Prospective, Multicenter, Non-randomized Study With Consecutive, Eligible Subject Enrollment at Each Site, for the Evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal Aortic Aneurysms.
Phase: NA
Conditions: 1 Paravisceral Abdominal Aortic Aneurysm, 2 Juxtarenal Abdominal Aortic Aneurysm, 3 Pararenal Abdominal Aortic Aneurysm, 4 Complex Abdominal Aortic Aneurysms
Sponsor: Endologix

Page 1 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
CLINICAL PROTOCOL
CP-0015 Rev 01 
The COMPLEX AAA Study 
Prospective, multicenter, non-randomized study with consecutive, eligible subject enrollment at each site, 
for the evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and 
Pararenal Abdominal Aortic Aneurysms.   

Endologix, Inc.  
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01  
The Complex AAA Study 
13 September 2019  
 
Page 2 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
 
 
THE COMPLEX AAA STUDY 
 
 
Prospective, multicenter, non-randomized study with consecutive, eligible subject enrollment at each site, 
for the evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and 
Pararenal Abdominal Aortic Aneurysms.   
Protocol Number: CP-0015 
National Clinical Trial (NCT) Identified Number:  NCT04252573 
National Principal Investigator: TBD 
 
Prospective, multicenter, non-randomized study with consecutive, eligible subject enrollment at each site, for the 
evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal 
Aortic Aneurysms.   
 
Revision Number:  01 
19August 2019 
 
 
 
 
Sponsor: 
Endologix, Inc. 
 
 
2 Musick 
 
 
Irvine, CA  92618 
 
 
USA 
 
 
 
Sponsor Signature/Date: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Endologix, Inc.  
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01  
The Complex AAA Study 
13 September 2019  
 
Page 3 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
 
 
Summary of Changes from Previous Revision: N/A for revision 01 
Revision 
Date 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
 
 
 
 
 

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Endologix, Inc  
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev.01 
The Complex AAA Study 
13 September 2019    
 
Page 7 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
LIST OF TABLES 
TABLE 1 : SCHEDULE OF ACTIVITIES (SOA) ..................................................................................................... 12 
TABLE 2: STUDY CHARACTERISTICS OF ARTICLES REPORTING ON CHEVAS FOR THE 
TREATMENT OF COMPLEX AAA ................................................................................................................. 28 
TABLE 3: PERFORMANCE AND SAFETY OUTCOMES FOR CHEVAS IN THE TREATMENT 
OF COMPLEX AAA FROM THE LITERATURE ........................................................................................... 29 
TABLE 4 : VISIT WINDOW SCHEDULE ................................................................................................................ 54 
 
 
 
 
 
 

Endologix, Inc  
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev.01 
The Complex AAA Study 
13 September 2019    
 
Page 8 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
LIST OF FIGURES 
FIGURE 1: CLASSIFICATION OF COMPLEX ABDOMINAL AORTIC ANEURYSMS BASED 
ON RELATIONSHIP TO RENAL AND SUPERIOR MESENTERIC ARTERIES. ........................................ 15 
FIGURE 2: CHIMNEY ENDOVASCULAR AORTIC REPAIR FOR COMPLEX AAA ......................................... 17 
FIGURE 3: COOK ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT ................................................. 19 
FIGURE 4: VENTANA FENESTRATED SYSTEM ................................................................................................. 21 
FIGURE 5: COOK ZENITH P-BRANCH .................................................................................................................. 22 
FIGURE 6: PHYSICIAN MODIFIED ENDOVASCULAR STENT GRAFT FOR TREATMENT 
OF COMPLEX AAA .......................................................................................................................................... 24 
FIGURE 7: NELLIX SYSTEM WITH BRANCH STENTS IN A 3-VESSEL REPAIR ........................................... 26 
FIGURE 8: NELLIX SYSTEM ................................................................................................................................... 42 
FIGURE 9: CHEVAS SYSTEM WITH BRANCH STENTS IN A 3-VESSEL REPAIR .......................................... 43 
FIGURE 10: NELLIX 3.5 DELIVERY CATHETER ................................................................................................. 45 
FIGURE 11: NELLIX STENT SHOWN AFTER EXPANSION ............................................................................... 46 
FIGURE 12: ENDOBAG ............................................................................................................................................ 46 
FIGURE 13: POLYMER CARTRIDGE ..................................................................................................................... 46 
FIGURE 14: CONSOLE ............................................................................................................................................. 47 
FIGURE 15: ACCESSORIES ..................................................................................................................................... 48 
FIGURE 16: REUSABLE DISPENSER (LEFT) AND DISPOSABLE DISPENSER (RIGHT) ............................... 48 
FIGURE 17: OVATION IX ILIAC LIMB (LEFT) AND EXTENSION (RIGHT) .................................................... 49 
FIGURE 18: OVATION IX ILIAC STENT GRAFT DELIVERY CATHETER ....................................................... 49 
FIGURE 19: VERTA SELF-EXPANDING BRANCH STENT GRAFT ................................................................... 50 
FIGURE 20: VERTA SELF-EXPANDING BRANCH STENT GRAFT DELIVERY SYSTEM ............................. 50 
 
 
 

Endologix, Inc.   
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
Page 9 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
1 
STATEMENT OF COMPLIANCE 
 
This trial will be carried out in accordance with International Conference on Harmonization Good Clinical 
Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (21 CFR Part 
50, 54, 56, and 812)  
• 
ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical 
practice 
• 
Additional national and local Regulations as required for study compliance 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the Institutional Review Board (IRB) or Ethics Committee (EC) for review and approval.  At 
a minimum, IRB or EC Approval of the protocol and the informed consent form must be obtained before 
any participant is enrolled.  All amendments to the protocol will require review and approval by the IRB or 
EC.  In addition, all changes to the informed consent form will be IRB or EC approved.  The IRB and/or 
EC will determine whether existing participants will require re-consenting of the revised informed consent 
form, unless specified by Sponsor.  
 
1 
 
PROTOCOL SUMMARY 
 
1.1 
SYNOPSIS  
Title: 
The COMPLEX AAA Study 
Study Description: 
Prospective, multicenter, non-randomized study with consecutive, eligible 
subject enrollment at each site, for the evaluation of the ChEVAS System 
for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal 
Abdominal Aortic Aneurysms.  The total enrollment will be 120 subjects, 
and the total number of sites will be up to 50. 
Objectives: 
 
To study the safety and effectiveness of the ChEVAS System for 
Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal 
Aortic Aneurysms.   
Endpoints: 
Primary 1-month Endpoint: Technical success and the absence of severe 
bowel ischemia, permanent paraplegia/paraparesis, renal failure, disabling 
stroke, abdominal aortic aneurysm rupture, and aneurysm-related mortality 
within 30 days of the index procedure. 
Primary 1-year Endpoint: Freedom from abdominal aortic aneurysm 
rupture and aneurysm-related mortality up until 1 year (day 365), freedom 
from imaging-related findings in the 1-year window (Type I or III 
endoleak, migration > 10 mm, AAA sac expansion > 5 mm, and occlusion 
within the ChEVAS System not seen at the index procedure), and open 
conversions and other major device-related interventions through day 365. 
Study Population: 
Patients diagnosed with an abdominal aortic or aortoiliac aneurysm and an 
infra-renal neck <10mm (including 0mm), with at least one, and a 
maximum of three, required chimney stent graft deployment(s) who are 
considered candidates for endovascular repair using the ChEVAS System 
and who meet the study eligibility criteria for the ChEVAS study may be 
screened for enrollment in the study. 

Endologix, Inc.   
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
Page 10 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
Description of 
Sites/Facilities 
Enrolling Participants: 
Physicians (vascular surgeons or interventional cardiologists/radiologists as 
part of a multi-specialty team with vascular surgeons) with well-established 
experience in complex endovascular aneurysm repair techniques using 
upper extremity access (e.g. ≥5 cases in the prior year) may participate. 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. 
Up to 50 sites will be activated for participation in the trial, with data from 
up to 15 of the 50 sites being outside the USA, in geographies such at 
Europe and Asia. 
Description of Study 
Intervention: 
The ChEVAS System consists of the Nellix® System (to treat juxtarenal, 
pararenal, and/or paravisceral aneurysms) used in conjunction with the 
VertaTM Self-Expanding Branch Stent Graft System (to maintain 
renal/visceral blood flow) and Ovation® iX iliac limbs/extensions, if 
needed (to ensure adequate distal seal zone). The ChEVAS System is 
intended to provide a sealing zone from the proximal extent of the device 
(healthy aortic neck) throughout the aneurysm and to the distal aspect of the 
device implanted into the iliac arteries. The proximal end of target landing 
zone is below the celiac for SMA and bilateral renal artery chimneys, below 
the SMA for bilateral renal artery chimneys, and below the proximal renal 
artery for distal renal artery chimney. 
Study Duration: 
The study enrollment is projected to last from 18 to 24 months, with a 
primary endpoint at 1 year of follow-up.  The total follow-up requirement 
will be 5 years.  Therefore, the primary endpoint will be ready for analysis 
roughly 30 to 36 months after trial initiation, with the final subject exiting 
the trial 96 months after enrollment began. 
Participant Duration: 
Subjects will be followed procedurally to discharge, at 30 days, six months, 
one year and annually thereafter to five years (total follow-up 
commitment). 
 
 
 

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•Obtain informed consent.
•Site screens potential participants by inclusion and exclusion 
criteria.
•Qualified CTA submitted to the Core Lab.
Screening (Site)
•Core Lab reviews the CTA for anatomical inclusion/exclusion 
criteria conformity.  If the subject does not pass this step the 
subject is dropped from further consideration.
•If the subject passes Core Lab, the subject is referred to the 
Case Review Board (CRB) for further evaluation.
Screening (Core Lab)
•The Case Review Board (CRB) reviews case for overall study 
suitability.  The CRB may also make procedural 
recomendations to the Site. 
•If the CRB recommends the subject for the study, the subject 
is approved for implantation.  Baseline and Medical History 
data are entered by the site.
Screening (CRB)
•The subject is enrolled into the study upon the first attempt 
to insert one of the ChEVAS System catheters into the 
patient.
•The subject is treated with the ChEVAS System.
•Procedural data are collected.
Enrollment
•Ward stay information collected.
•Vitals and creatinine lab results collected.
•Medications and Adverse Event records.
Discharge
•CTA and X-rays are submitted to Core Lab.
•Vitals and creatinine lab results collected.
•Medications and Adverse Event records.
1 Month, 6 Months, Annually

Endologix, Inc.   
 
 
 
 
 
 
 
           
 
 
 
 
  
Protocol CP-0015 Rev. 01  
The Complex AAA Study 
 
 
13 September 2019 
    
 
Page 12 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, disclosed, or reproduced with prior written 
permission from Endologix, Inc. 
 
1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
A schedule of activities is provided in Table 1 below, with further detail provided in Section 8. 
 
TABLE 1 : SCHEDULE OF ACTIVITIES (SOA) 
Procedures 
Screening 
Enrollment 
Day 0 
Discharge  
Day 0 till discharge 
30-Day Visit 
Day 30 +/- 14 days 
6-Month Visit 
Day 180 +/-30 days 
1-Year Visit 
Day 365 +/-60 days 
2-Year Visit 
Day 730 +/-90 days 
3-Year Visit 
Day 1095 +/-90 days 
4-Year Visit 
Day 1460 +/-90 days 
5-Year Visit 
Day 1825 +/-90 days 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
Device Implantation 
 
X 
 
 
 
 
 
 
 
 
Vitals (including height and weight) 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
Serum creatinine 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
Serum Pregnancy Test a 
X 
 
 
 
 
 
 
 
 
 
CTAb 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X-rayc 
 
 
 
X 
 
X 
 
X 
 
X 
Complete Case Report Forms (CRFs)/Data collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse event review and evaluation 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
a: Only for women of childbearing potential 
b: For follow-up (not screening), a non-contrast CT and duplex ultrasound may be done in place of the CTA, if the subject has renal insufficiency. 
c: 2-view abdominal (left and right oblique) 

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The Complex AAA Study 
13 September 2019    
 
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Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
shorter hospital stays, and quicker return to functional status. However, current infrarenal device indications 
are lacking for aneurysms with complex anatomies, such as unfavorable neck or iliac anatomy. An 
evaluation of 10,228 patients treated with EVAR 1999 to 2008 showed only 42-69% of patients had 
anatomy that met the IFU.61 Current treatment options to treat complex aneurysms include chimney EVAR 
(ChEVAR), fenestrated EVAR (fEVAR), physician modified endovascular stent grafts (PMESG), and 
utilization of off-label infrarenal devices. 
2.3.3.1 CHIMNEY ENDOVASCULAR ANEURYSM REPAIR 
 
Chimney Endovascular Aneurysm Repair (ChEVAR) is a parallel graft chimney technique which uses 
commercially available covered stents combined with a standard aortic stent graft. With ChEVAR, covered 
grafts are placed parallel to the aortic stent graft to maintain perfusion through the visceral branches. As 
with fEVAR, this endovascular technique is suitable in nonsurgical candidates. However, in contrast to 
custom fEVAR, the components required for ChEVAR are available off-the-shelf. Although Medtronic 
received CE approval for the Medtronic Endurant graft in conjunction with commercially available renal 
stent grafts, the ChEVAR technique remains off-label in the US.   
 
The ChEVAR technique typically involves a minimum of 2 access points: femoral and an upper extremity. 
Femoral access can be completed in a percutaneous fashion. One or both upper extremities are accessed 
dependent on the number of chimney grafts planned. Once the selected branches have wires and sheaths in 
place, the aortic endograft is deployed and subsequently, each chimney graft is deployed with a planned 15 
mm to 20 mm overlap with the aortic endograft and extending 10 mm to 15 mm beyond the proximal extent 
of fabric of the aortic endograft. An effort is made to place the chimney graft below the “suprarenal” or 
active fixation of the device (Figure 2).  If utilizing the ChEVAR technique using devices designed with 
suprarenal fixation, the chimney stents are placed above the fabric of the device, but below the fixation, so 
that fixation is not compromised.  
 
FIGURE 2: CHIMNEY ENDOVASCULAR AORTIC REPAIR FOR COMPLEX AAA 
 
Two of the largest studies of the ChEVAR technique include the PERICLES Registry and the 
PROTAGORAS study.  
 

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The Complex AAA Study 
13 September 2019    
 
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Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
The PERICLES Registry treated 517 high-risk patients with paravisceral AAAs between 2008 and 2014.62 
There were 119 patients treated at 2 U.S. centers and 398 patients treated at 3 European centers. A total of 
898 chimney grafts were implanted in conjunction with a variety of commercially available endografts. Of 
the total 898 chimney grafts, 692 were renal chimneys, 156 were SMA chimneys, and 50 were celiac 
chimneys. Of these, 49.2% (442 stents) were balloon-expandable covered stents (Advanta V12/iCAST) and 
39.6% (355 stents) were self-expanding covered stents (Viabahn). Balloon-expandable bare-metal stents 
were used as the primary chimney stent in 11.2% of the cases. Bare-metal Nitinol stents were used to reline 
the inside of a covered chimney stent in 25.4% (220/898) of the cases. Twenty-five post-operative deaths 
(4.9%) occurred within 30 days for the entire cohort, but 18 (3.7%) post-operative deaths occurred within 
30 days in elective patients. Nine (9) patients (1.7%) had an embolic stroke. At a mean follow-up of 17 
months, primary patency was 94%, secondary patency of 95%, 7.9% presented with Type Ia endoleak, and 
6.6% required a secondary intervention. Survival was 85% at 1-year follow-up and 77% at 2 years. 
 
The PROTAGORAS study treated 128 high-risk patients with pararenal AAAs at 2 European centers.63 A 
total of 187 chimney grafts were implanted in conjunction with the Endurant endograft. All procedures 
were completed successfully. One post-operative death occurred within 30 days (0.8%) due to cardiac 
decompensation. Two patients (1.6%) presented with new onset of Type Ia endoleak. Primary chimney 
graft patency was 95.7%. Eight (8) chimney grafts were occluded during follow-up. Six (6) patients 
required intervention to resolve renal artery stenosis. Freedom from chimney graft-related reinterventions 
was 93.1%. Over 17 months mean follow-up, survival was 83%.  
2.3.3.1.1 CHEVAR LIMITATIONS 
 
The ChEVAR technique is an off-label technique in the US but is gaining popularity as early feasibility 
studies demonstrate promising results. Due to the lack of long-term data and this unapproved technique 
being performed in a non-standardized manner with varying combinations of endografts and branch stents, 
there are concerns regarding durability and component interaction. 
 
Despite favorable outcomes of ChEVAR at experienced centers, systematic reviews have reported Type Ia 
endoleak rates of 10-14%, which may be even higher when more than two chimney grafts are used.46,64,65 
Left untreated, Type Ia endoleak in the setting of complex AAA poses the same problems as with standard 
EVAR, namely repressurization of the aneurysm sac with potential for sac growth and rupture. 
 
Additionally, loss of long-term efficacy through aortic neck dilatation remains a concern since neck 
dilatation has been associated with oversizing, leading to increased rates of Type I endoleaks, migration 
and re-interventions. 66 The aortic and chimney grafts need to accommodate each other in the aorta, 
therefore adequate sizing is essential to prevent Type I endoleaks. Currently, there is a lack of consensus 
on how to size the aortic graft parallel to the chimney graft. A size selection model has been proposed, but 
it currently lacks supporting data.67 Oversizing (by >30%) in relation to the suprarenal aorta or inadequate 
apposition to the aortic wall can lead to infolding of the endograft and a Type Ia endoleak.68 Whereas, 
inadequate stent-graft oversizing can lead to a Type Ia gutter endoleak, involving blood flow through small 
channels between the main body of the aortic endograft and the chimney grafts that perfuse the aneurysm 
sac.68 A retrospective analysis of the results from the PERICLES Registry on the degree of oversizing of 
the Endurant stent-graft showed that oversizing of 30% was associated with a significantly lower incidence 
of reintervention for Type Ia endoleaks in patients treated with ChEVAR.69 
 
Additional risks that are specific to ChEVAR techniques relate to the necessity for upper extremity access 
to place the chimney grafts in the target vessels. 70  The need to cross the vertebral arteries and aortic arch 

Endologix, Inc.   
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 19 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
may increase risk of stroke. Further, management of hemostasis is a consideration with ChEVAR since a 
higher number of chimney grafts is associated with greater procedural blood loss. 
2.3.3.2 FENESTRATED ENDOVASCULAR ANEURYSM REPAIR 
 
The goal of extending an endovascular option for aneurysms with short infrarenal necks or the involvement 
of visceral arteries led to the development of the Fenestrated Endovascular Aneurysm Repair (fEVAR) 
method for treating complex AAA. The fEVAR technique extends the seal zone proximally above the renal 
arteries by use of a fenestrated endograft with branch stent grafts that pass through the fenestrations and 
into the target vessel providing perfusion to the abdominal viscera. Two categories of fEVAR designs have 
been developed; custom fEVAR and off-the-shelf fEVAR as discussed in further detail in Sections 2.3.3.2.1 
and 2.3.3.2.2 below.  
2.3.3.2.1 CUSTOM FEVAR 
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (ZFEN): 
Currently, the only branched/fenestrated stent graft approved and marketed in the US is a custom 
fEVAR device called the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Figure 3).71 
This device is indicated to treat short-neck (≥4mm) infrarenal aneurysms and features fenestrations 
and scallops that accommodate a variety of patient anatomies. In order to account for anatomical 
variation, each stent graft is custom-made with up to three fenestrations for a specific patient.  
 
FIGURE 3: COOK ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT 
 
During the procedure, the proximal body is advanced to align the fenestrations and/or scallops with 
the visceral vessels and deployed within the suprarenal abdominal aorta by means of a catheter 
delivery system. Multisheath access is achieved in the femoral artery using a 20- or 22-F sheath for 
two or three fenestrations, respectively. After alignment of the fenestrations and the stents, the 
proximal end of the aortic stent is deployed and dilated. The stents are then deployed across small 
fenestrations to assist in maintaining the patency of the renal arteries and to complete the 
endovascular repair. A short segment of the stents within the visceral arteries protrudes into the aorta 
and may be subsequently flared to essentially rivet the stent graft to the aortic wall. The universal 
bifurcated component is then deployed, followed by iliac extensions. 
 
In the prospective trial71, sixty-seven (67) patients with juxtarenal AAAs were treated. A total of 178 
visceral arteries were incorporated (129 renal arteries and 49 SMAs). One post-operative death 
occurred within 30 days (1.5%) due to bowel ischemia. No aneurysm ruptures or conversions were 

Endologix, Inc.   
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 20 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
noted during a mean follow-up of 37 ± 17 months (range, 3-65 months). Two patients (3%) had 
migration ≥10 mm with no endoleak, both due to cranial progression of aortic disease. Of a total of 
129 renal arteries targeted by a fenestration, there were four (3%) renal artery occlusions and 12 (9%) 
stenoses. Placement of two stents was required in seven renal arteries and one SMA due to the 
presence of a kink or inadequate overlap between the fenestration and the first stent. Fifteen patients 
(22%) required secondary interventions for renal artery stenosis/occlusion in 11 patients, Type II 
endoleak in three patients, and Type I endoleak in one patient. 
CUSTOM FEVAR LIMITATIONS 
While fenestrated endografts are custom made, specifically for the patient’s anatomy, this also limits 
the application of fEVAR as the technique cannot be used in urgent situations, compared to ChEVAR 
which is available for “off the shelf” use. For instance, the customized Zenith device requires a 
minimum of 3-4 weeks for manufacture and delivery72.  
 
Although the Zenith Fenestrated device has been proven to be effective in treating complex aortic 
disease, anatomical restrictions remain a primary limitation in treatment. The design of the Zenith 
device requires the distance and orientation of the vessels to fit within a handful of engineering rules, 
resulting in limited patient applicability in those with close proximity of the SMA and the most cranial 
renal artery.72 Additionally, the larger delivery sheath profile limits the applicability for subjects with 
hostile iliofemoral access. In a study conducted between July 2012 and September 2013, 85 subjects 
with complex AAA were treated, of which 37 (44%) did not meet the criteria for the Zenith 
Fenestrated device. 73   In contrast, ChEVAR is not as limited by the patient’s anatomy as 
commercially available covered stents are used in combination with a standard aortic stent graft. In 
addition, the costs are lower compared to a customized endograft. 
 
A study using the National Surgical Quality Initiative, compared fEVAR and ChEVAR to open 
surgery and found lower mortality and morbidity following endovascular repair. 74 Procedure time 
was longer with fEVAR than ChEVAR or open repair, which increases the fluoroscopy time, 
radiation, dose and the risk of renal failure. 74 Overall, there were no significant differences in 
outcomes between fEVAR and ChEVAR.74 Larger prospective studies are required to confirm these 
results.  
2.3.3.2.2 OFF THE SHELF FEVAR 
 
Due to the constraints that limit the proportion of patients who have access to fenestrated graft technology, 
manufacturers have attempted to develop an off-the-shelf fenestrated solution. These devices incorporate 
fenestrations and/or scallops in a variety of designs to accommodate a range of visceral artery positions. 
Two off-the-shelf devices have been investigated to date: the Ventana Fenestrated System and the Zenith 
P-Branch. 
 
VENTANA FENESTRATED SYSTEM 
The Ventana Fenestrated System (Ventana System, Endologix, Inc., Figure 4) was designed as an 
off-the-shelf system for the treatment of JAA or PAA. The Ventana System consisted of an integrated 
endovascular stent graft system deployed as a proximal extension to the AFX infrarenal stent graft 
(Endologix, Inc.).  
 

Endologix, Inc.   
 
 
 
 
 
 
 
 
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Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
A scalloped section with length 4 cm from the most proximal edge was present to align below the 
SMA and celiac artery. The mid-section contained oversized graft having circular 3 mm diameter 
fenestrations that could be expanded up to 10 mm for cannulation of the renal arteries and 
introduction of renal stent grafts. Balloon expandable renal stent grafts were preloaded into the sheath 
to maintain renal artery patency. 
 
During the endovascular aneurysm repair procedure, the Ventana self-expanding stent graft was 
deployed within the suprarenal abdominal aorta by means of a catheter delivery system and the distal 
end was deployed within the proximal end of an AFX stent graft. Balloon-expandable renal stent 
grafts were delivered through the Ventana System and across the fenestrations to assist in maintaining 
the patency of the renal arteries and to complete the endovascular repair. The renal stent grafts could 
be moved in-situ to accommodate the renal artery spacing for each patient. A scallop was designed 
in the proximal segment for placement below the superior mesenteric artery (SMA) and the celiac 
artery. 
 
FIGURE 4: VENTANA FENESTRATED SYSTEM 
 
 
The Ventana System clinical program was initiated in 2010 and enrolled 125 patients (49 patients in 
the feasibility study, 76 patients in the US IDE study), with an additional 7 patients treated outside of 
the US under individual compassionate use requests, resulting in a total of 132 patients treated 
globally. Two hundred forty-nine (249) renal stents were implanted (129 left and 120 right). In 
addition, 26 patients (20.8%) had received more than one device in one or both renal arteries mainly 
due to the patient’s anatomy and/or to obtain adequate apposition. All procedures were successfully 
completed. No post-operative deaths occurred within 30 days. In April 2013, it was noted that the 
rates associated with renal occlusions and reinterventions increased. In addition, one patient treated 
under a compassionate use request had undergone device explant due to renal failure, implant lateral 
movement, and device integrity failure, including stent strut fracture in the Ventana ‘W’ mid-section, 
separation of the renal stent from the Ventana stent graft and renal stent fracture. As a result, 
Endologix placed all enrollment (US and OUS) on hold in May 2013 (G110067/S013) and 
subsequently terminated enrollment in March 2015 (G110067/S019). 
As of the October 22, 2018 data cut, a total of 76 secondary interventions were performed in 46 
patients (36.8%) that were endovascular in nature (G110067/R028). Of these secondary 
interventions, 47 secondary interventions were performed for renal stenosis or occlusion. Thirty-one 

Endologix, Inc.   
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 22 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
(31) patients were observed with 75 fractures of the Ventana device. Twenty-one (21) patients were 
observed with 68 renal stent fractures.  
ZENITH P-BRANCH 
The Zenith pivot-branch (p-branch) device (Cook Medical, Figure 5) is an investigational off-the-
shelf fenestrated graft. The device is indicated to treat juxtarenal and pararenal aneurysms with at 
least 4mm healthy neck available below the superior mesenteric artery (SMA) to ensure a 
circumferential seal.75 The device consists of a tubular proximal stent graft with a scallop for the 
celiac artery, a fenestration for the SMA, and 2 pivot fenestrations for the renal arteries (p-branches).76 
The stent graft is available in two designs with either pivot fenestrations at the same level or offset 
with the right renal fenestration located more cranially.  
 
FIGURE 5: COOK ZENITH P-BRANCH77 
 
During the procedure, the proximal body is advanced to align the SMA fenestration with the SMA 
orifice and deployed within the suprarenal abdominal aorta by means of a catheter delivery system. 
Multisheath access is achieved in the femoral artery using a 20-F sheath. After the delivery sheath is 
withdrawn, the preloaded renal sheaths are advanced to the pivot fenestrations, the SMA sheath is 
advanced and placed within the SMA, and the renal sheaths are advanced. The mating renal stent 
grafts are deployed and flared, followed by the SMA stent graft. The universal bifurcated component 
is then deployed, followed by iliac extensions. 
 
A review of four single-center studies evaluated the safety and effectiveness of the Zenith p-Branch 
device in 76 patients between August 2011 and September 2015 in the United States and Europe.78 
The device was deployed successfully in all patients, and stents were placed in all target vessels 
except in three cases. There was no 30-day mortality, but 10 late deaths occurred unrelated to the 
device or procedure. No aneurysm ruptures or conversions were noted during a mean follow-up of 
25 ± 13 months. Two patients experienced bowel ischemia. Renal artery occlusion occurred in eight 
patients (11%) and was deemed procedure related in 63% (5/8) of these patients. Renal artery stenosis 
requiring intervention occurred in 6 patients (8%). Two patients required adjunctive stenting of the 
renal arteries during the procedure due to occlusion caused by stent deformation.  
 
Patient applicability remains the top unmet need in off-the-shelf fEVAR devices. In a study conducted 
between July 2012 and September 2013, 85 subjects with complex AAA were treated, of which only 

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Page 23 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
23 (27%) were eligible for off-the-shelf devices based on their anatomy, whereas ChEVAR has fewer 
anatomical restrictions.73 Patients were excluded from the Ventana device mainly because of either 
an insufficient proximal sealing region below the SMA or renal anatomic criteria. The major 
exclusion criteria for the p-Branch device was renal axial or circumferential position. 
 
From a technical standpoint, implantation of these devices can be more difficult compared with 
custom-made stent grafts because of the mismatch between aortic anatomy and the intended off-the-
shelf configuration. Bailout maneuvers for errors of design or deployment may be needed if the 
fenestration is not properly aligned with the target.38 One advantage of ChEVAR compared to fEVAR 
is that procedure time is lower than for fEVAR, and this is likely to be true for off-the-shelf fEVAR 
also.74 However, ChEVAR requires more extensive upper extremity access.70 
 
Durability is a concern in the setting of misaligned bridging stents that can be prone to kinks, fracture, 
or migration. These concerns proved correct in Ventana, which had a high renal artery occlusion rate 
and fractures, resulting in termination of the IDE study and halting commercialization of the device 
in other regions. 
 
2.3.3.3 PHYSICIAN MODIFIED ENDOVASCULAR STENT GRAFTS (PMESG) 
 
A Physician Modified Endovascular Stent Graft (PMESG) is an off-label technique that modifies an off-
the-shelf stent (Figure 6) while the patient is prepared for surgery.79 This option was developed to offer a 
solution for patients with complex AAA deemed unsuitable for traditional open surgical repair or who, 
while presenting in an urgent fashion, cannot wait for entry into a clinical trial or wait for a custom-made 
fEVAR device. 
 
There are limited data to support the long-term safety and effectiveness of this technique. Nevertheless, a 
few recent studies present short-term data supporting the applicability of PMESGs.70,80,81 There is some 
evidence to show equivalence of PMESGs to other techniques for complex endovascular repair.70,80 Due to 
availability, PMESGs may be used more frequently for urgent repairs, which is important to consider when 
reviewing the outcomes for these procedures.80  Also, it is recommended that oversizing of devices should 
not exceed 10-15%. 81 Results from the Vascular Quality Initiative (VQI) show that PMESGs were used 
more often for extensive aneurysms, that were more likely to include the celiac and superior mesenteric 
vessels.70 Perioperative mortality, acute kidney injury (AKI), and overall complications were similar 
between the PMESG, fEVAR and ChEVAR groups in the VQI study.70 A study by Dossabhoy et al. showed 
no statistical advantage between PMESGs and custom-fEVAR, however, procedure time and 
reinterventions at 1-year were higher in the PMESGs group.80 The results of a single-arm study on the use 
of PMESGs in juxtarenal aneurysm repair support the use of PMESGs, as there was a significant decrease 
in aneurysm size up to 3 years post-procedure and there were no Type Ia endoleaks reported in 4 years of 
follow-up.81  
 
Overall, more studies and longer follow-up are required to confirm the suitability of PMESGs. The 
limitations of this technique are that once a commercially available device has been modified the long-term 
data associated with the approved device is no longer applicable. Longer-term follow-up is needed to 
determine the durability of this approach and the potential for device-related complications. For now, 
PMSEG should be considered a solution to be employed in an individual patient where the anatomy 
precludes the use of currently-marketed devices and where the patient’s medical comorbidities preclude an 

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Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 24 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
open surgical approach.82 In all cases, the risk of repair with a PMSEG must be balanced against the risks 
of observation alone. 
 
FIGURE 6: PHYSICIAN MODIFIED ENDOVASCULAR STENT GRAFT FOR TREATMENT OF COMPLEX AAA 
 
2.3.3.4 OFF-LABEL USE OF EVAR DEVICES 
 
Short and complex infrarenal aortic neck seal zones result in a restricted patient applicability and remain a 
primary limitation for commercially approved EVAR devices. Complex neck anatomy is the primary reason 
that patients with infrarenal aortic aneurysm must undergo open repair. 83 As a result, a large population of 
patients who are high-risk for open repair and undergo EVAR are considered off-label.61,84 
 
Off-label treatment can result in more endoleaks, however spontaneous sealing is still possible in these 
cases.84 Several studies have compared different aspects of aortic neck morphology as a predictor of 
outcomes after EVAR, including neck length and angle.85 As patients are treated off-label, patient outcomes 
decline, including Type I endoleak and aneurysm enlargement. 
2.3.3.5 ENDOANCHORS 
 
One common treatment option to improve the performance of endograft fixation and seal to the aorta in 
short and/or complex necks includes the use of EndoAnchors. EndoAnchors, such as the Heli-FX 
EndoAnchor System, were developed to provide active fixation of existing endografts, thereby reducing 
migration and Type Ia endoleaks due to inadequate sealing and fixation to the aortic wall. EndoAnchors 
may be implanted at the time of the initial endograft placement or during a secondary procedure. Although 
Medtronic received approval for the Medtronic Endurant graft in conjunction with the Heli-FX EndoAnchor 
System in patients with proximal neck lengths ≥ 4mm and < 10 mm, the use with other endografts remains 
off-label for complex anatomy. 
 
The ANCHOR study treated 319 patients with the Heli-FX EndoAnchor at the time of an initial EVAR 
procedure (primary arm, 242 patients) or with an existing endograft and proximal aortic neck complications 
(revision arm, 77 patients).86 Technical success was achieved in 303 patients (95.0%) and procedural 
success in 279 patients (87.5%), 217 of 240 (89.7%) and 62 of 77 (80.5%) in the primary and revision arms, 
respectively. There were 29 residual Type Ia endoleaks (9.1%) at the end of the procedure. During mean 

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The Complex AAA Study 
13 September 2019    
 
Page 26 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
exclusion while maintaining patency of the visceral arteries. The chimney stents are positioned first.  Once 
the chimney stents are in position, the Nellix System EndoBags are introduced. The Nellix System is 
positioned so as the Nellix stents align with the top of the parallel stents and are aligned proximally to the 
planned sealing zone.96,97 Intraoperative angiography is used to confirm stent position. The chimney stents 
are deployed, and the chimney delivery systems are exchanged for PTA balloons. Some investigators prefer 
to use balloon expandable stents, as the balloons can be left in place during polymer curing, thereby 
protecting the chimney stents.94,96 The Nellix EndoBags are then filled with saline solution and 
intraoperative angiography is performed to confirm the absence of endoleaks. The saline is then removed 
from the EndoBags and they are filled with a polymer up under pressure monitoring. The polymer conforms 
around the branch stents and aortic vessel wall, thereby creating a seal to exclude blood flow to the 
aneurysm sac. The Nellix stents form lumens through which blood flows to the distal limbs and vasculature 
and the branch stents maintain blood flow to the visceral arteries. The EndoBags with cured polymer 
exclude the aneurysm from blood flow, preventing aneurysm pressurization and rupture. This seals the 
entire anatomy from the proximal end of target landing zone to the iliac arteries with a distal seal zone 
(Figure 7). To assess the technical success of the procedure, intraoperative angiography is performed to 
confirm exclusion of the aneurysm and to assess for endoleaks. 
 
 
 
FIGURE 7: NELLIX SYSTEM WITH BRANCH STENTS IN A 3-VESSEL REPAIR 
 
 

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The Complex AAA Study 
13 September 2019    
 
Page 27 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
2.3.4.1 CURRENT CLINICAL EXPERIENCE 
 
The 
ChEVAS 
procedure 
has 
been 
described 
in 
benchtop 
studies,
99
,
100
 case 
reports94,98,101,102,103,104,105,106,107,108,109 and in small series involving mainly emergent cases.110,111,112  It was 
apparent from the early experience that standardization of the therapy with regard to technique and 
components was desirable.  
 
To date there have been five articles reporting on the feasibility and safety of ChEVAS in retrospective and 
prospective studies of > 10 patients. The characteristics of these studies are presented in Table 2. The 
majority of patients included in these studies were male and in the eighth decade of life. A summary of the 
performance and safety outcomes from these studies is presented in Table 3.  
 
These studies reported on primary repair or repair of a previous EVAR or aortic graft using ChEVAS. There 
have been other reports where ChEVAS was used, however the outcomes were not stratified by type of 
EVAS repair and were therefore not included in the analysis below.113,114 These studies, Paraskevas et al. 
(2018) and Youssef et al. (2017) are discussed qualitatively below. 
 
Paraskevas et al. conducted a retrospective analysis of a prospectively maintained aneurysm database to 
investigate late complications following EVAR.113 There were 10 patients included in the analysis who 
underwent interventions for complications of the EVAR procedure. All interventions were performed using 
EVAS with or without chimney grafts. Technical success for Type Ia endoleaks was 100%, with no 
perioperative deaths. One Type Ia endoleak re-occurred during follow-up, and 2 undetermined endoleaks 
were explored with laparotomy were found to be Type II endoleaks.  
 
Youssef et al. also conducted a retrospective study of patients who required reintervention following 
EVAR.114 Fifteen patients were included in the study and all patient were treated with EVAS. There were 
10 patients treated with ChEVAS. Technical success was 100%, with sealing of all endoleaks. There was 1 
aneurysm related death 2 months post-procedure and there was 1 renal artery injury. No other complications 
were observed during a mean of 8 months follow-up. 
 
Both studies show that EVAS/ChEVAS is a beneficial treatment for failed EVAR. With good short-term 
results. More studies with longer follow-up are required to fully evaluate long-term outcomes.  
 

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13 September 2019 
The Complex AAA Study 
    
 
Page 28 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, disclosed, or reproduced with prior written 
permission from Endologix, Inc. 
 
TABLE 2: STUDY CHARACTERISTICS OF ARTICLES REPORTING ON CHEVAS FOR THE TREATMENT OF COMPLEX AAA  
Publication 
Subjects 
Treatment 
Period 
Mean/Median 
Follow-Up 
(months) 
Mean/Median 
Age (years) 
Male 
(%) 
Study 
Design* 
Country/Countries 
De Bruin, J. L., J. R. Brownrigg, B. O. Patterson, A. 
Karthikesalingam, P. J. Holt, R. J. Hinchliffe, I. M. Loftus 
and M. M. Thompson. "The Endovascular Sealing Device 
in Combination with Parallel Grafts for Treatment of 
Juxta/Suprarenal Abdominal Aortic Aneurysms: Short-term 
Results of a Novel Alternative." Eur J Vasc Endovasc Surg 
52(2016): 458-465115 
28 
March 2013-
April 2015 
4 
75 
79 
P1SN 
1 site in the U.K. 
Dinkelman, M. K., S. P. Overeem, D. Bockler, D. E. V. JP 
and J. M. Heyligers. "Chimney technique in combination 
with a sac-anchoring endograft for juxtarenal aortic 
aneurysms: technical aspects and early results." J 
Cardiovasc Surg (Torino) 57(2016): 730-736116 
16 
November 
2014-March 
2016 
1 
73 
87.5 
P1MN 
2 sites in Europe 
Harrison SC, Winterbottom AJ, Coughlin PA, Hayes PD, 
Boyle JR. Editor's Choice - Mid-term Migration and Device 
Failure Following Endovascular Aneurysm Sealing with the 
Nellix Stent Graft System - A Single Centre Experience. 
Eur J Vasc Endovasc Surg 2018;56(3):342-348.117 
18 
February 
2013- 
August 2017 
53 
NS 
NS 
R1SN 
1 site in the U.K. 
Stenson K, Patterson B, Grima MJ, de Bruin J, Holt P, 
Loftus I. Endovascular Aneurysm  
Sealing with Chimney Grafts to Treat Juxtarenal and 
Suprarenal Abdominal Aortic Aneurysms: Early Results 
from 62 Cases. J Vasc Surg. 2018. (E-publication ahead of 
print). †96 
62 
July 2013-
June-2016 
13 
73.9 
77.4 
P1SN 
1 site in the U.K. 
Thompson M, Youssef M, Jacob R, et al. Early Experience 
with Endovascular Aneurysm Sealing in Combination with 
Parallel Grafts for the Treatment of Complex Abdominal 
Aneurysms: The ASCEND Registry. J Endovasc 
Ther.2017;24(6):764-772. ‡97  
154 
July 2013-
March 2016 
5.6 
72.3 
80.5% 
R1MN 
7 sites in European 
and 1 site in New 
Zealand 
NS, Not specified 
*P, Prospective: R, Retrospective; 1, Single-Arm Study; S, Single-Center Study; M, Multi-Center Study; N, Non-Randomized Study  
†Stenson et al. reports on the first 50 patients from the ASCEND Registry, which are included in the study by Thompson et al. 
‡Note: the first author of this study is now the chief medical officer of Endologix. 
 
 

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13 September 2019 
The Complex AAA Study 
    
 
Page 29 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, disclosed, or reproduced with prior written 
permission from Endologix, Inc. 
 
TABLE 3: PERFORMANCE AND SAFETY OUTCOMES FOR CHEVAS IN THE TREATMENT OF COMPLEX AAA FROM THE LITERATURE 
Outcome  
Study 
De Bruin et 
al115 
Dinkelman et al116  
Harrison et al117 
Stenson et al*96 
Thompson et al97 
Performance Outcomes 
Technical success (%) 
100 
100 
100 
100 
100 
Median number of chimney grafts (range) 
1 (1-2) 
2 (1-3) 
NS 
1 (1-3) 
2 (1-4) 
Mean procedure time (min) 
185 
165 
NS 
205 
216 
Mean blood loss (ml) 
300 
175 
NS 
390 
339 
Graft failure (%) 
NS 
NS 
16.7 
NS 
NS 
Migration (%) 
NS 
NS 
NS 
4.8 
NS 
Safety Outcomes 
30-day all-cause mortality (%) 
3.6 
0 
11.1 
3.2 
2.8 
All-cause mortality (%) 
14.33 
0 
16.7 
16.1 
7.4 
AAA-related mortality (%) 
3.6 
0 
5.5 
3.2 
2.8 
Stroke (%) 
7.1 
6.25 
NS 
6.5 
2.6 
Transient ischemic attack (%) 
3.6 
NS 
NS 
NS 
NS 
Type I endoleak (%) 
3.6 
6.25 
11.1 
12.9 
5.8 
Type II endoleak (%) 
3.6 
NS 
NS 
1.6 
0 
Secondary intervention (%) 
14.3 
18.75 
NS 
17.7 
17.1 
Limb occlusion (%) 
NS 
6.25 
NS 
3.2 
NS 
Graft occlusion (%) 
NS 
6.25 
NS 
3.0 
NS 
Chimney graft patency (%) 
100 
NS 
NS 
97 
99 
Dialysis (%) 
NS 
6.25 
NS 
1.6 
1.3 
NS, Not specified 
*Stenson et al. reports on the first 50 patients from the ASCEND Registry, which are included in the study by Thompson et al.  
 
 
 
 
 
 

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The Complex AAA Study 
13 September 2019    
 
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Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
The results presented in Table 3 on the use of ChEVAS for the treatment of complex AAAs in general are 
promising. These data support a proof of concept for the use of polymer technology and EVAS with parallel 
grafts in managing patients with complex aortic disease. Technical success was achieved in all cases and 
AAA-related mortality was low (≤5.5%). The rate of stroke was similar across studies (2.6% – 7.1%). The 
rate of Type I endoleaks varied from 3.6%-12.9%. A systematic review showed Type I endoleaks and 
chimney graft thrombosis following ChEVAR were higher than with ChEVAS, however the difference was 
not statistically different.94 As to be expected, given the nature of the EVAS technique, Type II endoleaks 
were low across all studies. There were no Type III endoleaks reported in any of the study reviewed above. 
 
Chimney graft patency was high across ChEVAS studies presented in Table 3. The majority of patients 
included in the studies listed in Table 2 we treated with 1-2 chimney grafts (see Table 3). Stenson et al. 
found that with ChEVAS there were more complications where there was only a single chimney graft. They 
speculate that the shorter sealing zone and asymmetry of the single chimney configuration may have an 
effect on the columnar strength of the endograft, however the exact reasons for these complications is 
unknown.96  
 
There was one study, Thompson et al., where up to 4 chimney grafts were used.97 They reported increased 
procedural blood loss in procedures with 3 or 4 chimneys, compared to procedures where there were 1 or 2 
chimney grafts implanted.97 There is evidence from ChEVAR studies that complications increase with the 
number of chimney grafts, which is logical, since there is a greater chance of endoleaks developing with 
more chimney grafts.118 In general, there is a lack of Nellix experience with ChEVAS with 4 chimney grafts, 
as only a small number of patients in the ASCEND registry were treated with 4 chimney grafts (2.6%), and 
there were no patients in the other studies included in Table 3 treated with 4 chimney grafts. Due to the 
fact that the majority of patients can be treated with 1-3 chimney grafts and the number of complications 
increase with the number of chimney grafts, only 3 branches will be allowed in the IDE. In addition, 
ChEVAS with 4 chimney grafts is technically challenging with an increased risk of complications due to 
managing 4 self-expanding stents and the auxiliary vessels with increased procedure time and blood loss. 
At this stage, ChEVAS is not designed for complex, thoracoabdominal vessels, it is designed for the 
juxtrarenal/pararenal aneurysm (1-3 vessels).  
 
There were several limitations associated with EVAS that were identified in these studies. Harrison et al. 
was the only EVAS study identified with longer term follow-up (4.4 years). In this study the long-term 
durability of EVAS was questioned, due to a high rate of graft failure > 2 years post-procedure.117 Therefore, 
frequent monitoring and imaging of patients is warranted.  
 
Another limitation of the chimney technique is that an additional upper extremity access site is required in 
order to cannulate target vessels. The use of an additional upper extremity access site increases the risk of 
cerebral embolization when compared to fEVAR. Stroke rates of up to 10% have been reported with 
ChEVAR, and the incidence of stoke was higher with ChEVAR compared to open repair and fEVAR.115 
119 120 Therefore, methods to minimize embolizations prior, during and following the procedure are 
required, such as pre-operative clopidogrel and antiplatelet drugs post-operatively.96 
 
Despite the limitations outlined above, the results from these early experiences with ChEVAS are 
encouraging and show the feasibility of the technique. However, apart from the ASCEND registry, all of 
these studies were small and with the exception of the Harrison et al. study, lacked longer term follow-up. 
Therefore, larger controlled studies, with longer follow-up are required, as well as studies with comparisons 
to other techniques for the treatment of complex AAAs. When interpreting the results of these EVAS studies 
it should be noted that the majority of patients in these studies were treated prior the modifications to the 

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Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 32 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
The conformability of the Nellix EndoBag filled with polymer offers a unique solution capable of sealing 
around the branch stent grafts to create a more durable seal with a potential reduction in risk of gutter or 
Type I endoleak.94 A systematic review of ChEVAS versus ChEVAR showed a trend towards a lower rate 
of Type I endoleaks in patients treated with ChEVAS.94 Additionally, chimney graft thrombosis trended 
lower with ChEVAS.94 The results of the ChEVAS studies presented in Table 3 show excellent chimney 
graft patency due to the improved seal of the chimney graft patency, and a low level of chimney graft 
occlusion.96,97,115,116 Better sealing and incorporation of the chimney grafts, without impacting the radial 
strength of the device may reduce the risk of chimney graft occlusion with ChEVAS. 
 
The ability to completely fill the aneurysm combined with the material properties of polymer may also help 
stabilize the visceral segment of the aorta and reduce the occurrence rates of branch stent graft fractures. 
Furthermore, the polymer based ChEVAS technique may be associated with less aortic neck dilatation, 
since a self-expanding aortic stent is not used at the proximal seal zone. This speculation, however, must 
await long term anatomic outcomes.122  
 
As with EVAS, ChEVAS should offer the same unique advantages associated with the aneurysm sealing 
technique. Firstly, there may be a reduction in the Type II endoleak rate through active sac management. 
Type II endoleaks were only reported in 2 patients out of > 200 patients treated with ChEVAS in the 5 
studies that were reviewed above (Table 3). Only 1 of these Type II endoleaks required interevention.96,115 
A recent systematic review of EVAS studies showed the rate of Type II endoleaks was 1.8%, a 30-days.123 
This compares well to a rate of 10.2% for Type II endoleaks at 30-days, that has been reported for EVAR, 
in a systematic review of 32 studies.124  
 
Another advantage of EVAS, which may also apply to ChEVAS is a reduction of radiation dose and 
procedural time compared to EVAR.125 Also, systematic review of EVAS showed a 30-day mortality rate 
of 1.0% for elective patients and 2.6% including emergency cases.123 These rates are comparable to EVAR, 
but lower than for open repair.126 
 
Finally, as Nellix utilizes active sac management in both EVAS and ChEVAS, it is expected that the 
potential mortality benefit may also be applicable to the ChEVAS procedure.  Although many factors 
impact the long-term survival, underlying cardiovascular disease explains much of the risk associated with 
the high rate of adverse cardiovascular events. The relationship between inflammation and 
atherothrombosis has been established in the last decade. After an endograft excludes the aneurysm sac 
using EVAR, the aneurysm remains biologically active. The aneurysm sac undergoes a biological response 
related to a change in pressure and produces an inflammatory response in order to induce fibrosis and 
regression. If the aneurysm sac is not successfully excluded due to endoleaks, intraluminal thrombus, and 
pressure transmitted from a porous endograft, the inflammation does not subside and may accelerate. 
Consequently, the risk of cardiovascular events may increase due to the ongoing inflammatory response. 
However, EVAS utilizes active sac management to completely seal with the EndoBags and exclude the 
aneurysm sac. As a result, this seal may reduce the wall stress on the aneurysm sac and blunt the 
inflammatory response and cardiovascular risk.  
 
Despite the potential risk associated with ChEVAS, it also offers distinct potential benefits over currently 
available standard treatments for complex AAA, including open surgical repair, fEVAR, and ChEVAR. As 
such, there is adequate justification to initiate a study to further evaluate the risks and benefits of ChEVAS.  
 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 33 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
3 
OBJECTIVES AND ENDPOINTS 
 
3.1 
1-MONTH PRIMARY ENDPOINT 
 
The primary 1-month endpoint is defined in terms of an event rate, and includes technical failure and any 
of the following:  
• 
Severe Bowel Ischemia – lack of adequate blood flow to the intestines leading to 
surgical/endovascular intervention or death and reported within 30 days of the index procedure 
• 
Permanent Paraplegia/Paraparesis- event reported within 30 days of the index procedure without 
resolution at 30 days post-procedure 
• 
Renal Failure – new onset renal failure requiring dialysis that remains on-going at 30 days post-
procedure 
• 
Disabling Stroke – new neurological deficit resulting from vascular insult reported within 30 days 
of the index procedure without resolution at 6 months post-procedure.  Disabling is considered a 
value of 2 (slight disability) or above on the modified Rankin Scale (mRS) at both the 1-month and 
6-month visits. 
• 
Abdominal Aortic Aneurysm Rupture - Intraoperative and Post-procedural rupture through the 
aneurysm wall within the stented segment of the aorta reported within 30 days of the index 
procedure. 
• 
Aneurysm-related mortality - death reported within 30 days of the index endovascular procedure 
 
The technical success component of the endpoint (counterpart to technical failure) is defined as: 
a. Successful access and delivery of all ChEVAS components (i.e., ability to deliver each 
component to the intended location, without the need for unanticipated corrective 
intervention related to delivery); 
b. Successful and accurate deployment, defined as: 
i. Deployment of the Nellix stent-grafts, Ovation limbs, and chimney(s) in the 
planned location; 
ii. Patency of the Nellix stent-grafts, Ovation limbs, and chimney(s) with absence of 
device deformations (e.g., kinks1, mal-deployment2, misaligned deployment3) 
requiring unplanned placement of an additional device within the endovascular 
stent-grafts or chimney(s); 
iii. Adequate seal without the need for unanticipated corrective interventions4. No use 
of components outside the defined ChEVAS System for the purpose of achieving 
seal. The use of adjunctive stenting for purposes outside of achieving seal or use 
 
 
1 Defined as a focal narrowing of the stent lumen of >50%, with concurrent stent wall deformation at that location. 
2 Defined as concluding the procedure without having all components of the ChEVAS System successfully deployed. 
3 Defined as, at the conclusion of the procedure, a > 10mm difference between the top of the Nellix stents, or the top of a visceral stent being > 
14mm below the Nellix stent (the bag shelf is 4mm below the top of the Nellix stents). 
4 Concomitant procedures, including those for infrequently encountered circumstances, may be anticipated and prepared for as part of a 
comprehensive endovascular approach  

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 34 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
of adjunctive stents that are part of the defined system, does not result in technical 
failure.5 
c. Successful withdrawal (i.e., successful withdrawal of the delivery systems without the need 
for unanticipated corrective intervention related to withdrawal). 
 
Multiple events occurring to a subject are considered a single subject failure for the purposes of calculating 
the composite one-month rate, as the rate is based on the total number of subjects.  Since none of these 
variables are restricted by imaging requirements for detection, the cutoff date for the endpoint is exactly 30 
days from the index procedure.   
 
 
3.2 
1-YEAR PRIMARY ENDPOINT 
 
The primary 1-year endpoint is a blend of safety and effectiveness indicators.  The endpoint is defined as 
the absence of: 
• 
Abdominal aortic aneurysm rupture (0 - 365 days);  
• 
Aneurysm-related mortality (0 – 365 days) 
• 
Imaging-determined events at the 12-month imaging window.  These do not require an intervention 
within 12 months to count as events: 
o Type I or Type III endoleak 
o Migration6 > 10mm  
o Sac Expansion7 > 5mm 
o Loss of Patency (100% occlusion) in Branches8, Nellix, or iliac limbs not seen at the index 
procedure 
• 
Open conversion through day 365  
 
 
5 Examples of acceptable procedures include: 
o 
Placing an additional stent (Verta or Lifestent) to correct kink in visceral vessel (or a kink in the stent resulting from the vessel anatomy) or to 
smooth transition from Verta to visceral vessel (transition stenting) 
o 
Placing an additional stent (Verta or Lifestent to treat pre-existing visceral artery stenosis (spot stenting) 
o 
Placing Verta stent within initial Verta stent due to length discrepancy, need to achieve a Verta length not covered by available lengths, or 
inadequate initial seal 
o 
Placing Ovation limb to extend Nellix in order to obtain an adequate distal seal; 
o 
Coiling of non-treated branch vessels 
o 
Ballooning of any vessel or stent 
 
6 As measured by the proximal end of the Nellix stents relative to the reference artery 
7 As measured across the maximum transverse sac diameter relative to the 1-month scan 
8 Branches refer to stents in the left renal artery, right renal artery, and superior mesenteric artery 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 35 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
• 
Other major device-related9 surgical or endovascular re-interventions through day 365 for: 
o Type I or III endoleak, or gutters 
o Migration 
o Thrombotic events/Occlusions - complete loss of patency in any of the components of the 
ChEVAS System due to thrombotic events and/or device deformation 
o Device deformation resulting from fracture, that leads to clinical sequelae of vessel 
stenosis progressing to decreased perfusion, or puncturing of graft material leading to 
endoleak 
o Relining of the Nellix Stents to correct stenosis or kink 
o Mal-deployed device that leads to clinical sequelae of migration, endoleak, or thrombosis 
o Device infection 
 
Non-major interventions are not included in the endpoint: 
▪ 
Endovascular intervention for branch stenosis (within the stent or distal to the 
stent) for a reason other than stent fracture 
▪ 
Interventions for Type II endoleaks 
▪ 
Non endovascular treatments for procedural complications that are non-device 
specific, e.g., seroma, surgical site infection etc. 
 
The 1-year endpoint is a collection of variables that may be detected at any time or require imaging to be 
detected.  As such, variables are evaluated differently for the “1-year” timeframe.  Variables lacking 
imaging restrictions (rupture, mortality, interventions) are evaluated until day 365 for the 1-year endpoint 
as the exact day of the event will be known.  Onset dates for imaging-driven variables are unknown (they 
have may occurred at any time prior to the imaging scan that detected them) and thus are evaluated at the 
one-year imaging window as determined by the scan date. Presence of positive imaging-related findings 
within the 1-month or 6-month imaging windows does not factor into the endpoint analysis.  Rather, the 
endpoint analysis restricts positive findings to only those within the 1-year imaging window.  Imaging 
results used in the endpoint analysis will be sourced from core lab assessments.     
 
In contrast to classic EVAR studies that analyze safety at 1 month and effectiveness at 1 year, the ChEVAS 
study is designed to evaluate both safety and effectiveness across dual endpoints (thus, passing both 
endpoints will indicate the trial has demonstrated safety and effectiveness).   
 
 
 
9 Device refers to main Nellix EndoVascular Aneurysm Sealing System (Nellix System), Verta Self-Expanding Stent Graft and Ovation iX iliac 
Limbs/Extensions  
 

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Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 38 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
• 
Gutters 
• 
Device Patency and Integrity 
o Stenosis 
o Occlusion 
o Kinking 
o Fracture 
• 
Aneurysm Sac Diameter 
• 
Migration (e.g., migration > 5 mm, migration > 10 mm, clinically significant migration) 
• 
Secondary Procedures 
o All Types of Endoleaks 
o Device stenosis/occlusion 
o Device kink 
o Device fracture 
o Luminal thrombus 
o Rupture 
o Migration 
o Aneurysm sac expansion 
o Device defect 
o Gutters 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
 
This is a prospective multicenter study with consecutive eligible subject enrollment at each site.  Enrollment 
will include up to 150 subjects (120 ChEVAS subjects and up to 30 infrarenal roll-in subjects) at a 
maximum of 50 sites.  A maximum of 15 sites among those 50 may be outside of the United States (OUS).  
A maximum of 50% of the subjects in the analysis cohort may be from OUS sites.  These OUS sites will 
leverage a harmonized protocol and will be pooled with the data from the sites in the United States to reach 
the required sample size of 120 ChEVAS subjects.  
 
The trial will consist of three (3) cohorts.  The infrarenal Roll-In cohort consists of the first one (1) infrarenal 
subject enrolled at sites where the investigator has no prior EVAS treatment experience.  The ChEVAS 
Roll-In cohort consists of one (1) subject and will be enrolled at sites where the investigator has no prior 
ChEVAS treatment experience.  The ChEVAS Pivotal cohort consists of all ChEVAS cases subsequently 
implanted.  Among the ChEVAS Pivotal and Roll-In cohorts, a single site may not enroll more than 20% 
of the total enrollment.  
Thus, three distinct cohorts are included in this study: 
• 
Infrarenal Roll-In Cohort: This is comprised of the first one (1) infrarenal EVAS subject enrolled 
at a site if EVAS cases have not been performed prior.  These cases are intended to be reported 
with the EVAS2 study (CP-0008) and will not be analyzed as part of the endpoint for the ChEVAS 
study.  Sites will follow the EVAS infrarenal Roll-In protocol (Appendix 1) for inclusion/exclusion 
purposes. 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 39 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
• 
ChEVAS Roll-In Cohort: This consists of the first one (1) ChEVAS subject enrolled at a site when 
the investigator has no prior ChEVAS10 treatment experience. Please note only certain OUS sites 
will have prior ChEVAS experience. 
• 
ChEVAS Pivotal Cohort: If a site has previously performed a ChEVAS case (whether as part of 
the study or not) then subsequent cases are considered Pivotal subjects.   
 
The Pivotal and Roll-In ChEVAS cohorts will be combined to reach the sample size of 120 subjects for 
analysis of the primary endpoints. 
 
A subject is enrolled into the trial at the point where one of the ChEVAS System catheters is inserted into 
the subject.  All enrolled ChEVAS subjects will undergo the endovascular aneurysm repair procedure with 
the Nellix System, Verta stent grafts, and Ovation iX iliac limb extensions when needed.  Subjects will be 
followed procedurally to discharge, at 30 days (primary 30-day endpoint), six months, one year (primary 
1-year endpoint), and annually thereafter to five years (total follow-up commitment).  These are the required 
follow-up imaging and visits of the study, though all subjects should be monitored and evaluated per 
instructions for use, standardized protocols, and institutional standards of care for patients who receive an 
endovascular stent graft, as long as the required follow-up (imaging and visits) within this protocol are 
followed.   
 
The Primary analysis will be conducted on the implanted population within the ChEVAS Roll-In and 
Pivotal cohorts.  A subpopulation is the per-protocol population, consisting of subjects that have an 
implanted device, and have not violated the anatomical or procedural IFU criteria.  Standardized training 
and baseline imaging review should prevent the enrollment of subjects who would be considered off 
protocol. The primary 1-year (i.e. late) endpoint requires evaluable subjects, so completed cases (subjects 
who have enough information to be evaluated at 1 year) comprise an additional way to stratify the 
population.  ChEVAS Roll-In subjects may be evaluated as a separate group for investigational purposes.  
The analysis is only meant to provide information as to the presence and extent of a learning curve and 
makes no impact to the method that will be utilized to evaluate the primary study endpoints.  Subjects who 
initially consent but then withdraw prior to the procedure will not be included in any analysis.     
 
An external Core Lab will be used for this study. The Core Lab will be responsible for reading both 
screening and follow-up scans provided by the sites. Their findings and measurements will be recorded into 
the Electronic Data Capture (EDC) system. The results from the Core Lab will be used in the assessment 
for device-related findings, including endoleaks, aneurysm enlargement, gutters, kinking, and stent 
fractures. Occlusion will be primarily reported by the site due to a clinical finding (e.g., claudication) and 
confirmed via angiogram with the subject in the operating theater (i.e., utilizing CT scan results would 
under-report this event). 
 
 
 
10 Secondary ChEVAS does not count as prior ChEVAS experience 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 40 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
4.2 
END OF STUDY DEFINITION 
 
A clinical trial is considered completed when the last participant’s last study visit has occurred or the final 
subjects have reached the end of the 5-year window with no follow-up (which would count as a missed 
visit).  Any subject who passes the end of the 5-year follow-up window may be exited from the trial with 
appropriate documentation shows diligence on the part of the site to bring the subject in for their visit within 
window. 
 
A subject has completed the trial after the Year 5 visit has been completed and all protocol required data 
has been collected.     
 
A subject may withdraw consent at any time.  At the discretion of the Investigator, the subject may be exited 
from the trial at any time with required documentation.   
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Adults at least 18 years old;  
2. Subject provided informed consent;  
3. Subject agrees to all follow-up visits; 
4. 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. Adequate iliac/femoral access compatible with the required delivery systems 
6. Aneurysm blood lumen diameter ≤60mm; 
7. Proximal non-aneurysmal aortic neck: length11 15mm; diameter12 19 to 29mm for one visceral 
vessel repair, 19-30mm for two visceral vessels repair, 22-31mm for three visceral vessels repair; 
angle (β) 60° to the aneurysm sac;  
8. Absence of significant cranial angulation of the visceral vessels that would preclude vessel 
cannulation and stenting 
9. Proximal end of target landing zone to each hypogastric artery length 100mm; 
10. Proximal end of target landing zone to the bifurcation length ≤185mm; 
11. Renal artery diameter 5-9mm (if targeted to be stented); 
12. Superior mesenteric artery diameter 5-9mm (if targeted to be stented); 
13. Common iliac artery lumen diameter between 9 and 35mm outside the distal seal zone; 
14. Distal iliac artery seal zone with length of ≥10mm and diameter13 range of 9 to 25mm;  
15. Ability to preserve at least one hypogastric artery; 
 
 
11 The length from the proximal end of target landing zone to a point distally where the inner vessel wall to wall diameter increase 
is 10% and within the proximal neck diameter range.  The proximal end of target landing zone is below the celiac for SMA and 
bilateral renal arteries repair, below the SMA for bilateral renal arteries repair, and below the proximal renal artery for distal renal 
artery repair. 
12 The proximal non-aneurysmal aortic neck diameter is determined by inner vessel wall to wall measurement. 
13 The inner vessel wall to wall diameter of the iliac artery at the intended sealing zone. 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 41 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
16. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.40. 
17. Suitable anatomy of the thoracic aorta and great vessels allowing for upper extremity access to 
the visceral vessels; 
18. Suitable anatomy of the paravisceral segment of the abdominal aorta allowing for visceral vessel 
cannulation and stent implantation.  
 
5.2 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Life expectancy <2 years as judged by the Investigator;  
2. Requirement of home oxygen;                                                                                
3. Psychiatric or other condition that may interfere with the study;  
4. Participating in another clinical drug and/or device study, which could confound the results of 
this study (patient must have completed the primary endpoint of any previous study at least 30 
days prior to enrollment in this study); 
5. Known allergy or contraindication to any device material, contrast, or anticoagulants; 
6. Body habitus or other medical condition which prevents adequate fluoroscopic and CT 
visualization of the aorta; 
7. Systemic infection which may increase risk of endovascular graft infection; 
8. Coagulopathy or uncontrolled bleeding disorder;  
9. Ruptured, leaking or mycotic aneurysm;  
10. Serum creatinine level >1.8mg/dL;  
11. CVA or MI within three months of enrollment/treatment;  
12. Aneurysmal disease of the descending thoracic aorta;  
13. Prior renal transplant; 
14. Prior stent in any target visceral vessel, the aorta or iliac artery that may interfere with delivery 
system introduction or stent placement; 
15. Significant occlusive disease (stenosis >75%), calcification, or tortuosity of visceral vessels (if 
stented); 
16. Significant mural thrombus and/or calcification within the proximal landing zone of the non-
aneurysmal neck that can compromise the seal;  
17. Landing zone in any visceral vessel14 < 10mm (if stented) 
18. Connective tissue diseases (e.g., Marfan Syndrome); 
19. Unsuitable vascular anatomy that may interfere with device introduction or deployment;  
20. Pregnant, planning to become pregnant within 60 months, or breastfeeding. 
 
5.3 
SCREEN FAILURES 
 
Candidates who are consented to the trial, meet inclusion criteria, and do not meet any exclusion criteria 
will be considered a potential study subject.  Subjects may be screen failed from the trial for any reason 
during the screening process.  A subject is not considered enrolled until a ChEVAS System catheter is 
inserted in the subject.  Once enrolled, subjects will be followed according to this protocol.  The reasons 
for screen failures and all study exits must be reported on the case report form. 
 
 
 
14 Landing zone is defined as the segment of a visceral vessel to be stented that does not include a significant branch artery 

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Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 43 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
arteries. The Nellix EndoBags are then filled with polymer, which conforms around the branch stents and 
aortic vessel wall, thereby creating a seal to exclude blood flow to the aneurysm sac. The Nellix stents form 
lumens through which blood flows to the distal limbs and vasculature and the branch stents maintain blood 
flow to the visceral arteries. The EndoBags with cured polymer exclude the aneurysm from blood flow, 
preventing aneurysm pressurization and rupture. This seals the entire anatomy from the proximal end of 
target landing zone to the iliac arteries with a distal seal zone (Figure 9). 
 
 
FIGURE 9: CHEVAS SYSTEM15 WITH BRANCH STENTS IN A 3-VESSEL REPAIR 
 
The Nellix System is identical to the Nellix System currently approved in the EVAS2 study via 
G130005/S020 and G130005/S030. There are no changes required to the design or components of the 
Nellix System for use as part of the ChEVAS System. 
 
The ChEVAS System consists of the following components:  
• 
Nellix EndoVascular Aneurysm Sealing System (Nellix System) 
• 
Ovation iX Iliac Limb and Iliac Extension Stent Grafts (as needed) 
• 
Verta Self-Expanding Branch Stent Graft System (Verta System) 
 
Each of these are discussed in further detail in the subsequent sections.  
Additionally, optional adjunctive stents may be used, as described in Section 6.5 below. 
 
6.2 
NELLIX SYSTEM 
 
 
15 Note: Ovation iX Iliac Limb and Iliac Extension Stent Grafts are not pictured in Figure 9. 

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Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 45 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
FIGURE 10: NELLIX 3.5 DELIVERY CATHETER 
 
Figure Legend 
1. Sheath handle 
2. Sheath-handle locking knob 
3. Catheter handle 
4. Hemostasis valve and guidewire lumen 
5. EndoBag fill-line knob 
6. EndoBag fill line 
7. Stent balloon inflation line 
8. Angiographic line with stopcock 
9. Sheath-handle angiographic line and flush port 
10. Outer sheath, 17 Fr outside diameter (OD) 
11. Balloon (shown expanded inside EndoBag) 
12. EndoBag (shown expanded) 
13. AngioTip 
14. Lockwire 
15. Sheath stopper 
16. Inner core 
17. Outer sheath length: 45 cm (nominal) 
18. Working length: 50 cm (nominal) 
19. Overall length: 99 cm (nominal) 
 
The delivery system is comprised of the following features/sub-assemblies: 
• 
Outer Sheath: The outer sheath has a 17 Fr OD profile and is made from stainless steel braid 
reinforced PEBAX® with a hydrophilic coating. It is mated with the AngioTip to provide 
atraumatic delivery through the vasculature. The sheath handle is used to retract the sheath 
exposing the implant and includes a knob to secure the sheath handle to the delivery system 
to provide device stability. The sheath injection port allows for device preparation as well as 
retrograde angiography if desired. 
• 
Angiographic Line: The angiographic central lumen, through which the guidewire passes, and 
the tip of the catheter are designed to allow contrast medium to be injected through the 
catheter, proximal of the implant without the need of a separate angiographic catheter to image 
the aorta near the renal arteries and provide an image of the anatomy. 
• 
Fill Line: The polymer filling system is a coaxial tubing system that is comprised of an outer 
and inner fill tube. The outer fill tube attaches to the iliac end of the implant and terminates at 
the handle. The inner fill tube is positioned inside of the outer fill tube with the tip ending 
inside of the EndoBag and terminating at the handle. The inner lumen is used for the primary 
filling procedure. The inner fill tube is removed from the device at the end of the procedure 
before device removal. The outer fill tube provides added support for the inner fill tube and 

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Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 52 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
 
Any unused investigational devices must be returned to Endologix after completion of the procedure. 
Waybills for return are included in all packages. 
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
 
If an attempt is made to insert one of the ChEVAS System catheters into the subject, the subject is 
considered enrolled.  If the procedure is aborted subsequent to the attempted insertion, the case will be 
considered a technical failure.  The subject will be exited from the study after having completed 30 days of 
follow-up and recording of all adverse events up until 30 days.  A 30-day CT on such a subject is not 
required. 
 
If a subject in Converted to Open Repair at any time during the study, the subject will be exited from the 
study after 30 days of follow-up post-surgery.  
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request.  The investigator 
should make it clear to participants that regular follow-up visits are strongly recommended, regardless of 
study participation, as the subject will still have an implanted investigational device. 
 
An investigator may discontinue or withdraw a participant from the study for the following reasons: 
• 
Significant study intervention non-compliance  
• 
If any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
participant. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded on the Exit CRFs. 
Subjects who sign the informed consent form, and receive the study intervention, and subsequently 
withdraw, or are withdrawn or discontinued from the study, will not be replaced. 
 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if he or she fails to return for 2 scheduled visits and is 
unable to be contacted by the study site staff.  
 
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 
• 
The site will attempt to contact the participant and reschedule the missed visit and counsel the 
participant on the importance of maintaining the assigned visit schedule and ascertain if the 
participant wishes to and/or should continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every effort 
to regain contact with the participant (where possible, 3 telephone calls and, if necessary, a certified 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 53 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
letter to the participant’s last known mailing address or local equivalent methods). These contact 
attempts should be documented in the participant’s medical record or study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
SCREENING 
 
The site begins the screening process by obtaining informed consent from the patient.  The site must ensure 
they are using the correct IRB approved version of the informed consent and are following their informed 
consent process.  After obtaining informed consent for the patient, the site records the informed consent 
date in the Electronic Data Capture System (EDC), and then completes the inclusion/exclusion CRF page 
(this might also involve a serum pregnancy test if the subject is a female of childbearing potential).   The 
site then submits the patient’s CTA to the Core Lab, which can be done either electronically, or via mail.  
The site may now enter the Demographics & Vascular Characteristics (including vitals and serum 
creatinine) and Medical History information into the EDC. 
 
The Core Lab reviews the CTA for anatomical inclusion/exclusion criteria conformity.  If the subject does 
not pass this step the subject is dropped from further consideration. If the subject passes Core Lab, the 
subject is referred to the Case Review Board (CRB) for further evaluation. 
 
The CRB reviews the case for overall trial suitability.  The CRB may also make procedural 
recommendations to the Site.  If the CRB recommends the subject for the study, the subject is approved for 
implantation.   
 
Reasons for subject exclusions (Core Lab or CRB), along with any CRB procedural recommendations, will 
be captured and reported. 
 
8.2 
CASE REVIEW BOARD (CRB) 
 
The Case Review Board consists of clinicians in the fields of vascular disease or radiology that have 
experience in the treatment of subjects with abdominal aortic aneurysm (AAA) and experience with the 
Nellix device.  The CRB will evaluate clinical and anatomical criteria of each subject, as appropriate, 
and give advice regarding technical aspects of the procedure.  The CRB may also recommend/require 
procedural steps. 
 
8.3 
SCHEDULE OF ACTIVITIES 
 
Implantation  
The subject is enrolled into the study upon the first attempt to insert the Nellix catheter into the patient. The 
subject is treated with the ChEVAS System, following the IFU. Procedural data is collected, including 
concomitant procedures, and device accountability information. 
 
Discharge 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 54 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
Upon discharge of the subject from the hospital, ward stay information is collected, along with creatinine 
levels, blood pressure, and medications. 
Follow-up visits (30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years) 
The site will schedule and conduct a clinical visit with each subject within the required follow-up visit 
windows (Table 4), where vitals will be collected. Required imaging and labs must also be conducted 
during the required visit window. The required imaging and labs include: 
• 
CT with contrast (CTA), 3mm slice thickness maximum 
o Note: In cases of renal insufficiency, CT without contrast (3mm slice thickness maximum) 
and a duplex ultrasound may be conducted instead of the CTA 
• 
X-ray (30-day, 1 year, 3 year and 5 year): 2-view abdominal (left and right oblique) 
• 
Serum Creatinine 
In addition to imaging, at each follow-up visit, medication categories will be collected, along with Adverse 
Event collection and assessment 
 
The following table (Table 4) shows the required visit schedule.  Subjects must have their required scans, 
visits, and labs completed within the given time frames. 
 
TABLE 4 : VISIT WINDOW SCHEDULE 
Visit 
Beginning of 
visit window 
Target Day 
End of Visit 
Window 
1 Month 
16 
30 
44 
6 Month 
150 
180 
210 
1 Year 
305 
365 
425 
2 Years 
640 
730 
820 
3 Years 
1005 
1095 
1185 
4 Years 
1370 
1460 
1550 
5 Years 
1735 
1825 
1915 
 
 
8.4 
SAFETY AND OTHER ASSESSMENTS 
 
Information collected at the following procedures/evaluations, as applicable: 
• 
Physical examination Including weight, blood pressure, medication assessment. If patient 
exhibits potential neurological change, the patient will undergo an mRS exam for endpoint 
analysis 
• 
Blood Laboratory Analysis Including Serum Creatinine, eGFR (calculated) 
• 
Contrast-enhanced CT scan: imaging requirements include slice thickness of ≤3mm; axial, 
coronary, sagittal views. To ensure consistency, below are the requirements for CT acquisition: 
o Only high resolution, contrast-enhanced spiral CT scans are acceptable. Sites are required 
to use radiation reduction techniques 
o Data must be uncompressed 
o Preferred maximum slice spacing is 2mm. In no case should it exceed 3mm 
o 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. 
o 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. 
 

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Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 61 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
following initial successful endovascular treatment for any reason. Conversion to Open Repair 
shall always be captured as a re-intervention 
• 
Distal Ischemia – New onset of compromised peripheral blood flow resulting in femoral or 
peripheral arteria 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 
• 
Endoleak – Clear evidence of contrast outside of one or both EndoBags, which communicates 
with the aneurysm sac 
o Type Ia – originating proximally at the infrarenal segment 
o Type Ib – originating distally 
o Type Ic – originating at a chimney stent (visceral vessel) 
o Type II – originating from a patent lumbar artery, inferior mesenteric artery, or other 
collateral visceral vessel 
o Type III – between components, if an extender is used 
o Type IV – trans-device  
• 
Gutters – – Clear evidence of contrast outside of one or both EndoBags, which does not 
communicate with the aneurysm sac 
• 
Implant Occlusion – Radiological finding indicating 100% blockage of device lumen 
• 
Luminal Thrombus – endograft thrombosis resulting in any endovascular or surgical intervention 
after completion of the Nellix system implantation 
• 
Migration – CoreLab reported individual stent distal movement >5mm from the original implant 
location relative to the center of the distal renal artery 
o Clinically Significant Migration – CoreLab reported distal movement >10mm from the 
original implant location relative to the center of the distal renal artery resulting in an 
intervention or serious complication  
• 
Secondary Procedure – any non-diagnostic surgical intervention after the index procedure 
intended to correct or repair any site reported endoleak, gutters, device occlusion, migration, 
aneurysm sac expansion and/or a device defect, including infection  
• 
Stent Thrombosis – Blood clot that results in stenosis or occlusion of a stent 
• 
Thromboembolic Event – Blood clot that has broken loose and is carried distally 
 
8.6 
UNANTICIPATED ADVERSE DEVICE EFFECTS 
8.6.1 DEFINITION OF UNANTICIPATED ADVERSE DEVICE EFFECTS (UADES) 
 
A 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, or degree of incidence in the investigational plan or application (including a supplementary plan 
or application), or any other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects (21 CFR 812.3(s)). 
 
The reporting of UADEs applies to non-exempt human subjects’ research conducted or supported by HHS. 
Provide the definition of an UADE being used for this clinical trial. An incident, experience, or outcome 
that meets the definition of an UADE generally will warrant consideration of changes to the protocol or 
consent in order to protect the safety, welfare, or rights of participants or others. Other UADEs may warrant 
corrective actions at a specific study site. Examples of corrective actions or changes that might need to be 
considered in response to an UADE may include: 

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Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 63 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
composite endpoint is statistically significantly less than the performance goal of 0.25.  This is discussed 
further in the SAP. 
 
Primary 1-Year Endpoint 
 
The primary 1-year endpoint is defined as freedom from abdominal aortic aneurysm rupture and aneurysm-
related mortality through 1 year (day 365), freedom from imaging-related findings in the 1-year window 
(Type or III endoleak, migration > 10 mm, AAA sac expansion > 5 mm, and occlusion within the ChEVAS 
System not seen at the index procedure), and open conversions and other major device-related interventions 
through day 365.  The primary 1-year analysis will compare the treatment success composite to a target 
performance goal of 75%.  The null and alternative hypotheses are defined below. 
H0:  π ≤ 0.75   vs. H1:  π > 0.75 
where π = the proportion of treated patients who meet the Treatment Success definition.  A univariate test 
will be performed to determine if the frequency of subjects who meet the treatment success definition is 
statistically significantly higher than the performance goal of 0.75.  This is discussed further in the SAP. 
 
9.2 
SAMPLE SIZE DETERMINATION 
 
The number of patients enrolled into this study is driven by the performance goals, expected device 
performance, and requirements for the alpha error and power. Due to the decrease in number of evaluable 
subjects at 1 year, the size of the study is determined entirely by the 1-year primary endpoint.  Given a 
minimum power requirement of 80%, alpha=0.05, target goal=75%, estimated 1-year performance of 
85.7%, and the univariate binomial test plan, a minimum evaluable sample size of 103 is needed.  
Accounting for an approximate drop-out rate of 14%, 120 subjects would be needed to achieve the 
minimum power and alpha requirements.  The 1-month endpoint assumes a target goal of 25%, estimated 
performance of 14.5%, and a similar univariate binomial test structure.  Given that all 120 subjects will be 
analyzed for the primary 1-month endpoint, the 1-month endpoint has power of 85.6%.  This is described 
further in the SAP. 
9.3 
POPULATIONS FOR ANALYSES 
 
The Primary analysis will be conducted on the implanted population within the ChEVAS Roll-In and 
Pivotal cohorts.  The Intention-to-Treat paradigm is not applied here as this is conventionally applied to 
two-armed randomized studies.  Rather, all subjects receiving an implant are analyzed for the endpoint.  
The primary 1-year endpoint requires evaluable subjects, so completed cases (subjects who have enough 
information to be evaluated at 1 year) comprise an additional way to stratify the population.  A 
subpopulation is the per-protocol population, consisting of subjects that have an implanted device, and have 
not violated the anatomical or procedural IFU criteria.  Details of populations are explained further in the 
SAP. 
 
9.4 
STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 64 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
Analysis depends on the variable type.  For nominal variables, summary statistics will include counts and 
proportions.  Exact confidence limits for binomial variables will be given when they aid in understanding 
the results.  Comparisons will be made with Fisher’s Exact Test for 2x2 tables, and the extension of the test 
(Fisher-Freeman-Halton) when more than 2 categories exist. For continuous variables, summary statistics 
will be presented including means (or medians for non-normal distributions), standard deviations (or 
quartile estimates for non-normal distributions), and range.  Quantitative comparisons of demographics and 
vascular variables between sites will be performed by 2-sided F-tests.  Unless otherwise specified, the exact 
form of each algorithm will be the default of SAS version 9.4 or later (SAS Institute, Cary, NC).   
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
The components that go into the endpoints and the methodology of their analysis are detailed thoroughly 
in the SAP. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
There will be no formal statistical testing of secondary endpoints.  However, the imaging-driven outcomes 
(migration and sac enlargement) will be evaluated at the 2nd year using a one-sided 95% exact confidence 
interval.  Please refer to the SAP for additional details. 
9.4.4 SAFETY ANALYSES 
 
As mentioned, prior, there is no specific endpoint dedicated solely to safety.  Both primary endpoints will 
be evaluated, and each contains information regarding safety.  Additional analyses regarding major adverse 
events will be presented in a descriptive fashion.  Adverse events will be tabulated per their system organ 
class and presented descriptively.  Please refer to the SAP for additional details. 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
Demographic and baseline characteristics such as medical history and vascular characteristics will be 
descriptively summarized.  A set of important demographic or prognostic variables will be compared across 
study sites to determine homogeneity of sites in terms of baseline subject characteristics.  Nominal variables 
will be tested via Fisher-Freeman-Halton test, and continuous variables will be tested via the F-test.  Please 
refer to the SAP for detailed descriptions of these variables. 
9.4.6 PLANNED INTERIM ANALYSES  
 
No interim analyses are planned.  The Data Safety Monitoring Board (DSMB) analyses that will be 
conducted are considered routine and descriptive in nature, and do not include any hypothesis testing.   
9.4.7 SUB-GROUP ANALYSES 
 
The primary endpoints will be stratified by juxtarenal, pararenal, and paravisceral aneurysm subtype and 
tabulated.  These analyses will be descriptive in nature and no statistical tests will be performed on the 
groups. 
 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 65 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
The primary endpoints will be stratified by gender and tabulated.  These analyses will be descriptive in 
nature and no statistical tests will be performed on the gender groups.  In addition, the primary endpoints 
will also be stratified on geography (US vs OUS).  Again, these will be descriptive in nature. 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
Subject-level listings will be presented to support the information presented in tables.  This includes the 
analyses covered in the SAP.   
9.4.9 EXPLORATORY ANALYSES 
 
If site-to-site differences are noted, baseline risk factors will be explored to evaluate for the presence of 
possible contributors.  No other exploratory analyses are planned. 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
 
In obtaining and documenting informed consent, the investigator must comply with applicable regulatory 
requirements (e.g., 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56) and should adhere to ISO 14155 and 
ICH GCP. Prior to the beginning of the trial, the investigator should have the IRB’s written approval for 
the protocol and the written informed consent form(s) and any other written information to be provided to 
the participants.  
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED 
TO PARTICIPANTS 
 
The consent form will describe in detail the study intervention, study procedures, risks given to the 
participant. Written documentation of informed consent is required prior to enrollment in the study.   
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
The informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be Institutional 
Review Board (IRB)/ Ethics Committee (EC)-approved and the participant will be asked to read and review 
the document. The investigator will explain the research study to the participant and answer any questions 
that may arise. A verbal explanation will be provided in terms suited to the participant’s comprehension of 
the purposes, procedures, and potential risks of the study and of their rights as research participants.  
Participants will have the opportunity to carefully review the written consent form and ask questions prior 
to signing. The participants should have the opportunity to discuss the study with their family or surrogates 
or think about it prior to agreeing to participate. The participant will sign the informed consent document 
prior to enrollment in the study. Participants must be informed that participation is voluntary and that they 
may withdraw from the study at any time, without prejudice. A copy of the informed consent document 

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Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 67 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
and the sponsor(s) and their interventions. This confidentiality is extended to cover testing of biological 
samples in addition to the clinical information relating to participants. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict confidence. No information 
concerning the study, or the data will be released to any unauthorized third party without prior written 
approval of the sponsor.  
 
All research activities will be conducted in as private a setting as possible. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the Institutional 
Review Board (IRB), regulatory agencies or pharmaceutical company supplying study product may inspect 
all documents and records required to be maintained by the investigator, including but not limited to, 
medical records (office, clinic, or hospital) and pharmacy records for the participants in this study. The 
clinical study site will permit access to such records. 
 
Study participant de-identified research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored in the IBM eClinicalOS database system.  This will not include 
the participant’s contact or identifying information. Rather, individual participants and their research data 
will be identified by a unique study identification number. The study data entry and study management 
systems used by clinical sites and by Endologix research staff will be secured and password protected. At 
the end of the study, all study databases will be de-identified and archived.  Sites are responsible for 
ensuring that source medical data, when required for Adverse Event analysis by the sponsor, is de-identified 
prior to uploading to the database. 
 
This study makes use of an independent core lab, for the purpose of reviewing Computerized Tomography 
(CT) scans.  If the scans are uploaded by the sites through the AgMedNet system, that system will 
automatically de-identify the films prior to the core lab receiving the data.  If the scans are sent via mail, 
without the site de-identifying the film, the independent core lab may also have visibility to personal 
identifying information.  In this case, the core lab, prior to making the film available to the sponsor, will 
de-identify the scans.  The sponsor will therefore, regardless of the method of transmission, not have access 
to identifying information from CT or other scanning medical data. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as long 
a period as dictated by the reviewing IRB, Institutional policies, or sponsor requirements. 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 68 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
10.1.4 KEY ROLES AND STUDY GOVERNANCE 
 
Function 
DSMB & CEC 
Core Lab 
Company Name 
 
 
 
Contact Name 
 
 
Address 
 
 
 
 
  
Phone Number 
 
 
Email 
 
 
 
Function 
EDC 
Monitoring 
Company Name 
 
 
Contact Name 
 
 
Address 
 
 
 
 
Phone Number 
 
 
Email 
 
 
10.1.5 SAFETY OVERSIGHT 
 
All adverse events (AEs) will be reviewed by the Endologix Safety Representative or qualified personnel. 
Assessments on device and procedure relationships, event classification, potential for adjudication and any 
additionally required assessments will be made each business day by a qualified Safety representative.  
 
Information to be collected will include classifications and coding as appropriate, dates of onset, assessment 
of severity and serious adverse event (SAE) potential, action taken, outcome, as well as further details on 
the clinical presentation or management of the event. If required, queries to the sites will be placed to clarify 
or confirm information, and if required, source documents will be requested for review. 
 
In the instance of endpoint events or events of special interest, independent review will be performed by 
the Clinical Events Committee (CEC), comprised of 3 independent physicians who have significant 
experience in the disease space and therapy. The CEC will provide an independent review and adjudication 
of adverse events identified by the study team. CEC adjudicable events will be identified in the CEC Charter 
including, but not limited to: 
 
• 
All Serious Adverse Events with a potentially positive (possible, probable, or definite) device 
relationship. 
• 
All events resulting in a secondary intervention 
• 
All aneurysm ruptures 
• 
All deaths, regardless of cause 
• 
All events that may potentially be considered a Major Adverse Event (MAE) 
 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 69 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
The CEC will convene a minimum of once a quarter. CEC activities will be managed by Syntactx, Inc. and 
results will be provided to the Data Safety and Monitoring Board (DSMB).  
 
The DSMB, comprised of 4 independent physicians and a biostatistician (none of them may be members 
of the CEC), will review aggregate study data at regular intervals to ensure patient safety across all sites in 
the study. The DSMB will convene at a minimum after 30-day follow-up data are collected on the 30th, 60th, 
90th, and final patient enrollment. All available clinical data on the study subjects (out to all time points) 
will be provided to the DSMB. Ad-hoc meetings and analyses may be called by the Sponsor or the DSMB 
at any point.  
 
The DSMB will provide their recommendations on study conduct as per their review of the study data at 
Meetings. The recommendations will include but not be limited to, modifications to the protocol, 
suspension or termination of enrollment, modification of inclusion/exclusion criteria, modification of 
follow-up scheduling or assessments, or no recommendations on modification. The decision to implement 
any DSMB recommendations lies solely with the Sponsor.   
 
Events will be followed for outcome information until resolution or stabilization. 
 
For additional training and risk mitigation, all roll-in subjects will have a proctor (physician with prior 
relevant experience) present during the procedure. 
10.1.6 CLINICAL MONITORING 
 
Clinical site monitoring is conducted to ensure that the rights and well-being of trial participants are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial 
is in compliance with the currently approved protocol/amendment(s), with International Conference on 
Harmonization Good Clinical Practice (ICH GCP), any local IRB/EC conditions imposed, the signed 
Clinical Trial and Investigator Agreements,  and with applicable national and local regulatory requirements.  
 
 Endologix staff and designees will monitor the study in accordance with Standard Operating Procedures 
(SOP) and a study specific clinical monitoring plan (CMP). The CMP uses a risk-based approach.  It 
includes who will conduct the monitoring, at what frequency monitoring will be done, at what level of detail 
monitoring will be performed, and the review and distribution of monitoring reports.  The CMP focuses on 
preventing or mitigating important and likely risks to data integrity and compliance. The types of 
monitoring visit (e.g., on-site, centralized), frequency, and extent of source document verification (SDV).  
Considerations during the risk assessment, including the complexity of the study design, types of study 
endpoints, clinical complexity of the study population, geography, relative experience of the PI and of the 
sponsor with the PI, electronic data capture, relative safety of the study intervention, stage of the study, 
quantity of data, and related study processes. 
 
The CMP for ChEVAS will include 100% SDV for primary endpoints.  The frequency of onsite visits will 
be determined by study enrollment, adverse event rates, and other compliance considerations such as 
protocol deviations and study record keeping.   

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 70 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
10.1.7 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Endologix will send a Case Specialist out for each implant case during enrollment. The Case Specialist will 
verify that all expiration dates are correct and check the device while being opened. If the device is unable 
to be used for some reason, the Case Specialist will return the device to the Sponsor. 
 
Each participating site is expected to maintain appropriate medical and research records for this trial, in 
compliance with ICH GCP and regulatory and institutional requirements for the protection of 
confidentiality of participants. A monitor will be on site four to six weeks after initial implant for each site 
to verify all subject source and regulatory documents (e.g. Device Accountability Log, training logs, 
Delegation of Authority log, etc). A quality verification of the data entered into the Electronic Data Capture 
system will be part of this process.  
 
Investigators are responsible for maintaining accurate, complete and current records pertaining to 
correspondence, device accountability, individual subject case history including informed consent. Reports 
of any IRB/EC withdrawal, unanticipated adverse device effects, deviations from the protocol, use of a 
device without obtaining subject consent, as well as progress reports to the IRB/EC (annually at minimum) 
are also the responsibility of the investigator.  
 
Endologix retains the right to terminate the study and remove all study materials from the investigational 
site at any time. Specific instances, which may precipitate study termination are:  
• 
Unsatisfactory subject enrollment  
• 
Deviations from protocol, without prior approval from Endologix 
• 
Inaccurate, incomplete and/or untimely data recording on a recurrent basis. 
• 
The incidence and/or severity of adverse experiences in this or other studies indicating a potential 
health hazard caused by the device. 
• 
Submission of fraudulent data 
10.1.8 DATA HANDLING AND RECORD KEEPING  
10.1.8.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Each participating site will maintain appropriate medical and research records for this trial, in compliance 
with ICH GCP and regulatory and institutional requirements for the protection of confidentiality of 
participants.  As part of participating in IDE Pivotal study, each site will permit authorized representatives 
of the sponsor, and regulatory agencies to examine (and when permitted by applicable law, to copy) clinical 
records for the purposes of quality assurance reviews, audits, and evaluation of the study safety, progress, 
and data validity. All documents that are copied, sent, or uploaded into electronic data capture (EDC) 
system must be redacted of any study subject identifiable personal information except the study assigned 
subject identification. All study documents must be archived per their institutional procedures during 
conduct and after closure of the study.  
 
The data management or their designee is responsible for design of case report forms to collect study data, 
electronic data capture database development, validation, control and management of input from study 
sites/monitored data, maintenance, and reporting for statistical analysis. The EDC system will be developed 
on IBM Clinical Development “eClinicalOS” system, an FDA part 11 compliant platform. A detailed 
clinical data management plan (DMP) will be developed for this study per Endologix procedures CWI-096, 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 71 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
CWI-097 and CWI-099. The DMP will define roles that will have access to the clinical study data in the 
EDC, responsibilities, the EDC system design, study update, and validation process, data query / edit check 
types and the handling of them, data entry/correction, source data verification, quality control, data 
cleaning, ad hoc and final EDC closure processes.  The DMP will be kept in the Sponsor Trial Master File. 
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of 
data. 
 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant enrolled in the study.  Data recorded in the electronic case report form 
(eCRF) derived from source documents should be consistent with the data recorded on the source 
documents.  
 
Clinical data (including adverse events (AEs), concomitant medications, and expected adverse reactions 
data) and clinical laboratory / Corelab data will be entered into EDC by the sites. The data system includes 
password protection and internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source documents. 
 
Source data are all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial.  Electronic source data are data 
initially recorded in electronic form. Examples of source data include, but are not limited to, hospital 
records, clinical and office charts, laboratory notes, memoranda, participants’ memory aids or evaluation 
checklists, pharmacy dispensing records, audio recordings of counseling sessions, recorded data from 
automated instruments, copies or transcriptions certified after verification as being accurate and complete, 
microfiches, photographic negatives, microfilm or magnetic media, x-rays, and participant files and records 
kept at the pharmacy, at the laboratories, and medico-technical departments involved in the clinical trial. In 
the event that device-specific information is not regularly recorded within the hospital medical record, study 
worksheets may be used to record the information.  Any such worksheet must be kept within the study files.  
In all cases, the primary source document is considered the medical record. 
 
It is not acceptable for the CRF to be the only record of a participant’s inclusion in the study.  Study 
participation should be captured in a participant’s medical record.  This is to ensure that anyone who would 
access the patient medical record has adequate knowledge that the patient is participating in a clinical trial. 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 72 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
10.1.8.2 STUDY RECORDS RETENTION  
 
Study documents should be retained for a minimum of 2 years after the last approval of a marketing 
application in an International Conference on Harmonization (ICH) region and until there are no pending 
or contemplated marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study intervention. These documents should be 
retained for a longer period, however, if required by local regulations. No records will be destroyed without 
the written consent of the sponsor, if applicable. It is the responsibility of the sponsor to inform the 
investigator when these documents no longer need to be retained. 
10.1.9 PROTOCOL DEVIATIONS  
 
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on 
Harmonization Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, Sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, Section 5.1.1  
• 
5.20 Noncompliance, Sections 5.20.1, and 5.20.2.  
 
It is the responsibility of the site investigator to use continuous vigilance to identify and report deviations 
within 5 working days of identification of the protocol deviation, or within 5 working days of the scheduled 
protocol-required activity.  All deviations must be addressed in study source documents.  Protocol 
deviations must be sent to the reviewing Institutional Review Board (IRB) per their policies. The site 
investigator is responsible for knowing and adhering to the reviewing IRB requirements. 
 
10.1.10 
CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical.  Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a way 
that is appropriate to their participation in the design and conduct of this trial.  Financial Disclosures will 
be collected from all investigators in the trial.  
 
The cost of the device in the study does not constitute commercialization as defined in 21 CFR 812.7(b). 
 
10.2 ABBREVIATIONS 
 
The list below includes abbreviations utilized in this template.  However, this list should be customized for 
each protocol (i.e., abbreviations not used should be removed and new abbreviations used should be added 
to this list). 
 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 73 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
AAA 
Abdominal Aortic Aneurysm 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
ASA 
American Society of Anesthesiologists 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CTA 
Coronary Computed Tomography Angiography 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
eGFR 
Estimated Glomerular Filtration Rate 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ISO 
International Organization for Standardization 
ITT 
Intention-To-Treat 
LSMEANS Least-squares Means 
MAE 
Major Adverse Event 
MI 
Myocardial Infarction 
MOP 
Manual of Procedures 
MSDS 
Material Safety Data Sheet 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
Protocol CP-0015 Rev. 01 
The Complex AAA Study 
13 September 2019    
 
Page 74 of 82 
Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SDV 
Source Document Verification 
SMA 
Superior Mesenteric Artery 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
11 REFERENCES  
 
CP-0008 – Nellix US IDE for Infra-renal indication (ongoing) 
 
12 BIBLIOGRAPHY 
 
 
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2 A comparative study of the prevalence of abdominal aortic aneurysms in the United Kingdom, Denmark, 
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3 Svensjo S, Bjorck M, Gurtelschmid M, Djavani Gidlund K, Hellberg A, Wanhainen A. Low prevalence 
of abdominal aortic aneurysm among 65-year-old Swedish men indicates a change in the epidemiology of 
the disease. Circulation 2011;124:1118-23. 
4 Forsdahl SH, Singh K, Solberg S, Jacobsen BK. "Risk factors for abdominal aortic aneurysms: a 7-year prospective 
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5 Kent KC, Zwolak RM, Egorova NN, et al. "Analysis of risk factors for abdominal aortic aneurysm in a cohort of 
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6 Salem MK, Rayt HS, Hussey G, et al. "Should Asian men be included in abdominal aortic aneurysm 
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7 Abdominal Aortic Aneurysm. n.d. 2 February 2017. 
<http://www.nhs.uk/Conditions/repairofabdominalaneurysm/Pages/Introduction.aspx>. 
8 Xu J, Murphy S, Kochanek K, Bastian B, Arias E. "Deaths: Final Data for 2016." Natl Vital Stat Rep 67 
(2018) 
9 Assar AN, Zarins CK. "Ruptured abdominal aortic aneurysm: a surgical emergency with many clinical 
presentations." Postgrad Med J 85 (2009): 268-73. 
10  Bhogal RH, Downing R. "The Evolution of Aortic Aneurysm Repair: Past Lessons and Future 
Directions." Aneurysmal Disease of the Thoracic and Abdominal Aorta. 2011. 21-54. 
11 Poppe JK. "Cellophane treatment of syphilitic aneurysms with report of results in six cases." Am Heart J 
36 (1948): 252-6. 
 

Endologix, Inc.   
 
 
 
 
 
 
 
 
 
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The Complex AAA Study 
13 September 2019    
 
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Confidential. The data and information contained herein is proprietary and confidential and may not be used, 
disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
 
 
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14 Volodos NL, Shekhanin VE, Karpovich IP, Troian VI, Gur'ev IA. "A self-fixing synthetic blood vessel 
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20 Dua A, Kuy S, Lee CJ, Upchurch GR, Jr, Desai SS. "Epidemiology of aortic aneurysm repair in the 
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21 Bush RL, Johnson ML, Collins TC. "Open versus endovascular abdominal aortic aneurysm repair in VA 
hospitals." J Am Coll Surg 202 (2006): 577-87. 
22 Chuter TA. "Durability of endovascular infrarenal aneurysm repair: when does late failure occur and 
why?" Semin Vasc Surg 22 (2009): 102-10. 
23 Participants ET. "Endovascular aneurysm repair versus open repair in patients iwth abdominal aortic 
aneurysm (EVAR 1): randomised controlled trial." Lancet 365 (2005): 2179-86. 
24 Hobo R, Buth J. "Secondary interventions following endovascular abdominal aortic aneurysm repair 
using current endografts." J Vasc Surg 43 (2006): 896-902. 
25 Jacobs TS, Won J, Gravereaux EC. "Mechanical failure of prosthetic human implants: a 10-year 
experience with aortic stent graft devices." J Vasc Surg 37 (2003): 16-26. 
26 Schermerhorn ML, Buck DB, O'Malley AJ. "Long-Term Outcomes of Abdominal Aortic Aneurysm in 
the Medicare Population." N Engl J Med 373 (2015): 328-38. 
27 Chang DC, Parina RP, Wilson SE. "Survival After Endovascular vs Open Aortic Aneurysm Repairs." 
JAMA Surg 150 (2015): 1160-6. 
28 Paravastu SC, Jayarajasingam R, Cottam R, Palfreyman SJ, Michaels JA, Thomas SM. Endovascular 
repair of abdominal aortic aneurysm. Cochrane Database Syst Rev 2014;1:CD004178. 
29 Arko FR, Filis KA, Seidel SA, Gonzalez J, Lengle SJ, Webb R, et al. "How many patients with infrarenal 
aneurysms are candidates for endovascular repair? The Northern California experience." J Endovasc Ther 
11 (2004): 33-40. 
30 Armon MP, Yusuf SW, Latief K, Whitaker SC, Gregson RH, Wenham PW, et al. "Anatomical suitability 
of abdominal aortic aneurysms for endovascular repair." Br J Surg 84 (1997): 178-180. 
31 Carpenter JP, Baum RA, Barker CF, Golden MA, Mitchell ME, Velazquez OC, et al. "Impact of 
exclusion criteria on patient selection for endovascular abdominal aortic aneurysm repair." J Vasc Surg 34 
(2001): 1050-1054. 
 

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disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
 
 
32 Elkouri S, Martelli E, Gloviczki P, McKusick MA, Panneton JM, Andrews JC, et al. "Most patients with 
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37 Aburahma AF, Yacoub M, Mousa AY, Abu-Halimah S, Hass SM, Kazil J, et al. "Aortic Neck Anatomic 
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873-880. 
 

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disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
 
 
66 Kouvelos GN, Oikonomou K, Antoniou GA, Verhoeven ELG, Katsargyris A. “A Systematic Review of 
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76 Kristmundsson T, Sveinsson M, Bjorses K, Tornqvist P, Dias N. "Suitability of the Zenith p-Branch 
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79 Starnes BW. "Physician-modified endovascular grafts for the treatment of elective, symptomatic, or 
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80 Dossabhoy, S. S., J. P. Simons, J. M. Flahive, F. A. Aiello, P. Sheth, E. J. Arous, L. M. Messina and A. Schanzer. 
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81 Qaderi, S. M., N. T. Tran, B. Tatum, J. D. Blankensteijn, N. Singh and B. W. Starnes. "Aortic neck dilation is not 
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82 Georgiadis, G. S., J. A. van Herwaarden, G. A. Antoniou, C. E. Hazenberg, A. D. Giannoukas, M. K. Lazarides 
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83 AbuRahma AF, Campbell J, Stone PA, Nanjundappa A, Jain A, Dean LC, Habib J, Keiffer T, Emmett 
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85 AbuRahma AF, Campbell JE, Mousa AY, Hass SM, Stone PA, Jain A, Nanjundappa A, Dean LS, Keiffer 
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86 Jordan WD, Mehta M, Varnagy D, Moore WM, Arko FR, Joye J, Ouriel K, de Vries JP. “Results of the 
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87 Goudeketting, S. R., J. Wille, D. A. F. van den Heuvel, J. A. Vos and J. P. M. de Vries. "Midterm Single-
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88 Goudeketting, S. R., K. van Noort, J. J. M. Vermeulen, K. Ouriel, W. D. Jordan, Jr., J. M. Panneton, C. 
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90 Goudeketting, S. R., J. Wille, D. A. F. van den Heuvel, J. A. Vos and J. P. M. de Vries. "Midterm Single-Center 
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92 Donselaar, E. J., R. J. van der Vijver-Coppen, L. H. van den Ham, J. W. Lardenoye and M. M. Reijnen. 
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94 Stella, N., R. Ficarelli, R. Dito, D. Brancadoro, M. Rossi and M. Taurino. "A Double Nellix and Chimney 
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96 Stenson, K., B. Patterson, M. J. Grima, J. de Bruin, P. Holt and I. Loftus. "Endovascular aneurysm sealing with 
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99 Boersen JT, Donselaar EJ, Groot Jebbink E, Starreveld R, Overeem SP, Slump CH, et al. "Benchtop 
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101 Dijkstra ML, Lardenoye JW, van Oostayen JA, Zeebregts CJ, Reijnen MM. "Endovascular aneurysm 
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102 Kisis K, Savlovskis J, Gedins M, Ezite N, Zellans E, Krievins D. "Chimney Technique with Nellix 
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103 Malkawi AH, de Bruin JL, Loftus IM, Thompson MM. "Treatment of a juxtarenal aneurysm with the 
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104 Quintas A, Alves G. "Three-vessel Chimney Technique Combined with Endovascular Aortic Sealing 
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106 Varetto G, Castagno C, Quaglino S, Garneri P, Trevisan A, Destro M, et al. "Bailout Chimney Technique 
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107 Garriboli, L. and A. M. Jannello. "Uncovered Chimney Stent Graft for Renal Arteries With the Nellix 
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108 Klonaris, C., A. Katsargyris, D. Athanasiadis and T. Liakakos. "Use of the Nellix Endovascular Aneurysm 
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109 Malaj, A., O. Martinelli, M. Fresilli, V. Picone, A. Giglio, C. Belli, J. Ben Hamida and B. Gossetti. "Treatment 
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110 Youssef M, Dunschede F, El Beyrouti H, Salem O, Vahl CF, Dorweiler B. "Endovascular Repair of 
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111 Youssef M, Zerwes S, Jakob R, Salem O, Dunschede F, Vahl CF, et al. "Endovascular Aneurysm Sealing 
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112 Joseph, S. Z., C. H. R. Kwok, J. A. Hockley, M. W. Garbowski, J. Ferguson, S. Samuelson and S. J. Jansen. "A 
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113 Paraskevas, K. I., M. Karouki, A. Rehman, F. Torella, R. G. McWilliams, A. England and R. K. Fisher. 
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114 Youssef, M., S. Zerwes, R. Jakob, O. Salem, F. Dunschede, C. F. Vahl and B. Dorweiler. "Endovascular 
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115 De Bruin, J. L., J. R. Brownrigg, B. O. Patterson, A. Karthikesalingam, P. J. Holt, R. J. Hinchliffe, I. M. Loftus 
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116 Dinkelman, M. K., S. P. Overeem, D. Bockler, D. E. V. JP and J. M. Heyligers. "Chimney technique in 
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118 Scali, S. T., A. W. Beck, G. Torsello, M. Lachat, P. Kubilis, F. J. Veith, J. T. Lee and K. P. Donas. 
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119 Katsargyris, A., K. Oikonomou, C. Klonaris, I. Töpel and E. L. G. Verhoeven. "Comparison of 
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100(2013): 863-872 
 
 
APPENDICES 
 
APPENDIX 1- EVAS Infrarenal Roll-In Protocol 
 
 
 
 
 

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disclosed, or reproduced with prior written permission from Endologix, Inc. 
 
 
 
 
 
 
 
 
 
 
APPENDIX 1 - EVAS Infrarenal Roll-In Protocol