Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study (EVAS 2 Confirmatory IDE Study)
Phase: NA
Conditions: Abdominal Aortic Aneurysm Without Rupture
Sponsor: Endologix

 
2 Musick • Irvine, CA 92618 • (949) 595-7200 • Fax (949) 595-7373 
www.endologix.com 
Page 1 
 
 
 
 
 
 
 
 
CLINICAL STUDY PROTOCOL  
CP-0008 Rev. 12.7  
 
REVISION DATE: MARCH 30, 2020 
 
 
 
 
Prospective, Multicenter, Single Arm Safety and Effectiveness 
Confirmatory Study of Endovascular Abdominal Aortic 
Aneurysm Repair using the Nellix® System  
 
EVAS II Confirmatory Study  
 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
2 
Table of Contents 
 
Section 
Page 
1. 
INVESTIGATOR SIGNATURE PAGE ......................................................................................................... 22 
2. 
STUDY CONTACT PERSONNEL ................................................................................................................. 23 
 
SPONSOR ................................................................................................................................................. 23 
 
CONTACT NAMES AND TELEPHONE NUMBERS ...................................................................................... 23 
3. 
PROTOCOL SYNOPSIS ................................................................................................................................. 24 
4. 
TRIAL OVERVIEW ........................................................................................................................................ 28 
4.1. 
OBJECTIVE .............................................................................................................................................. 28 
4.2. 
BACKGROUND ......................................................................................................................................... 28 
4.3. 
STUDY DESIGN ........................................................................................................................................ 30 
5. 
STUDY POPULATION ................................................................................................................................... 31 
5.1. 
ENROLLMENT ......................................................................................................................................... 31 
5.2. 
INCLUSION CRITERIA ............................................................................................................................. 31 
5.3. 
EXCLUSION CRITERIA ............................................................................................................................ 32 
6. 
RESPONSE MEASURES ................................................................................................................................ 32 
6.1. 
PRIMARY SAFETY ................................................................................................................................... 32 
6.2. 
PRIMARY EFFECTIVENESS ...................................................................................................................... 33 
6.3. 
ADDITIONAL EVALUATIONS ................................................................................................................... 34 
7. 
STUDY MATERIALS ...................................................................................................................................... 35 
7.1. 
DEVICE DESCRIPTION ............................................................................................................................ 35 
7.2. 
INVESTIGATOR TRAINING AND EXPERIENCE ........................................................................................ 38 
7.3. 
DEVICE ACCOUNTABILITY ..................................................................................................................... 38 
7.4. 
PATIENT AND DEVICE PREPARATION .................................................................................................... 39 
8. 
STUDY METHODS.......................................................................................................................................... 39 
8.1. 
GENERAL ENTRY PROCEDURES ............................................................................................................. 39 
8.2. 
INFORMED CONSENT .............................................................................................................................. 39 
8.3. 
SUBJECT IDENTIFICATION ...................................................................................................................... 39 
8.4. 
SCHEDULE OF MEASUREMENTS ............................................................................................................. 40 
8.5. 
STUDY PROCEDURES AND EVALUATIONS .............................................................................................. 40 
8.5.1. 
Informed Consent ...................................................................................................................... 40 
8.5.2. 
CT Scan Protocol ...................................................................................................................... 40 
8.5.3. 
Pre-Operative Activities ............................................................................................................ 41 
8.5.4. 
Subject Enrollment .................................................................................................................... 41 
8.5.5. 
Post-Operative Follow-up Visits ............................................................................................... 41 
8.5.6. 
Enhanced Post-Operative Follow-up Visits .............................................................................. 42 
8.6. 
RECOMMENDED SECONDARY INTERVENTION TREATMENT OPTIONS ................................................. 42 
8.6.1. 
Treament Options for Type 1 Endoleaks................................................................................... 43 
8.6.1.1.  Type 1A Endoleaks ................................................................................................................... 43 
8.6.1.2.  Type 1B Endoleaks ................................................................................................................... 43 
8.6.2. 
Treatment Options for Migration .............................................................................................. 44 
8.6.3. 
Treatment Options for Aneurysm Expansion ............................................................................ 44 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
3 
8.7. 
PROTOCOL DEVIATIONS ................................................................................................................ 45 
8.7.1. 
Deviations with Expedited Reporting Requirements ................................................................ 45 
8.7.2. 
Deviations Requiring Prior Approval ........................................................................................ 45 
8.7.3. 
Non-Urgent Deviations ............................................................................................................. 45 
8.8. 
ADVERSE EVENT REPORTING ................................................................................................................ 46 
8.8.1. 
General Definitions ................................................................................................................... 46 
8.8.2. 
Reporting of Adverse Events .................................................................................................... 47 
8.8.3. 
Adverse Events: required reporting timeframes ........................................................................ 48 
8.8.4. 
Secondary procedures ............................................................................................................... 48 
8.8.5. 
Anticipated Adverse Events ...................................................................................................... 48 
8.8.6. 
Unanticipated Adverse Device Effect ....................................................................................... 49 
8.8.7. 
Adverse Event Definitions ........................................................................................................ 49 
9. 
RISK ANALYSIS ............................................................................................................................................. 51 
10.  STATISTICAL PROCEDURES ..................................................................................................................... 52 
10.1 
ANALYSIS POPULATIONS ........................................................................................................................ 52 
10.2 
PATIENT ACCOUNTABILITY AND MISSING DATA .................................................................................. 52 
10.3 
GENERAL NOTES .................................................................................................................................... 52 
10.4 
BASELINE COMPARABILITY ANALYSIS .................................................................................................. 52 
10.5 
POOLING ................................................................................................................................................. 53 
10.6 
PRIMARY SAFETY ANALYSIS .................................................................................................................. 53 
10.6.1 PRIMARY SAFETY HYPOTHESIS ............................................................................................................. 53 
10.7 
SAMPLE SIZE ........................................................................................................................................... 53 
10.8 
ADDITIONAL EVALUATIONS ................................................................................................................... 53 
11.  ADMINISTRATIVE PROCEDURES ............................................................................................................ 55 
11.1 
STATEMENT OF COMPLIANCE ................................................................................................................ 55 
11.2 
RESPONSIBILITIES .................................................................................................................................. 55 
11.3 
PATIENT PROTECTION ............................................................................................................................ 56 
11.4 
PROTOCOL CHANGES ............................................................................................................................. 57 
11.5 
DOCUMENTATION ................................................................................................................................... 57 
11.6 
MONITORING PLAN ................................................................................................................................ 58 
12.  REFERENCES .................................................................................................................................................. 59 
13.  APPENDIX A: LIST OF COILS INVESTIGATORS MAY USE ADJUNCTIVELY WITH ONYX® ... 60 
 
 
List of Attachments 
Attachment 1: Instructions for Use 
Attachment 2: Informed Consent Form Template 
Attachment 3: Electronic Case Report Form 
 
 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
4 
Revision 02 Change Summary 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 01 to version 02, Date 03 July 2012 to 9 Dec 2012. 
Reason: Reflected revision date change in the header. 
Table of 
Contents 
Updated to reflect revision changes 
1 (4) 
Updated Investigator Signature page 
Reason: Modified first paragraph to reflect accordance with all applicable global laws.  
2.1 (5) 
 
Updated General Sponsor Contact 
Reason: to reflect change in Sponsor personnel. 
3 (6) 
5.1 (13) 
Updated subject population 
Reason: to clarify the number of Roll-in subjects and up to 150 patients in the Intent to Treat Pivotal 
Cohort. 
3 (6) 
7.2 (18) 
Updated Physician Training 
Reason: The training requirement has been changed to 3 required cases rather than 5 to be cleared 
for study enrollment.  
  4.1 (10) 
Updated Objective: Added EndoVascular Aneurysm Sealing System 
Reason: To reflect updated product name 
5.2 (13) 
Inclusion Criteria has been updated: changed d. proximal non-aneurysmal aortic neck; length ≥ 
10mm; lumen diameter 16 to 32mm; angle ≤60° to the aneurysm sac 
added f. Common Iliac artery lumen diameter between 8 and ≤35mm with blood lumen diameter 
with blood lumen diameter ≤35mm g. Ability to preserve at least one hypogastric artery 
Reason: to reflect Anatomic eligibility for the Nellix System per the instructions for use 
6.2 (14) 
Primary Effectiveness has been updated. Removed defined as migration resulting in serious adverse 
event or requiring secondary intervention through 12 months. 
Revised Secondary endovascular procedure for resolution for endoleak added (type I or type III) 
Reason: To clarify safety and effectiveness 
6.3 (15) 
Updated Additional Evaluations. Revised Secondary endovascular procedure within 30 days, at 6 
months, and annually to 5 years for resolution of endoleak Type I and II. 
Reason: to identify the procedure and resolution of endoleak Type I and III 
4.2 (11) 
Updated Background to include ePTFE covered stent. 
Reason: To reflect the Instructions for Use 
8.6 (23) 
Updated Protocol Deviation 
Reason: to clearly define a protocol deviation 
8.7.1 (24) 
Updated Serious Adverse Event Definition 
Reason: For alignment with ISO 14155 definition. 
8.7.3 (26) 
Added reference to Social Security Death Index (SSD) and CDC National Death Index (NDI) to 
obtain patient death information. 
Reason: Added additional information for sites to acquire patient death information 
(43) 
Updated monitoring will be performed under the direction of Avi Sharma, Director, Clinical Affairs 
Reason: A new CRO will be contracted. 
Attachment 
2 (2) 
Revised Informed Consent section 3. Up to 180 patients will be enrolled in the study overall. 
Reason: To reflect the change in the protocol. 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
5 
Section 
(Page) 
Change and Reason for the Change 
Attachment 
2 (3) 
Revised Informed Consent section 4. The US sites will be conducted under an IDE, or Canada under 
an investigational test authorization. 
Attachment 
3  
Formatting changed to DD/MMM/YY throughout all Case Report Forms 
Reason: To correct formatting 
Attachment 
3 (1) 
Revised Screening and Baseline case report form inclusion criteria section 3. Patient aneurysm 
increase of 1.0cm. 
Reason: to reflect the IFU 
Attachment 
3 (1) 
Revised Screening and Baseline case report form inclusion criteria to include in section 4. Most 
caudal renal artery to aortoiliac bifurcation length ≥ 70 mm 
Reason: to reflect the current IFU 
 
Revision 03 changes 
Note: minor punctuation or formatting changes are not included in this table. 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 02 to version 03, Date 09 Dec 2012 to 12 June 2013. 
Reason: Reflected revision date change in the header. 
Table of 
Contents 
Updated to reflect revision changes 
1 (13) 
‘Global’ changed to ‘regional’ 
Reason: PIs follow regional regulations.  Protocol requirements will specify any non-regional 
requirements. 
2 (23) 
CEC and DSMB Name and Address added (Syntactx) 
Reason: CRO is now under contract with Endologix. 
3 (24) 
Regions of study populations added 
Reason: Clarification of enrollment sites by region. 
3 (24) 
 
Site enrollment maximum set to 10% 
Reason: To ensure a more equitable enrollment profile across sites 
3(25) 
7.2 (38) 
Training section – changed from 3 roll-in per site to 1 roll-in.  Grammatical changes. 
Reason: Reflect correct roll-in population as specified in Subject Population (page 10) and other 
sections.   
3 (25) 
5.3 (32) 
Exclusion Criteria #3: Removed words ‘enrollment or 30 day follow-up phase of’ 
Reason: Subjects should not be involved in a competing study at any time frame, as the study 
population should be examining only the Nellix system as a treatment.  
3 (26) 
6.2 (33) 
Primary Effectiveness Endpoint: “Endoleak type I > 30 days, and Endoleak III” changed to 
“Endoleak type I or Endoleak type III at 12 months ” and additionally  “Secondary endovascular 
procedure up to 12 months for resolution of Endoleak (Type I or Type III)” was added. 
 
Reason: The existence of an endoleak is, by itself, not necessarily an indication of a clinically 
significant leakage.  Clinically, a failure of effectiveness related to endoleaks would be indicated by a 
re-intervention to re-exclude the aneurysm, or the existence of an endoleak sufficient to cause the 
aneurysm to expand.  Both of those occurrences are considered failures by this endpoint.  Type I or 
III Endoleaks at 12 months (regardless of intervention or effect) is included to conservatively allow 
for possible future corrective actions. 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
6 
Section 
(Page) 
Change and Reason for the Change 
3 (26) 
3(18) 
10.8 (53) 
Primary Effectiveness Endpoint: Added in ‘device occlusion’, and ‘may be due to thrombus or other 
causes) to list of secondary procedure causes.   
Reason: Clarity, as requested by FDA (question 44a) 
3 (26) 
Primary Effectiveness Endpoint: Re-arrangement of metrics. 
Reason: Clarity (most of the metrics refer to secondary interventions for various device issues; these 
were compiled into a list). 
3 (26) 
Additional Evaluations: MAE Individual Components: Changed ‘years 1 through 5’ to ‘annually to 5 
years’ 
Reason: Clarity (to match other metric descriptions in this section).  
3 (26) 
Additional Evaluations: Composite Major Adverse Events: added ’30 days’ to time frames of 
analysis. 
Reason: Error - should have been included (as in the other metrics in this section). 
3 (26) 
4.3 (30) 
6.3 (34) 
8.4 (40) 
10.8 (53) 
Additional Evaluations: Distal Blood Flow (ABI):  Removed 
Reason: Per the recommendation of the study P.I., ABI (ankle brachial index) is a poor indicator of 
device performance.  Due to the co-morbidities associated with this study population (peripheral 
artery disease), ABI can be permanently elevated in patients with calcified arteries, rendering ABI a 
poor tool for identifying future changes in blood flow.  Peripheral blood flow, should of course, be 
examined as per physician standard of care. 
J Am Coll Cardiol. 2008 Apr 1;51(13):1292-8. doi: 10.1016/j.jacc.2007.11.064. 
doi: 10.2337/diacare.26.12.3333 Diabetes Care December 2003 vol. 26 no. 12 3333-3341 
3 (26) 
6.3 (34) 
8.7.7 (46) 
10.8 (53) 
Additional Evaluations: Luminal Thrombus Requiring Intervention at each study timepoint: Metric 
and definition added 
Reason: Response to FDA’s request concerning thrombus formation (question 46), thrombus has also 
been added as a separate metric for evaluation (in addition to being part of the effectiveness 
endpoint). 
3 
Statistical Considerations: Study Population: 1st paragraph changes 
Reason: Clarity to Intent to treat population definition, and to enrolled status. 
3 
Statistical Considerations: Study Population: Per Protocol population paragraph added. 
Reason: Clarify the Per Protocol population definition. 
3 
Statistical Considerations: Study Population: Completed Cases paragraph added. 
Reason: Clarify the Completed Cases population definition. 
7 (35) 
Study Materials: Single use or multiple use added to each component. 
Reason: Clarity (and Dispenser should have been specified multiple use). 
 
 
7.2 (38) 
Investigator Training item #2: added word ‘approximately’ to case number requirement 
Reason: Sub-investigator qualifications for implantation with regard to prior EVAR experience will 
be done on a case-by-case basis; however, 25 cases will be treated as a rough baseline. 
7.3 (38) 
Device accountability: added in ‘prior to implantation’ 
Reason: Clarity.  Return of all device components can only occur if the device was not implanted. 
8.1 (39) 
11.2 (49) 
Addition of ‘independent physician review. 
Reason: Addition of more detail regarding patient approval process. 
8.2 (39) 
‘global standards’ changed to ‘Good Clinical Practices’ 
Reason: Clarity 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
7 
Section 
(Page) 
Change and Reason for the Change 
8.3 (27) 
Changed title of Section 8.3 to properly reflect subsequent content 
Reason: Error, and as noted in FDA question #49. 
8.3 (27) 
Removal of methodology for patient naming. 
Reason: Patient IDs will be automatically generated within the eDC system. 
8.5.4 (40) 
Addition of sentence “If, during the index procedure, the device is not implanted and/or there is 
conversion to open surgery, the patient will be followed until the 30 day follow-up” 
Reason: Clarification of follow-up process for patients that either do not receive the study device, or 
are converted to open surgery. 
8.7.1 (46) 
‘…administered a product…’ changed to ‘…enrolled in the trial…’ 
Reason: Correction.  AE reporting also applies to subjects who did not receive the product, but were 
enrolled. 
8.7.2 (46) 
8.7.3 (46) 
Sections rewrite 
Reason: Consolidation.  Many paragraphs in these two sections contained repetitious instructions.  
The adverse event reporting process is roughly the same regardless of the type of adverse event.   
 
AE reporting time requirements (from the site to Endologix), while mentioned, were scattered 
throughout text and difficult to access quickly.  A table of “Adverse Events: required reporting 
timeframes” was generated to address this.   
 
Requirements for reporting and investigating a subject death were consolidated into one section. 
There were no substantive changes. 
8.7.4 (46) 
Removal of word ‘endovascular’ from section title 
Reason: Correction.  Procedures discussed also refer to open repair. 
8.7.4 (46) 
Removal of fax information. 
Reason: reporting in this trial will be electronic via EDC. 
8.7.6 (46) 
Addition of Endologix reporting timeframes of UADEs.  Removal of fax information 
Reason: Reporting will be done by the EDC system in this trial.  Clarify Endologix response to such 
an event. 
8.7.7 (46) 
10.8 (53) 
Revised definition for Clinically Significant Migration: 
Reason: Updated for consistency within the document. 
8.7.7 (46) 
Removal of definitions of various adverse events 
Reason: Consolidation.  Definitions in the protocol will be limited to endpoints and device specific 
issues.  All other clinical events will be defined by the independent CEC (Syntactx) 
8.7.7 (46) 
Revised Distal Ischemia Definition: Removed”…A reduction in ABI of 0.15 or more attributable to 
the index procedure and not related to natural progression of atherosclerotic disease is included in this 
definition. 
Reason: See change #17 
8.7.7 (46) 
10.8 (53) 
Revised Migration definition: 
Reason: Defined per migration from the renal artery and removed intervention criteria to include all 
device migrations >5 mm. 
8.7.7 (46) 
Addition of device occlusion to secondary procedures. 
Reason: Treatment can also be open surgery.  Obstruction and occlusion will cover any thrombus 
related events (FDA Question 44). 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
8 
Section 
(Page) 
Change and Reason for the Change 
8.7.7 (46) 
Removal of word ‘endovascular’ from Secondary Procedure definition  
Reason: See change#47 
10.1 (52) 
Removal of ‘with imputation for missing data…” 
Reason: Removed for redundancy as this is explained in the next section.  
10.1 (52) 
Addition of ‘or have expired prior to 12 months’ 
Reason: Per FDA request (Question 47), provide further clarification on the Completed Cases 
analysis population. 
10.1 (52) 
Completed case (CC) changes; removal of one sentence, addition of another 
Reason: Clarity.   
10.2 (52) 
Addition ‘prior to procedure’ 
Reason: Clarity (this listing is for patients who never officially enrolled) 
10.2 (52) 
Change of ’15 subjects’ to ‘10% of study enrollment’ (2 places in paragraph) 
Reason: Quantify the amount of total enrollment a given clinical site can contribute to the study. 
10.2 (52) 
Removal of sentence “In the control group, no subjects were…” 
Reason: Per FDA request (Question 51), there will be no control group comparator for this study. 
10.2 (52) 
Addition of paragraph beginning with “In addition to the above…” 
Reason: Per FDA request (Question 52), Tipping Point Analyses has been included. 
10.5 (53) 
Addition of sentence beginning “The estimates obtained…” 
Reason: Per FDA request (Question 53), provided additional clarification pertaining to heterogeneity 
of study sites. 
10.6 (53) 
For entire section: removal of word ‘control’. 
Reason: Clarity.  SVS open surgery group provides a historical OPC for this trial.  The SVS group is 
not a direct control (i.e., patient level data) in this trial.  
10.6 (41) 
For entire section: change ‘test group’ to ‘study population’ 
Reason: Clarity.  ‘Test group’ normally refers to one arm of a two arm trial.  This trial is not designed 
as a two arm trial. 
10.6.2 
Changes to sentence beginning with ‘The sample size of this trial…” 
Reason: Clarity.  ‘Test group’ normally refers to one arm of a two arm trial.  This trial is not designed 
as a two arm trial. 
10.7.1 (51) 
Addition of sentence beginning with “The hypothesis test will be…” 
Reason:  Clarification of the significance level and for consistency within the document. 
10.7.2 (53) 
Revision of endpoint description 
Reason: Updated to reflect endpoint changes. 
11.2.5 (48) 
Added “An independent clinical safety review will examine all AEs and SAEs.  MAEs will undergo 
adjudication by the CEC panel.” 
Reason: Events that the CEC will review were clarified per FDA IDE response question #11. 
11.5 (57) 
Revised Study log maintenance description 
Reason: Updated to reflect current practices for study log maintenance.  
Attachment 
2 (2) 
Added prior clinical studies information to informed consent 
Reason: This change was implemented per a request in FDA IDE Response question #13. 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
9 
Section 
(Page) 
Change and Reason for the Change 
Attachment 
2 (4)  
Added information pertaining to follow-up of enrolled patients where the study device is not 
successfully implanted during the index procedure or patients where the device is explanted. 
Reason: Protocol CP-0008 Rev.03 was updated with a 30-day follow-up period for patients where the 
device is not successfully implanted, if the patient is converted to open surgery, or if the device is 
explanted with open surgical repair. 
Attachment 
2 (9) 
Added US Clinical Trials.gov publishing requirement  
Reason: To inform patients that information on this study will be available on the internet. 
Attachment 
3 (All) 
Paper CRFs were converted to electronic CRFs 
Attachment 
3 (5) 
Revised from: “Most caudal renal artery to aorto-iliac bifurcation length >= 70 mm”.  To: “Most 
caudal renal artery to each hypogastric artery length 100mm” 
Reason: Updated to reflect current inclusion exclusion criteria per discrepancy noted in FDA IDE 
response question #14. 
Attachment 
3 (5) 
Revised from: “Is there clinically significant infrarenal mural thrombus (>5mm thick over >60% 
circumference)” To:…(>5 mm thick over >50% circumference)  
Reason: Updated to reflect current inclusion exclusion criteria per discrepancy noted in FDA IDE 
response question #14.  
Attachment 
3 (17) 
Removed: Nellix Extenders were removed from the CRFs 
Reason: Extenders are not planned to be used in this clinical study. This addresses FDA IDE response 
question #12 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
10 
Revision 04 changes 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 03 to version 04, Date 12 June 2013 to May 2014. 
Reason: Reflected revision date change in the header. 
2 (13) 
Added “…with conditions of the approval imposed by the reviewing Ethics Committee or Institutional 
Review Board….I agree to maintain adequate source documentation records throughout the clinical 
investigation and make them available as requested during monitioring visits. I agree to maintain the 
device accountability records and ensure that the investigational device is used solely by authorized 
users as specified by this protocol.  
 
I agree to ensure that the requirements for obtaining informed consent are met.  
 
Additionally, I agree to disclose financial interests in accordance with 21 CFR 54, and certify that such 
financial interests, if any, will not interfere with my responsibilities as an investigator or influence study 
outcomes under my supervision.  
 
Reason: These statements were added to the investigator signature page to centralize requirements from 
21 CFR 812.43 (C) and ISO 14155 that were reflected across several study agreements.  
3 (15) 
Removal of Canada from the list of countries 
 
Reason: Canada no longer has active sites in this trial.  No patients were enrolled at either site. 
3 (15) 
Change the site maximum enrollment from 10% to 15%. 
 
Reason: For consistency with prior EVAR trials. 
3 (16) 
Revised Inclusion criteria #4 for the maximum abdominal aortic aneurysm (AAA) sac diameter size 
from: “≥5.5cm or ≥4.5 cm which has increased by >1.0cm within the last year” to:  “≥5.0cm, or ≥4.5 
cm which has increased by ≥0.5cm within the last 6 months, or which exceeds 1.5 times the 
transverse dimension of an adjacent non-aneurysmal aortic segment”. 
 
Reason: As recommended by the trial Physician Steering Committee, for alignment with SVS 
practice guideline recommendations and aneurysm dimensional inclusion criteria among most 
recently approved products/labeling, including Medtronic Endurant, Trivascular Ovation, Lombard 
Anaconda, and Endologix (PEVAR). 
3 (16) 
Revised Exclusion criteria#10 of section #3 of clinically significant mural thrombus from” Clinically 
significant infrarenal mural thrombus (>5mm thickness over >50% circumference)“ to “Clinically 
significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-
aneurysmal neck (>5mm thickness over >50% circumference)” 
 
Reason: Clarification of exclusion criterion.  This revision clarifies that the mural thrombus exclusion 
applies to the infrarenal non-aneurysmal neck. 
4.2 (20) 
Added text beginning with “There are a number of qualifiers…” 
 
Reason: For clarification only. 
5.1 (22) 
Change the site maximum enrollment from 10% to 15% 
 
Reason: For consistency with prior EVAR trials. 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
11 
Section 
(Page) 
Change and Reason for the Change 
5.2(22) 
Revised Inclusion criteria #4 for the maximum abdominal aortic aneurysm (AAA) sac diameter size 
from: “≥5.5cm or ≥4.5 cm which has increased by >1.0cm within the last year” to:  “≥5.0cm, or ≥4.5 
cm which has increased by ≥0.5cm within the last 6 months, or which exceeds 1.5 times the 
transverse dimension of an adjacent non-aneurysmal aortic segment”. 
 
Reason: As recommended by the trial Physician Steering Committee, for alignment with SVS 
practice guideline recommendations and aneurysm dimensional inclusion criteria among most 
recently approved products/labeling, including Medtronic Endurant, Trivascular Ovation, Lombard 
Anaconda, and Endologix (PEVAR). 
5.3 (23) 
Revised Exclusion criteria #10 of section 5.3 of clinically significant mural thrombus from” 
Clinically significant infrarenal mural thrombus (>5mm thickness over >50% circumference)“ to 
“Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the 
infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference)” 
 
Reason: Clarification of exclusion criterion.   
7.2 (28) 
Revised review requirement for investigator training from” review of Investigator Brochure” to 
“review of prior clinical safety and effectiveness information”. 
 
Reason: To reflect actual practice. 
7.2 (28) 
Added criteria for sub-Investigators who lead the implant procedures “For procedures led by a sub-
investigator, the PI must be present to provide supervision of the case, unless the sub-Investigator has 
completed investigational device training and has received documented approval by Endologix.” 
 
Reason: Clarification of possible sub-investigator qualifications. Some sub-investigators will receive 
the full PI/proctor training. 
8.3 (30) 
Added subject number allocation system “Subject numbers will be automatically assigned by the 
EDC system” 
 
Reason: Subject number allocation was inadvertently missed in the previous revision. 
8.3 (30) 
Clarified screening log maintenance “either on paper or electronically in the EDC” 
 
Reason: Screening log can be maintained by either method (paper or electronically). 
8.5.2(30) 
Clarified slice thickness criteria from “<3mm” to “<=3mm” 
 
Reason: Typographical error: CT Scan slice thickness equal to 3mm are acceptable.   
8.5.4 (30) 
Revised subject enrollment section to clarify screen failures. “If the device does not contact the 
patient, the patient will not be considered enrolled and the assigned study number will not be given to 
another patient and the patient is considered as a screen failure” 
 
Reason:  Further clarified screen failures and patient numbers assignment in screen failures. 
8.5.4 (31) 
Revised conditions, when device is not implanted during index procedure. “If, during the index 
procedure, the device is introduced but is not implanted and/or there is conversion to open surgery, 
the patient will be followed until the 30 day follow-up.” 
 
Reason:  Further clarified situation when devices are not implanted during index procedure. 
8.5.5 (32) 
Removed site reference manual from instruction to complete, from “site reference manual” to “site 
initiation visit”. 
Reason: The site personnel are trained during site initiation visit on how to enter data into eCRFs. 
8.7.2 (35) 
Added “If approval is obtained from the patient or a patient’s authorized family member, the site 
should notify Endologix of the explant”. 
 
Reason: Added requirement to include patient’s authorization and to notify the sponsor once 
obtained. 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
12 
Section 
(Page) 
Change and Reason for the Change 
8.7.7 (36) 
Pulmonary related death was moved from page 35 
 
Reason: Pulmonary related death was located in the wrong section. 
8.7.7(36) 
Removed definition for Migration from “death” section to “other definitions ” section 
 
Reason: Editorial correction only. 
8.7.7 (37) 
Added “…and is still present at the 30 day CT as read by the Core Lab” to Procedural Technical 
Failure definition. 
 
Reason: Clarify definition of unresolved endoleak. 
10.2 (41) 
Removed “…and imputing the mean from all subjects with outcomes.” 
 
Reason: Including this additional method is not relevant since the endpoint is dichotomous and not a 
continuous variable from which a mean can be calculated across patients.  
10.5 (42) 
Replaced Logisitic Regression using a univariate model of study site with … “extension of the 
Fisher’s exact test (Fisher-Freeman-Halton).” 
 
Reason: This replacement is better suited for testing homogeneity across study sites.  
10.5 (42)  
Added “Both the safety and effectivness measures will employ weighted proportions as the basis for 
the statistical test.”  
 
Reason: Changed for clarity, as the approach to weighing estimates of the proportions as described by 
the Method of Fleiss (1993) is the same for all endpoints. 
10.6 (43) 
Changed: “…greater…” to “…less…” 
 
Reason: This was a typographical error. The sentence was updated to reflect actual statistical test that 
shows significant heterogeneity when the p-value is less than 0.15.  
10.6 (43) 
Removed “Secondary Procedures” from the primary safety hypothesis  
 
Reason: This was inadvertently added to the primary safety hypothesis as secondary procedures are 
represented in the primary effectiveness analysis.  
10.6.3 (44) 
Updated equation:  


1
1
1









k
k
k
k
p
p
n
W
 
Reason: There was a typographical error in the previous version of this equation. This equation was 
intended to show that weight is equal to the inverse of the variance. 
ICF (3) 
Study Questions, #3: Changed to ‘enroll up to 31 patients’ 
 
Reason: to match up to maximum site enrollment 
ICF (4) 
Blood Pressure : removed descriptive text ‘… measured at your arms and ankles’ 
 
Reason: protocol only specifies a normal blood pressure exam. 
ICF (10) 
Change “Endologix fenestrated device” to “Nellix system” 
 
Reason : Incorrect system title. 
 
 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
13 
Revision 05 changes 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 04 to version 05, Date Jun 2014 to Nov 2014. 
Reason: Reflected revision date change in the header. 
Table of 
Contents 
Updated to reflect revision changes 
3 (16) 
Updated protocol title, both short and long, to reflect the addition of Continued Access (as a separate 
cohort) 
3 (16) 
Clarified ‘Study Devices’ to include full name of device 
3 (18) 
Enrollment section changed to clarify the two trial phases: the Primary Investigation, and the 
Extended Investigation (Continued Access). Added the expected Extended Investigation enrollment 
and closure timeframe. 
5.1 (23) 
Changed title of section to ‘Primary Investigation’ for clarity. 
5.2 (23) 
New section added to explain details of the Extended Investigation.  The section elucidates 1) the 
expected enrollment, 2) the expected time of enrollment, and 3) the sites that invited to participate. 
8.7.2 (36) 
Updated company clinical fax number 
10.9 (49) 
New section added to explain statistical treatment of the Continued Access cohort. 
 
Revision 06 changes 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 05 to version 06, Date Nov 2014 to Feb 2015. 
Reason: Reflected revision date change in the header. 
Table of 
Contents 
Updated to reflect revision changes 
3 (17) 
Updated Continued Access population size to 100 
Reason: Reflected total population size for Continued Access 
5 (24) 
Updated Continued Access population size to 100 
Reason: Reflected total population size for Continued Access 
 
Revision 07 changes 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
Title Page 
Updated company address 
Reason: 2 Musick, Irvine, CA 92618 is location of new headquarters 
All Pages 
Changed all pages to protocol version from 06 to version 07, Date Feb 2015 to Apr 2015. 
Reason: Reflected revision date change in the header. 
Table of 
Contents 
Updated to reflect revision changes 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
14 
Section 
(Page) 
Change and Reason for the Change 
2 (16) 
Updated company address 
Reason: 2 Musick, Irvine, CA 92618 is location of new headquarters 
3 (18) 
Updated minimum proximal non-anuerysmal aortic neck lumen diameter from 16mm to 18mm and 
the minimum common iliac artery lumen diameter from 8mm to 9mm 
Reason: Corresponds with updated IFU.  The original anatomical parameters in both the IFU and the 
earlier protocol versions allowed for the possible use of 8mm Nellix stent diameters. The Core Lab 
has already been using these more restrictive parameters to determine eligibility throughout the trial, 
as Nellix 8mm stents were never utilized or implanted during the study. 
5 (25) 
Updated minimum proximal non-anuerysmal aortic neck lumen diameter from 16mm to 18mm and 
the minimum common iliac artery lumen diameter from 8mm to 9mm 
Reason: Corresponds with updated IFU.  The original anatomical parameters in both the IFU and the 
earlier protocol versions allowed for the possible use of 8mm Nellix stent diameters. The Core Lab 
has already been using these more restrictive parameters to determine eligibility throughout the trial, 
as Nellix 8mm stents were never utilized or implanted during the study. 
11 (54) 
Updated company address 
Reason: 2 Musick, Irvine, CA 92618 is location of new headquarters 
 
Revision 08 changes (VERSION WAS NOT RELEASED) 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 07 to version 08, Date May 2015 to Aug 2015. 
Reason: Reflected revision date change in the header. 
3 (17) 
Updated Continued Access population size to 270 
Reason: Reflected total population size for Continued Access 
5 (24) 
Updated Continued Access population size to 270 
Reason: Reflected total population size for Continued Access 
 
Revision 08.1 changes 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 08 to version 08.1, Date May 2015 to October 2015 
Reason: Reflected revision date change in the header. 
3 (18) 
Updated Continued Access population size to 150 
Reason: Reflected total population size for Continued Access 
5 (25) 
Updated Continued Access population size to 150 
Reason: Reflected total population size for Continued Access 
 
 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
15 
Revision 09 changes 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 08.1 to version 09, Date October 2015 to April 2016 
Reason: Reflected revision date change in the header. 
3 (18) 
Updated Continued Access population size to 250 
Reason: Reflected total population size for Continued Access 
5 (25) 
Updated Continued Access population size to 250 
Reason: Reflected total population size for Continued Access 
 
Revision 10 changes (VERSION WAS NOT RELEASED) 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 09 to version 10, Date April 2016 to June 2016 
Reason: Reflected revision date change in the header. 
2.1 (18) 
Changed sponsor contact 
Reason: Updated based on current organizational structure.  
3 (20) 
Changed anatomical inclusion criteria of blood lumen diameter from ≤ 60 mm to ≤ 70 mm 
Reason: Expanded treatable blood lumen diameters in updated Instructions for Use (IFU). 
5 (27) 
Changed anatomical inclusion criteria of blood lumen diameter from ≤ 60 mm to ≤ 70 mm 
Reason: Expanded treatable blood lumen diameters in updated Instructions for Use (IFU). 
7 (30) 
Changed dispenser from multiple use to single use 
Reason: Disposable dispensers are now available to use.  
7.1 (30) 
Replaced "polyurethane bag (EndoBag) having a polyester reinforcement sleeve" with polyurethane 
EndoBag with welded seams and a lumen having an inner polyester (PET) sleeve is attached to the 
stent proximally and distally using polyethylene sutures 
Reason: Describes the changes to the the EndoBag, with the distal end now also attached to the stent. 
7.1 (31) 
Updated the name of the pressure monitor from Mirador Compass™ to Centurion™ Biomedical 
Compass™ 
Reason: Mirador Biomedical is now a subsidiary of Centurion Medical Products, Inc. 
7.1 (32) 
Replaced the picture of the console 
Reason: Console was updated from 4 ports to 3. 
8.7 (40) 
Added sentence: “These events must be reported if clinically significant.” 
Reason: To emphasize the importance of reporting any clinically significant AE. 
11.6 (57) 
Changed sponsor contact 
Reason: Updated based on current organizational structure.  
 
 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
16 
Revision 10.1 changes 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 09 to version 10.1, Date April 2016 to September 2016 
Reason: Reflected revision date change in the header. 
2.1 (18) 
Changed sponsor contact 
Reason: Updated based on current organizational structure.  
7 (30) 
Changed dispenser from multiple use to single use 
Reason: Disposable dispensers are now available to use.  
7.1 (30) 
Replaced "polyurethane bag (EndoBag) having a polyester reinforcement sleeve" with polyurethane 
EndoBag with welded seams and a lumen having an inner polyester (PET) sleeve is attached to the 
stent proximally and distally using polyethylene sutures 
Reason: Describes the changes to the the EndoBag, with the distal end now also attached to the stent. 
7.1 (31) 
Updated the name of the pressure monitor from Mirador Compass™ to Centurion™ Biomedical 
Compass™ 
Reason: Mirador Biomedical is now a subsidiary of Centurion Medical Products, Inc. 
7.1 (32) 
Replaced the picture of the console 
Reason: Console was updated from 4 ports to 3. 
8.7 (40) 
Added sentence: “These events must be reported if clinically significant.” 
Reason: To emphasize the importance of reporting any clinically significant AE. 
11.6 (57) 
Changed sponsor contact 
Reason: Updated based on current organizational structure.  
 
 
Revision 11.1 changes (VERSION WAS NOT RELEASED) 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 10.1 to version 11,0 Date September 2016 to May 2017 
Reason: Reflected revision date change in the header. 
3 (21) 
Updated proximal non-anuerysmal aortic neck lumen diameter from 18mm-32mm to a neck diameter 
of 18mm-28mm and added: Distal iliac artery seal zone with length of ≥10mm, diameter range of 9 
to 25mm and ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter 
<1.40.   
Reason: Corresponds with updated IFU.    
5 (28) 
Updated proximal non-anuerysmal aortic neck lumen diameter from 18mm-32mm to a neck diameter 
of 18mm-28mm and added: Distal iliac artery seal zone with length of ≥10mm, diameter range of 9 
to 25mm and ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter 
<1.40.   
Reason: Corresponds with updated IFU.    
8.4 (37) 
Updated table to reflect enhanced follow-up visits 
Reason: Schedule of Measurements summarize assessments at each timepoint in the study, including 
enhanced follow-up.  Added footnote to table to clarify population affected by the new follow-up 
recommendations. 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
17 
Section 
(Page) 
Change and Reason for the Change 
8.5.6 (38) 
Added section for enhanced post-operative follow-up visit. 
Reason: Enhanced follow-ups are recommended to monitor at-risk for migration, Type 1A 
endoleaks and/or AAA sac enlargement.   
 
8.6 (38) 
Added section of recommended secondary intervention treatment options. 
Reason: Provides options to Nellix Investigators to treat subjects who experience migration, Type 
1A endoleaks and/or AAA sac enlargement. 
 
Revision 11.2 changes (VERSION WAS NOT RELEASED) 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 11.0 to version 11,2 Date June 2017 to July 
Reason: Reflected revision date change in the header. 
8.6 (38) 
Added section of recommended secondary intervention treatment options. 
Reason: Provides options to Nellix Investigators to treat subjects who experience migration, Type 
1A endoleaks and/or AAA sac enlargement. 
 
Revision 11.3 changes 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 11.2 to version 11.3 Date July 2017 to August 
Reason: Reflected revision date change in the header. 
8.6.1 (40) 
Updated table to reflected recommended secondary intervention treatment options for Type 1A 
Endoleaks 
Reason: When positioned correctly, with adequate seal, Onyx® can be used to treat Type 1A 
endoleaks. 
Appendix 
Added appendix of coils to be used with the Onyx Liquid Embolics System 
Reason: Reflects list of peripheral vascular coils available in the US, that allows physican to use 
preferred standard coil.  
 
 
Revision 12.0 changes (VERSION WAS NOT RELEASED) 
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
Cover 
Page 
Added Confirmatory indication   
Reason: Updated based on protocol being a confirmatory evaluation. 
All Pages 
Changed all pages to protocol version from 11.2 to version 12.0 Date July 2017   
Reason: Reflected revision date change in the header. 
3 (21) 
Updated Protocol Synopsis 
Reason: Updates align with details found in Trial Overview, Study Population and Response 
Measures sections. 
5.1 (29) 
Revised to reflect study design for confirmatory study 
Reason: Updates align with conformational design 
6.3 (32) 
Updated Additional Evaluations to reflect evaluation time points used in Pivotal study 
Reason: Adverse events are analyzed through the duration of the 1-year endpoint. 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
18 
Section 
(Page) 
Change and Reason for the Change 
7.3 (36) 
Revised Device Accountability 
Reason: Provided clarification of specific components of the Nellix System tracked on the device 
accountability log. 
8.1 (37) 
11.2 (60) 
Updated Physician Reviewer to Case Review Board 
Reason: Reflects updates needed to ensure IFU is followed 
8.8.7 (50) 
Removed duplicate definition of Clinically Significant Migration. 
Reason: Duplication not needed. 
10.6 (54) 
Revised Primary Safety 
Reason: Details of the analysis plan are in SAP. 
10.7 (55) 
Revised Primary Effectiveness 
Reason: Details of the analysis plan are in SAP. 
 
Revision 12.1 changes  
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
Cover 
Page 
Added Confirmatory indication   
Reason: Updated based on protocol being a confirmatory evaluation. 
All Pages 
Changed all pages to protocol version from 12.0 to version 12.1 Date August 2017   
Reason: Reflected revision date change in the header. 
3 (22) 
Updated total number of sites from up to 35 to up to 28   
Reason: To help control enrollment distribution across sites. 
3 (25) 
Removed Statistical Considerations referenced in the synopsis 
Reason: The SAP is the reference for statistical methodology. 
5 (59) 
Updated total number of sites from up to 35 to up to 28   
Reason: To help control enrollment distribution across sites. 
5.1 (30) 
Added “In the Primary Investigation, a single site may not enroll more than 15% of the total 
enrollment.” 
Reason: To clarify that there is a site enrollment maximum. 
8.8.6 (48) 
Clarified that type 1 endoleaks, device migration and aneurysm sac enlargement are not considered 
UADEs 
Reason: Aligns with refining IFU to mitigate those events previously noted to be at higher than 
expected rates.  
7 (30) 
7.1 (31) 
7.2 (34) 
Included Ovation iX Iliac Stent Graft as part of the Nellix System. Included device description and 
training requirements. 
 
Revision 12.2 changes  
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 12.1 to version 12.2 Date September 2017   
Reason: Reflected revision date change in the header. 
3 (24-25) 
6.3 (31) 
Added Additional Evaluations from SAP   
Reason: Updated to align with SAP per FDA’s request. 
 
 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
19 
 
Revision 12.3 changes  
Note: minor punctuation or formatting changes are not included in this table. 
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 12.2 to version 12.3 Date March 15, 2018   
Reason: Reflected revision date change in the header. 
2.1 (21) 
Updated General Sponsor Contact 
Reason: Updated based on current organizational structure 
4.3 (28) 
Revised language 
Reason: To reflect current terminology 
5.1 (29) 
Revised language 
Reason: To provide additional clarification 
6.3 (32) 
Relocation of existing footnotes 
Reason: Formatting change to reflect the accurate location of the footnote entries 
7.1 (33) 
Deleted existing footnotes 
Reason: Formatting change to reflect the accurate location of the footnote entries 
7.2 (36) 
Revised language 
Reason: To provide additional clarification 
7.3 (36) 
Revised language 
Reason: To provide additional clarification 
8.2 (37) 
Added language 
Reason: To provide additional clarification 
8.4 (38) 
Revised language 
Reason: To provide additional clarification and correct editorial error 
8.5.1 (38) 
Revised language 
Reason: To provide additional clarification 
8.5.3 (39) 
Revised language 
Reason: To provide additional clarification 
8.5.6 (40) 
Added language 
Reason: To define inadequate procedures in the revised definition of “at risk” to ensure enhanced 
follow-up is recommended.  
8.6 (41-42) 
Added secondary intervention terminology 
Reason: To reflect current terminology 
11.6 (57) 
Revised language 
Reason: To provide additional clarification 
11.6 (58) 
Updated Monitoring contact 
Reason: Updated based on current organizational structure 
 
Revision 12.4 changes  
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 12.3 to version 12.4 Date March 28, 2018.   
Reason: Reflected revision date change in the header. 
8.5.6 (40) 
Added punctuation to an inadequate procedure definition. 
Reason: Updated per FDA request 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
20 
Revision 12.5 changes  
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 12.4 to version 12.5 Date April, 2018.   
Reason: Reflected revision date change in the header. 
8.5.6 (41) 
Added clarification.  
Reason: Updated per FDA request 
 
Revision 12.6 changes  
 
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 12.5 to DRAFT September 21, 2018.   
Reason: Reflected revision date change in the header. 
2.1 (22) 
Updated General Sponsor Contact 
Reason: Updated based on current organizational structure 
3.0 (23) 
Changed 90 subjects to 105 subjects 
Reason: To align with the revised SAP 
3.0 (24) 
Clarified Total Enrollment, the Pivotal Cohort, and the Roll-In Cohort 
Reason: To align with the revised SAP 
3.0 (24) 
Changed maximum of 28 US sites to 38 US sites 
Reason: Additional sites required due to enrollment challenges  
3.0 (25) 
Changed Primary Effectiveness Endpoint to 2 year 
Reason: To align with the revised SAP 
5.1 (30,31) 
Changed 90 subjects to 105 subjects. Clarified Total Enrollment, the Pivotal Cohort, and the Roll-
In Cohort.  Revised Section Title.  
Reason: To align with the revised SAP 
5.1 (30) 
Changed maximum of 28 US sites to 38 US sites 
Reason: Additional sites required due to enrollment challenges 
5.1 (31) 
Changed maximum of 28 US sites to 38 US sites 
Reason: Additional sites required due to enrollment challenges 
5.2 (31) 
Revised Inclusion numbering for consistency with the Synopsis 
Reason: Administrative 
5.2 (31) 
Revised Inclusion numbering for consistency with the Synopsis 
Reason: Administrative 
6.1 (33) 
Updated to reference the SAP 
Reason: Administrative 
6.2 (33) 
Changed Primary Effectiveness Endpoint to 2 year 
Reason: To align with the revised SAP 
6.2 (33) 
Updated to reference the SAP 
Reason: Administrative  
7.2 (38) 
Deleted Roll-In Subjects section 
Reason: Language included in Section  
8.2 (38)  
Deleted reference to the Informed Consent Form 
Reason: Is not included in the protocol as an attachment 
8.8.1 (46) 
Replaced current definition of Adverse Event 
Reason: Updated language for consistency with ISO 14155 
8.8.1 (46) 
Added reference to 21 CFR 812(s) 
Reason: To provide additional clarification 
8.8.1 (46, 
47) 
Added definition of device-related and procedure-related 
Reason: To provide additional clarification 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
21 
Section 
(Page) 
Change and Reason for the Change 
8.8.2 (47) 
Revised language 
Reason: To align with the protocol 
8.8.2 (47) 
Revised language 
Reason: To provide additional clarification 
8.8.5 (49) 
Added Fistula as an anticipated Adverse Event  
Reason: To align with the protocol 
8.8.7 (50) 
Revised language 
Reason: To provide additional clarification 
10.7.1 (53) 
Deleted section 10.7.1  
Reason: Section is repeated in the protocol 
10.7.2 (53) 
Moved Sample Size from 10.7.1 to 10.7 
Reason: Formatting change 
10.7.2 (53) 
Changed from Bayesian approach to Frequentist approach 
Reason: To align with the revised SAP 
11.2 (56) 
Revised language 
Reason: To align with the protocol 
11.2 (56) 
Added language 
Reason: To provide additional clarification 
11.3 (57) 
Deleted language 
Reason: Section is repeated in the protocol 
11.5 (57) 
Deleted language 
Reason: To align with HIPAA 
11.6 (58) 
Deleted language 
Reason: Administrative change 
  
 
Revision 12.7 changes  
Section 
(Page) 
Change and Reason for the Change 
All Pages 
Changed all pages to protocol version from 12.6 to version 12.7, datedMarch 30, 2020.   
Reason: Reflected revision date change in the header. 
8.5.6 (41) 
Updated sample size from 105 subjects to 95 subjects and added footnotes detailing the impact of 
existing sites that already reached the 15 subject enrollment cap.  
Reason: Updated due to COVID-19 considerations 
 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
22 
1. INVESTIGATOR SIGNATURE PAGE 
 
I agree to conduct the study as detailed in the protocol and in accordance with conditions of the approval 
imposed by the reviewing Ethics Committee or Institutional Review Board, all applicable regional laws 
and regulations. I agree to maintain adequate source documentation records throughout the clinical 
investigation and make them available as requested during monitioring visits. I agree to maintain the 
device accountability records and ensure that the investigational device is used solely by authorized 
users as specified by this protocol. In addition, I agree to provide all the information requested in the 
electronic Case Report Forms presented to me by the Sponsor in a manner to assure completeness and 
accuracy.   
I agree to ensure that the requirements for obtaining informed consent are met. I agree to actively enroll 
consecutive subjects into this study and confirm that I am not currently participating in any clinical 
investigations for similar types of medical devices that would inhibit my ability to participate fully in 
this study. Additionally, I agree to disclose financial interests in accordance with 21 CFR 54, and certify 
that such financial interests, if any, will not interfere with my responsibilities as an investigator or 
influence study outcomes under my supervision.  
I also agree that all information provided to me by the Sponsor, including pre-clinical data, protocols, 
Case Report Forms, and any verbal and written information, will be kept strictly confidential and 
confined to the clinical personnel involved in conducting the study. It is recognized that this information 
may be relayed in confidence to the Ethics Committee or Institutional Review Board, or to regulatory 
authorities.   
In addition, no reports or information about the study or its progress will be provided to anyone not 
involved in the study other than the Sponsor, or its representatives, the Ethics Committee(s), the 
Institutional Review Board(s), or the core lab. Any such submission will indicate that the material is 
confidential. 
 
 
 
 
 
 
 
 
 
Investigator Signature 
 
Date 
 
 
 
 
 
Investigator Printed Name 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
23 
2. STUDY CONTACT PERSONNEL 
 
SPONSOR 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
  
  
  
 
 
 
 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
24 
3. PROTOCOL SYNOPSIS 
 
Title: 
Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study 
of  EndoVascular Abdominal Aortic Aneurysm Repair Using the Nellix® System  
 
Short Title:  
         EVAS II Confirmatory Study  
 
Study Devices: 
Nellix EndoVascular Aneurysm Sealing System (Nellix System) 
 
Study Sponsor: 
Endologix, Inc. 
 
Objectives: 
To study the safety and effectiveness of the Nellix System for Endovascular 
Abdominal Aortic Aneurysm (AAA) repair. Procedures will be performed per the 
instructions for use, and per institutional protocols and standard of care for 
endovascular aneurysm repair. As such, this study will evaluate the safety and 
effectiveness of the device system among a wide range of physicians and in 
consecutively enrolled subjects to assess outcomes generalizability.  
 
Study Design: 
Prospective, multicenter, single arm study with consecutive, eligible subject 
enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair 
procedure with the Nellix System. Sites have been chosen with a suitable research 
infrastructure and physician experience in endovascular aneurysm repair to ensure 
adequate enrollment. Subjects will be followed procedurally to discharge, at 30 days 
(primary safety endpoint), six months, one year (primary effectiveness endpoint) and 
annually thereafter to five years (total follow-up commitment). 
 
Investigators: 
Physicians (vascular surgeons or interventional cardiologists/radiologists as part of 
a multi-specialty team with vascular surgeons) with well-established experience in 
open repair and endovascular aneurysm repair techniques (i.e., ≥25 cases in the prior 
year) may participate. Details of the procedural and device usage techniques are 
incorporated into the study protocol on the basis of prior experience with an earlier 
generation device system, and more recent device refinements that have been 
developed. In those cases where the investigator is an interventionalist, a vascular 
surgeon must be immediately available during the procedure to perform any 
necessary surgical intervention. 
 
Subject Population: Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are 
considered candidates for endovascular repair and who meet the study eligibility 
criteria may be screened for enrollment in the study.  
 
Enrollment: 
A total of 95 subjects will be enrolled at a maximum of 38 US sites.  There will be 
two (2) cohorts in the trial.  There will be a Pivotal Cohort and a Roll-In Cohort. The 
Roll-In Cohort consists of the first enrolled subject at a site who has never used the 
Nellix System.   A single site may not enroll more than 15% of the total enrollment*.  
 
 
* Per the protocol revision 12.6, which required a total of 105 subjects, an enrollment cap of 15% limited a site to 
enroll no more than 15 subjects in order to guard against overrepresentation of higher enrollers. With the enrollment 
revision from 105 subjects to 95 subjects, this can lead to a slightly higher percentage than 15% (15 subjects is 
15.8%) for any site that already reached the enrollment cap. As described in the corresponding Statistical Analysis 
Plan (SAP) maintained by the Endologix, this is not a substantial deviation from the original intent. 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
25 
Training: 
Nellix operators will be directly supervised in each Nellix case by an Endologix 
trainer or Proctor. This training period will continue until a minimum of one case 
has been successfully completed and each investigator is cleared to proceed with 
Study enrollment without proctor supervision.  An Endologix Clinical Specialist will 
attend every case. This training requirement may be modified at the discretion of 
Endologix. 
 
Inclusion Criteria: 
 
1. Male or female at least 18 years old;  
2. Informed consent understood and signed;  
3. Patient agrees to all follow-up visits; 
4. Have an infrarenal abdominal aortic aneurysm (AAA) with maximum sac 
diameter ≥5.0cm, or ≥ 4.5 cm which has increased by ≥0.5cm within the last 
6 months, or which exceeds 1.5 times the transverse dimension of an adjacent 
non-aneurysmal aortic segment.  No AAA <4 cm will be included.   
5. Anatomic eligibility for the Nellix System per the instructions for use: 
a. Adequate iliac/femoral access compatible with the required delivery 
systems (diameter 6 mm); 
b. Aneurysm blood lumen diameter ≤60mm; 
c. Proximal non-aneurysmal aortic neck: length 10mm; diameter 18 to 
28mm; angle 60° to the aneurysm sac;  
d. Most caudal renal artery to each hypogastric artery length 100mm; 
e. Common iliac artery lumen diameter between 9 and 35mm; 
f. Distal iliac artery seal zone with length of ≥10mm and diameter 
range of 9 to 25mm; 
g. Ability to preserve at least one hypogastric artery. 
h. Ratio of maximum aortic aneurysm diameter to maximum aortic 
blood lumen diameter <1.40 
Exclusion Criteria: 
 
1. Life expectancy <2 years;                                                                                 
2. Psychiatric or other condition that may interfere with the study;  
3. Participating in another clinical study 
4.  Known allergy to any device component; 
5. Coagulopathy or uncontrolled bleeding disorder;  
6. Ruptured, leaking or mycotic aneurysm;  
7. Serum creatinine level >2.0mg/dL;  
8. CVA or MI within three months of enrollment/treatment;  
9. Aneurysmal disease of the descending thoracic aorta;  

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March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
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26 
10. Clinically significant mural thrombus within the proximal landing zone 
(minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness 
over >50% circumference);  
11. Connective tissue diseases (e.g., Marfan Syndrome) 
12. Unsuitable vascular anatomy;  
13. Pregnant (females of childbearing potential only). 
 
Primary  
Endpoints:* 
Safety: Major adverse events at 30 days.  
 
Effectiveness: Treatment Success at 2 year.  
This is defined as procedural technical success and the absence of:  
 
Abdominal aortic aneurysm rupture;  
 
Conversion to open surgical repair;   
 
Endoleak Type I or Type III at  Year 2 
 
Clinically significant migration;  
 
> 5mm aneurysm sac enlargement of the maximal diameter as measured by the 
difference from the one month CT time point; or  
 
Secondary endovascular procedure up to Year 2 for resolution of:  
o Endoleak (Type I or Type III)  
o Device obstruction or occlusion  
o Device migration  
o Abdominal aneurysm sac expansion  
o Device defect.  
 
Additional  
Evaluations: 
A summary analysis of the Effectiveness endpoint will also be presented at 1 year.  
 
 
A descriptive analysis and a Kaplan-Meier analysis will be performed on All-Cause 
Mortality, Cardiovascular Mortality, and Adverse Cardiovascular Events (ACE). 
 
Additional evaluations include: 
 
Procedural and in-hospital evaluations:  
o Anesthesia type; 
o Vascular access type;  
o Contrast media volume used;  
o Estimated blood loss; 
o Fluoroscopy time;  
o Catheter time; 
o Polymer fill volume; 
o Polymer fill pressure 
 
* Detailed definitions are provided in subsequent sections in the protocol.  

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
27 
o Adjunctive device placement; 
o Subjects requiring blood transfusion; 
o Total procedure time; 
o Anesthesia time; 
o Concomitant procedures; 
o Time in ICU;  
o Time to hospital discharge. 
 
Mortality (all-cause and aneurysm-related) within 30 days, 31 to 365 days, and 
annually at years 1 to 5; 
 
MAE Individual Components within 30 days, 31 to 365 days, and at 1 year; 
 
Aneurysm Rupture within 30 days, 31 to 365 days, and annually at years 1 to 5; 
 
Conversion to open repair within 30 days, 31 to 365 days, and annually at years 
1 to 5; 
 
Adverse Events: All serious and non-serious events within 30 days, 31 to 365 
days, and annually at years 1 to 5; 
 
Renal function as assessed by estimated glomerular filtration rate (eGFR) pre-
discharge and at 30 days, 6 months, and annually at years 1 to 5; 
 
Endoleak as reported by Core Lab at 30 days, 6 months, and annually at years 1 
to 5; 
 
Device Patency and Integrity at 30 days, 6 months, and annually at years 1 to 5; 
 
Aneurysm Sac Diameter as reported by Core Lab at 30 days, 6 months, and 
annually at years 1 to 5; 
 
Migration (>5mm, >10mm) and clinically significant migration as reported by 
Core Lab at 30 days, 6 months, and annually at years 1 to 5; 
 
Secondary endovascular procedures (including those performed for resolution of 
endoleaks, device thrombosis/occlusion, rupture, migration, fracture, kinking, 
infection, aneurysm sac expansion, renal artery stenosis, and/or a device defect) 
within 30 days, 31 to 365 days, and annually at years 1 to 5. 
 
Gender Analysis for the primary safety and effectiveness endpoints. 
 
Site Comparisons Analysis for the primary safety and effectiveness endpoints. 
 
Schedule of Tests: 
Pre-procedural high resolution, contrast-enhanced CT scan evaluation to determine 
anatomical eligibility for enrollment will be performed within three months of the 
study procedure. Following EC/IRB approval of the study and the written informed 
consent form, patients will be screened for eligibility. Following informed consent, 
a physical exam and laboratory testing will be performed prior to the procedure. 
Subjects will be followed procedurally and to hospital discharge, and will then be 
followed at intervals: 30 days; 6 months; 1 year; and annually to 5 years.   
 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
28 
4. TRIAL OVERVIEW 
4.1. 
OBJECTIVE 
The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® 
EndoVascular Aneurysm Sealing System for the endovascular repair of infrarenal abdominal 
aortic aneurysms (AAA). Procedures will be performed per the Nellix Instructions For Use 
(IFU) and per institutional protocols and standard of care for endovascular aneurysm repair. As 
such, this study will evaluate the safety and effectiveness of this device system among a wide 
range of physicians and in consecutively enrolled subjects to assess outcomes generalizability. 
4.2. 
BACKGROUND 
Mortality due to AAA rupture ranks 13th in the United States and 10th in Canada among men 
older than 65 years.* In addition, several authors have suggested an increase in the mortality rate 
due to rupture of AAA in the past decades in both the United Stated and England, with more 
than 14,000 and 7,259 deaths/year in those respective countries.†,‡ Despite being significant, 
such figures are probably underestimated, because many deaths resulting from ruptured 
aneurysms are not verified by autopsy, and are consequently not documented.§ Some researchers 
have reported that the overall lethality associated with rupture of AAA approaches 80%, 
including dead on arrival subjects or those who die before the diagnosis is made.**  
AAA is defined clinically as a focal dilatation of the aorta causing a diameter increase of >50% 
of the expected normal diameter.†† Although any artery may develop an aneurysm, they are most 
commonly observed in the infrarenal abdominal aorta, thoracic aorta, popliteal artery and 
common iliac artery.   
The principal risks related to aneurysms are rupture and thrombus migration. Aneurysms slowly 
and continually increase in size leading to the aneurysm rupture. The larger an aneurysm 
becomes, the likelihood of eventual rupture increases. The natural history of aortic aneurysms 
is to enlarge and rupture. Other potential complications of the aneurysm include compression of 
adjacent organs which may result in aortoenteric fistula, or aortocaval fistula. If the thrombus 
embolizes and flows down the blood stream, this can induce acute or chronic arterial obliteration 
of the lower limbs.   
The risk of rupture is weighed against the risk of perioperative morbidity. The United Kingdom 
Small Aneurysm trial (UKSAT) reported 103 aneurysm ruptures in 2,257 subjects over a period 
 
*Semenciew R, Morrison H, Wigle D, et al.  Recent trends in morbidity and mortality rates for abdominal aortic aneurysms. Rev 
Canadien Santé Publique 1992;83:274-6. 
†Lelienfeld DE, Gurdenson PD, Sprafka JM, et al. Epidemiology of aortic aneurysms: Mortality trends in the United States 1951-
1981. Atherosclerosis 1987;7:637-43. 
‡Fowkes FRG, Macintyre CCA, Rucjerley CV. Increasing incidence of aortic aneurysms in England and Wales. Brit Med J 
1989;298:33-5. 
§Quil DS, Colgan MP, Summer DS. Ultrasonic screening for the detection of abdominal aortic aneurysms. Surg Clin North Am 
1989;69:713-20.  
**Bengtsson H, Bergqvist D.  Ruptured abdominal aortic aneurysm: a population-based study. J Vasc Surg 1993; 18:74-80. 
††Hallett JW Jr. Diseases of the aorta and its branches – aneurysms. Merck Manual, Online Medical Manual (2008). Retrieved on 
19March2010 from http://www.merck.com/mmpe/sec07/ch079/ch079b.html.  

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
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29 
of seven years, with an annual rupture rate of 2.2%.* The decision to treat a patient that presents 
with an asymptomatic aneurysm is primarily dependent upon the size of the aneurysm. Current 
Society for Vascular Surgery (SVS) practice guidelines recommend surveillance for most 
subjects with a fusiform AAA in the range of 4.0 to 5.4cm in maximum diameter; therefore, 
surgical repair of abdominal aneurysms of 5.5 cm or greater in diameter is recommended in 
healthy subjects, as is repair of saccular aneurysms. There are a number of qualifiers within the 
SVS guidelines that recommend AAA repair at 5.0cm, such as rapidly expanding aneurysms, 
and women.   
It is estimated that approximately 25% to 40% of infrarenal AAA are not suitable for 
endovascular aneurysm repair (EVAR) due to unfavorable proximal neck anatomy (e.g., highly 
angulated, dilated, short, or encroaching on or involving the renal arteries.†,‡  In most studies of 
endovascular AAA repair, the infrarenal non-aneurysmal neck length and angulation to the 
aneurysm sac requirements are ≥15mm and ≤60°, respectively; shorter lengths or greater 
angulation have been reported to increase the risk of migration and type 1A endoleak and 
associated need for intervention.§,** 
When selecting the specific stent graft to be used for EVAR, the characteristics of the graft must 
be considered in light of the patient’s anatomic and physiologic characteristics. Endovascular 
devices vary in the type of stent design. For example, most of the currently available devices 
seal aneurysm by proximal and distal fixation of the stent graft by either active fixation 
(anchoring pins) or oversizing the stent diameter for increased radial force thereby achieving 
seal and excluding the aneurysm sac lumen. Greater than 25% of subjects develop an endoleak 
(mostly type II endoleaks due to back-bleeding of lumbar or visceral arteries within the 
aneurysm sac) within the first two years following endoluminal stent-graft repair,†† and 
approximately 15-20% of the endoleaks persist at five years.8 Endoleaks may lead to sac 
enlargement and migration and may require reintervention, using either catheter-based 
techniques or conversion to open repair. These secondary procedures increase the risk to the 
patient and increase the cost of treatment.‡‡  Accordingly, EVAR subjects are routinely 
monitored annually by contrast-enhanced CT scan after treatment contributing further to 
treatment costs and increasing patient exposure to nephrotoxic contrast agents and radiation. 
 
*Mortality results for randomized controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal 
aortic aneurysms Lancet 1998; 352:1649-55.  
†Carpenter JP, Baum RA, Barker CF, et al. Impact of exclusion criteria on patient selection for endovascular abdominal aortic 
aneurysm repair. J Vasc Surg 2001;34:1050-4.  
‡Arko FA, Filis KA, Seidel SA, et al. How many patients with infrarenal aneurysms are candidates for endovascular repair? J 
Endovasc Ther 2004;11:33-40. 
§Leurs LJ, Kievit J, Dagnelie PC, et al. Influence of infrarenal neck length on outcome of endovascular abdominal aortic aneurysm 
repair. J Endovasc Ther 2006;13:640–8. 
**AbuRahma A, Campbell J, Stone PA, et al. The correlation of aortic neck length to early and late outcomes in endovascular repair 
patients. J Vasc Surg 2009;50:738-48. 
††Stavropoulos SW and Charagundla SR. Imaging techniques for detection and management of endoleaks after endovascular 
aortic aneurysm repair. Radiology 2007; 243(3):641-55.  
‡‡Vogel TR, Symons RG, Flum DR. Longitudinal outcomes after endovascular repair of abdominal aortic aneurysms. J Vasc 
Endovasc Surg 2008;47(2):264-9.  

Endologix, Inc. 
 
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Nellix IDE EVAS II Confirmatory Study  
 
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30 
Recent reports suggest contrast nephrotoxicity affects 7 to 12% of subjects after CT 
angiography.* 
The Nellix System was designed to withstand the migration and lateral displacement forces 
acting on endografts, while at the same time excluding the aneurysm sac lumen and minimizing 
endoleaks of any kind. The system is comprised of two independent flow channels, one to each 
iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded 
by a Polymer-filled EndoBag which fills the blood lumen within the aorta, thus providing 
positional stability of the endograft and sealing the aneurysm completely from side-branch 
flow.† A clinical trial has been performed to assess the safety and effectiveness of the first 
generation Nellix system for endovascular AAA repair and results serve as the basis for CE 
Mark approval (October 2012); initial results to one year have been reported.‡ Results of this 
trial demonstrate the versatility of the Nellix System in treating a variety of AAA anatomies, 
including those that have common iliac artery involvement bilaterally. 
Continued clinical evaluation of the Nellix System in a broader group of institutions and 
physicians is therefore appropriate to assess the safety and effectiveness of the device for AAA 
repair and the generalizability of the approach.  
4.3. 
STUDY DESIGN 
This is a US multicenter, prospective, single arm clinical study. Subjects with infrarenal AAA 
who are suitable candidates for endovascular repair using the Nellix System, based on protocol 
Inclusion/Exclusion criteria, will be considered for enrollment. 
After this protocol and the patient informed consent form are reviewed and approved by the 
local Ethics Committee/Institutional Review Board (EC/IRB), patients having infrarenal AAA 
will be offered participation in the study. This will be accomplished through the patient’s reading 
of the informed consent form in the patient’s native language and discussion of the study with 
the patient by the Principal Investigator (PI) and site personnel. Agreement to participate and to 
attend all follow-up visits will be documented with the patient’s signature on the informed 
consent form, with appropriate signatures of the site PI and an impartial witness. 
After providing written informed consent, screening and eligibility determinations will be 
performed by the site, independent Core Lab, Case Review Board and Endologix. Subjects will 
undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of 
the relevant aortic and aortoiliac vasculature within the prior three months of the scheduled 
procedure. Evaluation of the aortic and vascular anatomy suitability per this protocol, as 
depicted on the CT scan, will be performed by the site PI, reviewd by an independent core 
laboratory, and will undergo Case Review Board. Other tests include a physical examination, 
review of medical history for exclusionary conditions, and selected blood laboratory analyses. 
 
*Chaer RA, Gushchin A, Rhee R, et al. Duplex ultrasound as the sole long-term surveillance method post-endovascular aneurysm 
repair: a safe alternative for stable aneurysms. J Vasc Surg 2009; 49:845-9.  
†Donayre CE, Zarins CK, Krievins DK, et al. Initial clinical experience with a sac anchoring endoprosthesis for abdominal aortic 
aneurysm repair. J Vasc Surg 2011;53:574-82. 
‡Krievins DK, Holden A, Savlovskis J, et al. EVAR using the Nellix sac anchoring endoprosthesis: treatment of favorable and 
adverse anatomy. Eur J Vasc Endovasc Surg 2011;42:38-46. 

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Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
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31 
Endologix will notify, in writing, each potential patients final eligibility status before a case may 
be scheduled. 
Following discharge from the hospital, the first follow-up visit will be made at 30 days (±2 
weeks). A CT scan will be performed to assess aneurysm morphology and device integrity and 
patency, as well as the status of the implanted devices. Subsequent follow-up visits will be made 
at six months, one year, and annually to five years per institutional standard of care for subjects 
with endovascular stent grafts. Continued subject follow-up beyond five years is outside of the 
scope of this study. Nonetheless, all subjects should be monitored and evaluated per the 
institutional standards of care for patients with an implanted endovascular stent graft.  
5. STUDY POPULATION 
5.1. 
ENROLLMENT 
A total of 95 subjects will be enrolled at a maximum of 38 US sites.  There will be two (2) 
cohorts in the trial.  There will be a Pivotal Cohort and a Roll-In Cohort. The Roll-In Cohort 
consists of the first enrolled subject at a site who has never used the Nellix System.   A single 
site may not enroll more than 15% of the total enrollment*. Following investigator training, each 
new infrarenal Principal Investigator (PI) will commence patient screening and enrollment 
under approval per applicable national and local clinical trial requirements, and complete a 
minimum of one (1) successful Nellix case (Roll-in) in their training phase. This training period 
may be modified at the discretion of Endologix. Physicians will be directly supervised in each 
case by designated Endologix staff.   
 
Total Enrollment: Up to 95 subjects will be enrolled at a maximum of 38 US sites.   
 
Pivotal Cohort: If a site that has used a Nellix device, the first and subsequent subjects will be 
in the Pivotal Cohort. 
 
Roll-In Cohort: One (1) roll-in subject will be enrolled at each new site (those sites/PIs that have 
never used a Nellix device) to allow for new infrarenal Investigator(s) to receive additional 
training on the Nellix System. Any roll-in subjects will be screened, consented, treated and 
followed identically to the pivotal cohort. However, the roll-in cohort of this study may be 
evaluated separately.  
 
5.2. 
INCLUSION CRITERIA 
A patient who meets all of the following criteria potentially may be included in the study: 
1. Male or female at least 18 years old; 
2. Informed consent form understood and signed 
3. Patient agrees to all follow-up visits; 
 
* Per the protocol revision 12.6, which required a total of 105 subjects, an enrollment cap of 15% limited a site to 
enroll no more than 15 subjects in order to guard against overrepresentation of higher enrollers. With the enrollment 
revision from 105 subjects to 95 subjects, this can lead to a slightly higher percentage than 15%  (15 subjects is 15.8%) 
for any site that already reached the enrollment cap. As described in the corresponding Statistical Analysis Plan (SAP) 
maintained by Endologix, this is not a substantial deviation from the original intent. 

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March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
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32 
4. Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by 
≥0.5cm within the last 6 months,  or  or which exceeds 1.5 times the transverse dimension 
of an adjacent non-aneurysmal aortic segment.  No AAA <4 cm will be included. 
5. Anatomically eligible for the Nellix System (per Instructions For Use): 
a. Adequate iliac/femoral access compatible with the required delivery systems 
(diameter 6 mm); 
b. Aneurysm blood lumen diameter ≤60mm; 
c. Proximal non-aneurysmal aortic neck: length 10mm; diameter 18 to 28mm; angle 
60° to the aneurysm sac;  
d. Most caudal renal artery to each hypogastric artery length 100mm; 
e. Common iliac artery lumen diameter between 9 and 35mm; 
f. Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm; 
g. Ability to preserve at least one hypogastric artery. 
h. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen 
diameter <1.40  
5.3. 
EXCLUSION CRITERIA 
A patient who meets none of the following criteria potentially may be included in the study: 
1. Life expectancy <2 years as judged by the Investigator; 
2. Psychiatric or other condition that may interfere with the study; 
3. Participating in another clinical study; 
4. Known allergy or contraindication to any device material; 
5. Coagulopathy or uncontrolled bleeding disorder;  
6. Ruptured, leaking or mycotic aneurysm;  
7. Serum creatinine (S-Cr) level >2.0 mg/dL;† 
8. CVA or MI within three months of enrollment/treatment;  
9. Aneurysmal disease of the descending thoracic aorta;  
10. Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) 
of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);  
11. Connective tissue diseases (e.g., Marfan Syndrome); 
12. Unsuitable vascular anatomy that may interfere with device introduction or deployment; 
13. Pregnant (female of childbearing potential only). 
 
6. RESPONSE MEASURES 
6.1. 
PRIMARY SAFETY 
The safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, 
defined as the composite of the following. Event definitions are provided in §8.8.7. 
 
All-Cause Mortality; 
 
†This criterion does not apply to patients on dialysis prior to study screening/enrollment. 

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33 
 
Bowel Ischemia; 
 
Myocardial Infarction; 
 
Paraplegia; 
 
Renal Failure; 
 
Respiratory Failure; 
 
Stroke; 
 
Procedural Blood Loss ≥1,000cc 
 
Refer to the Statistical Analysis Plan for primary safety endpoint analysis details. 
6.2. 
PRIMARY EFFECTIVENESS 
The primary effectiveness endpoint is defined as the rate of Treatment Success at year 2. 
Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of 
infrarenal AAA as follows. Event and related definitions are provided in §8.8.7. 
Treatment Success: Procedural technical success ¥ and absence of:  
 
Abdominal aortic aneurysm rupture;  
 
Conversion to open surgical repair; 
 
Endoleak Type I or III at year 2; 
 
Clinically significant migration‡;  
 
> 5mm aneurysm sac enlargement of the maximal diameter as measured by the difference 
from the one month CT time point Secondary endovascular procedure up to year 2 for 
resolution of  
o Endoleak (Type I or Type III)  
o Device obstruction or occlusion  
o Device migration  
o Abdominal aneurysm sac expansion  
o Device defect. 
 
 
A summary analysis of this endpoint will also be presented at 1 year.  Refer to the Statistical 
Analysis Plan for primary effectiveness endpoint analysis details. 
 
¥ Procedural technical success is deployment of the Nellix System in the planned location and without unintentional coverage of 
both internal iliac arteries or any visceral aortic branches and with the removal of the delivery system. 
‡Refer to protocol §8.8.7 for detailed definitions. 

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34 
6.3. 
ADDITIONAL EVALUATIONS 
As outlined in the SAP, additional evaluations include: 
Secondary Mortality and Adverse Cardiovascular Event Endpoint, a Kaplan-Meier analysis and 
descriptive analysis within 30 days (early), 31 to 365 days (late), and annually at years 1 through 
5. 
Procedural and In-Hospital Evaluations:  
o Anesthesia type; 
o Vascular access type; 
o Volume of contrast media used; 
o Adjunctive device placement 
o Subjects requiring blood transfusion 
o Total procedure time* 
o Estimated blood loss; 
o Fluoroscopy time; 
o Anesthesia time;† 
o Concomitant procedures; 
o Catheter time; 
o Polymer fill volume; 
o Time in ICU;‡ 
o Time to hospital discharge;* 
o Polymer fill pressure; 
 
Mortality, all-cause and aneurysm-related, within 30 days, 31 to 365 days, and annually to 5 
years; 
MAE Individual Components within 30 days, 31 to 365 days, and annually to 5 years; 
Aneurysm Rupture within 30 days, 31 to 365 days, and annually to 5 years; 
Conversion to Open Repair within 30 days, 31 to 365 days, and annually to 5 years; 
Adverse Events (serious and non-serious) within 30 days, 31 to 365 days, and annually to 5 
years;  
Renal Function pre-discharge and at 30 days, 6 months, and annually to 5 years, as assessed by 
the estimated glomerular filtration rate (eGFR) and changes over time; 
Device Patency and Integrity within 30 days, at 6 months, and annually to 5 years. 
Device Performance (aneurysm sac diameter change from the first post-operative visit; device 
migration; clinically significant device migration, incidence of endoleak) at 30 days, 6 months, 
and annually to 5 years; 
Secondary Procedure within 30 days, 31 to 365 days, and annually to 5 years for resolution of 
endoleak, device occlusion, migration, aneurysm sac expansion and/or a device defect. 
Gender Analysis of the primary safety and effectiveness endpoints. 
Site Comparison Analysis of the primary safety and effectiveness endpoints. 
 
 
 
 
* Elapsed time from the first break of skin to final closure (i.e., skin to skin time). 
† Elapsed time from the initiation to the end of the anesthesia protocol. 
‡ Elapsed time from the first administration of anesthesia to release from the ICU or post-anesthesia care unit providing ICU-
level care. If the patient is not admitted to the ICU, this is defined as 0 hours. 

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March 30, 2020 
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Nellix IDE EVAS II Confirmatory Study  
 
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35 
7. STUDY MATERIALS  
The Nellix System is comprised of five components as further described below:  
1. Nellix Catheters (single use); 
2. Nellix Accessory kit (single use);  
3. Nellix Dispenser (single-use or reusable); 
4. Nellix Polymer (single-use). 
5. Ovation iX Iliac Stent Grafts (single use, as needed) 
7.1. 
DEVICE DESCRIPTION 
Implanted Devices. The Nellix implant consists of two devices, each advanced from the 
respective femoral artery via a catheter-based delivery system over a standard .035” guidewire. 
Each 
implanted 
device 
has 
the 
following 
main 
components: 
an 
expanded 
polytetrafluouroethylene (ePTFE) covered balloon expandable cobalt chromium alloy stent 
surrounded by a polyurethane EndoBag with welded seams and a lumen having an inner 
polyester (PET) sleeve is attached to the stent proximally and distally using polyethylene 
sutures, and a biostable Polymer formulation which is introduced through the catheter system to 
the EndoBag and cures in situ.  
An illustration of the implant procedure is shown below. Images of the stent (with and without 
ePTFE graft), EndoBag, and the final implant in a silicone model are shown subsequently. 
                 
 
 
 
 
* Elapsed time from initiation of the procedure to physical discharge from the hospital. 

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36 
Stent 
ePTFE Covered 
Stent 
 
 
Stent 
EndoBag 
Final Implant 
 
The mechanism of action is as follows: The ePTFE covered stents form lumens through which 
blood flows to the distal limbs and vasculature. The EndoBags with cured polymer exclude the 
aneurysm from blood flow, preventing aneurysm pressurization and rupture. This seals the entire 
anatomy from the infrarenal segment to the origin of the hypogastric arteries. 
In the case of distal extension, the Ovation iX Iliac Stent Grafts can be used. These iliac limbs 
and extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. The 
iliac limbs are deployed into the distal end of the Nellix stent. 
Delivery Systems. The 17Fr profile (OD) delivery systems are sterile, single use, catheter-based 
systems used to deploy the stents with EndoBags and are compatible with standard 0.035-inch 
guidewires. All delivery systems are of the same design regardless of stent/EndoBag model. 
Three other single use components complete the Nellix System: 
 
Sterile Polymer dual chamber cartridges requiring storage at or below -20°C until use. 
Immediately prior to use (1-2 hours), the required Polymer cartridge(s) are thawed per the 
Instructions For Use (IFU). 
 
Sterile accessory kit including a console with dual sets of tubing and quick connects for 
simultaneous attachment to two delivery catheters; two mixers, and a Centurion 
Compass™ GP Pressure Transducer.† The mixer attaches to the end of the Polymer 
cartridge and mixes the two chamber solutions during transfer into the EndoBags. A 
second mixer is provided as a back-up if needed.  
 
Polymer dispenser 
The pre-operative high resolution, contrast enhanced CT scan serves to determine anatomical 
measures for subject eligibility and device initial sizing determinations. Arteriography with the 
aid of a marker catheter bilaterally serves to verify the specific device length needed on each 
 
†The pressure monitoring device is marketed by Centurion Medical Products, Inc. (Williamston, MI, USA) and is 510(k) cleared 
through K112203. 
 

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Protocol CP-0008 Rev.12.7 
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37 
side to ensure full coverage of the Nellix device from the infrarenal segment to the supra-
hypogastric segments. 
After selected delivery system is introduced through femoral arteriotomy under fluoroscopic 
guidance, each is advanced and positioned across the aneurysm sac at the desired location to 
place the stents below the most caudal renal artery and aligned at their proximal edge. The outer 
sheath of each delivery system is retracted to expose each constrained stent/EndoBag. (Note: A 
tether wire attaches each EndoBag to the catheter. The catheter can be removed only after 
disengaging the tether wire. This is a safety mechanism designed to hold the implant in place 
during deployment.) 
At this time, the console is attached to both delivery systems using the mating, color-coded 
quick connects as depicted in the image below. White connectors denote the EndoBag 
evacuation and Polymer fill line; black connectors denote the stent balloon expansion line; luer 
connectors denote the angiographic media injection line (exiting the ports in the delivery system 
tip). The .035” guidewire lumens are on the outermost ends of the delivery catheter handles. 
 
 
EndoBag evacuation, balloon expansion, Polymer introduction, and angiographic media 
injection are all performed through the console: 
 
A vacuum is applied via console port 1 with the switch in the ‘open’ position to 
simultaneously evacuate air from both EndoBags. After evacuation, the switch is placed in 
the ‘closed’ position. 
 
An inflation device is attached to control console port 2 to simultaneously balloon expand 
both ePTFE covered stents with contrast enhanced saline per the IFU. The stents expand 
from each end toward the center. The balloons are then simultaneously deflated per standard 
technique.  
 
The EndoBags are then filled by dispensing Polymer through console port 3 with the 
pressure transducer placed between the mixer and the port 3 luer. Polymer filling of the 
EndoBags occurs simultaneously, and is to continue until the pressure transducer displays a 
reading of 180mmHg. In the case of a patient with systolic blood pressure exceeding 
180mmHg, Polymer filling continues to a pressure that is 20mmHg above the patient’s 
systolic pressure. Once Polymer is completely injected into the EndoBags, the physician 
will allow the polymer to cure for approximately 3 to 5 minutes. Polymer curing is visually 

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38 
observable through the window on console port 3, which will change in color from red to 
white when cured. 
A final angiographic run is done to confirm the complete seal of the aneurysm sac and absence 
of endoleaks. If deemed appropriate by the physician, a secondary fill may be performed to add 
additional Polymer to each EndoBag independently. The delivery systems are then detached 
from the implant by releasing the tether wires, and are removed from the patient and discarded 
per hospital standard practice. 
7.2. 
INVESTIGATOR TRAINING AND EXPERIENCE 
Investigators will be directly supervised in each case by an Endologix trainer or a certified 
Proctor until a minimum of one Nellix case have been successfully completed.  One Principal 
Investigator (PI) at each participating site will be responsible for supervision of study conduct.   
He/she and any authorized sub-investigator must satisfy the following criteria prior to the 
enrollment of their first patient in the confirmational trial.  
1. Complete review of prior clinical safety and effectiveness information regarding the earlier 
generation device (3SQ), as well as design qualification testing regarding the Nellix System 
under study, and the scientific literature review. 
2. Have prior training and experience in the open surgical or endovascular repair of AAA 
(approximately ≥25 cases as an institutional team, in the prior year). 
3. Undergo didactic training on the device anatomy and design, Instructions for Use (IFU) 
including patient selection criteria, contraindications, warnings, precautions, and proper 
device use, and troubleshooting methods. 
4. Practice using the Nellix System in a simulated use bench top model. Completion of each 
criterion will be documented for each PI and site prior to performance of the first clinical 
procedure at a given site under this protocol. Sub-Investigators will also be required to meet 
training requirements.  This may be completed at a later date per Endologix discretion. 
 
For procedures lead by a sub-investigator, the PI is expected to be present to provide proper 
supervision of the case, unless the sub-Investigator has been through investigational device 
training and approval by Endologix. 
 
For those physicians who have not had commercial access to or experience with Ovation, 
Endologix will require they undergo standard Ovation device and procedure training prior to 
use. 
7.3. 
DEVICE ACCOUNTABILITY 
Usage of the Nellix catheter, polymer, and polymer dispenser will be documented in the 
electronic Case Report Forms (eCRF) and within an Investigational Device Accountability Log.  
In the case of a device malfunction prior to implantation, the information will be noted in the 
eCRFs and all device components must be returned to Endologix. Should the device be removed 
from the body, the device must  be returned to Endologix for evaluation per the IFU.  Endologix 
must be informed if there is a circumstance that precludes return of any investigational 
product/components. Usage of the devices will be documented in the eCRFs and on the site’s 
inventory log. 

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39 
7.4. 
PATIENT AND DEVICE PREPARATION 
All procedures must be performed in an operating room, or in an endovascular suite having full 
imaging capabilities, vascular surgery and anesthesia services. The PI will refer to institutional 
protocols relating to anesthesia and monitoring of vital signs. The appropriate devices will be 
selected in accordance with the patient eligibility determination. The devices will be prepared 
and handled in accordance with the IFU, which is provided in Attachment 1.† Other ancillary 
devices will be selected by the physician per institutional standards.  
8. STUDY METHODS 
8.1. 
GENERAL ENTRY PROCEDURES 
Prospective subjects as defined by the criteria in §5.2 and 5.3 will be considered for entry into 
this study.  
All site personnel involved in patient screening and data collection procedures will be trained 
on this protocol and the electronic remote data capture (eDC) system. Following patient consent, 
inclusion/exclusion criteria information will be entered into the eDC system. This action will 
notify Endologix that a patient has been consented and is being considered for enrollment. In 
parallel, the pre-operative CT scan will be uploaded to Core Lab by the site.  The Core Lab will 
subsequently provide the anatomical measurements for confirming eligibility. Endologix will 
then facilitate a Case Review Board to examine anatomical and medical information for final 
sign off.  Sites will be notified of individual study subject eligibility via the eDC system. 
8.2. 
INFORMED CONSENT 
Written informed consent, in accordance with ICH E6 (as applicable), 21 CFR 50 (Informed 
Consent of Human Subjects), applicable Good Clinical Practice standards, and study center 
regulations, shall be obtained from each patient, or from their legal representative, prior to the 
study procedures. The PI will retain a copy of the signed informed consent document in each 
patient’s record, and provide a copy to the patient.  
The PI must not request the written informed consent of any patient, and must not allow any 
potential patient to participate in the investigation before obtaining governing EC/IRB approval.  
Prior to starting the study, the PI will provide Endologix with a copy of the sample Informed 
Consent document approved by the EC/IRB with documented evidence that the EC/IRB has 
approved the protocol. 
8.3. 
SUBJECT IDENTIFICATION 
Upon satisfactory completion of all site start-up training and documentation requirements, 
Endologix will supply the site with written ‘Go’ notification that initiation of subject 
screening/consenting for study enrollment is authorized. 
Subject numbers will be automatically assigned by the eDC system. 
 
†Ancillary devices recommended for use during the procedure are listed in the IFU. 

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40 
A Screening Log will be maintained by the site, either on paper or electronically in the eDC, to 
document each subject who undergoes the screening process and the determination of eligibility. 
The actual procedure date will serve as the “start” date from which follow-up evaluations will 
be measured. After treatment, each patient will be evaluated prior to hospital discharge and will 
then be evaluated at one month (defined as 30 ± 14 days), at six months (defined as 180 ± 30 
days), and at annual follow-ups at 1 year (defined as 365 ± 60 days), and at 2 to 5 years (± 90 
days). 
8.4. 
SCHEDULE OF MEASUREMENTS 
A summary of the tests and measurements to be conducted pre-study/at baseline, operatively, 
prior to discharge, and during follow-up is illustrated in the following chart: 
Schedule of Tests: 
Screening/ 
Baseline 
Procedure 
(Day 0) 
Pre-
Discharge 
1  
Mo. 
± 14 days 
6  
Mo. 
± 30 days 
1  
Yr. 
± 60 days 
Every 6 
months 
(Enhanced 
Follow-up)£ 
2 to 5  
Yrs. 
± 90 days 
Inclusion/Exclusion 
x 
 
 
 
 
 
 
 
Demographics/Medical History 
x 
 
 
 
 
 
 
 
Physical Exam†  
x 
 
x 
x 
x 
x 
x 
x 
Blood Laboratory Analysis‡ 
x 
 
x 
x 
x 
x 
 
x 
Contrast-enhanced CT scan¥ 
x 
 
 
x 
x 
x 
x 
x 
Procedural Information 
 
x 
 
 
 
 
 
 
Adverse Events 
 
x 
x 
x 
x 
x 
x 
x 
 
†The physical exam includes overall health, physical assessment, and vital signs.  
‡Only serum creatinine will be collected. 
¥The baseline high resolution, contrast-enhanced CT scan performed within the prior three months will be performed to determine anatomical 
eligibility. 
£Subjects who experience migration, AAA sac enlargement and/or a Type 1A or 1B endoleak or who are at risk of experiencing any of these 
events (e.g., those subjects who would not meet the new inclusion/exclusion criteria) are recommended to be followed every 6 months  
 
8.5. 
STUDY PROCEDURES AND EVALUATIONS  
8.5.1. Informed Consent 
The patient, or his/her legal representative, is to be informed about the study and provide 
written consent. Confirmation of written consent will be entered in the eCRF by the site 
for verification by the Sponsor prior to enrollment eligibility determination. Please see 
Attachment 2 for the informed consent template and Attachment 3 for the study eCRFs.  
8.5.2. CT Scan Protocol 
Patient enrollment into this study is based on the site evaluation of patient conformance 
with the protocol-specified selection criteria §5.2 and 5.3, including anatomical 
requirements for the device based on the high resolution (slice thickness minimum 
≤3mm; axial, coronary, sagittal views), contrast-enhanced CT scans*. To ensure 
consistency, below are the requirements for CT acquisition: 
 
Only high resolution, contrast-enhanced spiral CT scans are acceptable.  
 
Data must be uncompressed. 

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 
Preferred maximum slice spacing is 2mm. In no case should it exceed 3mm. 
 
The preferred protocol, shown below, is easier to attain with a multi-row scanner. 
If the preferred protocol cannot be used, an alternate protocol is provided. 
 
Instruct patient not to move during scan. Do not move table height, position, or field 
of view during scan. If such movement occurs, repeat scan in its entirety. 
*For those subjects with renal insufficiency, a non-contrast CT and duplex ultrasound will be 
acceptable. 
 
8.5.3. Pre-Operative Activities 
Following informed consent, the SCREENING AND BASELINE eCRFs are to be 
completed.  The PI is to proceed with procedure scheduling only after receiving 
acknowledgement from Endologix that the patient meets the enrollment criteria. This 
determination is based on the documented responses and data provided by the PI, the 
Core Lab CT assessment and the Case Review Board. 
8.5.4. Subject Enrollment 
Enrollment in the study only occurs upon advancement of the study device into the 
subject’s vasculature. Therefore, the date of study enrollment is the date of the Nellix 
System implant, as documented in the Visit Date field in the Index Procedure eCRF. If 
the device does not contact the patient, the patient will be considered as screen failure 
and the assigned study number will not be given to another patient. If, during the index 
procedure, the device is introduced but is not implanted and/or there is conversion to 
open surgery, the patient will be followed until the 30 day follow-up. 
8.5.5. Post-Operative Follow-up Visits 
The eCRFs are to be entered for each subject at the post-operative follow-up visits.  
These visits should be scheduled post-procedurally at 30±14 days (one month visit), 
Parameter 
Preferred 
Alternate 
Scan Mode 
Helical/Spiral 
Scan Parameters 
140kVp, Auto mA, 0.5sec 
140kVp, 280mA (min), 1.0sec 
Collimation 
0.625 to 2mm 
3mm 
Slice Spacing 
0.625 to 2mm 
3mm 
Superior Extent 
Superior to the celiac artery origin 
Inferior Extent 
Lesser trochanter of femur 
Patient Instruction 
Single breath hold 
1st hold: above celiac to bifurcation 
2nd hold: bifurcation to lesser trochanter 
Contrast* 
Standard non-ionic 
Volume and Rate 
150mL at 3 to 4 mL/sec or as per institutional standards 
Scan Delay 
ROI - threshold 90Hu in aorta 
Field of View 
Large body 
Window Level 
400/40 

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42 
180±30 days (six month visit), 365±60 days (one year visit), 730±90 days (two year 
visit), 1095±90 days (three year visit), 1460±90 days (four year visit), and 1825±90 
days (five year visit).   
8.5.6. Enhanced Post-Operative Follow-up Visits 
Subjects who experience migration, AAA sac enlargement and/or a Type 1A or 1B 
endoleak during follow-up  are recommended to be followed every 6 months with a 
contrast enhanced CT as part of the follow-up.  For those subjects with renal 
insufficiency, a non-contrast CT and duplex ultrasound will be acceptable.  Please 
reference the Schedule of Measurements in section 8.4 for a summary of tests and 
measurements to be performed at the enhanced follow-up visit. 
All Investigators are trained to best practices and the IFU prior to the index 
procedure.  If any inadequate procedural issues are observed that could results in “at 
risk” subjects (as observed on the first available post-operative CT), enhanced follow-
up visits are recommended.   
An inadequate procedure is defined as not meeting any one of the following: 
1. (CoreLab Proximal Seal – 4 mm) ≥ 10 mm 
2. Acquired distal seal ≥ 10 mm 
3. Lowest stent within 10 mm of the lowest renal artery 
Instructions for eCRF completion and the study-required evaluations for each visit will 
be provided at the site initiation visit.    
8.6. 
RECOMMENDED SECONDARY INTERVENTION TREATMENT OPTIONS 
Endologix submitted an Unanticipated Adverse Device Effect (UADE) report to the FDA on 
October 14, 2016 to report higher than anticipated rates of migration, endoleak (Type IA), and 
AAA sac enlargement, based on the 2-year follow-up data from the Nellix US IDE trial.  As 
part of the investigation of the higher than anticipated rates of Type 1A endoleaks, migration 
and AAA sac enlargement, Endologix, in consultation with physicians, reviewed alternative 
treatment options from clinical studies, commercial use, literature, physician experience and use 
in similar technologies (e.g., EVAR) to develop a list of recommended treatment options.  For 
many of the treatment options, the clinical data to support the safety and effectiveness of the 
treatment is limited.  
 
The treating physician should consider multiple factors such as subject anatomy, subject risk 
profile, hospital standard of care and physician preference when determining the appropriate 
treatment option. Endologix’s treatment recommendation is based on a subset of those factors, 
and as such, should be used as a reference for physicians and not a requirement.  The 
recommended treatment options are provided below. 
 
It should be noted conversion to open repair should be used if a less invasive option is not 
feasible for the subject, based on the physician’s clinical judgment.  Even with the other 
recommended treatment options available, conversion to open repair can be performed at any 
time, per the physician’s discretion. 
 

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8.6.1. Treament Options for Type 1 Endoleaks 
8.6.1.1. Type 1A Endoleaks 
The recommendation for treatment of Type 1A endoleaks is based on 
evaluation of the implant position and proximal seal zone. The Nellix implant 
is correctly aligned if the bottom of the first stent cell element is aligned with 
the distal origin of the most caudal renal artery and the second stent not more 
than one stent strut higher on the opposite side.  The Nellix implant has an 
adequate proximal seal zone if at least 10mm of the Nellix Endobags are in 
contact with healthy (i.e. minimal tortuosity, occlusive disease, and/or 
calcification)  aortic proximal neck vessel wall.  The length of the aortic 
proximal seal is measured from the lower margin of the most caudal renal 
artery to the point distally where the lumen diameter change is 10%.  Based 
on evaluation of these factors, two potential treatment options for the 
treatment of Type 1A endoleaks have been identified: 
 
Coils (see Appendix A on page 60 for list of recommended coils) and 
liquid embolics (Onyx®) with or without proximal covered stent 
extenders (balloon-expandable or self-expanding)  
 
Nellix proximal extenders with or without commercially available stent 
grafts in the visceral arteries (NiNA with polymer/ Secondary ChEVAS) 
o Covered stents are placed in the visceral arteries to allow blood flow 
and the Nellix implant is placed in a sufficient length of healthy 
supra-renal aortic neck to enable aneurysm sealing. 
 
The table below summarizes these options, aligning each with evaluation criteria: 
Implant and Anatomic 
Evaluation Criteria  
Potential Treatment Options for Type IA Endoleaks 
Implant positioned correctly with 
adequate sealing zone 
‐ 
Coils* and liquid embolics (Onyx®) 
‐ 
 
Implant positioned incorrectly 
with adequate sealing zone 
‐ 
Coils* and liquid embolics (Onyx) with 
proximal covered stent extenders (iCAST) 
Implant positioned correctly with 
inadequate sealing zone 
‐ 
Nellix Proximal Extenders with commercially 
available stent grafts in the visceral arteries 
(iCAST) (Secondary ChEVAS) 
Implant positioned incorrectly 
with inadequate sealing zone 
‐ 
Nellix Proximal Extenders (NiNA with 
Polymer) 
‐ 
Nellix Proximal Extenders with commercially 
available stent grafts in the visceral arteries 
(iCAST) (Secondary ChEVAS) 
* See Appendix A on page 60 for a list of recommended coils 
 
8.6.1.2. Type 1B Endoleaks  
A potential treatment option for Type 1B endoleaks have been identified, 
which can be used based on the physician’s preference: 
 
Distal Covered Stents 
 
     The table below summarizes this options, aligning each with evaluation criteria: 
Implant and Anatomic 
Evaluation Criteria  
Potential Treatment Options for Type IB Endoleaks 

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Inadequate sealing in between the 
Nellix Endobags and the iliac 
vessel wall 
‐ 
Distal Covered Stent Extenders (Ovation iX 
Iliac Stent Graft) 
 
 
8.6.2. Treatment Options for Migration 
The recommendation for treatment of migration is based on evaluation of the distance 
the implant has migrated, presence of endoleak and comparison between proximal and 
distal migration distances.  Based on evaluation of these factors, three potential 
treatment options for the treatment of migration have been identified: 
 
CT Surveillance 
 
Nellix proximal extenders with or without commercially available stent grafts in the 
visceral arteries (NiNA with polymer/ Secondary ChEVAS) 
 
Nellix Stent Relining (NiNA without Polymer) 
o For subjects in which the proximal migration is more significant than the distal 
migration of the Nellix implant, stent relining should prevent or slow the rate 
of migration.  Relining the stent will increase the stiffness and column strength 
of the Nellix implant which will increase its resistance to the hemodynamic 
forces acting upon it. 
 
The table below summarizes these options, aligning each with evaluation criteria: 
Implant and Anatomic Evaluation 
Criteria  
Potential Treatment Options for Migration 
Nellix implant has migrated <10mm, in 
the absence of Type 1A endoleak and a 
proximal seal zone of at least 10mm 
remains 
‐ 
CT Surveillance (Enhanced Follow-
up) 
Nellix implant has migrated ≥10mm, in 
the absence of Type 1A endoleak and a 
proximal seal zone of at least 10mm 
remains 
‐ 
Nellix Relining (NiNA without 
Polymer) 
Implant migration associated with Type 
1A endoleak and a proximal neck of at 
least 30mm is available 
‐ 
Nellix Proximal Extenders (NiNA 
with Polymer) 
Implant migration associated with Type 
1A endoleak and a proximal neck of less 
than 30mm is available 
‐ 
Nellix Proximal Extenders with 
commercially available stent grafts 
(iCAST) in the visceral arteries 
(Secondary ChEVAS) 
 
8.6.3. Treatment Options for Aneurysm Expansion 
The recommendation for treatment of aneurysm expansion is based on the presence of 
Type 1A/B endoleaks.  Based on evaluation of these factors, two potential treatment 
options for the treatment of aneurysm expansion have been identified: 
 
Type 1A Endoleak Treatments 
 
Distal Extension (Ovation iX Iliac Stent Graft) 
 
 
     The table below summarizes these options, aligning each with evaluation criteria: 
Implant and Anatomic Evaluation 
Criteria  
Potential Treatment Options for Aneurysm 
Expansion 

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45 
Aneurysm expansion is associated with 
Type 1A endoleak  
Refer to treatment option for Type IA endoleak 
for further detail 
Aneurysm expansion is associated with 
Type 1B endoleak   
‐ 
Distal Covered Stent Extenders 
(Ovation iX Iliac Stent Graft) 
 
Aneurysm expansion in the absence of 
endoleak 
‐ 
Distal Covered Stent Extenders 
(Ovation iX Iliac Stent Graft) 
 
 
8.7. 
PROTOCOL DEVIATIONS 
A protocol deviation occurs when a clinical investigator and/or study site personnel do not 
conduct the study according to the clinical investigational plan.  All deviations are recorded on 
a Protocol Deviation Form.  United States regulations (21 CFR 812.140) require that 
investigators maintain accurate, complete, and current records relating to the clinical study.  
This includes documents showing the dates and reasons for each deviation from the clinical 
investigational plan.  Depending upon the nature of the protocol deviation, expedited reporting 
and prior approval from Endologix may be required.  All deviations will be summarized and 
submitted in IDE progress reports, annual reports, and the final study report to FDA. 
 
If Endologix finds that an investigator is not complying with the executed study agreements, 
the investigational plan, FDA regulations, or the requirements of the reviewing IRB, prompt 
action will be taken to secure compliance.  In addition, shipment of the device may be stopped 
or the participation of the investigator may be terminated. 
 
8.7.1. Deviations with Expedited Reporting Requirements 
For the following types of protocol deviations (per 21 CFR 812.150), an investigator 
is required to notify Endologix and the IRB within 5 business days of the deviation. 
 
• Emergency Deviation from the Investigational Plan (a deviation to protect the life 
or physical well-being of a subject in an emergency). 
• 
Failure to obtain Informed Consent 
 
Notification to Endologix and/or the IRB should be documented and maintained in the 
clinical study file at the site and at Endologix. 
8.7.2. Deviations Requiring Prior Approval 
An investigator is required to obtain prior approval from clinical study management at 
Endologix and the IRB before initiating deviations from the Investigational Plan that 
affect the scientific soundness of the plan, or the rights, safety, and welfare of the 
subjects (non-emergent situation).  However, prior approval is not required in situations 
where unforeseen circumstances are beyond the investigator’s control, e.g., subject did 
not attend scheduled follow-up visit, laboratory test was performed incorrectly, and test 
equipment did not operate properly. 
8.7.3. Non-Urgent Deviations 
Protocol deviations which do not have the urgency associated with expedited 
notification or prior Endologix/ IRB approval (as discussed in the above paragraphs) 
will be reported upon discovery, such as during completion of eCRFs or a monitoring 
visit. 

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8.8. 
ADVERSE EVENT REPORTING 
Adverse events will be entered on the applicable eCRF and in the patient’s medical records. The 
date of onset, severity, and action taken are requested to be identified by the PI. 
8.8.1. General Definitions 
An adverse event (AE) is any untoward medical occurrence, unintended disease, injury 
or untoward clinical sign (including an abnormal laboratory finding) in subjects, users 
or other persons, whether or not related to the investigational medical device (ISO 
14155). 
 
A serious adverse event (SAE) is an adverse event that: 
• Led to a death. 
• Led to a serious deterioration in the health of the subject that: 
a. Resulted in life threatening illness or injury. 
b. Resulted in a permanent impairment of a body structure or a body function. 
c. Required in-patient hospitalization or prolongation of existing hospitalization. 
• Resulted in medical or surgical endovascular procedure to prevent permanent 
impairment to a body structure or a body function. 
• Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
An unanticipated adverse device effect (UADE) is 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, degree 
of incidence. Additionally, an unanticipated adverse device effect includes any other 
unanticipated serious problem associated with a device that relates to the rights, safety, 
or welfare of subjects (21 CFR 812.3 (s)). 
Severity of an AE is a clinical determination of the event intensity. The severity 
assessment for a clinical AE should be completed using the following definitions as 
guidelines: 
Mild (+1): Awareness of sign or symptom, but easily tolerated. 
Moderate (+2): Discomfort enough to cause interference with usual activity. 
Severe (+3): Incapacitating with inability to work or do usual activity. 
NOTE: An event that is fatal should be recorded as death on the ADVERSE EVENT 
eCRF. The cause of death will be detailed on the Serious Adverse Events 
section of the form. 
A relationship to device or procedure of an AE is a judgment determination made by 
the PI that there is a logical connection between device use (e.g., delivery system 
manipulation) and the occurrence of the AE.  
Device Related – Complication associated with the device design as it relates to 
placement, efficacy or durability, (these may involve the delivery system). 

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Procedure Related – Complication associated with the initial placement of the device or 
any necessary secondary interventions. This includes morbidity associated with either 
anesthesia or surgical procedure. This also includes inappropriate patient selection and 
errors attributed to inappropriate operator techniques, measurements or judgement 
8.8.2. Reporting of Adverse Events 
For all adverse events occurring during the study period, data must be entered in the 
Adverse Event eCRF in the eDC system.  For serious adverse events (SAEs), the section 
of the eCRF describing the serious nature of the AE must also be completed. 
All adverse events will be investigated by Endologix. 
The PI should supply to Endologix and the responsible EC/IRB with a complete, written 
case history (AE forms) and any additional redacted source documentation and 
information (e.g., other diagnostic testing, discharge reports, autopsy reports, etc.) as it 
is available. 
Deaths 
For any death, regardless of cause or timing, it is recommended that the site notify 
the Endologix Clinical Department via the EDC system within 1 working day of 
awareness. The PI should supply to Endologix and the responsible EC/IRB with a 
complete, written case history (AE forms) and any additional redacted source 
documentation and information (e.g., other diagnostic testing, discharge reports, 
autopsy reports, etc.).   
In all cases, the death certificate is to be uploaded to the eDC system. Every attempt 
should be made to obtain as much detailed information on the events or conditions 
leading up to the death as possible. If the patient was hospitalized, a copy of the 
discharge summary source document is required. Also sites can search Social Security 
Death Index (SSDI) or CDC National Death Index (NDI) to obtain more information. 
If the device is explanted after death, the site should notify Endologix for submission of 
the explant to Endologix.  A device explant kit will be provided to the hospital for 
processing and shipment to an independent pathologist per established methods. To 
request a kit, send a fax to Endologix at +1 949-954-7601, or contact Endologix by 
telephone at +1 (949) 595-7200. 

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8.8.3. Adverse Events: required reporting timeframes 
Note: Site reporting times to Endologix only; responsible IRB/EC reporting 
requirements must still be followed by the site, in addition to those recommended below. 
AE Type 
Reporting Recommendations 
Non-device or procedure related AE 
Recommended monthly at minimum 
Device or procedure related AE 
Within 10 working days 
Non-device or procedure related SAE 
Within 10 working days 
Device or Procedure related SAE 
Within 1 working day 
Death as outcome (regardless of cause) 
Within 1 working day 
Unanticipated Adverse Device Effect 
Within 1 working day 
8.8.4. Secondary procedures  
For subjects that experience any non-diagnostic invasive secondary treatment of the 
groin access areas or of the abdominal aortoiliac vessels (e.g., hematoma drainage, 
vascular exploration for bleeding, iliac stenting, thrombectomy, additional device 
placement for endoleak, embolization for Type II endoleak, conversion to open repair, 
etc.), it is important to identify the specific procedure performed on the relevant 
ADVERSE EVENT eCRF. A copy of the discharge summary source document should be 
uploaded to the eDC system. 
8.8.5. Anticipated Adverse Events 
Adverse events that could potentially occur during this investigation are called 
anticipated adverse events.  These events must be reported if clinically significant.  A 
list of anticipated AEs are listed in alphabetical order: 
 Access site complications and sequelae (e.g., dehiscence, infection, pain, hematoma, 
pseudoaneurysm) 
 Allergic reaction to contrast agent (e.g., pruritus, urticaria, bronchospasm, 
angioedema, hypotension or anaphylaxis that occurs during or post-procedure) 
 Amputation 
 Anesthetic complications and sequelae (e.g., aspiration) 
 Aneurysm enlargement 
 Aneurysm rupture  
 Arterial damage or trauma (e.g., bleeding, perforation, dissection, rupture) 
 Arterial or venous thrombosis and/or pseudoaneurysm 
 Arteriovenous fistula 
 Bleeding requiring transfusion and/or surgical intervention 
 Bowel complications (e.g., ileus, ischemia, infarction, necrosis) 
 Cardiac complications and sequelae (e.g., arrhythmia, myocardial infarction, 
congestive heart failure, hypotension, hypertension) 
 Catheter or implant component fragmentation and sequelae (e.g., embolization, 
vessel trauma) 
 Claudication  
 Coagulopathy 
 Death (due to any cause) 
 Edema 
 Embolization (micro and macro) with transient or permanent ischemia or infarction 
 Endoleak  

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 Fever and localized inflammation 
 Fistula (vascular or aoroenteric) 
 Genitourinary complications and sequelae (e.g., ischemia, fistula, incontinence, 
hematuria, impotence, infection) 
 Hepatic failure 
 Infection of the aneurysm, device access site, including abscess formation, transient 
fever and pain. 
 Local or systemic neurologic complications and sequelae, transient or permanent 
(e.g., stroke, transient ischemic attack, paraplegia, paraparesis, paralysis, numbness 
and/or tingling in legs) 
 Lymphatic complications and sequelae (e.g., lymph fistula) 
 Nellix implant: improper component placement; incomplete component deployment; 
component migration; occlusion/thrombosis; infection; stent fracture; EndoBag 
material wear; dilatation; erosion; puncture and perigraft flow 
 Thrombosis or occlusion of stent graft or arterial vessel of the lower extremities 
 Pulmonary/respiratory complications and sequelae (e.g., pneumonia, respiratory 
failure, prolonged intubation, pulmonary embolism) 
 Renal complications and sequelae (e.g., artery occlusion, infarction, insufficiency, 
failure) 
 Secondary Intervention  
 Surgical conversion to open repair 
8.8.6. Unanticipated Adverse Device Effect 
The investigator shall submit to Endologix and to the reviewing EC/IRB a report of any 
unanticipated adverse device effect occurring during an investigation as soon as 
possible, but in no event later than 24 hours after the PI first learns of the effect. PIs 
must submit to Endologix documentation of the report made to the EC/IRB via  the 
EDC system.  Endologix will report a UADE to the FDA within 5 working days of 
becoming aware of the event, as required by regulations.  
Please note: The following events are associated with endovascular repair and these 
became UADEs in the prior 3SQ+ protocol due to the higher than anticipated rates at 
which they were observed. This study is now being executed to evaluate the refined 
indications; therefore, the event rates have been returned to baseline and would not be 
considered UADEs without further evaluation: 
o Type 1 endoleaks 
o Device migration 
o Aneurysm sac enlargement  
8.8.7. Adverse Event Definitions 
The following event definitions will be applied during this study.  
 
Death: Any death occurring during the study period, regardless of cause. 
o Aneurysm-related death is defined as any death occurring within 30 days from 
the date of the procedure, regardless of cause, and death due to aneurysm 
rupture or following any procedure intended to treat the aneurysm.  
o Cardiac-related death is defined as death due to arrhythmia, heart failure 
(including cardiogenic shock), or myocardial infarction. 
o Pulmonary-related death is defined as death due to due to pulmonary edema, 

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respiratory failure, or pulmonary embolism. 
o Vascular-related death is defined as death due to stroke, cerebral hemorrhage, 
or other clear vascular event that is not categorized as cardiac-related or 
pulmonary-related. 
o Other is to be used to identify a death due to any event that cannot be clearly 
categorized as above, but where some information is available. 
o Unknown is to be used to identify a death where no information is available. 
 
Procedural Technical Failure is defined as a failure of the Nellix system to be 
delivered and deployed, such that the procedure is not completed, or the device 
failure results in a serious complication, or a residual endoleak occurs that cannot 
be resolved during the index procedure and is still present at the 30 day CT as read 
by the Core Lab. 
 
Major Adverse Event: An event occurring during the study that meets one of the 
following criteria: 
o All-Cause Death (see above);  
o Bowel Ischemia: the lack of adequate blood flow to the intestines that requires 
intensification of medical therapy or surgical/endovascular intervention; 
o Myocardial Infarction: the presence of raised levels of one or more cardiac 
biomarkers in comparison to local laboratory reference ranges;  
o Paraplegia: Paralysis of the lower extremities inclusive of the lower trunk;  
o Renal Failure: the need for temporary or permanent dialysis or >0.5mg/dL 
increase in pre-operative serum creatinine level at two consecutive intervals; 
o Respiratory Failure: pneumonia or respiratory failure requiring ventilator 
support beyond 24 hours post-procedure; 
o Stroke: a sudden development of neurological deficit due to vascular lesions of 
the brain such as hemorrhage, embolism, or thrombosis that persists for >24 
hours; 
o Procedural Blood Loss >1,000mL: Estimated blood loss during the index 
procedure ≥1,000cc. 
 
Other Definitions: 
o Aneurysm Sac Enlargement: Aneurysm sac maximum diameter increase of 
>5mm in late follow-up as compared to the one month CT time point. 
o Aneurysm Rupture: bleeding or leaking of blood from the aneurysm subsequent 
to the index procedure. 
o Clinically significant migration: Core Lab reported stent distal movement 
>10mm from the original implant location relative to the center of the distal 
renal artery resulting in an intervention or in a serious complication. 
o Conversion to Open Repair: open surgical repair of the abdominal aortic 
aneurysm due to unsuccessful delivery or deployment of the stent graft, due to 
complications or other clinical situations that precluded successful 

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endovascular treatment, or at any time following initial successful endovascular 
treatment for any reason. 
o Device Positional Stability: Core Lab reported position of each stent relative to 
the center of the L3 vertebrae. Stable positioning is defined as within 5mm of 
the positioning on the first post-operative CT scan. 
o Luminal Thrombus: any endovascular surgical intervention after completion of 
the Nellix System implantation for resolution of endograft thrombosis. 
o Distal Ischemia: New onset of compromised peripheral blood flow resulting in 
femoral or peripheral arterial occlusion or stenosis (attributable to the index 
procedure and not related to natural progression of atherosclerotic disease) 
causing a threat to the viability of the limb and requiring surgical or 
percutaneous intervention; or stent graft occlusion requiring any intervention.. 
o Endoleak: Clear evidence of contrast outside of one or both EndoBags which 
communicates with the aneurysm sac originating proximally at the infrarenal 
segment (Type IA), distally (Type IB); between components, if an extender is 
used (Type III); trans-device (Type IV); or from a patent collateral vessel (Type 
II: e.g., lumbar artery; inferior mesenteric artery). Contrast outside of an 
EndoBag that does not communicate with the aneurysm sac is not to be reported 
as an endoleak. 
o Migration: Core Lab reported stent distal movement >5mm from the original 
implant location relative to the center of the distal renal artery.  
o Occlusion: Intervention for stent occlusion or as reported by the Core Lab. 
o Secondary procedure: any non-diagnostic intervention after the index 
procedure intended to correct or repair an endoleak, device occlusion, 
migration, aneurysm sac expansion and/or a device defect (including infection). 
 
9. RISK ANALYSIS 
The decision to repair an aortic aneurysm is generally based on the risk of rupture, the risk of 
complications of surgery, and patient preference. There are currently two methods used to repair 
aortic aneurysms. The conventional method is an open surgical repair, with the implantation of 
a synthetic graft to replace the diseased aneurysmal vessel through a large abdominal incision. 
More recent technological developments have resulted in an alternative, minimally invasive, 
endovascular aneurysm repair, in which a prosthesis is placed within the aorta through a small 
incision in the groin. Blood can then flow through the implanted device and is excluded from 
the aneurysmal portion of the aorta. 
The disadvantages of open surgical repair are: general anesthesia is required, it is a major 
abdominal surgery (large incision), has a significant surgical complication rate, and typically 
requires a long hospital stay and recovery. EVAR/EVAS enables local or regional anesthesia to 
be used, uses a minimally invasive groin incision for catheter-based access, and has been 
reported in multiple studies to offer a lower perioperative complication rate, reduced blood loss 
and procedure times, and shorter hospital stay. In contrast to open repair, EVAR/EVAS is a 
relatively new treatment, long term results have not been fully established, and life-long 

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surveillance is recommended to verify implant integrity and patency and continued aneurysm 
exclusion. Multiple device systems are CE Marked and marketed in the European Community 
for endovascular abdominal aortic aneurysm repair. All of these devices require the introduction 
of catheter-based treatment devices varying in outer diameter profile. Standard vascular 
exposure is indicated for access. Prospective clinical study results support the safety and 
effectiveness of these devices through early follow-up (to 30 days) and for some in late follow-
up to one year and beyond to up to five years.  
As with any procedure there are risks of serious complications, such as death. The inclusion and 
exclusion criteria for this population have been carefully established to limit the risk of mortality and 
morbidity in this population. The overall risk will be evaluated on an individual basis and discussed 
with each patient. All of the potential adverse events outlined previously could cause prolonged illness, 
permanent impairment of daily function or, in rare cases, death. Possible treatments could include, but 
are not limited to, emergency cardiac or vascular surgery.  
Eligibility criteria that exclude subjects who are at higher risk for experiencing an anticipated adverse 
event have been selected to reduce the potential risks to subjects who participate in this study. In 
addition, the assessment of patient computed tomography angiography imaging by an experienced Core 
Laboratory is also intended to reduce the potential risks to subjects who participate in this study. 
Pre-procedural high resolution, contrast-enhanced CT scanning and intraprocedural arteriography will 
be used to identify and target the aortic anatomy to facilitate the proper introduction, delivery, and 
deployment of the endovascular repair devices. Physician experience, rigorous application of a common 
protocol, and careful performance of the procedure with close monitoring of the patient after the 
procedure will also help to minimize risks. 
The alternative to endovascular repair of AAA is open surgical repair. 
10. STATISTICAL PROCEDURES 
10.1 
ANALYSIS POPULATIONS 
Refer to the SAP for details.  
10.2 
PATIENT ACCOUNTABILITY AND MISSING DATA 
The handling of missing data and patient compliance is discussed in the Statistical Analysis 
Plan (SAP). 
10.3 
GENERAL NOTES 
Analyses of MAEs and other adverse events will be conducted at exact time points. Early events 
are defined as those occurring from the date of the procedure to 30 calendar days post-
operatively. Late events are defined as those occurring from after 30 calendar days post-
operatively (from day 31 forward). Events within six months and one year, respectively, are 
those occurring up to and including 180 days and 365 days following the procedure. 
10.4 
BASELINE COMPARABILITY ANALYSIS  
A set of important demographic or prognostic variables will be compared across study sites to 
determine homogeneity of sites in terms of baseline patient characteristics. Factors found to 
differ significantly by site will identify that variable or site as a possible covariate in subsequent 
analyses.  

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In the analysis of comparability of trial sites, it is anticipated that a small number of sites may 
have a patient enrollment that is too small to allow meaningful statistical analysis. To allow the 
inclusion of sites with this condition, small sites will be combined into one pseudo-site the size 
of which will not exceed the size of the largest trial site. It is not possible to determine the 
number of subjects below which this aggregation will occur until after enrollment is completed, 
but generally trial sites with four or fewer subjects may be combined. 
10.5 
POOLING 
Data among the pivotal cohort will be pooled on a clinical basis including harmonized protocol, 
use of the same Core Lab, screening procedure, endpoints and the same training on the same 
implantable device and console.   
10.6 
PRIMARY SAFETY ANALYSIS 
10.6.1 
Primary Safety Hypothesis 
The primary safety endpoint will be analyzed at 30 days.  It is defined as the incidence 
of Major Adverse Events (MAE) at 30 days, defined as the composite of the 
following: 
 All-Cause Mortality; 
 Bowel Ischemia; 
 Myocardial Infarction; 
 Paraplegia; 
 Renal Failure; 
 Respiratory Failure; 
 Stroke; 
 Procedural Blood Loss ≥1,000cc   
 
Details for this analysis are provided in the SAP.  
10.7 
SAMPLE SIZE 
The sample size for this study is guided by the analysis of the effectiveness endpoint, using a 
Frequentist exact approach.   All studies with a harmonized protocol can be included in the 
analysis to meet the minimum sample size.  Details of power and type I error control are 
described in the SAP.      
10.8 
ADDITIONAL EVALUATIONS 
 
Procedural and In-Hospital Evaluations: The estimated blood loss volume, % of subjects 
receiving a blood transfusion, contrast volume, fluoroscopy time, endovascular device time, 
Polymer volume used, procedure time, anesthesia time and type, frequency of concomitant 
procedures, ICU time, time to hospital discharge, and % of subjects discharged to skilled 
nursing facilities or assisted living facilities who were not prior residents will be presented 
descriptively. Qualitative variables will be presented with rate. Quantitative variables will 
be presented with mean, standard deviation, median, minimum and maximum. 
 
Mortality: The proportion of subjects with mortality (all-cause and aneurysm-related) will 
be presented at 30 days and at each subsequent time point for which data are available (i.e., 

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six months, and annually at years 1 through 5). A descriptive analysis and a Kaplan-Meier 
analysis of all-cause and aneurysm-related mortality through 30 days and for late follow-up 
including 30 days will be presented.  
 
Major Adverse Events (MAE) Individual Components: The proportion of subjects 
experiencing each category of MAE within 30 days and after 30 days at each subsequent 
time point for which data are available will be presented.  
 
Composite Late MAEs (after 30 days): The proportion of subjects experiencing an MAE 
after 30 days will be presented at each subsequent time point for which data are available. 
A descriptive analysis and a Kaplan-Meier analysis of the MAE composite will be presented 
for follow-up through 30 days and for late follow-up including 30 days. The descriptive 
analysis will present the rates for the composite MAE and each individual adverse event 
that is part of the composite. 
 
Aneurysm Rupture: The proportion of subjects experiencing a rupture of the aneurysm will 
be presented at 30 days and at each subsequent time point for which data are available.  
 
Conversion to Open Repair: The proportion of subjects undergoing surgical conversion to 
open repair will be presented at 30 days and at each subsequent time point for which data 
are available.  
 
Serious Adverse Events (SAEs): The proportion of subjects experiencing an SAE will be 
presented descriptively by time point.  
 
Non-serious AEs: The proportion of subjects experiencing a non-serious AE will be 
presented descriptively by time point.  
 
Device Performance: A descriptive analysis of the following will be done based on Core 
Lab evaluations at 30 days and at each subsequent time point for which data are available. 
A determination will be made from the data as to whether any observation was associated 
with an SAE or device malfunction. 
 
Luminal Thrombus: any endovascular surgical intervention after completion of the Nellix 
System implant for resolution of endograft thrombosis. 
 
Aneurysm Sac Changes: The changes in aneurysm sac (vessel) diameter from the first post-
operative CT evaluation will be presented at each subsequent follow-up. The maximum 
diameter parameter will be used for the analysis because it is the basis for comparison to 
other studies with endografts. For each follow-up interval, the number and percent of 
subjects with increased sac diameter (>5mm), stable sac diameter (≤5mm), or decreased sac 
diameter (>5mm) will be presented.  
 
Incidence of Migration: Core Lab reported stent distal movement >5mm from the original implant 
location relative to the center of the distal renal artery. 
 
Incidence of Clinically Significant Migration: Core Lab reported stent distal movement >10mm 
from the original implant location relative to the center of the distal renal artery resulting in an 
intervention or in a serious complication. 
 
Incidence of Endoleak: The occurrence of endoleak (any type or location, new and 
persistent) will be presented descriptively at each follow-up.  
 
Incidence of Stent Occlusion: The occurrence of stent occlusion will be presented 
descriptively at each follow-up. Renal Function Evaluations: A descriptive analysis of renal 
function will be done based on serum creatinine levels and calculated estimated glomerular 
filtration rate (eGFR) at 30 days and at each subsequent timepoint for which data are 

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available. Renal dysfunction will be defined as a reduction in eGFR of >30% from the 
preoperative value.  
 
Nellix Implant Patency and Integrity: A descriptive analysis of stent patent luminal flow, 
absence of stent fracture, kinking, or occlusion, and absence of device failure will be 
determined by contrast-enhanced CT scan, as assessed by the independent core laboratory 
at 30 days and at each subsequent time point for which data are available. A determination 
will be made from the data as to whether the occurrence was associated with an SAE or 
device malfunction. 
 
Secondary Endovascular procedures: A descriptive analysis of secondary endovascular 
procedures for resolution of endoleak (Type I or III), device occlusion, migration, aneurysm 
sac expansion, and/or a device defect (including infection) will be done at 30 days and at 
each subsequent time point for which data are available. 
 
11. ADMINISTRATIVE PROCEDURES 
11.1 STATEMENT OF COMPLIANCE  
This clinical investigation will follow the international standard for Clinical Investigation of 
Medical Devices for Human Subjects -- Good Clinical Practice (ISO 14155:2011).  The Sponsor 
and Investigator(s) will comply with their responsibilities as defined in 21 CFR 812. 
11.2 RESPONSIBILITIES 
1. Sponsor: Endologix is responsible as the Sponsor to ensure proper site and investigator 
selection, availability of signed investigator agreements prior to study initiation, availability 
of regulatory and EC/IRB approval prior to the initiation of the study at any site, obtaining 
and maintaining appropriate insurance policies for the study, and management and monitoring 
of the study with special attention to verification of all clinical requirements, adherence to 
protocol, good clinical practices and compliance with applicable government and institutional 
regulations. Furthermore, the sponsor is responsible for ensuring proper regulatory approvals 
are obtained, and reporting to regulatory authorities per applicable regulations. 
2. Investigators: Each investigator and study site is required to conduct the clinical investigation 
in accordance with the protocol, the signed investigator agreement, Good Clinical Practices 
(GCP), all applicable laws and regulations and any conditions or restrictions imposed by the 
reviewing EC/IRB. This includes compliance with requirements related to EC/IRB approval 
and reporting, and proper patient informed consent prior to participation in the study. The 
investigator is also responsible for protecting the rights, safety, and welfare of the subjects 
under his or her care. 
a. Each investigator is responsible for supervising all procedures conducted under this 
protocol at his or her institution.  
b. Furthermore, the investigator is responsible for ensuring that data are completely, 
accurately, and promptly entered in each patient’s eCRFs and related documents are 
available to verify the accuracy of the eCRFs, and for ensuring the clinical monitor has 
access to all necessary records to ensure the integrity of the data.  
3. CT Scan Core Laboratory: The CT Scan Core Laboratory is a contract supplier having 
validated processes that is responsible for receipt, de-identification, handling, processing, and 

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assessment of all submitted CT scans preoperatively and postoperatively and for reporting of 
results per a written, approved protocol.  
4. Data Management Group: The data management group is responsible for electronic data 
capture database development, validation, control and management of input from study 
sites/monitored data, maintenance, and reporting for statistical analysis. 
5. Clinical Events Committee: The independent clinical events committee will consist of at least 
three physician members and is responsible for review of events and complications 
documented on the eCRFs and in source documents by the study PIs during the trial, and for 
categorization of these events according to the event definitions and primary endpoint criteria 
in this protocol.  The CEC will review all MAEs, Device-Related SAEs and Deaths that occur 
in the study. Reviews will occur on an ongoing basis throughout the trial as events are 
reported. The adjudicated events will be reviewed by the Data Safety Monitoring Board. 
6. Data Safety Monitoring Board (DSMB): Consistent with the U.S. FDA guidance document 
Establishment and Operation of Clinical Trial Data Monitoring Committees, Endologix has 
established a DSMB having pertinent expertise to review on a regular basis adjudicated safety 
data accumulated and trial progress (i.e., enrollment among groups; completeness and 
timeliness of data; protocol deviations; etc.) from its ongoing clinical investigations. The 
DSMB consists of five members, two of which must be physicians with specialty training in 
endovascular repair. One member of the DSMB is a statistician. The DSMB will be convened 
to review interim data accumulated during the trial and to render a recommendation for 
enrollment in the trial: continue; amend; suspend; or, terminate. All action items discussed 
during the meeting will be documented in the minutes, with agreed upon target completion 
dates for resolution. The final meeting minutes will be distributed to all DSMB members.  
Endologix will maintain sole decision-making of implementing recommendations proposed 
by the DSMB. Endologix will disclose the recommendations of the DSMB to the US FDA in 
its annual progress reports to the IDE. 
7. Case Review Board (CRB):  The Case Review Board will contain experts in endovascular 
therapy for repair of abdominal aortic and aortoiliac aneurysms. The Case Review Board will 
be chaired by a physician.  The CRB will review all aneurysm-related images prior to subject 
enrollment into the study. Approval by the CRB will include assessing vascular suitability for 
treatment with the study device and review of anatomic measurements provided by the Core 
Lab to determine each patient’s eligibility.  
8. Biostatistician: The biostatistician is responsible for the development and implementation of 
the data analysis plan, for conducting the data analysis, and for reporting it per the plan.   
11.3 PATIENT PROTECTION 
This clinical investigation will be conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki. Written informed consent, in accordance with 
applicable international and local study center regulations, must be obtained from each patient, 
or from their legal representative, prior to the formal screening process as outlined in this 
protocol. The PI will retain a copy of the signed informed consent document in each subject’s 
record, and provide a copy to the subject. The PI will not request the written informed consent of 
any patient, and will not allow any patient to participate in the investigation before obtaining 
EC/IRB approval. 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
57 
Appropriate precautions will be taken to maintain confidentiality of patient medical records and 
personal information. However, the patient’s name may be disclosed to the sponsor or designee, 
or any health authorities if they inspect the study records. A report of this study may be published; 
however the patient’s identity will not be disclosed. 
11.4 PROTOCOL CHANGES 
The PI should not implement any deviation from or changes to the protocol without approval by 
Endologix and prior review and documented approval from the governing EC/IRB. The only 
exception to this is where necessary to eliminate immediate hazards to study subjects, or when 
changes involve only administrative aspects (e.g., change in monitors, telephone numbers, etc.). 
A report of withdrawal of EC/ IRB approval must be submitted to the Sponsor within five 
working days. 
11.5 DOCUMENTATION 
Source Documents: Source documents may include a patient’s medical record, hospital charts, 
clinic charts, the investigator’s study files, questionnaires, as well as the results of diagnostic tests 
such as laboratory tests, CT scans, angiograms, and the like. Source document worksheets will 
be provided by Endologix for use by study personnel. 
The following information should be included in the patient’s medical record: 
 
The study title, number/name, and sponsor name; 
 
The patient ID number; 
 
A statement that written informed consent was obtained; 
 
Date of procedure and implanted device information; 
 
Dates of all visits; 
 
Occurrence of complication and adverse events, hospitalizations, or adverse events; 
 
Date patient exited the study, and a notation as to whether the patient completed the study or 
discontinued, with the corresponding reason. 
Electronic Case Report Form Completion: The PI who signs the protocol signature page must 
personally electronically sign the eCRFs to ensure that the observations and findings are entered 
correctly and completely. The eCRFs are to be entered in a timely manner at the intervals 
specified by Endologix and this protocol. 
All eCRFs must be entered as instructed. An explanation must be provided for any missing data 
points. Completion instructions and training will be provided to each site for reference. 
All eCRFs will be reviewed and monitored for completeness and clarity. Queries for missing or 
unclear data will be made as necessary throughout the study. Timely resolution of queries is 
required by institutional staff and the PI. 
Study Logs:  The following logs will be maintained for the study: 
 Investigator and site training to the protocol (Training Log) 
 Authorized study site personnel (Site Signature Log) 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
58 
 Patient consent and screening (Enrollment Log) 
 Monitoring visit tracking (Site Visit Log) 
 Nellix Inventory eTracking Log (Device Accountability Log) 
Document Retention: Study-related correspondence, patient records, consent forms, records of 
device implant, and source documents are to be maintained by the study site. Endologix requires 
that it be notified in writing if the PI wishes to relinquish ownership of the data and information 
so that mutually agreed upon arrangements can be made for transfer of ownership to a qualified 
entity. 
Publication: Endologix, as the sponsor of record, has a proprietary interest in this study. 
Authorship and manuscript composition will reflect joint cooperation between multiple 
investigators and sites, core laboratories, and Endologix. Authorship will be established prior to 
writing of the manuscript. No individual publications will be allowed prior to the completion of 
the final report for this study and as agreed in writing by Endologix.  
11.6 MONITORING PLAN 
Written procedures have been established by Endologix for monitoring clinical investigations, to 
assure the quality of the study and to assure that each person involved in the monitoring process 
carries out his or her duties. Standardized written procedures, sufficiently detailed to cover the 
general aspects of clinical investigations, will be used as a basic monitoring plan and will be 
supplemented by more specific or additional procedures, as required by the clinical investigation. 
A pre-study monitoring visit or Site Initiation Visit will be conducted to ensure that the PI clearly 
understands and accepts the obligations incurred in undertaking the clinical investigation as set 
forth in relevant international standard, and that the facilities are acceptable. Periodic monitoring 
visits will be conducted with adequate frequency to ensure that the PI’s obligations are being 
fulfilled and that the facilities continue to be acceptable.  
Site Termination: If the Sponsor or a clinical monitor becomes aware that a PI is not complying 
with the signed Investigator’s Agreement, the Investigational Plan, the requirements of applicable 
health authority regulations, or any conditions of approval imposed by the reviewing EC/IRB or 
health authority, Endologix will immediately either secure compliance or terminate the PI’s 
participation in the study. The final action will be taken with the goal of assuring the rights, safety 
and welfare of the subjects. 
 
 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
59 
12. REFERENCES 
1. AbuRahma A, Campbell J, Stone PA, et al. The correlation of aortic neck length to early and late outcomes 
in endovascular repair patients. J Vasc Surg 2009;50:738-48. 
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endovascular repair? J Endovasc Ther 2004;11:33-40. 
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7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008). 
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endovascular aneurysm sealing.  J Vasc Surg 2017;65:330-6. 
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pivotal trial for endovascular aneurysm sealing.  J Vasc Surg 2016;63:23-31. 
7. Carpenter JP, Baum RA, Barker CF, et al. Impact of exclusion criteria on patient selection for endovascular 
abdominal aortic aneurysm repair. J Vasc Surg 2001;34:1050-4. 
8. Fleiss, J.  The statistical basis of meta-analysis. Statistical Methods in Medical Research 1993;2: 121-45. 
9. Friedman L, Furberg C, and DeMets D.  Fundamentals of Clinical Trials. 1985: Mosby Year Book, St. 
Louis. 
10. Fulton JJ, Farber MA, Marston WA, et al. Endovascular stent-graft repair of pararenal and type IV 
thoracoabdominal aortic aneurysms with adjunctive visceral reconstruction. J Vasc Surg 2005;41:191-8. 
11. Harrell F, Lee K, and Mark D. Multivariable prognostic models: issues in developing models, evaluating 
assumptions, and adequacy, and measuring and reducing errors. Statistics in Medicine 1996;15:361-87 
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13. Jeyabalan G, Park T, Rhee RY, et al. Comparison of modern open infrarenal and pararenal abdominal 
aortic aneurysm repair on early outcomes and renal dysfunction at one year. J Vasc Surg 2011;54:654-9. 
14. ISO 14155:2011, Clinical Investigations of Medical Devices for Human Patients: Good Clinical Practice 
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abdominal aortic aneurysm repair. J Endovasc Ther 2006;13:640–8. 
16. Meinert C. Clinical Trials: Design, Conduct, and Analysis. 1986; Oxford University Press. New York, NY  
17. Park JH, Chung JW, Cho IW, et al. Fenestrated stent grafts for preserving visceral brnaches in the treatment 
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18. Pocock S. Clinical Trials (A Practical Approach). 1983: John Wiley and Sons, Chichester. 
19. Rubin D. Multiple Imputation for Nonresponse in Surveys. 1987: John Wiley and Sons, New York. 
20. Turnbull I, Criado FJ, Sanchez L, et al. Five year results for the Talent enhanced low profile system 
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51:537-44. 
21. U.S. Department of Health and Human Services, Guidance For Industry. E9 Statistical Principles for 
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Consolidated Guidance, April 1996. 
 
 

Endologix, Inc. 
 
March 30, 2020 
Protocol CP-0008 Rev.12.7 
Nellix IDE EVAS II Confirmatory Study  
 
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without written 
permission from Endologix, Inc. 
60 
 
13. APPENDIX A: LIST OF COILS INVESTIGATORS MAY USE ADJUNCTIVELY 
WITH ONYX®  
Coil Name 
Manufacturer 
Interlock 
Boston Scientific 
Nester 
Cook Medical 
Concerto 
Medtronic 
POD 
Penumbra 
Ruby 
Penumbra 
Azur 
Terumo