Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Sponsor: Endologix

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CLINICAL TRIAL PROTOCOL  
CP-0011 REV. 02 
 
 
REVISION 01:  07 JANUARY 2015 
REVISION 02:  29 AUGUST 2021 
 
Multicenter, Observational, Post-Market, Real World Trial to Assess Outcomes of Patients 
Treated with the AFX System compared to other EVAR devices for Endovascular 
Abdominal Aortic Aneurysm Repair  
 
LEOPARD: Looking at EVAR Outcomes by Primary Analysis of Randomized Data 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Number: CP-0011 
 
National Clinical Trial (NCT) Identified Number: NCT02407457 
 
National Principal Investigator: Dr. Christopher Kwolek, MD 
 
 
 
 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
2 
 
 
SUMMARY OF CHANGES FROM PREVIOUS REVISION 
 
Revision 
DCO# 
Date 
Affected 
Section(s) 
Summary of 
revisions made 
Rationale 
02 
21-
0542 
29 August 
2021 
Entire document 
Changed study with 
trial, 
general 
formatting and minor 
adjustments. 
FDA suggestion being a Randomized 
Controlled Trial rather study. 
2 
Changed 
Sponsor 
Contact. 
Provide most up to date contacts 
3 
Updated 
all 
the 
information changed 
in the document and 
that are reported into 
the synopsis. 
To stay consistent with the changes 
made. 
4.3 
Included 
that 
the 
Steering Committee 
has been used only 
for the start-up of the 
trial. 
As the Steering Committee has not 
been used afterward as we have an 
Independent Adjudicator and the 
Corelab. 
4.5 
Included that the 6 
months visit is not 
required as any other 
visit as standard of 
care will be followed 
for the follow-up. 
To be clear on the schedule of 
activities and lack of specific 
requirements for the follow-up and 
imaging. 
5.8 
Included details on 
the exit date for 
patients undergoing a 
conversion. Included 
table with schedule of 
activities. 
For consistency and to provide 
specific definition and guidelines on 
the study exit dates for these patients. 
Included the schedule of activities as 
per standard of care to provide details 
on follow-up. 
7 
Added the definition 
for technical failure. 
More clarity. 
10.1 
Changed to Modified 
Intention 
to 
Treat 
(mITT) 
population 
and 
added 
the 
definition 
and 
included reference to 
the Statistical Plan. 
To make sure to include in the 
analysis only the patients that 
effectively undergone an EVAR 
procedure.  
10.2  
Changed the sample 
size determination. 
The sample size has been changed to 
reflect the adequate sample size for 
evaluating non inferiority and not 
superiority as originally planned. 
11 
Included MAE and 
events 
that 
might 
meet the endpoint as 
monitored 
events, 
included 
that 
non 
serious adverse event 
with no relationship 
with the device won’t 
be 
considered. 
Included details on 
events 
to 
be 
adjudicated by the 
More clarity. 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
3 
independent 
adjudicator. 
11.1.1 
Included definition of 
UADE. 
More clarity. 
11.2 
Included definition of 
SAE. 
More clarity. 
12.1 
Updated 
a 
few 
definitions. 
Consistency. 
12.2. 
Updated 
AE 
definition. 
Consistency and clarity. 
12.3 
Updated 
MAE 
definition 
and 
included definition of 
type of deaths. 
Consistency and clarity. 
13.3 
Included UADE in 
the list of events to be 
adjudicated. 
For 
consistency 
with 
the 
Adjudication plan. 
13.4 
Included Corelab. 
Including Corelab review of the 
images provided by site. 
16 
Included 
into 
the 
Monitoring 
section 
references 
to 
the 
current 
COVID-19 
situation 
and 
consequent 
updates 
included 
in 
the 
monitoring plan.  
To reflect the changes done to the 
monitoring plan. 
16.1 
Included sub-section 
on 
protocol 
deviation. 
Missing before. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
4 
 
Table of Contents 
 
1 
INVESTIGATOR SIGNATURE PAGE ................................................................................... 6 
2. TRIAL CONTACT PERSONNEL ............................................................................................ 7 
2.1 
SPONSOR ............................................................................................................................. 7 
3 
PROTOCOL SYNOPSIS ............................................................................................................ 8 
4 
TRIAL OVERVIEW ................................................................................................................. 12 
4.1 
OBJECTIVE ....................................................................................................................... 12 
4.2 
BACKGROUND .................................................................................................................. 12 
4.3 
INITIAL TRIAL GOVERNANCE ................................................................................ 13 
4.4 
TRIAL DEVICE .................................................................................................................. 13 
4.5 
TRIAL DESIGN .................................................................................................................. 13 
4.6 
ENROLLMENT CLOSE ...................................................................................................... 14 
5 
TRIAL POPULATION AND PROCEDURES ....................................................................... 14 
5.1 
INCLUSION CRITERIA ...................................................................................................... 15 
5.2 
EXCLUSION CRITERIA ..................................................................................................... 15 
5.3 
PATIENT ASSESSMENT AND SCREENING ........................................................................ 15 
5.4 
ENROLLMENT CRITERIA ................................................................................................. 15 
5.5 
PATIENT INFORMED CONSENT ....................................................................................... 15 
5.6 
ENROLLMENT AND RANDOMIZATION ............................................................................ 15 
5.7 
IMPLANTATION PROCEDURE .......................................................................................... 16 
5.8 
FOLLOW-UP REQUIREMENTS ......................................................................................... 16 
6 
TRIAL EVALUATIONS .......................................................................................................... 17 
6.1 
PRIMARY TRIAL ENDPOINTS .......................................................................................... 17 
6.2 
SECONDARY TRIAL ENDPOINTS ...................................................................................... 17 
7 
ADDITIONAL EVALUATIONS ............................................................................................. 17 
8 
ELECTRONIC CASE REPORT FORMS .............................................................................. 18 
9 
DATA MANAGEMENT ........................................................................................................... 18 
10 STATISTICAL CONSIDERATIONS ..................................................................................... 19 
10.1 GENERAL CONSIDERATIONS ........................................................................................... 19 
10.2 STATISTICAL METHODS .................................................................................................. 19 
10.2.1 Distribution of the Patients................................................................................... 20 
10.2.2 Handling Missing Values ..................................................................................... 21 
10.2.3 DATA ANALYSIS .............................................................................................. 21 
11 ADVERSE EVENT REPORTING .......................................................................................... 21 
11.1 ADVERSE EVENT DEFINITIONS ....................................................................................... 21 
11.1.1 Unanticipated Adverse Device Effect (UADE) ................................................... 21 
11.2 SERIOUS ADVERSE EVENTS (SAE) ................................................................................. 22 
12 DEFINITIONS ........................................................................................................................... 23 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
5 
12.1 DEFINITIONS ASSOCIATED WITH THE COMPOSITE PRIMARY ENDPOINT ARC .......... 23 
12.2 ADVERSE EVENT DEFINITIONS ....................................................................................... 24 
12.3 MAJOR ADVERSE EVENT ................................................................................................. 24 
12.4 OTHER DEFINITIONS ....................................................................................................... 25 
13 RESPONSIBILITIES ................................................................................................................ 25 
13.1 SPONSOR RESPONSIBILITIES ........................................................................................... 25 
13.2 INVESTIGATOR RESPONSIBILITIES ................................................................................. 26 
13.3 INDEPENDENT EVENT REVIEWER RESPONSIBILITIES ................................................... 27 
13.4 INDEPENDENT CORE LAB RESPONSIBILITIES ................................................................ 27 
14 CONFIDENTIALITY AND PATIENT RIGHTS .................................................................. 27 
14.1 CONFIDENTIALITY ........................................................................................................... 27 
14.2 PATIENT RIGHTS .............................................................................................................. 27 
15 ETHICAL CONSIDERATIONS ............................................................................................. 27 
16 MONITORING .......................................................................................................................... 28 
16.1 PROTOCOL DEVIATION ............................................................................................ 28 
17 TRIAL TERMINATION .......................................................................................................... 28 
18 PUBLICATION ......................................................................................................................... 28 
 
 
 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
6 
1 
INVESTIGATOR SIGNATURE PAGE 
I agree to conduct the trial as detailed in this Clinical Investigational Plan and in accordance with 
all applicable regional laws and regulations. In addition, I agree to provide all the information 
requested in the case report forms presented to me by the sponsor in a manner to assure 
completeness, legibility and accuracy. 
I agree to actively enroll patients into this trial and confirm that I do not have any material 
conflicts including participation in any clinical investigations for similar types of medical devices. 
I will provide copies of this trial protocol and all necessary information about this trial to the trial 
staff under my supervision. I will discuss this material with them and ensure they are fully 
informed about the device under investigation as well as all aspects concerning the conduct of 
this trial. 
I also agree that all information provided to me by the sponsor, including pre-clinical data, 
protocols, case report forms, and any verbal and written information, will be kept strictly 
confidential and confined to the clinical personnel involved in conducting the trial. It is 
recognized that this information may be relayed in confidence to the Institutional Review Board 
or to regulatory authorities. 
In addition, no reports or information about the trial or its progress will be provided to anyone 
not involved in the trial other than the sponsor, or the Institutional Review Board(s), the Core 
Lab(s), or the independent medical reviewer. Any such submission will indicate that the material 
is confidential. 
I will supervise the conduct of the clinical investigation to be performed in compliance with the 
clinical investigational plan, Good Clinical Practice (GCP)/ICH, the Declaration of Helsinki, ISO 
14155 and all applicable regulatory and ethical requirements. 
 
 
 
 
 
 
 
 
 
 
 
Investigator Signature 
 
Date 
 
 
 
 
 
Investigator Printed Name 
 
 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
7 
2. TRIAL CONTACT PERSONNEL 
2.1 
SPONSOR 
SPONSOR CONTACT 
Carola Ciancioso 
Director Clinical Affairs 
Tel: 0039 392 91 04 786 
Endologix 
2 Musick 
Irvine, CA  92618 USA 
cciancioso@endologix.com  
 
 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
8 
3 
PROTOCOL SYNOPSIS 
Title of the Trial 
Multicenter, Post-Market, Real World Trial to Assess Outcomes of Patients Treated 
with the AFX System compared to other EVAR devices for Endovascular Abdominal 
Aortic Aneurysm Repair: LEOPARD (Looking at EVAR Outcomes by Primary 
Analysis of Randomized Data) 
Trial Devices 
AFX Endovascular AAA System and other approved Endovascular AAA stent graft 
systems  
Trial Sponsor 
Endologix 
2 Musick 
Irvine, CA 92618 (USA) 
Steering 
Committee 
Initial governance of the trial was provided by a Steering Committee (SC) comprised 
of physicians experienced in EVAR and considered global Thought Leaders in the 
field. The purpose of the Steering Committee was to provide scientific direction and 
oversight to start with the LEOPARD Trial involving Endologix’s EVAR System, 
AFX. Essential responsibilities of the SC included trial design and protocol review and 
to provide guidance and advice to the Investigators for patient selection and timely 
enrollment. Details of the SC are available on file, in the SC Charter. 
Objectives 
Objective of this post-market trial is to evaluate Endologix AFX endovascular AAA 
system with anatomical fixation against other approved Endovascular systems with 
proximal fixation. 
Trial Design 
Prospective, randomized, multi-center trial designed to evaluate the outcomes of 
contemporary EVAR in a real-world population. Patients will be followed procedurally 
to discharge, at 1, 6 (standard of care follow-up), 12 months and annually through to 5 
years (total follow-up commitment). 
Investigational 
Sites 
Up to 80 sites with experience in standard endovascular repair (EVAR). Each 
participating Investigator must be certified on the AFX system and comparator devices. 
Any Investigator wishing to employ percutaneous endovascular repair (PEVAR) must 
also provide documentation of certification on the procedure using the particular 
device. 
Subject 
Population 
Up to 800 consented patients diagnosed with AAA who are considered candidates for 
endovascular repair and meet the trial eligibility criteria. 
Data Capture 
Electronic Case Report Forms (eCRF) will be used for data collection. Internet access 
is required for data entry. 
Monitoring 
Source data verification will be performed by means of a combination of on-site and 
centralized monitoring using Endologix procedures.  
Trial Timelines 
Enrollment started: 23 March 2015 
Enrollment Completion: Q3 2017 
5-year Follow-Up Completion: Q4 2022 
Independent 
Adverse Event 
Review 
Independent physician(s) will adjudicate all Major Adverse Events (MAE), Adverse 
Device Effects (ADE), Serious Adverse Device Effects (SADE) and Unanticipated 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
9 
Adverse Device Effects (UADE) reported by the sites within this trial. Independent 
physician(s) will complete the eCRF data capture form for all adjudicated events. 
Imaging 
Assessment 
Available imaging will be evaluated by an independent Core Lab. 
Inclusion Criteria 
1. Male or female at least 18 years old 
2. Subjects with minimum of 2 years life expectancy 
3. Subjects have signed the informed consent document for data release  
4. Subjects with infrarenal AAA who are assessed by the Investigator to be eligible 
for endovascular Abdominal Aortic Aneurysm Repair with the trial devices 
Exclusion Criteria 
1. Currently participating in another trial where primary endpoint has not been 
reached yet 
2. Known allergy to any of the device components 
3. Pregnant (females of childbearing potential only) 
4. Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously 
failed EVAR. 
Trial 
Randomization  
The LEOPARD Trial is designed to compare the anatomically stabilized AFX 
Endograft System to a reference group of proximally fixated EVAR devices. Patients 
will be randomized between the two groups.  
Randomization will be 1:1. Each Investigator will select one comparator device of their 
choice before enrolling the first patient. The trial will sequentially evaluate non-
inferiority and superiority hypotheses. 
 
Randomization Scheme: 
      
                                           
 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
10 
Primary Endpoint 
One year survival in absence of Aneurysm Related Complications. ARC is a composite 
of the most relevant EVAR outcomes and includes: 
- 
Peri-Operative Death (< 30-days) 
- 
Rupture 
- 
Conversion to OSR 
- 
Endoleaks; post-operative 
- 
Migration (≥ 10mm) 
- 
Aneurysm Enlargement (≥ 5mm) 
- 
Endograft Limb Occlusions 
- 
Reinterventions for device- or aneurysm-related complications  
Any imaging driven observation at 365 days ± 60 days will be included in the one 
year evaluation window 
Secondary 
Endpoints 
 
 
• 
MAEs at 30-Days, 12 Months and Annually 
• 
ARC Post 12 Months up to Five Years 
• 
Aneurysm Related Mortality 
• 
Endoleaks Classified by Type 
• 
AAA Related Secondary Procedures up to Five Years 
• 
Device integrity 
• 
Any adjunctive procedures necessitated during the implant procedure 
Additional 
Evaluations 
• 
Total Endovascular time; from catheter introduction to catheter removal 
• 
Anaesthesia Time 
• 
Fluoroscopy Time 
• 
Contrast Volume used 
• 
Total Procedure Time; from cut-down to closure 
• 
Time in ICU 
• 
Total Radiation Exposure 
• 
Additional Imaging 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
11 
Statistical 
Considerations 
The primary endpoint will be evaluated in both the AFX and proximally fixated device 
groups.  The relative performance of the two groups will be evaluated through one-
sided tests for non-inferiority and superiority.  Combining the superiority and non-
inferiority trials into a single closed testing procedure allows for maintenance of a 
controlled Type 1 error rate.   An 8% margin will be used for the non-inferiority test.  If 
the non-inferiority null hypothesis is rejected, the null hypothesis for superiority will 
be investigated.    
Hypotheses for Non-Inferiority: 
Null Hypothesis:            𝐻𝐻10: 𝜇𝜇𝐴𝐴−𝜇𝜇𝐵𝐵≤−8% (AFX is inferior with respect to the 
primary endpoint) 
Alternative:                    𝐻𝐻11: 𝜇𝜇𝐴𝐴−𝜇𝜇𝐵𝐵> −8% (Statistical evidence of non-
inferiority) 
 
Hypotheses for Superiority: 
Null Hypothesis:   𝐻𝐻20: 𝜇𝜇𝐴𝐴−𝜇𝜇𝐵𝐵≤0 (The two device groups have equal effect) 
Alternative:       𝐻𝐻21: 𝜇𝜇𝐴𝐴−𝜇𝜇𝐵𝐵> 0 (Statistical evidence of superiority) 
 
The original trial size was selected to provide 80% power for the superiority test.  The 
original sample size required, for non-inferiority testing, is relatively smaller; thus, 
the power of the non-inferiority test approaches 100% with the revised sample size. 
Suggested  
Schedule of 
Tests 
Patient eligibility will be assessed by the Investigator per institutional standard of care 
pre-procedural imaging. Blood work and physical exam will also be collected as per 
routine schedule at each institution. 
Following Institutional Review board approval and patient written informed consent, 
the patient will be screened for eligibility. Subjects will be followed procedurally and 
to hospital discharge and per institutional standard of care thereafter through to 5 years 
(total follow-up commitment). 
Table 1 outlines a typical site follow-up schedule which will be altered to meet 
standard of care at individual sites. 
 
 
 
Table 1: Typical Site Follow-Up Schedule (may be altered to meet standard of care at sites) 
Suggested Schedule 
of Tests 
Screening/Baseline 
Procedure 
Pre-
Discharge 
1 
Month 
FUP 
6 Month 
FUP 
1 Year 
FUP 
>1 to 5 
Year 
FUP’s 
Inclusion/Exclusion 
x 
 
 
 
 
 
 
Demographics/Medical 
History 
x 
 
 
 
 
 
 
Physical Exam† 
x 
 
x 
x 
x 
x 
x 
Blood Labs‡ 
x 
 
x 
x 
x 
x 
x 
Contrast Enhanced CT 
Scan 
x¥ 
 
 
x* 
x* 
x* 
x* 
Procedural Information 
 
x 
 
 
 
 
 
Adverse Events 
 
x 
x 
x 
x 
x 
x 
†The physical exam includes overall health, physical assessment, and vital signs.  
‡Blood labs typically include serum creatinine and hemoglobin, if collected.  
¥High resolution (<3mm slice spacing), contrast and non-contrast CT scan is preferred up to 3 months prior to the scheduled procedure 
*If institution’s standard of care for EVAR involves another imaging modality e.g., duplex ultrasound, that modality may be collected 
alternatively. 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
12 
4 
TRIAL OVERVIEW 
4.1 
OBJECTIVE 
The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system 
with anatomical fixation against other approved Endovascular systems with proximal fixation.  
Multiple U.S clinical centers will be involved in the trial to include a broad range of experience.  
Imaging data will be evaluated by an independent Core Lab. 
4.2 
BACKGROUND 
Since the pioneering work of Dr. Parodi and Dr. Volodos in the late 1980s and early 1990s, 
there have been few pivotal moments in the history of endovascular repair of AAA (EVAR).  
The EVAR-1/2, DREAM, OVER and ACE trials have demonstrated early benefits of EVAR 
over open surgical repair but each of these studies included patients with prior generation 
endografts; many of which are rarely or never implanted today. The gradual evolution of EVAR 
practices has since expanded the use of the technique in a growing number of aortic anatomies 
outside the boundaries tested in clinical trials. Such practices have recently been questioned, 
reversing in some instances the utilization of EVAR as the technique of choice in AAA repair.  
Unfortunately, current evidence on so-called “hostile” versus “friendly” anatomies is limited to 
the retrospective analyses of the single-center cohorts treated with multiple generations of 
devices. In the age of increasing patient awareness and fiscal scrutiny over therapeutic 
outcomes, new prospective data on EVAR outcomes in the contemporary patient populations is 
long overdue. 
The evolution of EVAR technology has led to two distinct device concepts currently available 
in clinical practice. One concept incorporates the bifurcated component positioned high in the 
aneurysm sac and tubular limb components extended distally into iliac arteries. Such endograft 
systems rely on penetrating hooks and barbs for proximal fixation within the aorta. The majority 
of device manufacturers adopted this concept, producing devices with different proximal stent 
configurations (suprarenal versus infrarenal), stent designs, and graft materials. The alternative 
concept, developed by Endologix, relies on the bifurcated endograft component positioned 
directly on the native aortic bifurcation, with the proximal component extending cranially into 
the aortic neck. Fixation of the endograft on the aortic bifurcation (anatomic fixation) and the 
associated freedom to optimize the proximal configuration without constraints of the fixation 
elements, results in a system that most closely resembles the anatomy of the native aorta and 
the seal zones extended by the pressure of the native blood flow (ActiveSeal™), with potential 
advantages of optimized hemodynamics, migration resistance, and aneurysm exclusion. 
The purpose of the LEOPARD trial is to evaluate the outcomes of contemporary EVAR in a 
real-world population using two distinct endograft concepts (proximal versus anatomic 
fixation). The multicenter, Level 1 randomized evidence generated by LEOPARD will serve as 
modern reference for future therapy developments, the way earlier trials serve that purpose 
today. In addition, the LEOPARD trial will provide insight into the performance of the device 
design in a broad range of patient anatomies, guidance on EVAR strategy and clinical 
presentations, leading to the definitive choices in the years to come. 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
13 
4.3 
INITIAL TRIAL GOVERNANCE 
The initial governance of the trial will be provided by a Steering Committee (SC) comprised of 
physicians experienced in EVAR and considered thought leaders in the field. The purpose of 
the Steering Committee is to provide scientific direction and oversight to the start-up of the 
LEOPARD Trial involving Endologix’s EVAR System, AFX. Essential responsibilities of the 
SC include trial design and protocol review and to provide guidance and advice to the 
Investigators for patient selection and timely enrollment.  
Details of the SC are available in the Steering Committee Charter and are kept on file.  
4.4 
TRIAL DEVICE 
The devices used in this trial are endovascular stent grafts approved by the FDA to treat 
abdominal aortic aneurysms. All devices are commercially available in the U.S. and, for the 
purposes of this trial, include the latest iteration of the following devices: 
1. Endologix AFX® System (Test device) 
2. Cook Zenith® System (Comparator device) 
3. Gore Excluder System (Comparator device) 
4. Medtronic Endurant System (Comparator device) 
The description, specifications and indications/instructions for use may be found in their 
respective Instructions for Use. It is noted the AFX® System is anatomically fixated distally 
while the remaining three devices are fixated proximally within the aorta using penetrating 
barbs or hooks. 
This trial will allow for use of iterative changes to all devices indicated above. 
4.5 
TRIAL DESIGN 
The LEOPARD trial is a prospective, randomized, multi-center trial, intended to evaluate the 
outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real-world population. 
The trial is designed to compare the anatomically stabilized AFX Endograft System to a 
reference group of proximally fixated EVAR devices. Patients will be randomized between the 
two groups. 
Randomization will be 1:1. Each Investigator will select one comparator device of their choice 
before enrolling the first patient and this device will serve as the comparator device for that 
Investigator throughout the course of enrollment. The trial will sequentially evaluate non-
inferiority and superiority hypotheses. 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
14 
 
Figure 1: Randomization Scheme 
 
All subjects undergoing EVAR with either the AFX System or the reference group of other 
EVAR devices will be followed procedurally to discharge, at 1, 6 (standard of care follow-up, 
no specific trial visit is required), 12 months and annually through to 5 years (total follow-up 
commitment). 
After this protocol and the patient Informed Consent Form (ICF) are reviewed and approved 
by the local Institutional Review Board (IRB), potential subjects having infrarenal AAA will 
be offered participation in the trial. This will be accomplished through the patient’s reading 
of the informed consent form and discussion of the trial with the patient by the Investigator 
and site personnel. Agreement to participate and to attend all protocol required follow-up visits 
will be documented with the patient’s signature on the informed consent form. 
4.6 
ENROLLMENT CLOSE 
Total enrollment for the trial is up to 800 patients. When the sponsor has been notified that the 
necessary number of patients has been enrolled, the sites will be notified to discontinue 
enrollment. However, all consented patients will still be allowed to receive the treatment for 
their trial arm. This may result in a small number of additional patients in the trial. All such 
patients will be included in trial analysis. 
5 
TRIAL POPULATION AND PROCEDURES 
Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this trial. Each 
participating Investigator will be required to be certified on both the AFX system and their choice 
of comparator device. Any Investigator wishing to employ percutaneous endovascular repair 
(PEVAR) must also provide documentation of certification on the procedure using the particular 
device. Following completion of the ICF, the Investigator will commence patient screening and 
enrollment. Certification must be completed in accordance with each manufacturer’s certification 
process.   
 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
15 
5.1 
INCLUSION CRITERIA 
A patient who meets all of the following criteria may be considered as a potential trial subject: 
1. Male or female at least 18 years old 
2. Subjects with minimum of 2 years life expectancy 
3. Subjects have signed the informed consent document for data release  
4. Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for 
endovascular Abdominal Aortic Aneurysm Repair with the trial devices. 
5.2 
EXCLUSION CRITERIA 
A patient who does not meet any of the following criteria may be considered as a potential trial 
subject: 
1. Currently participating in another trial where the primary endpoint has not been 
reached yet.  
2. Known allergy to any of the device components 
3. Pregnant (females of childbearing potential only) 
4. Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously 
failed EVAR. 
5.3 
PATIENT ASSESSMENT AND SCREENING 
Patients will be consecutively assessed for inclusion in the trial by the Investigator according to 
standard of care. A log of all these assessments will be maintained. This will include information 
on any patients deemed unable to participate and the reasons for such. 
5.4 
ENROLLMENT CRITERIA 
Patients who fulfill all eligibility criteria and sign the ICF will be considered as a trial candidate. 
The randomization process will be initiated to determine the primary trial device for each trial 
candidate. A trial candidate is considered an enrolled subject in the trial only upon the insertion 
of the delivery system for the associated primary trial device. Any other adjective procedures 
before insertion of the delivery system for the primary device will be captured for all trial 
candidates. 
5.5 
PATIENT INFORMED CONSENT 
Written informed consent, documented on the ICF in accordance with Good Clinical Practice 
standards and trial center regulations, shall be obtained from each patient. The Investigator will 
retain a copy of the signed informed consent document in each patient’s record and provide a 
copy to the patient. There is no incremental risk and data will be collected anonymously. 
5.6 
ENROLLMENT AND RANDOMIZATION 
Patient enrollment into this trial is based on the site evaluation of patient conformance with the 
protocol-specified selection criteria (see §5.1), and the Investigator’s assessment of suitability 
for treatment with either the AFX-System or the comparator device. Blood work and physical 
exam will also be collected as per standard of care at each institution. 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
16 
Once consented and assessed for inclusion in the trial, the Investigator will elect to randomize 
the patient by entering required information into the EDC. Upon entering this information, the 
patient will be randomized to receive the AFX® System or the comparator device. The 
randomization result will be generated and accessible to the site prior to the scheduled procedure 
date. 
Enrollment in the trial only occurs upon advancement of the trial device into the subject’s 
vasculature.   
5.7 
IMPLANTATION PROCEDURE 
The EVAR procedure is performed according to the device IFU to which the patient has been 
randomized and the institutional standard of care. Patient sedation, vascular access and 
procedural techniques will be handled at the discretion of the Investigator.  
5.8 
FOLLOW-UP REQUIREMENTS 
Subjects will be followed procedurally and to hospital discharge and at 1, 6 (standard of care 
follow-up; no specific trial visit is required), 12 months and annually through five years (total 
follow-up commitment).   
Table 2 outlines a suggested follow-up schedule which may be altered to meet standard of care 
at individual sites. 
If a subject undergoes conversion to open surgical repair, the subject will continue follow-up 
for 30-days post-conversion, at which point the subject will exit. If the subject has not been 
discharged from the conversion hospitalization within 30-days, the date of discharge will be the 
date of trial exit.  
 
Table 2: Suggested Follow-Up Visit Schedule 
Suggested Schedule of 
Tests: 
Screening/ 
Baseline 
Procedure 
Pre-
Discharge 
FUP 1 
1 month 
30 ± 15 
days 
FUP 2 
6 Month 
182± 30 
days 
FUP 3 
1 Year 
365± 60 
days 
>1 to 5 
Years FUP 
(± 90 days 
window) 
Inclusion/Exclusion 
x 
- 
 
 
 
 
 
 
Demographics/Medical 
History 
x 
 
 
 
 
 
 
Physical Exam†  
x 
 
x 
x 
x 
x 
x 
Blood Labs‡ 
x 
 
x 
x 
x 
x 
x 
Contrast-enhanced CT 
scan 
x¥ 
 
 
x¥ 
x* 
x¥ 
x* 
Procedural Information 
 
x 
 
 
 
 
 
Adverse Events 
 
x 
x 
x 
x 
x 
x 
†The physical exam includes overall health, physical assessment, and vital signs.  
‡Blood labs typically include serum creatinine and hemoglobin, if collected 
¥ High resolution (<3mm slice spacing), contrast and non-contrast CT scan is preferred up to 3 months prior to the scheduled procedure 
*If the institution’s standard of care for EVAR subjects involves another imaging modality e.g., duplex ultrasound, that modality may be 
collected alternatively. 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
17 
6 
TRIAL EVALUATIONS 
6.1 
PRIMARY TRIAL ENDPOINTS 
The primary trial endpoint is one -year survival in the absence of Aneurysm Related 
Complications (ARC). ARC is a composite of the most relevant EVAR related outcomes and 
includes: 
• 
Peri-operative death (< 30-days) 
• 
Aneurysm rupture 
• 
Conversion to Open Surgical Repair (OSR) 
• 
Endoleaks; post-operative 
• 
Endograft migration (≥ 10mm) 
• 
Aneurysm enlargement (≥ 5mm compared to 1-month CT) 
• 
Endograft occlusion 
• 
Reinterventions for device- or aneurysm-related complications  
The outcomes above comprising of the ARC composite endpoint are defined in §12.1. 
 
Imaging driven observations will be based on the one-year evaluation window (365 days ± 60 
days).  If there are two diagnostic images available within the window, the convention will be 
to use any image with a positive finding.  
 
6.2 
SECONDARY TRIAL ENDPOINTS 
Secondary endpoints to be assessed up to five years include: 
1. Major Adverse Events (MAEs) at 30-Days, 12-Months and annually thereafter, up to 
five years: 
• 
Mortality (all-cause) 
• 
Bowel Ischemia 
• 
Myocardial Infarction 
• 
Paraplegia 
• 
Renal Failure 
• 
Respiratory Failure 
• 
Stroke 
• 
Procedural Blood Loss ≥1,000mL 
2. ARC post 12-Months 
3. Individual components of ARC post 12-Months and up to five years 
4. Aneurysm Related Mortality 
5. Endoleaks Classified by Type 
6. AAA Related Secondary Procedures  
7. Device Integrity 
8. Any adjunctive procedures necessitated during the implant procedure 
7 
ADDITIONAL EVALUATIONS 
Additional evaluations include the following procedural and in-hospital evaluations: 
1. Procedural Technical Failure 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
18 
2. Total Endovascular time; from catheter introduction to catheter removal 
3. Anesthesia Time 
4. Fluoroscopy Time 
5. Contrast Volume used 
6. Total Procedure Time; from cut-down to closure 
7. Time in ICU 
8. Total Radiation Exposure 
 
The procedural technical failure is defined as a failure of the AFX® System or comparator 
devices to be delivered and deployed, such that the procedure is not completed, or the device 
failure results in a serious complication, or residual Type I and Type III Endoleaks which occur 
and cannot be resolved during the index procedure. 
 
8 
ELECTRONIC CASE REPORT FORMS  
The trial will utilize an electronic Case Report Form (eCRF) system for data collection. All site 
staff will be trained on correct eCRF completion prior to site activation. Only trained personnel 
will receive access and be able to enter data in the eCRF. All eCRF pages will be electronically 
signed by the Investigator at each site. Each subject will be anonymized and given a specific trial 
number in the eCRF. 
 
9 
DATA MANAGEMENT 
The data required for the trial will be entered by the investigation sites into eCRF. Detailed edit 
checks will ensure a high-quality standard of the data entered in the database. Additionally, data 
management will review the collected data and issue possible queries. Queries should be resolved 
by the investigation site on an ongoing basis. When all trial data is complete, the database will be 
locked, and data analyzed. 
 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
19 
10 STATISTICAL CONSIDERATIONS 
10.1 GENERAL CONSIDERATIONS 
Primary analyses will be based on modified Intention-to-Treat (mITT) populations. An 
Intention-to-Treat (ITT) analysis population consists of all randomized subjects. While the 
intent of the trial is to implant all randomized subjects, some randomized subjects will not 
undergo implantation due to unforeseen issues. If this were to occur in a substantial number of 
subjects, it is possible that the results may be biased towards non-inferiority as the groups would 
become increasingly similar. Thus, a mITT population is defined, which consists of all 
randomized subjects that subsequently underwent EVAR. All endpoints in this trial, unless 
otherwise specifically noted, will be evaluated against the mITT analysis population. 
Randomization will be centralized using permuted block design. A randomization schedule will 
be generated with a random number generator in the SAS System®.  Sites/Investigators will be 
blinded to block size.  Due to the use of a large number of sites with a relatively small number 
of patients within specific sites, stratification by institution will not be performed. The intent is 
to allocate similar numbers of subjects between the two treatment groups across the total number 
of sites, to provide maximum power. Additionally, stratification using risk factors will not be 
performed.  
Additional information is available in the Statistical Analysis Plan (SAP). Statistical analyses 
will be performed using SAS System®, Version 9.4 or later. 
 
For additional information on the randomization process, refer to §5.6. 
10.2 STATISTICAL METHODS  
All non-imaging-driven variables in the composite endpoint will be evaluated to 1 year (day 
365 post-implant), whereas imaging-driven variables will be evaluated to a 1-year window (day 
365 +/- 60 days). The day of implantation will be set as day 0.  Early events are defined as those 
occurring from the date of the procedure up to 30 calendar days post-operatively. Late events 
are defined as those occurring from after 30 calendar days post-operatively (from day 31 
forward). 
The null hypotheses for both non-inferiority and superiority will be evaluated with one-sided 
alpha levels of 0.05. 
If the non-inferiority null hypothesis is rejected, the null hypothesis for superiority will be 
investigated. 
Hypotheses for Non-Inferiority: 
Null Hypothesis:           H10:μA −μB ≤−8% (AFX is inferior with respect to the primary 
endpoint) 
Alternative:                   H11: μA −μB > −8% (Statistical evidence of non-inferiority) 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
20 
Hypotheses for Superiority: 
Null Hypothesis: 
      H20:μA −μB ≤0 (The two device groups have equal effect) 
Alternative:                  H21: μA −μB > 0 (Statistical evidence of superiority) 
Data for the primary endpoint will be presented as point estimates for both the treatment (AFX 
device) and control (proximally fixated devices), along with a 95% confidence interval for the 
difference.  The lower bound of a one sided 95% confidence interval is used to evaluate the 
non-inferiority and superiority null hypotheses.  
 
Quantitative parameters will be described using the following summary descriptive statistics: 
number of non-missing values, mean, standard deviation, median, first and third quartiles, and 
minimum and maximum values. 
 
Qualitative parameters will be described overall using frequencies and percentages. 
Percentages will be calculated on the number of non-missing observations.  In all cases, the 
number of missing values will be specified. 
 
Kaplan-Meier estimates will be generated for the composite endpoint components across the 
duration of the trial. 
 
Sample Size Determination: 
Given an alpha error rate of 0.05, a desired power of 90%, and assuming a success rate (in 
terms of the primary endpoint) of 86% for AFX with an 8% advantage over the control 
group, the sample size required to demonstrate non-inferiority is 154 subjects in total.  In 
order to have enough power to evaluate all hypotheses the sample size for this trial was 
driven by the evaluation of superiority.  In this case, an alpha error rate of 0.05, power of 
80%, success rate of 86% for AFX, and a relative 8% advantage in AFX’s favor requires 
566 patients.  A 7% advantage in AFX’s favor requires 724 patients. An approximate drop-
out rate of 10%/1-year indicates 804 patients should be enrolled to provide 724 patients at 1 
year.  The original protocol thus called for enrollment of up to 800 subjects. The enrollment 
was completed at 455 subjects after an unplanned analysis supported that the superiority 
evaluation was futile. With a total of 455 subjects enrolled, 410 are assumed to reach the 1-
year endpoint after 10% dropout. This sample size results in 99% power for the non-
inferiority test under original assumptions, and thus the trial is considered adequately 
powered for evaluating non-inferiority. The sample size has been determined with PASS 
version 12.0.2. 
10.2.1 DISTRIBUTION OF THE PATIENTS 
The number of patients in the mITT population, as well as the distribution across sites will be 
presented. Descriptive statistical data will be used to draw up the characteristics of subjects at 
the time of enrollment (demographics, baseline data). 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
21 
10.2.2 HANDLING MISSING VALUES  
In order to provide unbiased and informative findings, no replacement of missing values is 
planned for any parameters. In all applicable cases, reported analysis will mention the number 
of missing values for each outcome in the mITT population. 
10.2.3 DATA ANALYSIS 
In the original analyses, the ARC endpoint has been evaluated by site reported events only.  
Now that Corelab data is available,  it will be considered during the future evaluations of the 
data. 
In future analyses, the data presented will utilize CoreLab findings in addition to site-reported 
findings. The analyses will defer to CoreLab results when the site and CoreLab disagree. In 
the absence of CoreLab-reviewed data, events will be assessed by the site. In addition to this, 
the clinical data and evaluation of the patients will be considered when reviewing data, and 
the clinical history of the patient as well as the review of the independent adjudicator may 
overrule site and Corelab findings. 
 
11  ADVERSE EVENT REPORTING 
The safety of the device will be monitored throughout the trial by assessment of serious adverse 
events (SAE), adverse device effects (ADE) serious adverse device effects (SADE), and major 
adverse events (MAE), or events that may potentially meet an endpoint. All SAEs will be 
recorded in the eCRF system and will be assessed by the Sponsor. Additionally, applicable events 
will be assessed by  the internal Complaint Handling Department in order to comply with adverse 
event reporting. Non-serious adverse events with no device relationship that do not meet a trial 
endpoint, will not be evaluated in this trial (definition according to ISO 14155:2011(E)). 
 
Independent adjudication will occur for all ADEs, MAEs and SADEs reported by the sites within 
this trial. For any adjudicated events, the adjudicator or designee will be required to complete the 
eCRF data capture form. 
11.1 ADVERSE EVENT DEFINITIONS1 
11.1.1 UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) 
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. Additionally, an unanticipated adverse 
event includes any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of subjects (US 21 CFR 812.3). 
 
 
1 Clinical investigation of medical devices for human subjects, good clinical practice.  ISO 14155:2011. 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
22 
Investigators shall submit to Endologix and to the reviewing ethics committee/IRB a report 
of any unanticipated adverse device effect occurring during an investigation as soon as 
possible, but no later than 24-hours after the Investigator first learns of the effect.  
 
Investigators must submit to Endologix documentation of the report made to the ethics 
committee. NOTE: Planned hospitalization for a pre-existing condition, or a procedure 
required by the CIP (Clinical Investigation Plan), without serious deterioration in health, is 
not considered an SAE. 
 
The relation to the investigational device, as well as the relation to the index procedure is 
classified by the Investigator as either “Related” or “Unrelated”. 
11.2 SERIOUS ADVERSE EVENTS (SAE) 
Per ISO 14155, a SAE is a serious adverse event that  
a) Led to death, 
b) Led to serious deterioration in the health of the subject, users or other persons as 
defined by one or more of the following:  
1) A life-threatening illness or injury, or 
2) A permanent impairment of a body structure or body function, including 
chronic diseases, or 
3) In-patient or prolonged hospitalization, or 
4) Medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure of a body function, 
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect, 
including physical or mental impairment. 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
23 
The Investigator must report any SAE in the eCRF to Endologix, Inc. as soon as they become 
aware of the event, preferably within 24-hours of awareness of the event. Refer to Figure 2 
for the decision tree for event reporting: 
 
 
 
Figure 2: Reporting Decision Tree 
 
12 DEFINITIONS 
12.1 DEFINITIONS ASSOCIATED WITH THE COMPOSITE PRIMARY ENDPOINT ARC 
  
The primary trial endpoint is an assessment at one year, where survival is in the absence of 
Aneurysm Related Complications (ARC). ARC is a composite of the most relevant EVAR 
related outcomes and include: 
• 
Aneurysm Rupture: bleeding or leaking of blood from the aneurysm subsequent to the 
index procedure. 
• 
Conversion to Open Surgical Repair (OSR): open surgical repair of the abdominal 
aortic aneurysm due to unsuccessful delivery or deployment of the stent graft, due to 
complications or other clinical situations that precluded successful endovascular 
treatment, or at any time following initial successful endovascular treatment for any 
reason. Excludes post-mortem explant of the trial device.  
• 
Endoleaks: clear evidence of contrast within the aneurysm sac 
- 
Endoleak Type Ia – Contrast material in the aneurysm sac adjacent to the 
proximal seal zone and/or between the endograft and the inner wall of the 
proximal attachment site. 
- 
Endoleak Type Ib – Contrast material in the aneurysm sac adjacent to the 
distal seal zone and/or between the endograft and the inner wall of the distal 
attachment site. 
- 
Endoleak Type II – Contrast material along the posterior sac wall with 
visualization of lumbar artery or the inferior mesenteric artery 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
24 
- 
Endoleak Type IIIa – Component disconnect 
- 
Endoleak Type IIIb – Mid-graft hole  
• 
Migration (≥10mm): stent distal movement ≥10mm from the original implant location 
relative to the center of the distal renal artery; as compared to the 1-month CT scan 
location. 
• 
Aneurysm Sac Enlargement: aneurysm sac diameter increase of ≥5mm in late follow-
up as compared to 1-month CT scan location. 
• 
Endograft Limb Occlusions: defined as total obstruction of blood within the lumen of 
a device limb – irrespective of whether a secondary intervention is necessary.   
• 
Endograft Stenosis: defined as a reduction in lumen >50% by, for example, thrombus, 
intimal hyperplasia, or endograft kink/twist. 
 
Elaboration of the above definitions can be found in the Adjudication Charter. 
12.2 ADVERSE EVENT DEFINITIONS 
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease, 
injury or untoward clinical sign (including abnormal laboratory values) in subjects, users or 
other persons, whether or not related to the medical device (ISO 14155). For the purposes of 
this study, adverse events that are not related to the study device will not be captured as shown 
in Figure 2.  
12.3 MAJOR ADVERSE EVENT  
An event occurring during the trial that meets one of the following criteria: 
• 
All-Cause Mortality:   
• 
Death is defined as any death occurring during the trial period, regardless of cause. 
o Aneurysm-related death: is defined as any death occurring within 30-days 
from the date of the index procedure, regardless of cause, and death due to 
aneurysm rupture or death within 30-days of any secondary procedure 
intended to treat the aneurysm.  
o Cardiac-related death: is defined as death due to arrhythmia, heart failure 
(including cardiogenic shock), or myocardial infarction 
o Pulmonary-related death: is defined as death due to due to pulmonary edema, 
respiratory failure, or pulmonary embolism 
o Vascular-related death: is defined as death due to stroke, cerebral hemorrhage, 
or other clear vascular event that is not categorized as cardiac-related or 
pulmonary-related or aneurysm-related. 
o Other: is to be used to identify a death due to any event that cannot be clearly 
categorized as above, but where some information is available. 
o Unknown: is to be used to identify a death where no information is available. 
• 
Bowel Ischemia: the lack of adequate blood flow to the intestines that requires 
intensification of medical therapy or surgical/endovascular intervention. 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
25 
• 
Myocardial Infarction: increase of one or more cardiac biomarkers (preferably 
troponin) with at least one value above the 99th percentile of the upper reference limit 
(URL) together with evidence of myocardial ischemia with at least one of the 
following:  myocardial ischemia; ECG changes indicative to new ischemia (new ST-T 
changes or left bundle branch block (LBBB)); development of pathological Q-waves 
in the ECG; imaging evidence of new loss of viable myocardium or new regional wall 
motion abnormality. 
• 
Paraplegia: paralysis of the lower extremities inclusive of the lower trunk;  
• 
Renal Failure – permanent dialysis dependence or kidney transplant 
• 
Respiratory Failure: respiratory failure requiring ventilator support beyond 24 hours 
post-procedure 
• 
Stroke: a sudden development of neurological deficit due to vascular lesions of the 
brain such as hemorrhage, embolism, or thrombosis that persists for >24 hours; 
• 
Index Procedural Blood Loss >1,000mL: estimated blood loss during the index 
procedure ≥1,000mL. 
12.4 OTHER DEFINITIONS 
• Luminal Thrombus Requiring Intervention: any endovascular surgical intervention after 
completion of the device implantation for resolution of endograft thrombosis. 
• Distal Ischemia: new onset of compromised peripheral blood flow resulting in femoral or 
peripheral arterial occlusion or stenosis (attributable to the index procedure or to the 
endograft and not related to natural progression of atherosclerotic disease) causing a threat 
to the viability of the limb and requiring surgical or percutaneous intervention; or stent graft 
occlusion requiring any intervention.  
• Occlusion requiring intervention: intervention for stent graft occlusion 
• Secondary Endovascular Procedure: any non-diagnostic intervention after the index 
procedure intended to correct or repair an Endoleak, device stenosis or occlusion, migration, 
aneurysm sac expansion and/or a device defect (including infection); 
• Successful Implantation: Successful delivery and deployment of the device. 
• Modified Intention-to-Treat: analysis of the results of implanted patients is based on the 
initial treatment assignment and not on the treatment eventually received. 
13 RESPONSIBILITIES 
13.1 SPONSOR RESPONSIBILITIES 
This trial is conducted under the responsibility of Endologix.  Only Endologix staff and 
designees approved by Endologix will participate in this trial.  Endologix is responsible as the 
Sponsor to ensure: 
• Proper site and Investigator selection 
• Availability of signed Investigator agreements prior to trial initiation 
• Availability of regulatory and IRB approval prior to the initiation of the trial at any site 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
26 
• Management and monitoring of the trial with special attention to verification of all clinical 
requirements, adherence to protocol, good clinical practices and compliance with applicable 
government and institutional regulations 
• Furthermore, the sponsor is responsible for ensuring proper regulatory approvals are 
obtained, and reporting to regulatory authorities per applicable regulations 
• Sites are supported and adequately trained on the device 
13.2 INVESTIGATOR RESPONSIBILITIES 
It’s the Investigator’s responsibility to conduct this trial in accordance with relevant rules and 
regulations, including but not limited to, this trial protocol, the signed Investigator agreement, 
Good Clinical Practices, all applicable laws and regulations and any conditions or restrictions 
imposed by the reviewing IRB. This includes compliance with requirements related to IRB 
approval and reporting, and proper patient informed consent prior to participation in the trial. 
The Investigator is also responsible for protecting the rights, safety, and welfare of the subjects 
under his/her care. 
• 
Each Investigator is responsible for supervising all procedures conducted under this 
protocol at his/her institution. 
• 
Furthermore, the Investigator is responsible for ensuring that data are completely, 
accurately, and promptly recorded on each patient’s eCRFs and related documents are 
available to verify the accuracy of the eCRFs, and for ensuring the clinical monitor 
has access to all necessary records to ensure the integrity of the data. 
 
In order to be considered for the participation in the trial the Investigator must: 
 
• 
Provide the sponsor with a complete signed trial contract. 
• 
Acquire and provide all applicable approvals, including but not limited to, the relevant 
IRB. 
• 
The Investigator must complete the above process and start enrollment within 3 
months from the date he/she receives the needed regulatory documents for the trial. If 
this deadline cannot be met the Investigator and his/her team may not be able to 
participate in this trial.  At this time the sponsor may opt to enroll an alternative site. 
In addition, all local regulations must be adhered to; in particular those which afford greater 
protection to the safety of trial subjects. Suitably qualified and trained clinical personnel of the 
investigation site must ensure compliance with the protocol, adherence to ethical and regulatory 
obligations and proper maintenance of trial records. 
By signing the protocol signature page, the Investigator agrees to conduct the trial according to 
protocol. 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
27 
13.3 INDEPENDENT EVENT REVIEWER RESPONSIBILITIES 
An independent physician(s) will adjudicate all MAEs, ADEs, SADEs and UADEs reported by 
the sites within this trial. The independent physician will complete the eCRF data capture form 
for all the adjudicated events. 
13.4 INDEPENDENT CORE LAB RESPONSIBILITIES 
All images obtained in this trial will be assessed by an external, independent Core Lab and 
measurements of the assessment will be recorded in the eCRF, to ensure uniform and unbiased 
image assessment throughout the trial. 
14 CONFIDENTIALITY AND PATIENT RIGHTS 
14.1 CONFIDENTIALITY 
Trial subjects will be identified only by a unique subject number used in all correspondence and 
the trial database. The Investigator and the investigation site team shall maintain patient 
confidentiality during all site audits and inspections and in all documentation. The Investigator 
will keep a list containing the names of all patients along with their assigned trial subject 
number. 
All information provided to the Investigator relevant to the device, as well as information 
obtained during the course of the trial, will be regarded as confidential. The Investigator and all 
members of his or her trial team agree not to disclose or publish such information in any way 
to any third party without prior written permission from Endologix, Inc. which will not be 
unreasonably withheld, except as required by law. The Investigator will take all measures to 
ensure patient confidentiality is maintained at all times. All subject data must be anonymized 
before retrieval from the clinical site. 
14.2 PATIENT RIGHTS  
The subject has the right to withdraw from the trial at any time and without reason. 
Upon early withdrawal from the trial, the eCRFs should be completed as far as possible and the 
reasons for withdrawal should be documented if possible. 
15 ETHICAL CONSIDERATIONS 
No data identifying the subject and no other confidential data will be recorded. No procedures 
and examinations are required in addition to those that are standard of care in each participating 
site. The knowledge gained from this trial might provide information to improve the treatment of 
patients with AAA eligible for endovascular treatment and/or the device.  
 
This trial is performed in accordance with the Declaration of Helsinki and in accordance with 
Good Clinical Practice. 
 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
28 
16 MONITORING 
The eCRF will not be considered as source document. Source data verification will be performed 
by means of intermittent on-site and/or off-site monitoring. Details will be outlined in the 
monitoring plan (CMP). Considering the COVID-19 public health emergency, the monitoring 
plan has been updated accordingly to include changes to the original plan that could become 
necessary due to the extraordinary situation. The Conduct of Clinical Trials of Medical products 
During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and 
Institutional Review Boards has been reviewed and used to identify and outline the most suitable 
changes. 
16.1 PROTOCOL DEVIATION 
 
A protocol deviation is any noncompliance with the clinical trial protocol, International 
Conference on Harmonization, or Good Clinical Practice (ICH GCP) 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. Considering the COVID-19 public health emergency, the 
monitoring plan has been updated accordingly to include changes to the identification of 
protocol deviations related to delayed or missed follow-up visits as well as delayed or missed 
images. 
17 TRIAL TERMINATION 
The trial can be terminated or suspended prematurely at a specific investigation site or in total 
due to low compliance to the Clinical Investigational Plan (CIP), lack of enrolled subjects or that 
it becomes apparent that the trial can no longer fulfill its aims. Endologix can do so at its own 
discretion without having any further obligations to the trial site(s). 
18 PUBLICATION 
Endologix intends to publish the results of this trial. Endologix reserves the right to include the 
report of this trial in any regulatory documentation or submission or in any informational 
materials prepared for the medical profession. The ownership of the data shall at all times be held 
by Endologix. Only Investigators from centers with high protocol compliance, fast enrollment, 
complete data sets from all follow-up visits, and participation on manuscript development will 
be considered as authors on publications. 
 

Endologix 
 
 
Clinical Trial Protocol - CP-0011 Rev. 02 
LEOPARD AAA US Post-Market Trial                                                                                                           August  2021  
Confidential. This document and the information contained herein may not be reproduced, used or disclosed without 
written permission from Endologix. 
29 
Any single center within the trial is not permitted to publish its own data prior to the publication 
of the multi-center data at any time throughout the trial.  
 
Endologix agrees that after publication of multicenter data Investigators shall be permitted to 
present at symposia, national or regional professional meetings, and to publish in journals, theses 
or dissertations, or otherwise of their own choosing, methods and results of the trial. Any prior 
publication in any way or form is not permitted, unless approved in writing by Endologix.