drainage procedure related serious 
adverse events in the original IDE is 10.0% (3/30) patients. A similar 
rate of AXIOSTM stent related or WON drainage procedure related 
serious adverse events is expected in this study.  This event rate is 
within the range of reported stent related or WON drainage procedure 
related serious adverse event rates in several recent publications [3-5, 
10] on plastic stent WON drainage, an established WON drainage 
method as described in the ASGE guidelines on treatment of pancreatic 
fluid collections [9]. 
Primary Safety 
Endpoint – Success 
Criteria 
An observed rate of 17.5% or lower for the proportion of AXIOSTM 
patients with AXIOSTM stent related or WON drainage procedure 
related serious adverse events is required for success. 
 
 
Sample Size – 
Statistical Methods 
The sample size of 40 patients was determined without statistical 
consideration based on previous clinical experience showing adequate 
effectiveness and safety with a similar sample size. 
 
 

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Table of Contents 
1 
Introduction ....................................................................................................................19 
2 
Device Use and Description ...........................................................................................20 
2.1 
Device Description and Device Use .......................................................................20 
3 
Study Objective ...............................................................................................................21 
4 
Endpoints and Study Design ..........................................................................................21 
4.1 
Primary Effectiveness Endpoint ..............................................................................21 
4.2 
Primary Safety Endpoint .........................................................................................21 
4.3 
Additional Endpoints ..............................................................................................22 
4.4 
Study Design ...........................................................................................................22 
5 
Subject Selection .............................................................................................................24 
5.1 
Inclusion Criteria .....................................................................................................24 
5.2 
Exclusion Criteria....................................................................................................24 
5.3 
Point of Enrollment .................................................................................................25 
5.4 
Withdrawal ..............................................................................................................25 
5.5 
Subject Status and Classification ............................................................................26 
5.6 
End of Study Action Plan ........................................................................................26 
6 
Study Methods ................................................................................................................27 
6.1 
Data Collection........................................................................................................27 
6.2 
Informed Consent ....................................................................................................28 
6.3 
Visit Schedule .........................................................................................................28 
Screening / Pre-op Visit – Office/Hospital Visit: .................................................................28 
Stent Placement Procedure – Office/Hospital Visit ............................................................28 
WON Resolution Assessment - 7 days (+/- 3 days) for inpatients and 14 (+/- 5 days) days 
for outpatients (needed until radiographic decrease of WON size to ≤ 3cm) – 
Office/Hospital Visit: .............................................................................................................29 
Reintervention/Necrosectomy Visits when needed during AXIOSTM stent indwell – 
Office/Hospital Visit: .............................................................................................................29 

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Stent Removal Visit - between 14 days and 60 days (+/- 7 days) of stent placement – 
Office/Hospital Visit...............................................................................................................30 
7 Day (+/-3 days) Post Stent Removal Visit – (Office or phone call):................................30 
6.4 
Study Completion ...................................................................................................30 
6.5 
Source Documents ..................................................................................................31 
7 
Statistical Considerations ..............................................................................................31 
7.1 
Effectiveness Endpoint............................................................................................31 
7.2 
Safety Endpoint .......................................................................................................32 
7.3 
Sample Size and Success Criteria ...........................................................................34 
7.4 
General Statistical Methods ....................................................................................35 
8 
Data Management ..........................................................................................................36 
8.1 
Data Collection, Processing, and Review ...............................................................36 
8.2 
Data Retention .........................................................................................................37 
9 
Amendments ...................................................................................................................37 
10 Deviations ........................................................................................................................37 
11 Device/Equipment Accountability ................................................................................38 
12 Compliance ......................................................................................................................38 
12.1 Statement of Compliance ........................................................................................38 
12.2 Investigator Responsibilities ...................................................................................39 
12.3 Institutional Review Board/ Ethics Committee.......................................................40 
12.4 Sponsor Responsibilities .........................................................................................41 
12.5 Insurance .................................................................................................................41 
13 Monitoring .......................................................................................................................41 
14 Potential Risks and Benefits ..........................................................................................42 
14.1 Anticipated Adverse Device Effects .......................................................................42 
14.2 Anticipated Benefits ................................................................................................42 
14.3 Risk to Benefit Rationale ........................................................................................43 
15 Safety Reporting .............................................................................................................43 
15.1 Reportable Events by Investigational Site to Boston Scientific..............................43 

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15.2 Definitions and Classification .................................................................................44 
15.3 Relationship to Study Device(s)..............................................................................45 
15.4 Investigator Reporting Requirements .....................................................................47 
15.5 Boston Scientific Device Deficiencies ....................................................................49 
15.6 Reporting to Regulatory Authorities / IRBs / ECs / Investigators ..........................49 
16 Informed Consent ...........................................................................................................49 
17 Suspension or Termination ............................................................................................51 
17.1 Premature Termination of the Study .......................................................................51 
17.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC 
Approval ..................................................................................................................51 
17.3 Requirements for Documentation and Subject Follow-up ......................................51 
17.4 Criteria for Suspending/Terminating a Study Center..............................................52 
18 Publication Policy ...........................................................................................................52 
19 Bibliography ....................................................................................................................53 
20 Abbreviations and Definitions .......................................................................................55 
21 Appendix A. Key points extracted from Bazerbachi et al (GIE 2017) [28] ...............57 
22 Appendix B. S-F12 ..........................................................................................................58 
 

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1  Introduction  
Walled-off pancreatic necrosis (WON) is a late complication of acute pancreatitis. Annually 
there are about 185,000 cases of WON that occur in the U.S, and the majority (at least 80%) 
are caused by alcohol and cholelithiasis [11].  
WON was formerly known as pancreatic abscess and in 2012, the Atlanta Classification 
system for pancreatitis was revised to update the terminology used to classify pancreatic fluid 
collections (PFCs) in an attempt to provide better clinical guidance on diagnosis and 
treatment of pancreatitis [12]. The revised classification introduced new terminology for the 
various types of PFCs that are based on the timing of the development of the collection into 
the clinical course of the disease, as well as on the presence or the absence of necrosis in the 
PFC. Fluid collections developing prior to 4 weeks are called acute peripancreatic fluid 
collections or acute necrotic collections. Once the collection develops a contrast-enhancing 
capsule, which usually occurs after 4 weeks, fluid collections are called either pseudocysts 
(no necrotic material present) or walled-off necroses (WONs) if necrotic material is present.  
Any of these PFC types can be sterile or infected according to the revised Atlanta 
Classification.  
When PFCs become infected or symptomatic, drainage procedures are performed.  Currently, 
drainage can be accomplished surgically, via percutaneous interventional radiology 
techniques, or endoscopically [13-15].  Surgery for PFCs is associated with relatively high 
rates of morbidity (7-37%) and mortality (6%) [16], and it has been reported that 
percutaneous drainage increases the risk of infection and the formation of 
pancreaticocutaneous fistulae [17, 18].  As a result, endoscopic drainage techniques have 
replaced surgery and percutaneous drainage techniques as the first-line therapy for 
symptomatic PFCs because they have high technical and clinical success rates with lower 
rates of complications, shorter recovery times, and lower cost [18, 19].  The most common 
type of endoscopic drainage procedure is the endoscopic ultrasound-guided transmural 
approach. During this type of procedure, the PFC is accessed via creation of a tract between 
the PFC and the lumen of the stomach or duodenum and a drainage device is placed through 
this tract.  The device connects the interior of the PFC with the lumen to allow internal 
drainage.  Double-pigtail plastic stents (usually 7-10F in size) and fully-covered, self-
expanding metal stents (usually those designed for the biliary tract) are used as the drainage 
device [20-23].  However, both of these stent types are associated with problems.  While the 
double-pigtail design of the plastic stents tends to prevent migration, the narrow lumen of 
these stents tends to occlude quickly, particularly in the drainage of WONs where solid 
necrotic material may be present within the collection in addition to fluid [19, 24].  This 
necessitates multiple stent exchanges or placement of additional stents.  The metal biliary 
stents offer a larger-diameter lumen and longer patency, but because they have a tubular 
design they can migrate quickly, resulting in poor drainage, leakage, and mucosal injury in 
the digestive tract [25].   
Recently, the use of “barbell” shaped lumen-apposing, fully covered self-expanding metal 
stents such as the AXIOSTM stent for drainage of WONs has been reported.  These large-
diameter stents may provide better drainage of both fluid and solid material from the WON 
with less chance of stent occlusion, and the flanges on this type of stent may prevent stent 

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migration by apposing the WON wall to the stomach or duodenal wall.  This could result in 
faster resolution of the WON using fewer endoscopic procedures.  Rinninella et al, 
performed a retrospective study examining the drainage of PFCs, including WON. They 
included 93 patients with PFCs (80% with complex collections) who underwent drainage 
with AXIOSTM, 52 of whom had WON. Among those with WON, the solid component was 
judged to be less than 25% of the collection in 14 patients, between 25% and 50% in 20 
patients, and more than 50% in the remaining 18 patients. Clinical success, resolution of 
PFCs without the need for additional endoscopic or percutaneous drainage procedures or 
surgery, was achieved in 47 of 52 patients (90.4%) with WON [26]. A separate study 
performed by Shah et. al. prospectively analyzed patients with chronic pancreatitis who 
received treatment of pancreatic pseudocysts or WONs using AXIOSTM. They concluded that 
the large lumen size of the metal stent allows for successful necrosectomy through the stent 
when needed [27]. 
The current study is proposed to supplement this literature by documenting the safety and 
effectiveness of the AXIOSTM lumen apposing self-expandable metal stent system for the 
drainage of WON containing greater than 30% necrotic material. 
2 Device Use and Description 
2.1 Device Description and Device Use 
Study devices are manufactured by Boston Scientific Corporation. The AXIOSTM Stent is a 
flexible, fully-covered self-expanding metal stent that is preloaded within the Electrocautery-
Enhanced Delivery System.  The stent is made of Nitinol and fully-covered with silicone.  
The AXIOSTM Stent and Electrocautery-Enhanced Delivery System is compatible with 
therapeutic echoendoscopes having a working channel of 3.7mm diameter or larger. 
Current cleared indication for use:  The AXIOSTM Stent and Electrocautery Enhanced 
Delivery System is cleared in the U.S. “for use to facilitate transgastric or transduodenal 
endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size and walled-off 
necrosis ≥ 6cm in size with ≥ 70% fluid content that are adherent to the gastric or bowel wall.  
Once placed, the AXIOSTM Stent functions as an access port allowing passage of standard 
and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy.  The stent is 
intended for implantation up to 60 days and should be removed upon confirmation of 
pseudocyst or walled-off necrosis resolution.” Outside the U.S., the AXIOSTM Stent and 
Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or 
transduodenal endoscopic drainage of a pancreatic pseudocyst or walled-off necrosis with ≥ 
70% fluid content or to facilitate drainage of the biliary tract. 
Proposed expanded indication for this IDE study:  The AXIOSTM Stent and Electrocautery 
Enhanced Delivery System is intended “for use to facilitate transgastric or transduodenal 
endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size and walled-off 
necrosis ≥ 6cm in size that are adherent to the gastric or bowel wall.  Once placed, the 
AXIOSTM Stent functions as an access port allowing passage of standard and therapeutic 
endoscopes to facilitate debridement, irrigation and cystoscopy.”   

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The study device is not approved for drainage of WONs with greater than 30% necrotic 
material and will be considered investigational for this indication.   Local Institutional 
Review Board (IRB)/ Ethics Committee (EC) approval will be obtained at each participating 
center.  
Study devices are labeled on the box and inner pouch and include information not limited to 
name of legal manufacturer, device name and dimensions, lot number, expiration date and 
investigational use statement. Device labeling will be provided in local language(s) as per 
national regulations.  Devices will be available in the following matrix: 
 
Table 2.0-1: Device Matrix 
Description 
Stent Size 
Delivery 
System 
Outer 
Diam. 
Lumen 
Diameter 
Saddle 
Length 
Flange 
Diameter 
Electrocautery Enhanced AXIOSTM 
System with 10x10 Stent 
10 mm 
10 mm 
21 mm 
10.8Fr 
Electrocautery Enhanced AXIOSTM 
System with 15x10 Stent 
15 mm 
10 mm 
24 mm 
10.8Fr 
Electrocautery Enhanced AXIOSTM 
System with 20x10 Stent 
20 mm 
10 mm 
29 mm 
10.8Fr 
 
For a detailed description of the AXIOS™ Stent and Electrocautery-Enhanced Delivery 
System, please reference the Investigator’s Brochure. 
3 Study Objective 
To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of 
WONs in patients with WONs with solid component >30%. 
4 Endpoints and Study Design 
4.1 Primary Effectiveness Endpoint 
Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size 
to ≤ 3cm evaluated by CT scan or MRI.  
4.2 Primary Safety Endpoint 
AXIOSTM stent related or WON drainage procedure related serious adverse events. 

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4.3 Additional Endpoints 
1. Reduction of WON-related clinical symptoms.                                                             
Note: WON-related symptoms as defined in Inclusion Criteria #4 
2. Technical AXIOSTM stent placement success, defined as placement in desired location 
using endoscopic/EUS techniques per standard of practice. 
3. Technical AXIOSTM stent removal success, defined as ability to remove the AXIOSTM 
stent using an endoscopic snare or forceps or graspers without AXIOSTM stent removal 
related serious adverse events. 
4. Drainage procedural time: Time elapsed between initial puncture of the WON with 
electrocautery to endoscope retrieval.   
5. Resolution of WON with or without necrosectomy by 6 months post AXIOSTM stent 
removal. 
6. Time to WON resolution using same definition as for primary endpoint, namely: 
• Resolution of WON with endoscopic drainage defined as radiographic decrease of 
WON size to ≤ 3cm evaluated by CT scan or MRI. 
7. Recurrence of WON after initial resolution and up to 6 months post AXIOSTM stent 
removal. 
8. Stent lumen patency, evaluated via imaging or direct visual inspection with endoscope, 
and defined as one or both of the following:  
• Drainage through AXIOSTM stent visualized from the stomach or bowel, and/or 
• Visual confirmation of AXIOSTM stent lumen patency 
9. Fluoroscopy (time) per endoscopic procedure.  
10. Incidence of new organ failure from drainage procedure to WON resolution. 
11. Change in Quality of life score (SF-12 questionnaire) from baseline to stent removal and 
end of study 
4.4 Study Design 
This study is a prospective, multi-center, single arm, consecutive series study. Treatment of 
up to 40 subjects will take place at up to 6 clinical centers. Subjects who meet all eligibility 
criteria will receive the AXIOSTM stent for up to 60 days stent indwell and 6 months follow-
up after stent removal. 

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Figure 4.4-1: WON Drainage IDE Study Design 
Screening / Pre Op Visit
(Office/Hospital Visit)
• 
Informed consent
• 
Demographics
• 
Etiology of Acute Pancreatitis 
• 
Onset date of AP
• 
WON related symptoms
• 
Baseline CT scan
• 
Organ failure assessment (Marshal scoring system)
• 
Severity of AP
• 
Quality of Life (SF-12)
• 
Current medication
Stent Placement Procedure
(Office/Hospital Visit)
• 
AXIOSTM Stent placement
• 
Lavaging of WON and/or placement of nasocystic 
drain
• 
Stent lumen patency assessment 
• 
Adverse event / device event assessment
• 
Current medication
WON Resolution Assessment Visit(s) 
7 – 14 days until WON ≤3cm
(Office/Hospital Visit)
• 
Cross sectional imaging (CT or MRI)
• 
Documentation of clinical improvement
• 
Necrosectomy (as needed)
• 
Adverse event / device event assessment
• 
Organ failure assessment (Marshal scoring system)
• 
Current medication
Stent Removal Procedure
Between 14 – 60 days of stent placement
(Office/Hospital Visit)
• 
Stent lumen patency assessment
• 
Stent removal after evidence of clinical and 
radiographic (CT / MRI) resolution of WON
• 
Adverse event / device event assessment
• 
Organ failure assessment (Marshal scoring system)
• 
Quality of Life (SF-12)
• 
Current medication
7 Day Post Stent Removal Visit
7 days after stent removal
(Office/Hospital/Phone Call Visit)
• 
Adverse event assessment
• 
Current medication
WON Recurrence Assessment / End of Study Visit
6 Months from stent removal
(Office/Hospital Visit)
• 
Recurrence assessment (radiographic evidence (via 
CT or MRI) and presence of clinical symptoms)
• 
Adverse event assessment
• 
Quality of Life (SF-12)
• 
Current Medication
Reintervention/Necrosectomy Visit
If WON reduction deemed insufficient
(Office/Hospital Visit)
• 
Necrosectomy/percutaneous drainage/
additional endoscopic drainage
• 
Stent lumen patency assessment
• 
Adverse event / device event 
assessment
• 
Current medication
 

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5 Subject Selection  
5.1 Inclusion Criteria 
Subjects who meet all of the following criteria may be given consideration for inclusion in 
this clinical investigation, provided no exclusion criteria is met. 
 
1. Age between 22 and 75 years old 
2. Severe or moderately severe acute necrotizing pancreatitis, defined per the 2012 
Revised Atlanta Classification1  
3. WON resulting from necrotizing pancreatitis per contrast-enhanced CT with the 
following characteristics, per the 2012 Revised Atlanta Classification: 1  
• Heterogeneous with liquid and non-liquid density with varying degrees of 
loculations (some may appear homogeneous) 
• Well defined wall 
• Location-intrapancreatic and/or extrapancreatic 
4. Infected WON or symptomatic sterile WON 
Note: WON-related symptoms may include: pain, fever, leukocytosis, failure to thrive 
or deterioration of overall heath score, gastric outlet obstruction (GOO), weight loss, 
biliary obstructive symptoms, systemic inflammatory response syndrome (SIRS), 
deteriorating organ function, chronic nausea, lethargy, and inability to eat or gain 
weight   
5. Imaging suggestive of greater than 30% necrotic material 
6. WON ≥ 6cm in size 
7. Eligible for endoscopic intervention 
8. Acceptable candidate for endoscopic transluminal drainage 
9. Patient understands the study requirements and the treatment procedures and provides 
written Informed Consent 
10. Patient is willing to comply with all specified follow-up evaluations, including 
willingness to undergo a pre/post CT imaging study 
5.2 Exclusion Criteria 
Subjects who meet any one of the following criteria will be excluded from this clinical study. 
1. Pseudocyst 
2. Cystic neoplasm 
3. Untreated Pseudoaneurysm > 1cm within the WON  
4. More than one WON clearly separated and requiring drainage 

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5. WONs that require dual modality interventions (endoscopic and percutaneous) from 
the beginning (i.e. deep paracolic space involvement that is inaccessible through the 
central drainage access)   
6. Prior surgical, interventional radiology or endoscopic procedures for the treatment of 
the WON 
7. Abnormal coagulation: 
• INR > 1.5 and not correctable 
• presence of a bleeding disorder 
• platelets < 50,000/mm3 
8. Intervening gastric varices or unavoidable blood vessels within the access tract 
(visible using endoscopy or endoscopic ultrasound) 
9. WON that poorly approximates the GI lumen (≥1cm away) 
10. Pericolic gutter necrosis 
11. Pelvic necrosis 
12. Prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone 
or any other materials contacting the patient 
13. Female of childbearing potential with a positive pregnancy test prior to the procedure 
or intends to become pregnant during the study 
14. Currently participating in another investigational drug or device study that has not 
completed the primary endpoint or that clinically interferes with the endpoints of this 
study 
5.3 Point of Enrollment 
A subject is considered “enrolled” after signing the study-specific Informed Consent Form 
(ICF). Subjects who sign the ICF but subsequently do not meet one or more of the selection 
criteria will be considered screen failures and excluded from the study. 
5.4 Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) shall be accounted for and documented. If a subject withdraws from the 
clinical investigation, the reason(s) shall be reported. If such withdrawal is due to problems 
related to investigational device safety or performance, the investigator shall ask for the 
subject’s permission to follow his/her status/condition outside of the clinical study. 
Reasons for withdrawal include physician discretion, subject choice to withdraw consent, 
loss to follow-up and death. While study withdrawal is discouraged, subjects may withdraw 
from the study at any time, with or without reason, and without prejudice to further 
treatment. All applicable case report forms up to the point of subject withdrawal must be 
completed. Additional data may no longer be collected after the point at which a subject has 
been withdrawn from the study or withdraws his/her consent, for whatever reason. All open 

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adverse events should be closed or include resolution status. Data collected up to the point of 
subject withdrawal may be used. Withdrawn subjects will not be replaced. Subjects who 
withdraw from the study with the study stent in place will be followed per standard of care at 
the local institution. 
5.5 Subject Status and Classification 
Enrolled Cohort 
A subject will be considered enrolled when the ICF is signed.   
Intent-to-treat Cohort 
The intent-to-treat (ITT) cohort is defined as all subjects who signed the ICF, were evaluated 
for inclusion/exclusion criteria, and in whom the endoscopic procedure was initiated.    
Treated Cohort 
The treated cohort is defined as all ITT subjects who have an AXIOSTM stent implanted for 
the purpose of WON drainage. Subjects in the trated cohort will be counted towards the 
enrollment ceiling and this cohort will be considered the primary analysis cohort.  
Per Protocol Cohort 
The per-protocol cohort is defined as all treated subjects for whom an AXIOSTM stent was 
implanted for the purpose of WON drainage and met all eligibility criteria. 
5.6 End of Study Action Plan 
Subjects will have the study test device, the AXIOSTM Stent, implanted temporarily for up to 
60 days. A subject will be considered lost to follow-up if the subject remains unresponsive to 
communication after three documented attempts by study staff. However, for those subjects 
who remain unresponsive to communication while the stent remains in place, additional 
attempts will be made to request the subject’s return for study stent removal. These 
additional attempts may include increased telephone and written communications and contact 
with the subject’s primary care physician (if this communication is consented to in the 
Informed Consent Form).

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6 Study Methods 
6.1 Data Collection 
Procedure/ 
Assessment 
Screening/ 
Pre-Op Visit 
Stent 
Placement 
Procedure 
WON 
Resolution 
Assessment 
Visit 
(7 (+/- 3 days) 
/14 (+/- 5 days)  
for 
inpatients/outpa
tients) 
 
Reintervention
/ Necrosectomy 
Visit              
(when needed)  
Stent 
Removal 
Visit               
(14 -60 days 
from stent 
placement)  
 
7 Day Post 
Stent 
Removal 
Visit (+/- 3 
days) 
WON 
Recurrence 
Assessment 
Visit/End of 
Study              
(6 months (+/- 
14 days) from 
stent removal) 
Informed 
Consent  
X 
 
 
 
 
 
 
Eligibility 
Criteria  
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Etiology of AP 
X 
 
 
 
 
 
 
Onset of AP 
X 
 
 
 
 
 
 
Severity of AP 
X 
 
 
 
 
 
 
WON related 
symptoms 
X 
 
X 
 
 
 
X 
Imaging+++ 
X+ 
 
X 
X** 
 
 
 
X** 
Organ Failure  
X 
 
X 
 
X 
 
 
Quality of Life 
( SF-12) 
  X* 
 
 
 
X 
 
X 
Laboratory 
Tests 
X 
X++ 
   X** 
   X** 
 
 
    X** 
Current 
Medication 
X 
     X*** 
X*** 
X*** 
X*** 
X*** 
X*** 
Stent Placement 
 
X 
 
 
 
 
 
Lavaging of 
WON and/or 
placement of 
Nasocystic 
Drain 
 
    X** 
 
 
 
 
 
Stent Lumen 
Patency 
 
X 
 
X 
X 
 
 
Necrosectomy 
 
    
  
    X** 
 
 
 
Percutaneous or 
Additional 
Endoscopic 
Drainage 
 
 
 
   X** 
   X** 
 
 
Stent Removal 
 
 
 
 
X 
 
 
Adverse Event 
Assessment 
 
X 
X 
X 
X 
X 
X 
Device Event 
Assessment 
 
X 
X 
X 
X 
 
 
X = Required 
* = If the SF-12 is not done due to the condition of the patient, this will not be considered a protocol deviation 

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** = As needed per standard of care 
*** = Documentation of any changes in medication since previous visit 
+ = Imaging should be done within 2 weeks of the initial drainage procedure 
++ = Labs need to be repeated at this visit ONLY IF they were colletect more than 3 days before the stent 
placement procedure. 
+++ = Imaging may include CT with contrast (unless contraindicated), MRI, EUS 
 
Study Candidate Screening 
No study-specific testing will be conducted until after the subject has signed an ICF. A 
Screen Failure/Enrolled Log will be maintained in the Electronic Data Capture (EDC) system 
by the center to document select information about candidates who signed consent.   
6.2 Informed Consent 
Written Informed Consent must be obtained for all subjects who are potential study 
candidates. Subjects will be asked to sign the ICF before any study-specific tests or 
procedures are performed. The ICF is study-specific and must be approved by the study 
IRB/EC and Competent Authority (CA), as applicable. Study personnel should explain that 
even if a subject agrees to participate in the study and signs the ICF, the EUS procedure may 
demonstrate that the subject is not a suitable candidate for the study.  
6.3 Visit Schedule 
Screening / Pre-op Visit – Office/Hospital Visit: 
• Informed Consent 
• Demographics 
• Etiology of AP 
• Onset date of AP 
• WON related symptoms 
• CT Scan or MRI (identification of percentage of necrosis and confirmation of absence of 
pseudoaneurysms inside WON) 
• Organ failure assessment (Marshal scoring system) 
• Severity of AP 
• Labs 
• Quality of Life (SF-12)  
Note: If the SF-12 is not done due to the condition of the patient, this will not be 
considered a protocol deviation 
• Current medication 
 
Stent Placement Procedure – Office/Hospital Visit 
• AXIOSTM stent placement 
Note: Physicians will select the site of the AXIOSTM stent placement under endoscopic 
guidance and choose an access location that is free from necrotic debris and intervening 
blood vessels, where the wall between the GI tract and fluid collection is 10mm or less, 

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and where it is possible to place the AXIOSTM stent in a position such that the inner 
flange (inside WON) has enough space to expand.   
• Lavaging of WON under endoscopic visualization and/or placement of nasocystic drain, 
or a single, 7fr double pigtail plastic stent (Boston Scientific 7Fr AdvanixTM Biliary 
Stent) through the AXIOSTM stent at the discretion of investigator 
• Stent lumen patency assessment 
• Adverse event assessment/device event assessment 
• Current medication 
• Labs (as needed) 
Note: Labs need to be repeated at this visit ONLY IF they were collected more than 3 
days before the stent placement procedure.    
 
Multiple Interventions During Index Procedure:  
Once stent is placed into the WON, dilation of the AXIOSTM stent is allowed to expand the 
stent if needed.  Dilation can be performed to the maximal diameter of the AXIOSTM stent. A 
single, 7 fr double pigtail plastic stent (Boston Scientific 7Fr AdvanixTM Biliary Stent) may 
be placed through the AXIOSTM stent at the discretion of the investigator. Access to the 
WON with a forward viewing diagnostic or therapeutic upper gastroscope is allowed up to 20 
minutes (from time of endoscopic access of the WON) to break-up large chunks of necrosis 
and lavage collection at the discrection of the physician. 
 
WON Resolution Assessment - 7 days (+/- 3 days) for inpatients and 14 (+/- 5 days) days for 
outpatients (needed until radiographic decrease of WON size to ≤ 3cm) – Office/Hospital 
Visit: 
• Cross sectional imaging (CT or MRI) to assess reduction in WON size.  If reduction in 
size is deemed insufficient, necrosectomy will be initiated 
• Documentation of clinical improvement defined as improvement of principal WON-
related symptoms 
• Necrosectomy (as needed) 
• Adverse event assessment/device event assessment 
• Organ failure assessment (Marshal scoring system) 
• Current medication 
• Labs (as needed) 
 
Reintervention/Necrosectomy Visits when needed during AXIOSTM stent indwell – 
Office/Hospital Visit:  
• Necrosectomy initiated if WON reduction in size is deemed insufficient during WON 
Resolution Assessment Visit. Duration of each necrosectomy session is limited to 60 
minutes 
• Percutaneous drainage or additional endoscopic drainage may be needed if reduction in 
WON size is insufficient or in cases of continued WON related symptoms such as 
infection/sepsis despite necrosectomy. Choice of stent (AXIOSTM or plastic double pigtail 

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stent(s)) for repeat endoscopic drainage procedures will be left to the discretion of the 
investigator. The double pigtail plastic stent(s) or new AXIOSTM stent may be placed 
through the tract established by the original AXIOSTM stent or in a separate location. 
• Stent lumen patency assessment 
• Imaging (as applicable) 
• Labs (as needed) 
• Adverse event assessment/device event assessment 
• Current medication 
 
Stent Removal Visit - between 14 days and 60 days (+/- 7 days) of stent placement – 
Office/Hospital Visit 
• Stent lumen patency assessment 
• Stent removal after evidence of clinical and radiographic (via CT or MRI) resolution of 
WON 
Note: Removal of stent by 60 days is required if WON not resolved. Patients with 
unsuccessful or incomplete WON resolution by 60 days will proceed to standard of care 
treatment outside of this protocol after removal of the AXIOSTM stent; however, the 
patient outcome will continue to be followed.  Alternative interventions may include 
surgery, endoscopic drainage with double pigtail plastic stents, percutaneous catheter 
drainage and necrosectomy (video-assisted retroperitoneal debridement (VARD), or 
endoscopic transluminal debridement, or open necrosectomy).  
• Adverse event assessment/device event assessment 
• Organ failure assessment (Marshal scoring system) 
• Quality of Life (SF-12) 
• Current medication 
   
7 Day (+/-3 days) Post Stent Removal Visit – (Office or phone call): 
• Adverse Event assessment 
• Current medication 
 
WON Recurrence Assessment Visit/End of Study – at 6 Months (+/- 14 days) from stent 
removal: 
• Recurrence assessment (presence of clinical symptoms and further diagnosis per standard 
of care (e.g. labs and imaging) 
• Adverse Events assessment 
• Quality of Life (SF-12) 
• Current medication  
6.4 Study Completion 
Subjects will be followed for 6 months after stent removal. 

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Additional visits may be conducted at the Investigator’s discretion in accordance with 
Adverse Event or Device Event data collection. A subject will be considered lost to follow-
up if the subject remains unresponsive to communication after three documented attempts by 
study staff. 
6.5 Source Documents 
The Investigator/institution guarantees direct access to original source documents, including 
imaging documentation, by BSC personnel, their designees, and appropriate regulatory 
authorities. In the event that the original medical records cannot be obtained for a patient that 
is seen by a non-study physician at a non-study institution, photocopies of the original source 
documents must be made available for review. 
7 Statistical Considerations 
7.1 Effectiveness Endpoint 
Primary Effectiveness Endpoint: 
The primary effectiveness endpoint for this study is the resolution of WON with endoscopic 
drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or 
MRI 
Primary Effectiveness Endpoint Assessment:  
Note: Success will be based on the number of WONs resolved, not on the number of AXIOSTM 
Stents required to achieve resolution. 
• If it is determined that the fluid collection is actually two separate collections, and each 
collection is drained via an AXIOSTM stent, then each collection will be assessed 
individually via the drainage success criteria of ≤3cm. 
• If it is determined that the fluid collection is a single collection but the drainage is 
inadequate via a single AXIOSTM stent, then the success of the AXIOSTM drainage will 
be assessed as follows: 
o If a second AXIOSTM stent is used at a new drainage site/original drainage site and 
the entire fluid collection is drained to meet the success criteria of ≤3cm then the 
collection will be considered to be a single collection drainage success. 
o If a second AXIOSTM stent is used at a new drainage site and the entire fluid 
collection does not drain adequately to meet the drainage success criteria of ≤3cm 
then the fluid drainage of the collection will be considered to be a single drainage 
failure. 
o If a plastic stent is used at a new drainage site and the entire fluid collection drains to 
meet the drainage success criteria of ≤3cm then the fluid drainage will be considered 
indeterminate. 

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o If a single, 7fr plastic stent is used at the same drainage site, through the AXIOSTM 
stent, and the entire fluid collection drains to meet the drainage success criteria of 
≤3cm then the fluid drainage will be considered a single collection drainage success. 
o If a plastic stent is used at a new drainage site and the entire fluid collection does not 
drain to meet the drainage success criteria of ≤3cm then the fluid drainage will be 
considered a single drainage failure. 
Hypothesis: 
As in the original IDE, #G130264, there is no formal statistical hypothesis for this study.  
The proportion of AXIOS patients with reduction of WON size to ≤ 3cm within 60 days from 
AXIOSTM stent placement in the original IDE is 76.7% (23/30) [95% CI (57.7%, 90.0%)] 
patients. Given that the WONs in the proposed IDE will have an estimated necrotic material 
content above 30%, namely larger than in IDE #G130264, a slightly lower success rate of 
70% is expected in this study.  This success rate is within the range of reported WON 
resolution rates in several recent publications [2-8]  representing 448 patients for which a 
random effects meta-analysis yields a mid-point WON resolution rate of 67.0% [95% CI 
(60.0%, 73.4%)] for WON drainage with plastic stents  (Table 7.1), an established WON 
drainage method as described in the ASGE guidelines on treatment of pancreatic fluid 
collections [9].  
 
Table 7.1 Plastic Stent WON Resolution Rates from Recent Publications 
Study 
% Resolution 
(x/N) 
95% Confidence 
Interval 
Bapaye (2017) 
73.8% (45/61) 
(60.9%, 84.2%) 
Gardner et al (2009) 
68.9% (31/45) 
(53.4%, 81.8%) 
Papachristou (2007) 
52.8% (28/53) 
(38.6%, 66.7%) 
Schmidt (2015) 
61.7% (50/81) 
(50.3%, 72.3%) 
Smoczynski (2015) 
75.9% (85/112) 
(66.9%, 83.5%) 
Abu Dayyeh (2017) 
75.0% (27/36) 
(57.8%, 87.9%) 
Varadarajulu (2011) 
60.0% (36/60) 
(46.5%, 72.4%) 
Random-Effects Meta-Analysis 
67.0% 
(60.0%, 73.4%) 
Statistical Methods: 
The primary effectiveness endpoint will be summarized as the proportion of patients who 
have resolution of WON with endoscopic drainage defined as radiographic decrease of WON 
size to ≤ 3cm evaluated by CT scan or MRI out of all patients who have an AXIOSTM stent 
successfully implanted.  A Clopper-Pearson exact 95% confidence interval will also be 
calculated. 
7.2 Safety Endpoint 
Primary Safety Endpoint: 

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The Primary Safety Endpoint is AXIOSTM stent related or WON drainage procedure related 
serious adverse events. 
Primary Safety Endpoint Assessment:  
If it is determined that the patient has an infection, then the primary safety success of the 
AXIOSTM device or the drainage procedure will be assessed as follows: 
• If the patient presents with an infected collection at the initial drainage procedure, the 
infection will be classified as a localized infection and will not be considered a stent 
related or WON drainage related serious adverse event 
• If the patient presents with a sterile collection at the initial drainage procedure and 
post-procedurally develops an infected collection, the infection will be classified as a 
localized infection and will not be considered a stent related or WON drainage related 
serious adverse event as this is a known consequence of any endoscopic drainage 
procedure, where the access route to the collection is through a non-sterile GI lumen 
and is not a function of a particular stent or device  
(Note: If the stent is occluded at the onset of infection, then the infection will be 
attributed to the device. If the stent remains unobstructed at the time of infection, then the 
infection will not be attributed to the device.) 
• If the patient presents with a sterile collection at the initial drainage procedure and 
then post-procedurally develops a wide-spread infection in the form of sepsis or blood 
stream infection, then the infection will be classified as systemic and will be 
considered a stent related or WON drainage related serious adverse event only if the 
AXIOS stent was clearly and visually occluded by solid necrosis at the time of repeat 
endoscopy. This determination will be made by the operating physician at the time of 
endoscopy  
 
Hypothesis: 
As in the original IDE, #G130264, there is no formal statistical hypothesis for this study.  
The proportion of AXIOS patients with AXIOSTM stent related or WON drainage procedure 
related serious adverse events in the original IDE is 10.0% (3/30) [95% CI (2.1%, 26.5%)] 
patients. A similar rate of AXIOSTM stent related or WON drainage procedure related serious 
adverse events is expected in this study.  This event rate is within the range of reported stent 
related or WON drainage procedure related serious adverse event rates in several recent 
publications  [3-5, 10] representing 306 patients for which a random effects meta-analysis 
yields a mid-point related SAE rate of 16.7% [95% CI (10.1%, 26.3%)] for WON drainage 
with plastic stents (see Table 7.2 and Table 7.3 (categorized events from Table 7.2)), an 
established WON drainage method as described in the ASGE guidelines on treatment of 
pancreatic fluid collections [9].  
 
 

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Table 7.2 Plastic Stent-related or WON Drainage-procedure related Serious Adverse 
Events Rates from Recent Publications [3-5, 10] 
Study 
% Related 
SAEs (x/N) 
95% Confidence 
Interval 
Papachristou (2007) 
20.8% (11/53) 
(10.8%, 34.1%) 
Schmidt (2015) 
12.3% (10/81) 
(6.1%, 21.5%) 
Smoczynski (2015) 
25.9% (29/112)  
(18.1%, 35.0%) 
Varadarajulu (2011) 
8.3% (5/60) 
(2.8%, 18.4%) 
Random-Effect Meta-Analysis 
16.7% 
(10.1%, 26.3%) 
 
Table 7.3 Categorized Plastic Stent-related or WON Drainage-procedure related 
Serious Adverse Events Rates from Recent Publications [3-5, 10] 
SAE 
% (x/N) 
Bleeding 
11.1% (34/306) 
Perforation 
2.6% (8/306) 
[5 GI; 2 Collections; 1 Undefined] 
Pneumoperitoneum  
1.3% (4/306) 
Sepsis 
0.7%  (2/306)* 
Stent migration 
1.0% (3/306) 
Multiple organ failure 
1.0% (3/306) 
Other - loss of access to the 
collection (due to hypertension) 
0.3% (1/306) 
*Note: 1 patient with septic shock also had multiple organ failure (death) 
 
Statistical Methods: 
The primary safety endpoint will be summarized as the proportion of patients who have 
AXIOSTM stent related or WON drainage procedure related serious adverse events out of all 
patients who have an AXIOS stent successfully implanted.  A Clopper-Pearson exact 95% 
confidence interval will also be calculated. 
7.3 Sample Size and Success Criteria 
The WON resolution rates and related SAE rates reported in the above provided study 
references are similar to those reported for WON drainage using plastic stents in a recent 
systematic review and meta-analysis comparing plastic stents to metal stents, including 
lumen-apposing metal stents (LAMS) for the management of WONs [28].  Appendix I in 
Section 21 provides a few key points from this systematic review.   
Although reported effectiveness and safety event rates from different sources appear similar, 
95% confidence intervals are fairly wide, mostly due to small sample sizes and heterogeneity 
in WONs and in detailed procedural WON drainage steps.  Therefore we chose to increase 
the sample size of the present study to be slightly larger than in the original IDE study 
#G130264, which was 30 patients.   

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We will conduct the present study in 40 patients.  
Effectiveness Endpoint Success Criteria 
An observed rate of 67% or higher for the proportion of AXIOS patients with reduction of 
WON size to ≤ 3cm within 60 days from AXIOSTM stent placement is required for success. 
This rate is the same as the point estimate of the random-effect meta-analysis of WON 
resolution rates provided in Table 7.1.  Note that in the recent systematic review and meta-
analysis [28] (Appendix I in Section 21) WON resolution rates were higher and number of 
procedures required to reach WON resolution were lower when using LAMS compared to 
plastic stents for WON drainage.  Thus the proposed success criteria for effectiveness seems 
reasonable.   
 
Safety Endpoint Success Criteria 
An observed rate of 17.5% or lower for the proportion of AXIOS patients with AXIOSTM 
stent related or WON drainage procedure related serious adverse events is required for 
success. 
This rate is similar to the point estimate of the random-effect meta-analysis of AXIOS stent 
related or WON drainage related serious adverse events provided in Table 7.2.  Note that in 
the recent systematic review and meta-analysis [28] (Appendix I in Section 21) the 
complication rates that showed statistically significant differences between plastic stents and 
LAMS for drainage of WONs were bleeding and stent occlusion, both in favor of LAMS.  
These findings are particularly important given that (a) bleeding is the most commonly 
reported serious adverse event, and (b) stent occlusion almost always requires reintervention.  
It should also be noted that of the plastic stent WON drainage references provided above, 
even the one reporting the highest complication rates, namely Smoczynski et al [5] conclude 
that the benefits outweigh the risks: “In a large group of selected patients with symptomatic 
walled-off necrosis, endoscopic drainage enables high success rate with acceptable 
complication rate and low procedure-related mortality.”  Thus the proposed success criteria 
for safety seems reasonable and acceptable. 
 
7.4 General Statistical Methods 
Control of Systematic Error/Bias: 
All subjects who have met the inclusion/exclusion criteria and have signed the ICF will be 
eligible for enrollment in the study. Visual and/or electronic data review will be performed to 
identify possible data discrepancies. Manual and/or automatic queries will be created in the 
EDC system and will be issued to the site for appropriate response. Site staff will be 
responsible for resolving all queries in the database. 
Number of Subjects per Investigative Site: 
There will be no limit to the number of subjects enrolled at each investigative site. 
Data Analysis: 

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Descriptive statistics will be presented for all ITT and treated subjects. If the treated and PP 
cohorts are different, the primary effectiveness and safety endpoints will be assessed for the 
PP cohort. The mean, standard deviation, minimum, and maximum will be used to describe 
continuous variables; the median (and interquartile range) will be calculated where 
appropriate. Frequency tables will be used to summarize discrete variables.  Proportions of 
subjects with adverse events and SAEs will be reported. 
Interim Analysis: 
No formal interim analyses are planned for the purpose of stopping this study early. Informal 
interim analysis may be conducted for the purpose of submissions of abstracts to major 
professional meetings. 
Subgroup Analysis: 
There are no planned subgroup analyses. 
Justification of Pooling: 
 
The analyses will be performed using data pooled across institutions and whether patients 
had a double pigtail plastic stent placed within the Axios stent. An assessment of the 
poolability of subjects across sites (double pigtail plastic stent groups) for the primary 
effectiveness and safety endpoints will be made by fitting logistic regression models with site 
(double pigtail plastic stent) as a factor and the primary effectiveness and safety endpoints as 
outcomes. Certain baseline variables may also be explored for pooling. 
 
If the P value for the site (double pigtail plastic stent) is ≥0.05, it will be concluded that the 
endpoint is not different across sites (double pigtail plastic stent groups), and the data can be 
pooled. If the P value for site (double pigtail plastic stent) from the logistic model is <0.05, 
site (double pigtail plastic stent group) differences will be explored. 
 
Multivariable Analyses: 
No multivariable analyses are planned for this study. 
Changes to Planned Analyses: 
Any changes to the planned statistical analyses made prior will be documented in an 
amended Statistical Analysis Plan. Changes from the planned statistical methods after 
performing the analysis will be documented in the clinical study report along with a reason 
for the deviation. 
8 Data Management 
8.1 Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure EDC system. The clinical database 
will reside on a production server hosted by EDC System.  All changes made to the clinical 
data will be captured in an electronic audit trail and available for review by the sponsor or its 

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representatives. The associated RAVE software and database have been designed to meet 
regulatory compliance for deployment as part of a validated system compliant with laws and 
regulations applicable to the conduct of clinical studies pertaining to the use of electronic 
records and signatures. Database backups are performed regularly. The Investigator provides 
his/her electronic signature on the appropriate electronic case report forms (eCRFs). A 
written signature on printouts of the eCRFs must also be provided if required by local 
regulation. Changes to data previously submitted to the sponsor require a new electronic 
signature by the Investigator acknowledging and approving the changes. Visual and/or 
electronic data review will be performed to identify possible data discrepancies. Manual 
and/or automatic queries will be created in the EDC system and will be issued to the site for 
appropriate response. Site staff will be responsible for resolving all queries in the database. 
8.2 Data Retention 
The Principal Investigator or his/her designee or Investigational site will maintain, at the 
investigative site, all essential study documents and source documentation that support the 
data collected on the study subjects in compliance with ICH/GCP guidelines.  Documents 
must be retained for at least 2 years after the last approval of a marketing application or until 
at least 2 years have elapsed since the formal discontinuation of the clinical investigation of 
the product. These documents will be retained for a longer period of time by agreement with 
BSC or in compliance with other country/regional/local regulations.  
The Principal Investigator or his/her designee will take measures to ensure that these 
essential documents are not accidentally damaged or destroyed. If for any reason the 
Principal Investigator or his/her designee withdraws responsibility for maintaining these 
essential documents, custody must be transferred to an individual who will assume 
responsibility and BSC must receive written notification of this custodial change. Sites are 
required to inform Boston Scientific in writing where paper or electronic files are maintained 
in case files are stored off site and are not readily available. 
9 Amendments  
If a protocol revision is necessary which affects the rights, safety or welfare of the subject or 
scientific integrity of the data, an amendment is required. Appropriate approvals (e.g., 
IRB/EC/FDA/CA) of the revised protocol must be obtained prior to implementation. 
10 Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject. An investigator shall notify the sponsor and the 
reviewing IRB/EC of any deviation from the investigational plan to protect the life or 
physical well-being of a subject, and those deviations which affect the scientific integrity of 
the clinical investigation. Such notice shall be given as soon as possible, but no later than 5 
working days after the emergency occurred, or per prevailing local requirements, if sooner 
than 5 working days.  

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All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using entry onto the eCRF. 
Sites may also be required to report deviations to the IRB/EC, per local guidelines and 
government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including notification, center re-training, or 
discontinuation) will be put into place by the sponsor. 
11 Device/Equipment Accountability 
The investigational devices shall be securely maintained, controlled, and used only in this 
clinical study. Equipment shall be returned in the condition in which it was provided, 
reasonable wear and tear excepted. 
The sponsor shall keep records to document the physical location of all investigational 
devices from shipment of investigational devices from BSC equipment to the investigation 
sites until return or disposal. 
Records shall be kept by study personnel to document the physical location and conditions of 
storage of all investigational devices.  
The principal investigator or an authorized designee shall keep records documenting the 
receipt, use, return and disposal of the investigational devices, which shall include the 
following: 
• Date of receipt 
• Identification of each investigational device (batch number or unique code) 
• Expiry date, as applicable 
• Date or dates of use 
• Subject identification 
• Date on which the investigational device/piece of equipment was returned/explanted from 
subject, if applicable 
• Date of return (and number) of unused, expired, or malfunctioning investigational 
devices/equipment, if applicable. 
Written procedures may be required by national regulations. 
12 Compliance 
12.1 Statement of Compliance 
This study will be conducted in accordance with relevant sections of the International 
Standard (ISO) 14155: Clinical Investigation of Medical devices for Human Subjects – Good 
Clinical Practice, the relevant parts of the ICH Guidelines for Good Clinical Practices, ethical 
principles that have their origins in the Declaration of Helsinki, and pertinent individual 
country laws and regulations. The study shall not begin until the required approval/favorable 

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opinion from the IRB/EC and/or regulatory authority has been obtained, if appropriate. Any 
additional requirements imposed by the IRB/EC or regulatory authority shall be followed, if 
appropriate. 
12.2 Investigator Responsibilities 
The Principal Investigator of an investigational center is responsible for ensuring that the 
study is conducted in accordance with the Clinical Study Agreement, the clinical 
investigation plan, ISO 14155, ethical principles that have their origins in the Declaration of 
Helsinki, any conditions of approval imposed by the reviewing IRB/EC, and prevailing local 
and/or country laws and/or regulations, whichever affords the greater protection to the 
subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
• Prior to beginning the study, sign the Clinical Study agreement and comply with the 
Investigator responsibilities as described in such Agreement. 
• Prior to the beginning of the study, sign the Investigator Brochure Signature Page and 
Protocol Signature page documenting his/her agreement to conduct the study in 
accordance with the protocol. 
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the center team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
• Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
• Record, report, and assess (seriousness and relationship to the device/procedure, 
including stent removal and complete distal migration) every adverse event and observed 
device deficiency. 
• Report to BSC per the protocol requirements and the IRB/EC, as applicable, all SAEs and 
device deficiencies that could have led to a Serious Adverse Device Event (SADE). 
• Allow the sponsor to perform monitoring and auditing activities, and be accessible to the 
monitor and respond to questions during monitoring visits. 
• Allow and support regulatory authorities and the IRB/EC when performing auditing 
activities. 

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• Ensure that informed consent is obtained in accordance with this protocol and local 
IRB/EC requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the ICF. 
• Inform the subject of the nature and possible cause of any adverse events experienced. 
• Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment. 
• Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
• Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical investigation. 
• Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation. 
• Ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable. 
12.2.1 Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the Principal Investigator is responsible for providing 
appropriate training, are competent to perform the tasks they have been delegated, and 
adequate supervision of those to whom tasks are delegated. Where there is a sub investigator 
at at site, the sub investigator should not be delegated the primary supervisory repsonsibility 
for the site. The investigator is accountable for regulatory violations resulting from failure to 
adequately supervise the conduct of the clinical study.  
12.3 Institutional Review Board/ Ethics Committee 
Prior to gaining Approval-to-Enroll status, the investigational center will provide to the 
sponsor documentation verifying that their IRB/EC is registered or that registration has been 
submitted to the appropriate agency, as applicable according to national/regulatory 
requirements.   

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A copy of the written IRB/EC/REB and/or Competent Authority (CA) approval of the 
protocol (or permission to conduct the study) and ICF, must be received by the sponsor 
before recruitment of subjects into the study and shipment of investigational 
product/equipment. Prior approval must also be obtained for other materials related to subject 
recruitment or which will be provided to the subject. 
Annual IRB/EC/REB approval and renewals will be obtained throughout the duration of the 
study as required by local/country or IRB/EC/REB requirements. Copies of the Investigator’s 
reports and the IRB/EC/REB continuance of approval must be provided to the sponsor.  
12.4 Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC and will be kept in accordance with all applicable 
laws and regulations. Only authorized BSC personnel and/or a BSC representative including 
but not limited to Contract Research Organization (CRO) will have access to these 
confidential records. Authorized regulatory personnel have the right to inspect and copy all 
records pertinent to this study. Study data collected during this study may be used by BSC 
for the purposes of this study, publication, and to support future research and/or other 
business purposes, such as overseeing and improving the performace of its device, new 
medical research and proposals for develping new medical products and procedures. All data 
used in the analysis and reporting of this study or shared with a third party researcher will be 
without identifiable reference to specific subject. 
Information received during the study will not be used to market to subject; subject names 
will not be placed on any mailing lists or sold to anyone for marketing purposes.  
12.5 Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC 
for subjects in the study will be obtained. 
13 Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the clinical research monitor verifies that 
study records are adequately maintained, that data are reported in a satisfactory manner with 
respect to timeliness, adequacy, and accuracy, and that the Principal Investigator continues to 
have sufficient staff and facilities to conduct the study safely and effectively. The Principal 
Investigator/institution guarantees direct access to original source documents by BSC 
personnel, their designees, and appropriate regulatory authorities. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Principal Investigator 
and relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 

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14 Potential Risks and Benefits 
14.1 Anticipated Adverse Device Effects  
Possible Adverse Events associated with the use of the AXIOS™ Stent and Electrocautery- 
Enhanced Delivery System may include those often associated with any endoscopic 
procedure. These complications include: 
 
• Anesthesia complications 
• Improper AXIOS Stent placement; incomplete deployment; stent migration into the 
fluid collection or, GI tract; separation of coating material from stent; stent fracture; 
coating material wear; coating material failure; puncture of coating material 
• Tissue ingrowth or overgrowth leading to difficulty or a failure to remove stent 
• Stent dislodgement 
• Adverse reaction to implant materials and/or delivery system (e.g., abdominal or back 
pain, nausea, infection, fever, chronic inflammation or foreign body reaction) 
• Minor or excessive bleeding requiring intervention 
• Leakage of fluid collection or bowel contents causing inflammation or peritonitis 
• Stent occlusion 
• Local infection at the implant site 
• Tissue damage during stent implantation and/or removal 
• Ulceration or erosion of mucosal or organ wall linings 
• Pneumoperitoneum 
• Sepsis (bacterial, endotoxin or fungal) 
• Perforation 
• Surgical intervention (endoscopy, transfusion or surgery) 
• Persistent connection to the fluid collection after removal (fistula) 
• Unintended electrical shock, muscle stimulation or burns 
• Cardiac arrhythmia or arrest 
• Death 
 
Please refer to the Investigator Brochure for a list of anticipated adverse device effects. 
14.2 Anticipated Benefits 
Subjects may not receive any benefit from participating in this study. However, medical 
science and future subjects may benefit from this study.  

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14.3 Risk to Benefit Rationale 
Based on collected reports in literature to-date, the risk-to-benefit ratio is within reason for 
foreseeable risks. However, literature reports do not always capture all side effects. 
Observation and follow-up of subjects is required as outlined in the protocol. 
15 Safety Reporting 
15.1 Reportable Events by Investigational Site to Boston Scientific 
It is the responsibility of the investigator to assess and report to BSC any event which occurs 
in any of following categories: 
• All Serious Adverse Events 
• All Investigational Device Deficiencies  
• Unanticipated Adverse Device Effects*  
• New findings/updates in relation to already reported events 
• All Device Related Adverse Events 
• All Study Procedure, Removal Procedure and Necrosectomy Procedure Related 
Adverse Events  
* BSC Medical Safety will be responsible for all UADE assessments.  Unanticipated means 
the effect, problem, or death is not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application, investigator’s brochure, DFU/IFU, 
informed consent or other risk documents.  
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Any AE event required by the protocol, experienced by the study subject after informed 
consent and once considered enrolled in the study (as defined in study subject classification 
section), whether during or subsequent to the procedure, must be recorded in the eCRF. 
Underlying diseases are not reported as AEs unless there is an increase in severity of 
frequency during the course of the investigation. Death should not be recorded as an AE, but 
should only be reflected as an outcome of ONE (1) specific SAE (see Table 15.2-1 for AE 
definitions). 
Refer to Section 14 for the known risks associated with the study device(s). 

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15.2 Definitions and Classification 
Adverse event definitions are provided in Table 15.2-1. Administrative edits were made on 
the definition of serious adverse event from ISO 14155 and MEDDEV 2.7/3 for clarification 
purposes. 
 
Table 15.2-1: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
 
 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, whether or not related to the 
investigational medical device.  
NOTE 1: This includes events related to the investigational medical 
device or comparator. 
NOTE 2: This definition includes events related to the procedures 
involved. 
NOTE 3: For users or other persons, this definition is restricted to events 
related to the investigational medical device.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Adverse event related to the use of an investigational medical device 
NOTE 1: This includes any adverse event resulting from insufficiencies 
or inadequacies in the instructions for use, the deployment, the 
implantation, the installation, the operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or  
intentional abnormal use of the investigational medical device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3  
Note: This definition meets the reporting objectives and requirements of 
ISO 14155 and MEDDEV 2.7/3. 
Adverse event that: 
• Led to death, 
• Led to  serious deterioration in the health of the subject, as defined by 
either: 
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-patient hospitalization or prolongation  of existing 
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 
 
• Led to fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without serious 
deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device Effect 
(SADE) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 

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Table 15.2-1: Safety Definitions 
Term 
Definition 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
 
Unanticipated Adverse Device 
Effect (UADE) 
 
Ref: 21 CFR Part 812 
 
 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or 
welfare of subjects.   
Device Deficiency 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
A device deficiency is any inadequacy of a medical device related to its 
identity, quality, durability, reliability, safety or performance.This may 
include malfunctions, use error, or inadequacy in the information supplied 
by the manufacturer. 
 
Abbreviations: EC=Ethics Committee; IRB=Institutional Review Board 
 
15.3 Relationship to Study Device(s) 
The Investigator must assess the relationship of any SAE  or AE to the study device, study 
stent placement or removal procedure, and necrosectomy procedure. See criteria in Table 
15.3-1: 

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Table 15.3-1: Criteria for Assessing Relationship of Study Device, Procedure, Stent 
Removal and any Complete Distal Migration to Adverse Event 
Classification 
Description 
Not Related 
Relationship to the device or procedures can be excluded when: 
- the event is not a known side effect of the product category the device belongs to 
or of similar devices and procedures; 
- the event has no temporal relationship with the use of the investigational device or 
the procedures; 
- the serious event does not follow a known response pattern to the medical device 
(if the response pattern is previously known) and is biologically implausible; 
- the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or 
increase of the level of activation/exposure), do not impact on the serious event; 
- the event involves a body-site or an organ not expected to be affected by the 
device or procedure; the serious event can be attributed to another cause (e.g. an 
underlying 
or concurrent illness/ clinical condition, an effect of another device, drug, treatment 
or other risk factors); 
- the event does not depend on a false result given by the investigational device 
used for diagnosis, when applicable; harms to the subject are not clearly due to use 
error; 
- In order to establish the non-relatedness, not all the criteria listed above might be 
met at the same time, depending on the type of device/procedures and the serious 
event. 
Unlikely Related 
The relationship with the use of the device seems not relevant and/or the event can 
be reasonably explained by another cause, but additional information may be 
obtained. 
Possibly Related 
The relationship with the use of the investigational device is weak but cannot be 
ruled out completely. Alternative causes are also possible (e.g. an underlying or 
concurrent illness/ clinical condition or/and an effect of another device, drug or 
treatment). Cases were relatedness cannot be assessed or no information has been 
obtained should also be classified as possible. 
Probably Related 
The relationship with the use of the investigational device seems relevant and/or 
the event cannot be reasonably explained by another cause, but additional 
information may be obtained. 
Causal Relationship 
The serious event is associated with the investigational device or with procedures 
beyond reasonable doubt when: 
- the event is a known side effect of the product category the device belongs to or 
of similar devices and procedures; 
- the event has a temporal relationship with investigational device use/application 
or procedures; 
- the event involves a body-site or organ that 
o the investigational device or procedures are applied to; 

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Table 15.3-1: Criteria for Assessing Relationship of Study Device, Procedure, Stent 
Removal and any Complete Distal Migration to Adverse Event 
Classification 
Description 
o the investigational device or procedures have an effect on; 
- the serious event follows a known response pattern to the medical device (if the 
response pattern is previously known); 
- the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
- other possible causes (e.g. an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment) have been adequately ruled 
out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the investigational device used for 
diagnosis, when applicable; 
- In order to establish the relatedness, not all the criteria listed above might be met 
at the same time, depending on the type of device/procedures and the serious event. 
15.4 Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 15.4-1. 
Table 15.4-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline (Pre-Market Studies) 
(MEDDEV 2.7/3 ):  
CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT 
REPORTING UNDER DIRECTIVES 90/385/EEC AND 
93/42/EEC) 
Unanticipated Adverse 
Device Effect / 
Unanticipated Serious 
Adverse Device Effect 
Complete AE eCRF page 
with all available new and 
updated information.  
• Within 1 business day of first becoming aware of 
the event. 
• Terminating at the end of the study 
Provide all relevant source 
documentation (de-
identified/pseudonymized) 
for reported event upon 
request of the sponsor 
• At request of sponsor 
Serious Adverse Event  
Complete AE eCRF page 
with all available new and 
updated information.  
• Within 3 calendar days of first becoming aware of 
the event or as per local/regional regulations.  
• Reporting required through the end of the study 
Provide all relevant source 
documentation (de-
identified/pseudonymized) 
for reported event upon 
request of the sponsor 
• At request of sponsor 

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Table 15.4-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline (Pre-Market Studies) 
(MEDDEV 2.7/3 ):  
CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT 
REPORTING UNDER DIRECTIVES 90/385/EEC AND 
93/42/EEC) 
Serious Adverse Device 
Effects 
Complete AE eCRF page 
with all available new and 
updated information. 
• Within 3 calendar days of first becoming aware of 
the event or as per local/regional regulations.  
• Reporting required through the end of the study 
Provide all relevant source 
documentation (de-
identified/pseudonymized) 
for reported event 
• When documentation is available 
• At sponsor request 
Device Deficiencies 
(including but not 
limited to failures, 
malfunctions, and 
product 
nonconformities) 
Note:  Any 
Investigational Device 
Deficiency that might 
have led to a serious 
adverse event if a) 
suitable action had not 
been taken or b) 
intervention had not 
been made or c) if 
circumstances had been 
less fortunate is 
considered a reportable 
event. 
Complete eCRF page with 
all available new and 
updated information.  
• Within 3 calendar days of first becoming aware of 
the event.  
• Reporting required through the end of the study 
Provide all relevant source 
documentation (de-
identified/pseudonymized) 
for reported event 
• At request of sponsor 
Adverse Event 
including Adverse 
Device Effects 
Complete AE eCRF page, 
which contains such 
information as date of AE, 
treatment of AE resolution, 
assessment of seriousness 
and relationship to the 
device.  
• In a timely manner  (e.g. Recommend within 10 
business days) after becoming aware of the 
information 
• Reporting required through end of study 
• At sponsor request 
Provide all relevant source 
documentation (de-
identified/pseudonymized) 
for reported event 
Abbreviations: AE=adverse event; CRF=case report form; IDE=Investigational Device Exemption; 
UADE=unanticipated adverse device effect 
* Please note that pre-market studies are clinical studies with investigational devices or with medical devices 
that bear the regulatory approval and are not being used for the same approved indications. 

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15.5 Boston Scientific Device Deficiencies 
All device deficiencies (including but not limited to failures, malfunctions, use errors, 
product nonconformities, and inadequacy in the information supplied by the manufacturer) 
will be documented and reported to BSC. If possible, the device(s) should be returned to 
BSC for analysis. Instructions for returning the investigational device(s) will be provided. If 
it is not possible to return the device, the investigator should document why the device was 
not returned and the final disposition of the device. Device failures and malfunctions should 
also be documented in the subject’s medical record. 
Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are not to be reported as adverse events. However, if there is an adverse 
event that results from a device failure or malfunction, that specific event would be recorded 
on the appropriate eCRF. 
Any Device Deficiency that might have led to a serious adverse event if a) suitable action 
had not been taken or b) intervention had not been made or c) if circumstances had been less 
fortunate is considered a reportable event. 
15.6 Reporting to Regulatory Authorities / IRBs / ECs / Investigators 
BSC is responsible for reporting adverse event information to all participating Principal 
Investigators and regulatory authorities, as applicable.  
The Principal Investigator is responsible for informing the IRB/EC, and regulatory 
authorities of any UADE and SAE as required by local/regional regulations. 
16 Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
each subject or his/her legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to the use of any investigational devices, 
study-required procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority, as applicable. The ICF must be accepted 
by BSC or its delegate (e.g. CRO), and approved by the site’s IRB/EC, or central IRB, if 
applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative site’s IRB/EC.  Any modification requires acceptance from BSC prior to use of 
the form.  The ICF must be in a language understandable to the subject and if needed, BSC 
will assist the site in obtaining a written consent translation. Translated consent forms must 
also have IRB/EC approval prior to their use.  Privacy language shall be included in the body 
of the form or as a separate form as applicable.   

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The process of obtaining Informed Consent shall: at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct the 
process,  
• include a description of all aspects of the clinical study that are relevant to the 
subject’s decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 
• use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 
• ensure important new information is provided to new and existing subjects 
throughout the clinical study.  
The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the site and a copy of the signed and dated document and any 
other written information must be given to the person signing the form.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory 
authorityaccording to their requirements (e.g., FDA requirement is within 5 working days of 
learning of such an event). Any violations of the informed consent process must be reported 
as deviations to the sponsor and local regulatory authorities (e.g. IRB/EC), as appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB/EC. The new version of the ICF must be approved by 
the IRB/EC. Acceptance by Boston Scientific is required if changes to the revised ICF are 
requested by the site’s IRB/EC. The IRB/EC will determine the subject population to be re-
consented. 

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17 Suspension or Termination 
17.1 Premature Termination of the Study 
Boston Scientific 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/ECs, and regulatory authorities, as applicable, 
will be notified in writing in the event of study termination. 
17.1.1 Criteria for Premature Termination of the Study 
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. 
• An enrollment rate far below expectation that prejudices the conclusion of the study.  
• A decision on the part of Boston Scientific to suspend or discontinue development of the 
device. 
17.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC 
Approval 
Any investigator, or associated IRB/ EC/REB or regulatory authority may discontinue 
participation in the study or withdraw approval of the study, respectively, with suitable 
written notice to Boston Scientific. Investigators, associated IRBs/ECs, and regulatory 
authorities, as applicable, will be notified in writing in the event of these occurrences. 
17.3 Requirements for Documentation and Subject Follow-up 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating centers by Boston Scientific. 
The IRB/EC/REB and regulatory authorities, as applicable, will be notified. Detailed 
information on how enrolled Subject will be managed thereafter will be provided.  
In the event an IRB/EC/REB terminates participation in the study, participating investigators, 
associated IRBs/ECs/REBs, and regulatory authorities, as applicable, will be notified in 
writing. Detailed information on how enrolled subjects will be managed thereafter will be 
provided by Boston Scientific. 
In the event a Prinicipal Investigator terminates participation in the study, study 
responsibility will be transferred to a co-investigator, if possible. In the event there are no 
opportunities to transfer Principal Investigator responsibility; detailed information on how 
enrolled subjects will be managed thereafter will be provided by Boston Scientific. 

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The Principal Investigator or his/her designee must return all study-related documents and 
investigational product to Boston Scientific, unless this action would jeopardize the rights, 
safety, or welfare of the subjects. 
17.4 Criteria for Suspending/Terminating a Study Center 
Boston Scientific reserves the right to stop the inclusion of subjects at a study center at any 
time after the study initiation visit if no subjects have been enrolled for a period beyond 12 
months after center initiation, or if the center has multiple or severe protocol 
violations/noncompliance without justification and/or fails to follow remedial actions. 
In the event of termination of site participation, all study devices and testing equipment, as 
applicable, will be returned to BSC unless this action would jeopardize the rights, safety or 
well-being of the subjects. The IRB/EC and regulatory authorities, as applicable, should be 
notified. All subjects enrolled in the study at the center will continue to be followed for the 
protocol follow-up period after study termination. The Principal Investigator at the center 
must make provision for these follow-up visits unless BSC notifies the investigational center 
otherwise. 
18 Publication Policy 
BSC requires disclosure of its involvement as a sponsor or financial supporter in any 
publication or presentation relating to a BSC study or its results. In accordance with the 
Corporate Policy for the Conduct of Human Subject Research, BSC will submit study results 
for publication (regardless of study outcome) following the conclusion or termination of the 
study. Boston Scientific adheres to the Contributorship Criteria set forth in the Uniform 
Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org). In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and investigators in publication preparation provided the following guidelines 
are followed. 
• All authorship and contributorship requirements as described above must be followed. 
• BSC involvement in the publication preparation and the BSC Publication Policy should 
be discussed with the Coordinating Principal Investigator(s) and/or Executive/Steering 
Committee at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  
The data, analytic methods, and study materials for this clinical trial may be made available 
to other researchers in accordance with the Boston Scientific Data Sharing Policy 
(https://www.bostonscientific.com/).  
 
 

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19 Bibliography 
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Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, et al. 
Classification of acute pancreatitis—2012: revision of the Atlanta classification and 
definitions by international consensus. Gut. 2013;62(1):102-11. 
2. 
Gardner TB, Chahal P, Papachristou GI, Vege SS, Petersen BT, Gostout CJ, et al. A 
comparison of direct endoscopic necrosectomy with transmural endoscopic drainage for the 
treatment of walled-off pancreatic necrosis. Gastrointest Endosc. 2009;69(6):1085-94. 
3. 
Papachristou GI, Takahashi N, Chahal P, Sarr MG, Baron TH. Peroral endoscopic 
drainage/debridement of walled-off pancreatic necrosis. Ann Surg. 2007;245(6):943-51. 
4. 
Schmidt PN, Novovic S, Roug S, Feldager E. Endoscopic, transmural drainage and 
necrosectomy for walled-off pancreatic and peripancreatic necrosis is associated with low 
mortality–a single-center experience. Scandinavian journal of gastroenterology. 
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Smoczynski M, Jagielski M, Jablonska A, Adrych K. Endoscopic necrosectomy 
under fluoroscopic guidance - a single center experience. Wideochir. 2015;10(2):237-43. 
6. 
Dayyeh BKA, Mukewar S, Majumder S, Zaghlol R, Valls EJV, Bazerbachi F, et al. 
Large-Caliber Metal Stents Versus Plastic Stents for the Management of Pancreatic Walled-
Off Necrosis. Gastrointestinal Endoscopy. 2017. 
7. 
Varadarajulu S, Phadnis MA, Christein JD, Wilcox CM. Multiple transluminal 
gateway technique for EUS-guided drainage of symptomatic walled-off pancreatic necrosis. 
Gastrointest Endosc. 2011;74(1):74-80. 
8. 
Bapaye A, Dubale NA, Sheth KA, Bapaye J, Ramesh J, Gadhikar H, et al. 
Endoscopic ultrasonography‐guided transmural drainage of walled‐off pancreatic necrosis: 
Comparison between a specially designed fully covered bi‐flanged metal stent and multiple 
plastic stents. Digestive Endoscopy. 2017;29(1):104-10. 
9. 
Muthusamy VR, Chandrasekhara V, Acosta RD, Bruining DH, Chathadi KV, 
Eloubeidi MA, et al. The role of endoscopy in the diagnosis and treatment of inflammatory 
pancreatic fluid collections. Gastrointestinal endoscopy. 2016;83(3):481-8. 
10. 
Varadarajulu S, Mel Wilcox C, Latif S, Phadnis M, Christein JD. Management of 
pancreatic fluid collections: a changing of the guard from surgery to endoscopy. The 
American surgeon. 2011;77(12):1650-5. 
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Stamatakos M, Stefanaki C, Kontzoglou K, Stergiopoulos S, Giannopoulos G, 
Safioleas M. Walled-off pancreatic necrosis. World J Gastroenterol. 2010;16(14):1707-12. 
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Thoeni RF. The revised Atlanta classification of acute pancreatitis: its importance for 
the radiologist and its effect on treatment. Radiology. 2012;262(3):751-64. 
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Baron TH, Harewood GC, Morgan DE, Yates MR. Outcome differences after 
endoscopic drainage of pancreatic necrosis, acute pancreatic pseudocysts, and chronic 
pancreatic pseudocysts. Gastrointestinal endoscopy. 2002;56(1):7-17. 
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Hookey LC, Debroux S, Delhaye M, Arvanitakis M, Le Moine O, Deviere J. 
Endoscopic drainage of pancreatic-fluid collections in 116 patients: a comparison of 
etiologies, drainage techniques, and outcomes. Gastrointest Endosc. 2006;63(4):635-43. 
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Varadarajulu S, Wilcox CM, Tamhane A, Eloubeidi MA, Blakely J, Canon CL. Role 
of EUS in drainage of peripancreatic fluid collections not amenable for endoscopic 
transmural drainage. Gastrointest Endosc. 2007;66(6):1107-19. 

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16. 
Raijman I. Biliary and pancreatic stents. Gastrointest Endosc Clin N Am. 
2003;13(4):561-92, vii-viii. 
17. 
Varadarajulu S, Christein JD, Wilcox CM. Frequency of complications during EUS-
guided drainage of pancreatic fluid collections in 148 consecutive patients. J Gastroenterol 
Hepatol. 2011;26(10):1504-8. 
18. 
Varadarajulu S, Bang JY, Sutton BS, Trevino JM, Christein JD, Wilcox CM. Equal 
efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a 
randomized trial. Gastroenterology. 2013;145(3):583-90 e1. 
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Varadarajulu S, Wilcox CM, Latif S, Phadnis M, Christein JD. Management of 
pancreatic fluid collections: a changing of the guard from surgery to endoscopy. Am Surg. 
2011;77(12):1650-5. 
20. 
Park DH, Lee SS, Moon SH, Choi SY, Jung SW, Seo DW, et al. Endoscopic 
ultrasound-guided versus conventional transmural drainage for pancreatic pseudocysts: a 
prospective randomized trial. Endoscopy. 2009;41(10):842-8. 
21. 
Johnson MD, Walsh RM, Henderson JM, Brown N, Ponsky J, Dumot J, et al. 
Surgical vs. non-surgical management of pancreatic pseudocysts. J Clin Gastroenterol. 
2009;43(6):586-90. 
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Diehl DL. The role of endoscopy in acute and chronic pancreatitis. In: Balthazar EJ, 
Megibow AJ, Pozzi-Mucelli R, editors. Imaging of the pancreas. Berlin: Springer Verlag; 
2009. 
23. 
Bang JY, Wilcox CM, Trevino J, Ramesh J, Peter S, Hasan M, et al. Factors 
impacting treatment outcomes in the endoscopic management of walled-off pancreatic 
necrosis. J Gastroenterol Hepatol. 2013;28(11):1725-32. 
24. 
Varadarajulu S, Tamhane A, Blakely J. Graded dilation technique for EUS-guided 
drainage of peripancreatic fluid collections: an assessment of outcomes and complications 
and technical proficiency (with video). Gastrointest Endosc. 2008;68(4):656-66. 
25. 
Talreja JP, Shami VM, Ku J, Morris TD, Ellen K, Kahaleh M. Transenteric drainage 
of pancreatic-fluid collections with fully covered self-expanding metallic stents (with video). 
Gastrointest Endosc. 2008;68(6):1199-203. 
26. 
Rinninella E, Kunda R, Dollhopf M, Sanchez-Yague A, Will U, Tarantino I, et al. 
EUS-guided drainage of pancreatic fluid collections using a novel lumen-apposing metal 
stent on an electrocautery-enhanced delivery system: a large retrospective study (with video). 
Gastrointestinal Endoscopy. 2015;82(6):1039-46. 
27. 
Shah RJ, Shah JN, Waxman I, Kowalski TE, Sanchez-Yague A, Nieto J, et al. Safety 
and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with 
lumen-apposing covered self-expanding metal stents. Clinical Gastroenterology and 
Hepatology. 2015;13(4):747-52. 
28. 
Bazerbachi F, Sawas T, Vargas EJ, Prokop LJ, Chari ST, Gleeson FC, et al. Metal 
stents versus plastic stents for the management of pancreatic walled-off necrosis: a 
systematic review and meta-analysis. Gastrointestinal endoscopy. 2017. 
 
 

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20 Abbreviations and Definitions  
Acronym          Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AP 
Acute Pancreatitis 
ASGE 
American Society for Gastrointestinal Endoscopy 
ASADE 
Anticipated Serious Adverse Device Effect 
BSC 
Boston Scientific Corporation 
CA 
Competent Authority 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CT 
Computerized Tomography 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EUS 
Endoscopic Ultrasound 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GI 
Gastrointestinal 
GOO 
Gastric Outlet Obstruction 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for 
Human Use 
ICMJE 
International Committee of Medical Journal Editors 
ICU 
Intensive Care Unit 
IDE 
Investigational Device Exemption 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
ITT 
Intent-To-Treat 
MRI 
Magnetic Resonance Imaging 
PFCs 
Pancreatic Fluid Collections 
PP 
Per Protocol 
SF12 
Short Form 12-item Survey 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SIRS 
Systemic Inflammatory Response Syndrome 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 

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VARD 
Video-Assisted Retroperitoneal Debridement 
WON 
Walled-off Pancreatic Necrosis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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21 Appendix A. Key points extracted from Bazerbachi et al (GIE 2017) 
[28] 
The WON drainage stent types for cases represented in the Bazerbachi et al (GIE 2017)[28] 
systematic review and meta-analysis included 2213 patients 
• 1202 patients with WON drainage using plastic stents 
• 1011 patients with WON drainage using metal stents 
o 871 patients with WON drainage using Lumen Apposing Metal Stents 
(LAMS) 
 503 patients with WON drainage using AXIOS LAMS 
 368 patients with WON drainage using non-AXIOS LAMS 
o 140 patients with WON drainage using non-LAMS  
 
Table A1.  Summary of Meta-Analysis Metrics Results 
 
 
 
 
 
 
 

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22 Appendix B. S-F12  
Your Health and Well-Being 
 
 
This survey asks for your views about your health. This information will 
help keep track of how you feel and how well you are able to do your 
usual activities. Thank you for completing this survey! 
 
For each of the following questions, please mark an 
 in the one box that 
best describes your answer. 
 
1. In general, would you say your health is: 
2. The following questions are about activities you might do during a 
typical day.  Does your health now limit you in these activities?  If so, 
how much? 
 
Yes, 
limited 
a lot 
Yes, 
limited 
a little 
No, not 
limited 
at all 
 
   
 
a Moderate activities, such as moving a table, pushing  
a vacuum cleaner, bowling, or playing golf ............................. 
 1 ............. 
 2
 
 3 
 
b Climbing several flights of stairs ............................................. 
 1 ............. 
 2
 ............................................................................................... 
 3 
 
 
Excellent 
Very good 
Good 
Fair 
Poor 
 
 
 
 
 
  
 1 
  
 2 
  
 3 
  
 4 
  
 5 

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1. During the past 4 weeks, how much of the time have you had any of 
the following problems with your work or other regular daily 
activities as a result of your physical health?  
2. During the past 4 weeks, how much of the time have you had any of 
the following problems with your work or other regular daily 
activities as a result of any emotional problems (such as feeling 
depressed or anxious)? 
3. During the past 4 weeks, how much did pain interfere with your 
normal work (including both work outside the home and 
housework)?  
Not at all 
A little bit 
Moderately 
Quite a bit 
Extremely 
 
 
 
 
 
  
 1 
  
 2 
  
 3 
  
 4 
  
 5 
 
 
All of 
the time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
     
a 
Accomplished less than you  
 
would like ......................................
 1 ............. 
 2 ..............
 3 .............. 
 4 .............
 5 
b 
Did work or other activities 
 
less carefully than usual ................
 1 ............. 
 2 ..............
 3 .............. 
 4 .............
 5 

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1. These questions are about how you feel and how things have been 
with you during the past 4 weeks.  For each question, please give the 
one answer that comes closest to the way you have been feeling.  How 
much of the time during the past 4 weeks… 
2. During the past 4 weeks, how much of the time has your physical 
health or emotional problems interfered with your social activities 
(like visiting with friends, relatives, etc.)? 
 
 
 
 
Thank you for completing these questions! 
 
All of 
the time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
     
a 
Have you felt calm and   
peaceful? ........................................
 1 .............. 
 2 ..............
 3 .............. 
 4 ..............
 5 
b 
Did you have a lot of energy? .......
 1 .............. 
 2 ..............
 3 .............. 
 4 ..............
 5 
c 
Have you felt downhearted   
and depressed? ...............................
 1 .............. 
 2 ..............
 3 .............. 
 4 ..............
 5 
All of 
the time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
 
 
 
 
  
 1 
  
 2 
  
 3 
  
 4 
  
 5