Endurant Evo US Clinical Trial
Phase: NA
Conditions: Abdominal Aortic Aneurysm, AAA
Sponsor: Medtronic Cardiovascular



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TABLE OF CONTENTS 
 
A 
SYNOPSIS ...................................................................................................................................... 6 
B 
GENERAL INFORMATION .......................................................................................................... 11 
B.1 
Introduction ....................................................................................................................... 11 
B.2 
Device Information ............................................................................................................ 12 
B.2.1 Device Description .................................................................................................... 12 
B.2.2 Indications for Use ............................................................................................................ 16 
C 
STUDY PLAN ................................................................................................................................ 17 
C.1 
Study Objectives ............................................................................................................... 17 
C.1.1 Primary Objectives .................................................................................................... 17 
C.1.2 Secondary Objectives ............................................................................................... 17 
C.2 
Clinical Endpoints ............................................................................................................. 17 
C.2.1 Primary Endpoints ..................................................................................................... 17 
C.2.2 Secondary Endpoints ................................................................................................ 18 
C.2.3 Additional Observations ............................................................................................ 18 
C.3 
Study Hypothesis .............................................................................................................. 19 
C.4 
Study Population ............................................................................................................... 19 
C.5 
Study Design...................................................................................................................... 19 
C.6 
Randomization and Blinding ............................................................................................ 19 
C.7 
Sample Size ....................................................................................................................... 19 
C.8 
Number of Investigational Sites and Study Duration .................................................... 20 
D 
SUBJECT SELECTION ................................................................................................................ 21 
D.1 
Inclusion Criteria ............................................................................................................... 21 
D.2 
Exclusion Criteria .............................................................................................................. 21 
E 
STUDY PREPARATION PROCEDURES..................................................................................... 23 
E.1 
Investigator / Investigational Site Selection ................................................................... 23 
E.1.1 Investigator Selection Criteria ................................................................................... 23 
E.1.2 Investigational Site Selection Criteria ....................................................................... 23 
E.1.3 Clinical Trial Agreement ............................................................................................ 23 
E.1.4 Curriculum Vitae ....................................................................................................... 23 
E.2 
Ethics .................................................................................................................................. 23 
E.2.1 EC/IRB Approval ....................................................................................................... 24 
E.2.2 Informed Consent Process ....................................................................................... 24 
E.2.3 Revisions in Informed Consent Form ....................................................................... 24 
E.2.4 Regulatory Submission ............................................................................................. 25 

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E.3    Regulatory Compliance ................................................................................................... 25 
E. 4    Training Requirements ..................................................................................................... 25 
E. 5    Clinical Study Materials ................................................................................................... 25 
E. 6    Study Device/Product Traceability ................................................................................. 26 
E.6.1 Supply of Investigational Devices/Products .............................................................. 26 
E.6.2 Storage and Handling of Investigational Devices/Products ...................................... 26 
E.6.3 Device Explant and Return Procedures/Products .................................................... 26 
E.6.4 Device/Product Disposition Requirements ............................................................... 26 
F 
STUDY METHODS ....................................................................................................................... 27 
F.1 
Point of Enrollment ........................................................................................................... 27 
F.2 
Implant and Follow up ...................................................................................................... 28 
F.2.1 Index Procedure ........................................................................................................ 28 
F.2.2 Hospital Discharge .................................................................................................... 28 
F.2.3 Follow-Up Visits and Procedures .............................................................................. 28 
F.3 
Data Collection Requirements ......................................................................................... 29 
F.4 
Role of the Sponsor Representatives ............................................................................. 31 
F.5 
Source Documents............................................................................................................ 31 
F.6 
Adverse Events ................................................................................................................. 31 
F.6.1 Definitions / Classifications ....................................................................................... 33 
F.6.2 Recording and Reporting of Adverse Events ............................................................ 34 
F.6.3 Recording and Reporting of Device Deficiencies ..................................................... 34 
F.6.4 Adverse Event and Device Deficiency Review Process ........................................... 34 
F.6.5 Clinical Event Committee .......................................................................................... 35 
F.6.6 Emergency Contact Details in Case of Serious AEs ................................................ 35 
F.7 
Subject accountability ...................................................................................................... 35 
F.7.1 Criteria and Procedures for Exit from Study ............................................................. 35 
F.7.2 Study Withdrawal ...................................................................................................... 36 
F.7.3 Missed Follow-up ...................................................................................................... 36 
F.7.4 Lost-to-Follow-up ...................................................................................................... 36 
F.7.5 Conversion to Open Repair ...................................................................................... 36 
F.7.6 Medical Care after Study Exit ................................................................................... 36 
F.8 
Study/Protocol Deviations and CIP Changes ................................................................. 36 
F.8.1 Request for Approval of Study Deviations ................................................................ 37 
F.8.2 Reporting Requirements for Study Deviations .......................................................... 37 
F.8.3 Amendments to the Clinical Investigation Plan ......................................................... 37 
G 
QUALITY CONTROL PROCEDURES ......................................................................................... 38 
G.1 
Procedures for database management ........................................................................... 38 
G.1.1 Data Collection .......................................................................................................... 38 

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G.1.2 Source Data to be Directly Recorded on the Case Report Forms ............................ 38 
G.1.3 Time Windows for Completion and Submission of Case Report Forms ................... 38 
G.1.4 Data Review and Processing .................................................................................... 38 
G.2 
Monitoring Procedures ..................................................................................................... 38 
G.2.1 Accessibility of Investigation Site Staff and Study Materials .................................... 39 
G.2.2 Audits and Investigation Site Inspections ................................................................. 39 
G.3 
Study Suspension or Early Termination ......................................................................... 39 
G.3.1 Early Study Suspension or Termination ................................................................... 39 
G.3.2 Early Investigation Site Suspension or Termination ................................................. 39 
G.3.3 Subject Follow-up in Case of Termination ................................................................ 40 
G.4 
Study Close Out ................................................................................................................ 40 
H 
DATA ANALYSIS AND REPORTING .......................................................................................... 41 
H.1 
Analysis of Clinical Data .................................................................................................. 41 
H.2 
Publication Policy ............................................................................................................. 43 
I 
STUDY MANAGEMENT ............................................................................................................... 44 
I.1 
Study Contact .................................................................................................................... 44 
I.2 
Advisory Committees ....................................................................................................... 44 
I.2.1 Clinical Event Committee (CEC) ............................................................................... 44 
I.2.2 Data Monitoring Committee ...................................................................................... 44 
I.2.3 Publication Committee .............................................................................................. 44 
I.2.4 Imaging Core Lab ..................................................................................................... 44 
I.3 
Records and Reports ........................................................................................................ 44 
I.3.1 Investigator Records ................................................................................................. 44 
I.3.2 Investigator Reporting Responsibilities ..................................................................... 45 
I.3.3 Sponsor Records ...................................................................................................... 45 
I.3.4 Sponsor Reporting Responsibilities .......................................................................... 46 
I.3.5 Record Retention ...................................................................................................... 47 
I.4 
Miscellaneous .................................................................................................................... 47 
I.4.1 Insurance .................................................................................................................. 47 
I.4.2 Subject Reimbursement and Indemnification ........................................................... 47 
I.4.3 Subject Confidentiality .............................................................................................. 47 
J 
RISKS AND BENEFITS ................................................................................................................ 48 
J.1 
Potential Risks ................................................................................................................... 48 
J.2 
Potential Benefits .............................................................................................................. 48 
J.3 
Risk-to-Benefit Rationale ................................................................................................. 49 
K 
REFERENCES .............................................................................................................................. 50 
L 
APPENDICES ............................................................................................................................... 52 
L.1 
Abbreviations .................................................................................................................... 52 

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L.2 
Definitions .......................................................................................................................... 53 
L.3 
Potential Adverse Events ................................................................................................. 56 
L.5 
Informed Consent Template ............................................................................................. 63 
L.6 
Imaging Technique and Sensitivity ................................................................................. 64 
L.7 
Center for Medicare and Medicaid Services (CMS) IDE Study Criteria ........................ 64 
Beneficiaries ........................................................................................................................ 64 
L.8 
Imaging Device Assessment Reporting Decision Tree ................................................. 65 
L.9 
Overview of description of changes from CIP Version 1D to 1E with rationale ......... 66 
 
 
 

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A 
SYNOPSIS 
Protocol Number 
10173341DOC 
Title 
Endurant Evo US Clinical Trial 
Investigational 
Device 
EndurantTM Evo AAA Stent Graft System 
Study Design 
The Endurant Evo US Clinical Trial is a prospective, multi-center, pre-market, 
non-randomized, single-arm trial. 
Purpose 
The purpose of the Endurant Evo US Clinical Trial is to demonstrate that the 
Endurant Evo AAA Stent graft system is safe and effective for endovascular 
treatment of infrarenal abdominal aortic or aortoiliac aneurysms. The clinical 
evidence collected as part of this trial will be used in conjunction with data 
collected during the concurrently enrolling Endurant Evo International 
Clinical Trial to support PMA Approval of the Endurant Evo AAA Stent graft 
system. 
Primary 
Objective 
The primary safety objective is to demonstrate the safety of the Endurant Evo 
AAA stent graft system for the endovascular treatment of infrarenal abdominal 
aortic or aortoiliac aneurysms. Safety will be assessed through the proportion of 
subjects who have a Major Adverse Events (MAE) reported within 30-days post- 
implantation.  
 
The primary effectiveness objective is to demonstrate successful delivery and 
deployment of the Endurant Evo AAA stent graft system with successful removal 
of the delivery system during the index procedure as well as the treatment 
success at 12 months. 
Secondary 
Objective 
Secondary objectives include descriptive analyses of secondary endpoints as 
well as acute procedural and clinical utility measures. 
Primary 
Endpoints 
Primary safety endpoint: 
The primary safety endpoint is defined as the proportion of subjects 
experiencing a MAE within 30 days post-implantation. MAEs include the 
occurrence of any of the following events: 
• 
All-cause mortality 
• 
Bowel ischemia 
• 
Myocardial infarction 
• 
Paraplegia 
• 
Procedural blood loss ≥1000 cc 
• 
Renal failure 
• 
Respiratory failure 
• 
Stroke 
Primary effectiveness endpoint: 
The primary effectiveness endpoint is defined as the proportion of subjects with 
both technical success at the time of index procedure and treatment success at 
12-months post-implantation. Successful aneurysm treatment is achieved based 
on the following criteria: 
• 
Technical success at the index procedure (as assessed intra-operatively)is 
defined as successful delivery and deployment of the Endurant Evo AAA 
stent graft system in the planned location and with no unintentional 
coverage of both internal iliac arteries or any visceral aortic branches and 
with successful removal of the delivery system 
AND 
• 
Treatment success consisting of freedom from: 
o AAA diameter increase, defined as > 5 mm increase in maximum 
diameter as measured on CT scan (or MRA/MRI ) at 12-month follow- 
up as compared to 1-month imaging 
o Types I and III endoleaks at 12-month follow-up including those 

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to fulfill all of the following inclusion criteria to be eligible for enrollment in the 
study: 
1) Subject is ≥ 18 years old 
2) Subject understands and voluntarily has signed and dated the Informed 
Consent approved by the Sponsor and by the Ethics Committee/Institutional 
Review Board. 
3) Subject is able and willing to comply with the protocol and to adhere to the 
follow-up requirements 
4) Subject is a suitable candidate for elective surgical repair of AAA as 
evaluated by American Society of Anesthesiologists (ASA) Physical Status 
Classification System I, II, or III 
5) Subject has an infrarenal abdominal aortic or aortoiliac aneurysm 
characterized by one or more of the following: 
a) Aneurysm is > 5 cm in diameter (diameter measured is 
perpendicular to the line of flow) 
b) Aneurysm is 4 – 5 cm in diameter and has increased in size ≥ 
0.5 cm within the previous 6 months 
6) Subject meets all the following anatomical criteria as demonstrated on 
contrast-enhanced CT or MRA imaging: 
a) Proximal neck length of ≥ 10 mm with ≤ 60° infrarenal and ≤ 45° 
suprarenal neck angulation or proximal neck length of ≥ 15 mm 
with ≤ 75° infrarenal and ≤ 60° suprarenal neck angulation 
b) Subject has vascular dimensions, e.g., aortic and iliac 
diameters, lengths from renal arteries to iliac bifurcation and 
hypogastric arteries, in the range of sizes available for the 
Endurant Evo AAA stent graft system (measured intima to 
intima) and within the sizing recommendations (refer to 
Endurant Evo AAA stent graft system Instructions for Use (IFU)) 
c) Subject has a proximal aortic neck diameter ≥18 mm and ≤32 
mm 
d) The distal fixation center of the iliac arteries must have a 
diameter ≥7 mm and ≤ 25 mm bilaterally for the bifur and 
unilaterally for the AUI 
e) Subject has documented imaging evidence of at least one 
patent iliac and one femoral artery, or can tolerate a vascular 
conduit that allows introduction of the Endurant Evo AAA stent 
graft system 
f) 
Subject has distal non-aneurysmal iliac (cylindrical) fixation 
length ≥ 20 mm bilaterally for the bifur and unilaterally for the 
AUI 
Exclusion Criteria 
Candidates who meet any of the following exclusion criteria will not be eligible 
for enrollment in the study: 
1) Subject has a life expectancy ≤ 1 year 
2) Subject is participating in another investigational drug or device study which 
would interfere with the endpoints and follow-ups of this study 
3) Subject is pregnant 
4) Subject has an aneurysm that is: 
a) Suprarenal/ pararenal/ juxtarenal 
b) Isolated ilio-femoral 
c) Mycotic 
d) Inflammatory 
e) Pseudoaneurysm 
f) 
Dissecting 
g) Ruptured 
h) Leaking but not ruptured 
5) Subject requires emergent aneurysm treatment 
6) Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at 

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time of screening 
7) Subject has been previously treated for an abdominal aortic aneurysm 
8) Subject has a history of bleeding diathesis or coagulopathy 
9) Subject has had or plans to have an unrelated major surgical or 
interventional procedure within 1 month before or after implantation of 
the Endurant Evo AAA stent graft 
10) Subject has had a myocardial infarction (MI) or cerebral vascular accident 
(CVA) within 3 months prior to implantation of the Endurant Evo AAA stent 
graft 
11) Subject has a conical neck defined as a >4 mm distal increase from the 
lowest renal artery over a 10 mm length 
12) Subject has a known allergy or intolerance to the device materials 
13) Subject has a known hypersensitivity or contraindication to anticoagulants, 
antiplatelets, or contrast media, which is not amenable to pre-treatment 
14) Subject has significant aortic thrombus and/or calcification at either the 
proximal or distal attachment centers that would compromise fixation 
and seal of the device at the discretion of the investigator 
15) Subject has ectatic iliac arteries requiring bilateral exclusion of 
hypogastric blood flow 
16) Subject whose arterial access site is not anticipated to accommodate the 
diameter of the Endurant Evo AAA delivery system (13F-17F) due to vessel 
size, calcification, or tortuosity 
17) Subject is morbidly obese or has other documented clinical conditions that 
severely inhibit radiographic visualization of the aorta at the discretion of the 
investigator 
18) Subject has active infection at the time of the index procedure documented 
by e.g. pain, fever, drainage, positive culture and/or leukocytosis considered 
to be clinically significant per investigator discretion 
19) Subject has congenital degenerative collagen disease, e.g., 
Marfan’s Syndrome 
20) Subject has a creatinine level >2.00 mg/dl (or >176.8 µmol/L) 
21) Subject is on dialysis 
Study Success 
Criteria 
Study success is defined as rejecting the null hypothesis for the primary 
safety endpoint test (≥20%), with a condition upon rejecting the null 
hypothesis for the post-market primary effectiveness test (≤80%). 
Analysis Sets 
The primary analysis set will consist of the Intent-to-Treat (ITT) population. 
This analysis set is defined as all subjects who were enrolled. 
 
A secondary analysis set will be the Per-Protocol population. This analysis 
set is comprised of all ITT subjects who met inclusion and exclusion criteria, 
received the test device, and completed 12-month follow-up (including death 
but excluding withdrawal or lost to follow-up subjects within the 12-month 
follow-up period). 
Data Oversight 
A Data Monitoring Committee, Clinical Events Committee, and imaging core 
Lab will be established to independently evaluate subject health status, 
device performance, and identify any safety concerns regarding subjects’ 
well-being. 
Contact details of the committees and the Core Lab will be available in the 
investigational site file. 
 
 
 

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B 
GENERAL INFORMATION 
 
B.1 
Introduction 
Background 
Abdominal aortic aneurysms (AAA) occur in approximately 5% of the general population as estimated 
by a systematic literature survey of 56 epidemiological studies.1 This estimate is similar to that 
observed in an autopsy report from Malmo Sweden, where AAA were found in 4.7% of men 
and 1.2% of women between 65 and 74 years of age.2 The prevalence is greater in males (6.0%) 
compared with females (1.6%) and aneurysms are found more frequently in western countries than 
in Asia. Risk factors for AAA include advanced age, smoking, family history of AAA, hypertension, 
atherosclerosis, and hyperlipidemia. The female gender and diabetes were associated with a lower 
prevalence of AAA.3 
Aneurysms are prophylactically treated to prevent premature death from rupture. More than one- 
third of patients with ruptured aneurysms succumb from the event; a proportion that has not 
decreased appreciably over the last several decades.4  By contrast, elective treatment of AAA  prior 
to rupture is associated with a perioperative mortality rate below 3%. For this reason, AAA are best 
managed electively, prior to rupture. Screening tests are recommended in patients at risk for AAA, 
usually with an abdominal ultrasound imaging study. When an AAA is identified, the clinician’s 
decision to repair the aneurysm rests on assessing the risk of rupture compared with the risk of the 
repair procedure itself. In this regard, the diameter of the AAA is the only consistent predictor of 
rupture. As such, patients with AAA greater than 50 mm in diameter are usually recommended for 
treatment  while  observation  with  regular  imaging  studies  is  advisable  for  those  with   smaller 
aneurysms5 The size threshold is reduced in women, since the normal aorta is smaller in  the female 
gender. The presence of symptoms from an aneurysm, rapid enlargement of the aneurysm, 
saccular aneurysm configuration, or the distal embolization of aneurysm contents are each 
considered indications for repair, irrespective of sac diameter. Lastly, a saccular aneurysm 
configuration is thought to be more prone to rupture and the threshold for AAA repair is lowered 
when saccular morphology is encountered6. 
There are two general methods for repair of an AAA; traditional open surgical repair and endovascular 
repair. Traditional open surgical repair has been the standard technique for over six 
decades.7,8 Open repair is performed through a transperitoneal or retroperitoneal incision; sewing a 
prosthetic graft to the aorta above and below the aneurysm. While durable, open repair is associated 
with a significant risk of perioperative complications. The risk is particularly high in the elderly and 
in those with multiple medical comorbidities; the population who characteristically develop AAA. The 
Lifeline registry documented postoperative respiratory failure in 4.3%, myocardial infarction in 4.0%, 
and renal failure in 2.5% within 30 days of open surgical AAA repair.9 
Endovascular aneurysm repair (EVAR) is the second general technique for aneurysm repair, first 
described by Volodos in 198610 and first successfully performed by Parodi in 1990.11 The  objective 
of EVAR is to repair the aneurysm through the trans-vascular insertion of an endograft. EVAR has 
been shown to reduce 30-day and in-hospital mortality, blood transfusions, mechanical ventilation, 
and ICU and hospital length of stay compared to open surgery.12 Current endografts, while much 
improved over earlier devices, still suffer from some shortcomings. Many of  the shortcomings of prior 
designs have been remediated with more durable materials, better stent architecture, and 
improved manufacturing processes. However, hostile proximal neck anatomies and poor quality 
access vessels still exclude EVAR as an option for many patients. Anatomical characteristics such 
as limited proximal aortic neck lengths, severe infrarenal neck angulation, and narrow, tortuous and/or 
calcified iliac arteries have been identified as risk factors that can limit EVAR success   rates 
and are associated with increased rates of secondary interventions.13-18 Complications associated 
with hostile proximal neck anatomy include type I endoleaks and graft migration.14 Challenging iliac 
access vessels can hinder placement accuracy resulting in inadequate distal seal zones16. Access 
related complications remain a common cause for conversion to open surgery.14 
 
Newer devices must address these previous endograft shortcomings if the applicability and the 
durability of endovascular repair are to be improved. Engineering of newer device iterations must 

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address interactions between design elements. For instance, lowering the profile of a device with 
newer sutures, fabrics, stents and assembly methods must also consider the effect such changes 
will have on one another; both during deployment as well as over long-term follow-up. 
 
Medtronic’s next generation AAA stent graft system on the Endurant product platform is the 
EndurantTM Evo Abdominal Aortic Aneurysm (AAA) stent graft system. The Endurant Evo AAA stent 
graft system was designed to further expand EVAR applicability and improve access in patients with 
challenging anatomies. Key design targets for Endurant Evo include the following: 
• 
Introduction of a lower profile delivery system to allow treatment of patients with challenging 
anatomies, expand overall patient applicability, and improve procedural ease of use of the 
system. 
• 
Graft flexibility and limb design optimization to improve conformability in challenging 
anatomies. 
• 
Introduction of a 3-piece modular system (similar to Endurant IIs), which is engineered to 
help with placement accuracy by allowing bilateral device length adjustment during 
deployment and also aids the physicians in better inventory management. 
• 
Enhanced delivery system ergonomic features to improve ease of use. 
 
These enhancements were incorporated in the Endurant Evo AAA stent graft design with an 
expressed focus on maintaining the high durability and high performance standards established 
previously in the Endurant family. Scientific literature discussing the clinical performance of the 
Endurant/Endurant II device documents excellent early and late results. The relatively low rate of 
device-related complications has the potential to be reduced further with incremental design 
modifications. Based on the existing scientific literature on Endurant/ Endurant II three primary 
areas of design change of the Endurant Evo AAA stent graft system cannot be fully evaluated; 
lower profile, helical limb stent graft optimization, delivery system enhancements. 
 
While these performance/design features are 
well understood 
technically and have been 
comprehensively analyzed/tested through preclinical testing (bench and animal), residual risks 
associated with the overall performance of the Endurant Evo AAA stent graft system will be confirmed 
in a clinical investigation designed to evaluate system performance. Therefore, the Endurant Evo 
Clinical Program composed of the Endurant Evo US Clinical Trial and the Endurant Evo International 
Clinical Trial were designed to evaluate the safety and effectiveness of the device in subjects who 
are candidates for endovascular repair of infrarenal AAA or aortoiliac aneurysms. Trial endpoints 
are described in more detail in Section C 2. 
 
Literature review and pre-clinical testing will be provided in the Report of Prior Investigations. 
 
B.2 
Device Information 
 
B.2.1 Device Description 
The Endurant Evo Abdominal Aortic Aneurysm (AAA) stent graft system (manufactured by Medtronic, 
Inc.) is designed for the endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms. 
When implanted within the target lesion, the stent graft provides a permanent, alternative conduit for 
blood flow within the subject's vasculature by excluding the lesion from blood flow and pressure. The 
stent graft system is comprised of the implantable stent graft and the disposable delivery system. 
The stent graft is preloaded into the delivery system, which is inserted endoluminally via the femoral 
or iliac artery and tracked through the subject's vasculature to deliver the stent graft to the target 
site. Upon deployment, the stent graft self-expands to conform to the shape and size of the seal 
zones above and below the aneurysm. 
 
The Endurant Evo AAA stent graft system is comprised of two primary components: the Endurant 
Evo stent graft and the Endurant Evo delivery system. All components of the Endurant Evo AAA 
stent graft system are pre-market and considered to be investigational. 
 
 

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Figure 3:  Endurant Evo Iliac Delivery System 
 
The Endurant Evo AAA stent graft system is an investigational class III device in all geographies 
and is labeled with all the required statements per geography: 
• 
Europe: “Exclusively for clinical investigations” (including translations into local languages) 
• 
United States: “CAUTION: Investigational Device. Limited by Federal Law (USA) to 
Investigational Use” 
 
The use of the Endurant Evo AAA stent graft system is limited to this clinical investigation and has to 
be done according to the clinical investigational plan and the Instructions for Use (IFU). Required 
Investigator training for the use of the Endurant Evo AAA stent graft system is described in  Section 
E. 4. 
 
B.2.2 Indications for Use 
The Endurant Evo bifurcated stent graft is indicated for the endovascular treatment of infrarenal 
abdominal aortic or aortoiliac aneurysms. The Endurant Evo aorto-uni-iliac (AUI) stent graft is 
indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in 
subjects whose anatomy does not allow the use of a bifurcated stent graft. The Endurant Evo AAA 
stent graft system is indicated for use in subjects with the following characteristics: 
• 
adequate iliac or femoral access that is compatible with vascular access techniques 
(femoral cutdown or percutaneous), devices, and accessories 
• 
proximal neck length of 
o 
≥10 mm and infrarenal neck angulation of ≤60° and suprarenal neck angulation of 
≤45°, or 
o 
≥15 mm and infrarenal neck angulation of ≤75° and suprarenal neck angulation of 
≤60° 
• 
aortic neck diameters with a range of 18 mm to 32 mm 
• 
distal fixation lengths of ≥20 mm 
• 
iliac diameters with a range of 7 mm to 25 mm 
• 
morphology suitable for aneurysm repair 
 
Note: Proximal neck length refers to minimum seal zone. 
 

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C 
STUDY PLAN 
 
C.1 
Study Objectives 
The purpose of the Endurant Evo US Clinical Trial is to demonstrate that the Endurant Evo AAA 
stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or 
aortoiliac aneurysms. The clinical evidence collected as part of this trial will be used in conjunction 
with data collected during the concurrently enrolling Endurant Evo International Clinical Trial to 
support PMA Approval of the Endurant Evo AAA Stent graft system. 
 
C.1.1 Primary Objectives 
The primary safety objective is to demonstrate the safety of the Endurant Evo AAA Stent graft 
system for the endovascular treatment of abdominal aortic or aortoiliac aneurysms. Safety will be 
assessed through the proportion of subjects who have a Major Adverse Events (MAE) reported 
within 30-days post-implantation. 
 
The primary effectiveness objective is to demonstrate successful delivery and deployment of the 
Endurant Evo AAA Stent graft system with successful removal of the delivery system during the 
index procedure as well as the treatment success at 12 months. 
(See section C.2.1 Primary Endpoints for a detailed description of the evaluation criteria used to 
assess Primary Objectives) 
 
C.1.2 Secondary Objectives 
Secondary objectives include descriptive analyses of secondary endpoints as well as acute 
procedural and clinical utility measures. 
(See section C.2.2 Secondary Endpoints for a detailed description of the evaluation criteria used to 
assess Secondary Objectives) 
 
C.2 
Clinical Endpoints 
 
C.2.1 Primary Endpoints 
C.2.1.1 Primary Safety Endpoint 
The primary safety endpoint is defined as the proportion of subjects experiencing a MAE within 30 
days post-implantation. MAEs include the occurrence of any of the following events: 
• 
All-cause mortality 
• 
Bowel ischemia 
• 
Myocardial infarction 
• 
Paraplegia 
• 
Procedural blood loss ≥1000 cc 
• 
Renal failure 
• 
Respiratory failure 
• 
Stroke 
 
Detailed definitions of MAEs are provided in Appendix L.2. 
 
C.2.1.2 Primary Effectiveness Endpoint 
The primary effectiveness endpoint is defined as the proportion of subjects with both technical 
success at the time of index procedure and treatment success at 12 months post-implantation. 
Successful aneurysm treatment is achieved based on the following criteria: 
 

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• 
Technical success at the index procedure (as assessed intra-operatively) is defined as 
successful delivery and deployment of the Endurant Evo AAA Stent graft system in the 
planned location and with no unintentional coverage of both internal iliac arteries or 
any visceral aortic branches and with successful removal of the delivery system 
AND 
• 
Treatment success consisting of freedom from: 
o AAA diameter increase, defined as > 5 mm increase in maximum diameter as measured 
on CT scan (or MRA/MRI) at 12-month follow-up as compared to 1-month imaging 
o Types I and III endoleaks at 12-month follow-up including those requiring intervention 
through 12 months 
o Aneurysm rupture within 365 days 
o Conversion to surgery within 365 days 
o Stent graft migration resulting in a serious adverse event or requiring secondary 
intervention through 12 months 
o Stent graft occlusion through 12 months 
 
C.2.2 Secondary Endpoints 
The following secondary endpoints will be evaluated: 
• 
All cause-mortality within 30, 183, and 365 days 
• 
Aneurysm-related mortality within 30, 183, and 365 days 
• 
Secondary procedures to correct Type I and III endoleaks within 183 and 365 days 
• 
Secondary procedures within 183 and 365 days 
• 
Serious adverse events within 30, 183, and 365 days 
• 
Conversion to open surgery within 183 and 365 days 
• 
Aneurysm rupture within 183 and 365 days major adverse events within 183 and 365 days 
• 
Stent graft migration at 6- and 12-month follow-up visits (as compared to 1-month imaging) 
• 
Aneurysm expansion >5 mm at 6- and 12-month follow-up visits (as compared to 1-month 
imaging) 
• 
All endoleaks based on imaging findings at 1-, 6-, and 12-month follow-up visits 
• 
Stent graft occlusions based on imaging findings through 1-, 6- and 12 months 
• 
Device deficiencies based on imaging findings through 6 and 12 months 
Detailed definitions for secondary endpoints are provided in Appendix L.2. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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C.3 
Study Hypothesis 
The Endurant Evo US Clinical Trial will focus on balancing pre- and post-market clinical data to 
establish safety and effectiveness. Study success is defined as rejecting the null hypothesis for the 
primary safety endpoint test (≥20%), with a condition upon rejecting the null hypothesis for the post- 
market primary effectiveness test (≤80%). As such, the following analyses will be submitted: 
• 
Pre-market: 30-day primary safety endpoint (hypothesis based, see H.1) 
• 
Pre-market: 6-month effectiveness analysis (descriptive) 
• 
Post-market: 12-month primary effectiveness endpoint (hypothesis based, see H.1) 
 
The proposed clinical strategy described in this section will allow for appropriate evaluation of the 
safety and effectiveness of the Endurant Evo AAA stent graft system. Safety will be established 
through the hypothesis-based primary safety endpoint at 30 days. Reasonable assurance of 
effectiveness will be provided via the pre-market 6-month analysis and then confirmed at the 12- 
month post-market primary effectiveness endpoint. 
C.4 
Study Population 
The study population will include those subjects who are appropriate candidates for endovascular 
repair of infrarenal abdominal aortic or aortoiliac aneurysms, and who meet the Inclusion/Exclusion 
criteria (defined in Section D). 
C.5 
Study Design 
The Endurant Evo US Clinical Trial is prospective, multi-center, pre-market, non-randomized, single-
arm trial. The trial is designed to assess the clinical safety and performance of the Endurant Evo AAA 
Stent graft system. 
 
Globally, a total of 140 subjects will be concurrently enrolled in the United States and outside the 
United States to support the primary endpoint2. Up to 50% of subject data used to support PMA 
approval may come from subjects enrolled at sites outside of the US under a separate CE Mark 
study protocol; the Endurant Evo International Clinical Trial protocol. The Endurant Evo International 
Clinical Trial protocol and Endurant Evo US Clinical Trial protocol will be identical with respect to 
the inclusion/exclusion criteria, and follow up data collection.  
 
Given the UADEs that have occurred within the Endurant Evo study (transition stent fracture, partial 
suprarenal stent detachment, and suprarenal stent fracture), enrollment was terminated.  Total global 
enrollment, upon termination, was 139 subjects.  This includes 70 subjects enrolled in the United 
States and 69 enrolled outside the United States. 
C.6 
Randomization and Blinding 
The study is a single arm study, therefore neither randomization nor blinding are applicable to this 
clinical trial. 
C.7 
Sample Size 
The sample size for the Endurant Evo global program is calculated for both the primary safety 
endpoint and the primary effectiveness endpoint. 
 
It is expected that the Endurant Evo AAA stent graft system will result in a MAE rate at 10% with 
respect to the primary safety endpoint and 90.5% treatment success for the primary effectiveness 
                                                          
2 A minimum of 50 subjects will be enrolled with the high neck angulation indication (defined as proximal neck length ≥15 mm, 
infrarenal neck angulation >60° and ≤75° and suprarenal neck angulation ≤60°). If a minimum of 50 subjects are not enrolled as 
part of the first 140 subject cohort, Medtronic will continue enrollment for the high angulation indication but submit the PMA 
application to obtain approval for the 60°angulation indication with the 140 subject cohort data. A minimum of 70 subjects 
enrolled in the study will have percutaneous access. 

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D 
SUBJECT SELECTION 
 
D.1 
Inclusion Criteria 
Candidates for the Endurant Evo US Clinical trial must be appropriate subjects for endovascular 
repair of infrarenal abdominal aortic aneurysms or aortoiliac aneurysms (evidenced by screening 
contrast-enhanced CT or MRA) and have to fulfill all of the following inclusion criteria to be eligible 
for enrollment in the study: 
1) Subject is ≥18 years old 
2) Subject understands and voluntarily has signed and dated the Informed Consent approved by 
the Sponsor and by the Ethics Committee/Institutional Review Board 
3) Subject is able and willing to comply with the protocol and to adhere to the follow-up 
requirements 
4) Subject is a suitable candidate for elective surgical repair of AAA as evaluated by American 
Society of Anesthesiologists (ASA) Physical Status Classification System I, II, or III 
5) Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one or more 
of the following: 
a) Aneurysm is >5 cm in diameter (diameter measured is perpendicular to the line of 
flow) 
b) Aneurysm is 4 – 5 cm in diameter and has increased in size ≥0.5 cm within the 
previous 6 months 
6) Subject meets all the following anatomical criteria as demonstrated on contrast-enhanced CT or 
MRA imaging: 
a) Proximal neck length of ≥ 10 mm with ≤ 60° infrarenal and ≤ 45° suprarenal neck 
angulation or Proximal neck length of ≥ 15 mm with ≤ 75° infrarenal and ≤ 60° 
suprarenal neck angulation 
b) Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal 
arteries to iliac bifurcation and hypogastric arteries, in the range of sizes available for 
the Endurant Evo AAA stent graft system (measured intima to intima) and within the 
sizing recommendations (refer to Endurant Evo AAA stent graft system Instructions 
for Use (IFU)) 
c) Subject has a proximal aortic neck diameter ≥ 18 mm and ≤ 32 mm 
d) The distal fixation center of the iliac arteries must have a diameter ≥ 7 mm and ≤ 25 
mm bilaterally for the bifur and unilaterally for the AUI 
e) Subject has documented imaging evidence of at least one patent iliac and one 
femoral artery, or can tolerate a vascular conduit that allows introduction of the 
Endurant Evo AAA stent graft system 
f) 
Subject has distal non-aneurysmal iliac (cylindrical) fixation length ≥20 mm bilateral 
for the bifur and unilaterally for the AUI 
 
D.2 
Exclusion Criteria 
Candidates who meet any of the following exclusion criteria will not be eligible for enrollment in the 
study: 
 
1) Subject has a life expectancy ≤1 year 
2) Subject is participating in another investigational drug or device study which would interfere with 
the endpoints and follow-ups of this study 
3) Subject is pregnant 
4) Subject has an aneurysm that is: 
a) Suprarenal/pararenal/juxtarenal 
b) Isolated ilio-femoral 

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c) Mycotic 
d) Inflammatory 
e) Pseudoaneurysm 
f) 
Dissecting 
g) Ruptured 
h) Leaking but not ruptured 
5) Subject requires emergent aneurysm treatment 
6) Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at the time of screening 
7) Subject has been previously treated for an abdominal aortic aneurysm 
8) Subject has a history of bleeding diathesis or coagulopathy 
9) Subject has had or plans to have an unrelated major surgical or interventional procedure within 
1 month before or after implantation of the Endurant Evo AAA stent graft 
10) Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 
months prior to implantation of the Endurant Evo AAA stent graft 
11) Subject has a conical neck defined as a >4 mm distal increase from the lowest renal artery 
over a 10 mm length 
12) Subject has a known allergy or intolerance to the device materials 
13) Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or 
contrast media, which is not amenable to pre-treatment 
14) Subject has significant aortic thrombus and/or calcification at either the proximal or distal 
attachment centers that would compromise fixation and seal of the device at the discretion of 
the investigator 
15) Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow 
16) Subject whose arterial access site is not anticipated to accommodate the diameter of the 
Endurant Evo AAA stent graft delivery system (13F-17F) due to vessel size, calcification, or 
tortuosity 
17) Subject is morbidly obese or has other documented clinical conditions that severely inhibit 
radiographic visualization of the aorta at the discretion of the investigator 
18) Subject has active infection at the time of the index procedure documented by e.g. pain, fever, 
drainage, positive culture and/or leukocytosis considered to be clinically significant 
per 
investigator discretion 
19) Subject has congenital degenerative collagen disease, e.g., Marfan’s Syndrome 
20) Subject has a creatinine level > 2.00 mg/dl (or >176.8 µmol/L) 
21) Subject is on dialysis 
 
 
 

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E 
STUDY PREPARATION PROCEDURES 
 
E.1 
Investigator / Investigational Site Selection 
 
E.1.1 Investigator Selection Criteria 
The role of the principal investigator is to implement and manage the day-to-day conduct of the clinical 
study as well as ensure data integrity and the rights, safety and well-being of the subjects involved 
in the clinical study. 
An investigator may be included in the clinical study if compliant with the following requirements: 
• Investigators are appropriately qualified practitioners and experienced in the diagnosis and 
treatment of subjects requiring an endovascular procedure with an abdominal stent graft 
• Investigators have adequate time to follow up on the clinical study 
• Investigators are willing to comply with the clinical investigation plan 
• Investigators are willing to sign the appropriate clinical trial agreement 
• Investigators have past experience with conducting clinical studies or appropriate training 
• Investigators are familiar with FDA/ ICH-GCP requirements 
• Investigators are willing to undergo auditing by sponsor or regulatory bodies 
• Investigators are willing to undergo study specific training 
 
E.1.2 Investigational Site Selection Criteria 
An investigational site may be selected for participation in the clinical study if compliant with the 
following requirements: 
• Adequate staff (sub-investigator and/or research coordinator) that is accessible and has 
time to manage the trial and data reporting requirements 
• Site personnel has demonstrated experience with conducting clinical (specifically device) 
trials that comply with applicable regulatory standards 
• Site has sufficient annual case volume of AAA stent graft procedures 
• Ability to securely store devices according to the Instructions for Use 
 
E.1.3 Clinical Trial Agreement 
A clinical trial agreement shall be in place, signed by the participating investigational site and/or 
principal investigator of each investigational site, as per the local legal requirements, and returned to 
Medtronic prior to the commencement of any clinical study activities. The investigator is indicating 
approval of the clinical investigation plan and subsequent amendments, with a fully executed 
agreement. 
 
E.1.4 Curriculum Vitae 
A current (within 3 years) signed and dated Curriculum Vitae from all key members of the 
investigational site team participating in this clinical study as listed on the Delegation of Authority 
Form shall be obtained, evidencing the required qualifications, including the year and where obtained, 
and  including their current position at the investigational site. 
 
The signature on the CV must be dated within 3 years prior to the date of activation of the 
investigational site. 
 
 
 
E.2 
Ethics 

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E.2.1 EC/IRB Approval 
Prior to enrolling subjects in this clinical study, each investigational site’s EC/IRB will be required to 
approve the current Clinical Investigation Plan, the Informed Consent Form, including any other 
written information to be provided to the subjects and, if applicable, materials used to recruit 
subjects. EC/IRB approval of the clinical study must be received in the form of a letter and a copy 
provided to Medtronic before commencement of the clinical study at an investigational site. The 
approval letter must contain enough information to identify the version or date of the documents 
approved. If this information is not contained in the approval letter, it must be retrievable from the 
corresponding submission letter. In addition, the approval letter needs to be accompanied by an 
EC/IRB roster or letter of compliance, to allow verification that the investigator, other investigation 
site personnel, and/or Medtronic personnel are not members of the EC/IRB. If they are members of 
the EC/IRB, written documentation is required stating that he/she did not participate in the approval 
process. If the EC/IRB imposes any additional requirements (e.g. safety reports, progress reports), 
the site must request these additional requirements in writing, and then Medtronic will prepare the 
required documents and send them to the investigator for reporting to the EC/IRB. Investigators must 
inform Medtronic of any change in status of EC/IRB approval once the investigational site has started 
enrollment. If any action is taken by an EC/IRB with respect to the investigation, that information 
will be forwarded to Medtronic by the respective investigator. 
 
E.2.2 Informed Consent Process 
The investigator or authorized designee must obtain written informed consent before any clinical 
study related activity takes place. 
 
In order to ensure the subject has sufficient time to review the materials, prior to the consent 
discussion, the subject should receive the EC/IRB approved Informed Consent Form. During the 
consent discussion the investigator or his/her authorized designee must fully inform the subject of 
all aspects of the clinical study that are relevant to the subject’s decision to participate in the clinical 
study. If a subject is unable to read and/ or write, an impartial witness must be present during the 
entire informed consent discussion. All items addressed in the Informed Consent Form must be 
explained. The language used shall be as non-technical as possible and must be understandable to 
the subject and the impartial witness, where applicable. 
 
The subject must have ample time and opportunity to read and understand the Informed Consent 
Form, to inquire about details of the clinical study, and to decide whether or not to participate in the 
clinical study. All questions about the clinical study should be answered to the satisfaction of the 
subject. 
 
Neither the investigator, nor the investigation site staff shall coerce or unduly influence a subject to 
participate or to continue to participate in the clinical study. The informed consent process shall not 
waive or appear to waive the subject’s rights. 
 
When the subject decides to participate in the clinical study, the Informed Consent Form must be 
signed and personally dated by the subject and the investigator or authorized designee. If applicable, 
the witness shall also sign and personally date the consent form to attest that the information 
in the Informed Consent Form was accurately explained and clearly understood by the subject, and 
that informed consent was freely given. 
 
After all persons have signed and dated the Informed Consent Form the investigator must provide 
the subject with a copy of the signed and dated Informed Consent Form. 
 
E.2.3 Revisions in Informed Consent Form 
Medtronic will inform the investigators whenever information becomes available that may  be relevant 
to the subject’s confirmed participation in the clinical study. The investigator or his/her authorized 
designee should inform the subject in a timely manner. 
 
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medical care, Medtronic will revise the written Informed Consent Form. The revised information will 
be sent to the investigator for approval by the EC/IRB. After approval by the EC/IRB, if relevant, all 
affected subjects shall be asked to confirm their continuing informed consent in writing. 
 
E.2.4 Regulatory Submission 
In countries where submission to the regulatory authority is required per local law, no subjects will be 
enrolled in the clinical study until the particular regulatory authority has approved the current 
clinical investigation plan of the clinical study and other documents as required according to the local 
requirements. 
If the regulatory authority imposes any additional requirements (e.g., safety reports, progress reports) 
Medtronic will prepare the required documents and send them to the respective authority. Other 
documents that are referred to in this clinical investigation plan are listed below and will be made 
available upon request: 
• 
Monitoring Plan 
• 
Data Management Plan 
• 
Informed Consent Form 
• 
Case Report Forms 
 
E.3    Regulatory Compliance 
The Endurant Evo US Clinical Trial will be conducted under an FDA Investigational Device Exemption 
(IDE) in compliance with the Declaration of Helsinki (October 2013), ISO 14155:2011 3.1, 3.15, 3.2, 
3.36, 3.37, 3.42  and 21 CFR Parts 11, 50, 54, 56, and 812. 
 
This study will be publicly registered before recruitment of the first enrollment in accordance with the 
2007 Food and Drug Administration Amendments Act (FDAAA) and Declaration of Helsinki 
(October 2013) on www.clinicaltrials.gov (PL 110-85, Section 810(a)). 
 
In case of conflicting requirements, the regulation affording the greatest protection to the subject will 
be followed. 
 
E. 4    Training Requirements 
Prior to investigation site activation or subsequent involvement in clinical study activities, the sponsor 
will provide clinical study training relevant and pertinent to the involvement of personnel conducting 
clinical study activities. At a minimum, investigator responsibilities, Title 21 CFR, the clinical 
investigation plan, Informed Consent Form, use of data collection tool, as well as applicable local 
regulations are required. Furthermore investigators that will perform the index procedure and 
implantation of the device will be trained on the Endurant Evo AAA stent graft system. Study- 
specific training will be documented prior to investigational site activation. 
Medtronic and/or its designees are responsible for the training of appropriate clinical site personnel, 
including the investigator, co-investigator(s), study coordinator(s), and as necessary other site 
personnel. Initial training will be conducted by Medtronic or its designees at a site initiation visit 
and/or Investigator meeting to ensure proper reporting of adverse events, uniform data collection 
and compliance with the protocol, consent processes and applicable regulations. 
Also after initial training, Medtronic will provide training to other clinical site study team members. 
Once the primary endpoint has been reached for all subjects, qualified site personnel may also 
provide training to other clinical site study team members. All study specific training must be 
documented on a formal training record that will be provided by Medtronic.  
 
E. 5    Clinical Study Materials 
Medtronic will provide study materials to the site after approval of the site for participation. Before a 
study site can enroll a subject or have access to the electronic data capture (EDC) system, the 

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investigator must be in receipt of a “Go letter” (this may be an email, fax or other written 
communication means) from Medtronic. 
 
E. 6    Study Device/Product Traceability 
E.6.1 Supply of Investigational Devices/Products 
Once the site has been activated and an eligible subject has been identified and consented through 
the protocol required screening process investigational devices/products will be ordered and shipped 
to the site. 
 
E.6.2 Storage and Handling of Investigational Devices/Products 
Investigational devices/products must be stored in a secured area. The method of storage shall 
prevent the use of investigational devices/products for other applications than mentioned in this 
clinical investigation plan. In addition, all information for the use, storage, and handling of the 
investigational device/product as indicated in the Instructions for Use must be taken into account. 
 
E.6.3 Device Explant and Return Procedures/Products 
All non-functioning or explanted investigational devices/products should be returned to Medtronic 
for analysis. Information pertaining to the explant procedure should be recorded. If a product is 
explanted and not returned to Medtronic, an explanation should be provided. The final disposition of 
the device must be recorded on the device disposition log. Relevant information should also be 
recorded on associated case report forms, e.g., Adverse Event and Study Exit Form. Detailed 
instructions for the return of non-functioning devices and explant of the device will be provided in 
the investigational site file and in appendix L.4. 
 
E.6.4 Device/Product Disposition Requirements 
Investigational devices/products will be traced during the clinical study by assigning unique identifiers 
to each device/product. The investigator is responsible for maintenance of a Device Disposition 
Log in the investigator site file. On this log, the receipt, use, return, and disposal of the investigational 
devices/products shall be documented. At the end of the clinical study the principal investigator must 
sign and date the original Device Disposition Log. 
 
 
 
 

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F 
STUDY METHODS 
 
F.1 
Point of Enrollment 
Pre Screening: 
Investigators will assess potential subjects with an infrarenal abdominal aortic or aortoiliac aneurysm 
for their suitability for enrollment in the trial. Initial subject eligibility will be determined by the 
investigator based upon review of their medical history, disease progress and anatomic suitability for 
inclusion in the trial as evidenced on screening contrast-enhanced CT/MRA. If the subject appears 
to meet the eligibility criteria, then the investigator will discuss the study with the potential subject 
and provide information related to the potential risks and benefits and required follow-up 
procedures per the informed consent process. 
 
Test results that are within the timeframes specified below may be used even though the actual test 
was done prior to a subject’s informed consent. This may be done only for standard of care tests 
with the intent to minimize stress and discomfort to the subject and reduce costs. Required screening 
evaluations include the following. 
• 
Pregnancy test (for female subjects of childbearing potential). Test must be completed at 
the time of screening (within 45 days the index procedure). Results must be negative. 
• 
Screening CT or MR with contrast (2 cm above the origin of the celiac artery through the 
bifurcation of the femoral arteries) (completed within 6 months prior to the index procedure). 
• 
Laboratory tests (completed within 45 days prior to the index procedure) including serum 
creatinine (required for all subjects) and INR (only required for subjects taking Warfarin 
preoperatively). 
 
Screening/Baseline Assessments: 
After the subject voluntarily has signed and dated the Informed Consent Form, the subject will be 
considered a study candidate. If a subject does not sign the Informed Consent Form, then no further 
study specific screening procedures can occur. 
Collection of screening and baseline information will take place only after the subject has given 
voluntary, documented informed consent and will include the following: 
• 
Subject demographics 
• 
Medical history 
• 
Concomitant medication 
• 
Current health status 
• 
Risk factors 
• 
ASA Physical Status Classification 
• 
Laboratory analyses (serum creatinine (required for all subjects), INR (only required for 
subjects taking Warfarin preoperatively)) 
• 
EQ5D Questionnaire 
 
Screening CT/MRA images will be sent to the Core Lab to assess the anatomical inclusion/exclusion 
requirements. An Independent Physician Reviewer (IPR) will review screening CT/MRA images to 
determine eligibility. Approval by the IPR must be obtained prior to a subject’s enrollment in the 
study. The decision of the IPR will be communicated to the investigational site by the Sponsor. 
Those subjects who sign and date the Informed Consent, meet all study eligibility criteria, and are 
approved by the IPR will be eligible for enrollment. Subjects that are not approved by the IPR are 
considered screen failures and will not be enrolled in the study. 
 
Subjects who do not qualify for enrollment will be documented as ineligible on the Screening and 
Enrollment log. 
 
 

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Enrollment: 
Those subjects who sign and date the informed consent document, meet all of the study eligibility 
criteria, and are approved by the IPR will be eligible for enrollment into the Endurant Evo US 
Clinical Trial. The subject will be considered to be enrolled when arterial access has been established 
with an attempt to introduce the Endurant Evo AAA stent graft. 
 
Enrolled subjects will be documented on the Screening and Enrollment Log. Subjects who are 
enrolled, but not implanted with the device will be followed through the 1 month follow-up only. 
 
The investigator will maintain a log of all subjects screened and enrolled in the clinical study, 
assigning an identification code linked to their names, alternative subject identification or contact 
information 
 
F.2 
Implant and Follow up 
F.2.1 Index Procedure 
All investigators will read, understand and be trained to the Endurant Evo AAA stent graft system 
Instructions for Use (IFU) prior to initiation of the procedure. The IFU is packaged with the device 
and must be followed for implantation of the stent graft system. 
 
Identification and/or serial numbers for all investigational components of the Endurant Evo AAA stent 
graft system used or opened during the index procedure will be recorded. 
 
Adverse event assessment should be done for all subjects as of the moment the subject is considered 
to be enrolled in the study. 
 
F.2.1.2 Treatment Failure 
Inability to implant the Endurant Evo AAA stent graft system following arterial access due to 
deployment issues or entrapment of the delivery system will be considered a treatment failure. 
These subjects will be followed through the 1-month follow-up time point and then exited from the 
study. 
 
If a primary conversion to open repair is required during the index procedure, then the subject will 
be followed for 1 month, at which time the subject will be exited from the study. 
 
After exiting the study, subjects will be followed as per their institutional standard of care. 
 
F.2.2 Hospital Discharge 
The following assessments and procedures will be performed and respective data will be collected at 
hospital discharge: 
• 
Adverse event assessment 
• 
Duration of intensive care unit stay after index procedure (in hours) 
 
F.2.3 Follow-Up Visits and Procedures 
Each subject will have required post-implantation follow-up visits at 30-days, 6-month, 12-months, 
and annually thereafter, for a total of 5 years from index procedure.  Follow-up visits and associated 
timeframe windows are summarized in Table F-1.  Given the UADEs that have occurred within the 
Endurant Evo study, the DMC has made additional imaging surveillance recommendations, beyond 
the required follow-up in the protocol.  The additional imaging surveillance recommendations are 
provided, under separate cover, in the most recent DMC Surveillance and Management letter that 
has been provided to each investigational site.    
 
 

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F.4 
Role of the Sponsor Representatives 
Sponsor representatives may provide support as required for the study, including technical support 
during implantation. The sponsor representative is an experienced expert of device sizing, placement 
and the technical features of the device and will advise the implanting physician during the implant 
procedure if needed. The sponsor representative will not be involved actively during the placement 
and deployment of the Endurant Evo AAA stent graft system. 
 
F.5 
Source Documents 
Investigators are required to maintain source data of each subject’s case history, exposure to the 
device and clinical follow-ups. Source data is all information in original records, certified copies of 
original records of clinical findings, observations, or other activities in a clinical investigation, 
necessary for the reconstruction and evaluation of the clinical investigation. 
 
Examples of these original documents and data records include, but are not limited to: hospital 
record (paper and electronic, as applicable), subject’s screening documentation, recording media 
such as CD, DVD, CT or other imaging reports, laboratory reports, device accountability records, 
worksheets and subject files at other departments. Where paper notes and worksheets are retained, 
these shall be signed and dated by the member of the investigational site team. Where copies of 
the original source document as well as print outs of original electronic source documents are 
retained, these shall be signed and dated by a member of the investigational site team with a 
statement that it is a true reproduction of the original source document. 
 
Source documents will be used for verification of the data documented in subject’s eCRF during 
monitoring visits, audits and inspections, and for the adjudication of AEs and must be accessible to 
the Medtronic field clinical support and the clinical study team 
 
The investigator will allow inspections of the study site and documentation by Clinical Research and 
audit personnel from Medtronic or designee, EC/IRB, external auditors, or representatives of 
regulatory authorities. The purpose of these inspections is to verify and corroborate the data collected 
on the eCRFs. In order to do this, direct access to medical or clinical records is necessary. 
 
F.6 
Adverse Events 
For the purpose of this clinical investigation Medtronic will define and classify the following events 
per ISO14155:2011 (followed for definitions of Adverse Events only) and Title 21 CFR part 812.3.  
 
Adverse event reporting for the remaining follow up (3-5 years) will focus on the reporting of the below 
listed events:  
 
• 
Adverse events with a possible relationship to the aneurysm (Excluding aneurysms in anatomic 
areas other than the Endurant grafted segment) 
• 
Adverse events with a possible relationship to the device 
• 
Adverse events with a possible relationship to the procedure 
• 
Adverse events leading to subject’s death  
 
Secondary procedures performed as a result of any of the above adverse events must be reported 
on the respective Adverse Event form. Please see guidance for reporting of adverse vents following 
image review in Appendix L.8. 
 
All adverse events that meet the study definitions will be reported to the sponsor and documented on 
the Adverse Event eCRF and in the subject’s medical records. 
Clinical events that are inherent to a surgical procedure and expected to occur in the majority of 
subjects for a projected duration may be considered unavoidable. Such events include, but are not 
limited to, those listed in Table F-3. These events should not be reported as adverse events during 
this study. 

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F.6.1 Definitions / Classifications 
 
Adverse Event (AE): (ISO14155:2011 3.2) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device. 
NOTE 1:  This definition includes events related to the investigational medical device. 
NOTE 2:  This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to investigational 
medical devices. 
 
Adverse Device Effect (ADE): (ISO14155:2011 3.1) 
Adverse event related to the use of an investigational medical device. 
NOTE 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device. 
 
Serious Adverse Event (SAE): (ISO 14155:2011 3.37) 
Adverse event that 
a) 
led to death, 
b) 
led to serious deterioration in the health of the subject, that either resulted in 
1) 
a life-threatening illness or injury, or 
2) 
a permanent impairment of a body structure or a body function, 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 or a body function, 
c) 
led to fetal distress, fetal death or a congenital abnormality or birth defect. 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a serious adverse event. 
 
Serious Adverse Device Effect (SADE): (ISO 14155:2011 3.36) 
Adverse device effect that has resulted in any of the consequences characteristic of a Serious 
Adverse Event. 
 
Unanticipated Serious Adverse Device Effect (USADE): (ISO 14155:2011 3.42) 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report. 
NOTE: 
Anticipated  serious  adverse  device  effect  (ASADE)  is  an  effect  which  by  its  nature, 
incidence, severity or outcome has been identified in the risk analysis report. 
 
Unanticipated Adverse Device Effect (UADE): (21 CFR 812.3) 
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, or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, or welfare of subjects. 
 
Device Deficiency:  (ISO 14155:2011 3.15) 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or 

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performance. 
NOTE: Device deficiencies include malfunctions, use errors, and inadequate labelling. 
 
F.6.2 Recording and Reporting of Adverse Events 
Adverse Event (AE) information will be collected throughout the study and reported to Medtronic on 
the Adverse Event eCRF.. The investigator is responsible for reporting all AE to Medtronic. See 
the Adverse Event eCRF for the information to be reported for each Adverse Event. 
Please see guidance for reporting of Adverse Events following image review in Appendix L.8. 
 
For Adverse Events that require immediate reporting (see Table F-4), initial reporting may be done 
by phone, e-mail (contact details will be provided in the investigational site file), or on the eCRF with 
as much information as is available. In case the investigator requires information from the Sponsor 
in an emergency situation, the contact details for emergency situations are given in the 
investigational site file. 
 
F.6.3 Recording and Reporting of Device Deficiencies 
Device Deficiency information will be collected throughout the study and reported to Medtronic. 
Device Deficiencies should be reported on a Device Deficiency Form in the eCRF. In case the eCRF 
is not available the Device Deficiency form needs to be completed manually and must be sent to 
Medtronic. Contact details are given in the investigational site file. The investigator is responsible 
for reporting all Device Deficiencies to Medtronic. 
Please see guidance for reporting of Device Deficiency following image review in Appendix L.8. 
 
See the Device Deficiency eCRF for the information to be reported for each Device Deficiency. 
Device deficiencies that did not lead to an Adverse Event but could have led to an SAE 
a) if either suitable action had not been taken, 
b) if intervention had not been made, or 
c) if circumstances had been less fortunate, 
require immediate reporting (see Table F-4). Initial reporting may be done by eCRF, phone, e-mail, 
with as much information as available. 
 
F.6.4 Adverse Event and Device Deficiency Review Process 
All Adverse Events and Device Deficiencies will be reviewed by Medtronic Study Management and/ 
or designee. This review will include the determination whether the Adverse Event/Device Deficiency 
meets regulatory reporting requirements. The sponsor will ensure timely Adverse Event/Device 
Deficiency reporting to meet global regulatory requirements. 
In case the Adverse Event/Device Deficiency is related to a Medtronic market released device used 
during the study, Medtronic Study Management and/ or designee will immediately report this device 
related Adverse Event/Device Deficiency to the Product Experience Management (PXM) group. The 
PXM group will ensure prompt review, and appropriate reporting. 
 
Table F-4: Adverse Event Reporting Requirements from Investigator to Medtronic 
Serious Adverse 
Device Effects (SADE), 
including 
Unanticipated Serious 
Adverse Device Effect 
(USADE): 
Immediately (but no later than 3 calendar days) after the investigator 
first learns of the event or of new information in relation with an already 
reported event. 
Unanticipated 
Adverse Device Effect 
(UADE) 
Immediately (but no later than 3 calendar days) after the investigator 
first learns of the event or of new information in relation with an already 
reported event. 

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Serious Adverse 
Events (SAE) 
Immediately (but no later than 3 calendar days) after the investigator 
first learns of the event or of new information in relation with an already 
reported event. 
Adverse Device 
Effects (ADE) 
Immediately (but no later than 3 calendar days) after the investigator 
first learns of the event. 
All other AEs 
Submit in a timely manner after the investigator first learns of the event. 
Device Deficiency 
(with SAE potential) 
Immediately (but no later than 3 calendar days) after the investigator 
first learns of the deficiency or of new information in relation with an 
already reported deficiency. 
All other 
Device 
Deficiencies 
Submit in a timely manner after the investigator first learns of the 
deficiency. 
 
In addition, Investigators are obligated to report adverse events in accordance with the 
requirements of their IRB/EC and local regulations. The Sponsor is obligated to report adverse 
events and device deficiencies that occur during this trial to the Regulatory Authorities and IRB/EC 
as per local requirements. The applicable timeframes are described in the Endurant Evo Clinical 
Trial safety plan. 
 
F.6.5 Clinical Event Committee 
A clinical event committee (CEC) will be established. The CEC is an independent committee made 
up of clinicians (interventional and non-interventional) with pertinent expertise who are not 
participants in the study and who do not have any other real or potential conflicts of interest. The 
CEC will meet periodically to review and adjudicate all major adverse events (except procedural 
blood loss), unanticipated adverse device effects, and all deaths that occur throughout the conduct 
of the clinical trial. A charter will be developed that will detail the criteria for selected complications 
and clinical events that need to be adjudicated as well as the CEC composition, duties, procedures 
and adjudication rules and meeting frequency. 
 
F.6.6 Emergency Contact Details in Case of Serious AEs 
In case of an immediately reportable Adverse Event the investigators can contact the Medtronic 
Study Manager. Contact details of Medtronic Study Management are given in the Investigational 
Site File. 
 
In case the investigator requires information in a medical emergency situation the investigator can 
contact the Medical Expert. Contact details of Medical Expert are given in the Investigational Site 
File. 
 
F.7 
Subject accountability 
Every subject should be encouraged to remain in the study until they have completed the required 
follow up per the study protocol. If the subject discontinues prematurely from the study (e.g. 
withdrawal of the consent, lost to follow-up), the reason for discontinuation must be documented in 
the subject’s hospital record and documented on the appropriate eCRF. Subjects will not be replaced 
in case of premature study discontinuation. 
 
F.7.1 Criteria and Procedures for Exit from Study 
The Study Exit eCRF should be completed after the subject is exited from the study. A subject will be 
considered to have exited from the study for any of the following reasons: 
• 
Subject completes follow-ups required by the investigational plan 
• 
Subject dies 
• 
Subject requests to be withdrawn 
• 
Investigator requests that subject be withdrawn to protect the welfare of the subject 

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• 
Subject is lost to follow-up 
• 
Subject has conversion to open repair 
• 
Other (specify). 
 
 
F.7.2 
Study Withdrawal 
Subjects may withdraw from the clinical study at any time and for any reason. If a subject decides to 
withdraw from the clinical study and agrees to provide the reason for withdrawal, the investigator 
will document the reason and indicate any relationship of the withdrawal to the study or products 
being investigated in the subject’s hospital record in the subject’s file. If discontinuation is because of 
safety or lack of effectiveness, the subject shall be asked to be followed as per their institution’s 
standard of care outside the clinical study as further described in section F.7.6. In addition, subject 
withdrawal will be documented on the Study Exit eCRF. 
 
F.7.3 Missed Follow-up 
A missed follow-up visit should be documented by the investigator and reported in the eCRF including 
the reason. If the date the subject is last known to be alive is obtained, this should be recorded 
on the Follow-up visit eCRF and the method of obtaining this date should be documented in the 
medical record. 
 
F.7.4 Lost-to-Follow-up 
A subject may be considered lost to follow-up once the investigator and/or research staff has made 
three documented attempts to contact the subject. The third attempt should be made by certified 
mail to the subject. 
 
F.7.5 Conversion to Open Repair 
If a primary conversion to open repair is required during the index procedure, then the subject will 
be followed for 1 month, at which time the subject will be exited from the study. 
If a secondary conversion to open repair is required during the follow-up period, then the subject will 
be followed for 30 days after the conversion, at which time the subject will be exited from the study. 
 
F.7.6 Medical Care after Study Exit 
After study exit the subjects will be followed as per routine standard of care by the investigational 
site or a treating physician which might be in line with the guidelines described in the Management of 
Abdominal Aortic Aneurysms Clinical Practice Guidelines of the European Society for Vascular 
Surgery19 or Society for Vascular Surgery practice guidelines for the care of patients with an 
abdominal aortic aneurysm20. 
 
F.8 
Study/Protocol Deviations and CIP Changes 
A protocol deviation is defined as an event where the clinical investigator or site personnel did not 
conduct the study according to the clinical investigational plan, applicable laws or regulations, or the 
Investigator Agreement. Every attempt must be made to avoid deviations. All deviations are recorded 
on a Protocol Deviation Case Report Form. United States regulations (21 CFR 812.140) require 
that investigators maintain accurate, complete, and current records relating to the clinical study. 
This includes documents showing the dates and reasons for each deviation from the clinical 
investigational plan. Depending on the nature of the protocol deviation, expedited reporting  and prior 
approval from Medtronic may be required. All protocol deviations must be reported to the 
Institutional Review Board (IRB) in accordance with IRB policies and/or local laws. All deviations will 
be summarized and reported in regular progress reports to the FDA. 
 
Medtronic will assess the significance of all deviations and evaluate the need to amend the clinical 
investigation plan or to early terminate the investigation, in accordance with Medtronic SOPs. 
 

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F.8.1 Request for Approval of Study Deviations 
The investigator shall obtain documented approval from Medtronic before implementation, for any 
change or deviation from the clinical investigation plan. In case of study deviations that can affect 
the subject’s rights, safety or well-being or the scientific integrity of the clinical study, approval from 
the EC/IRB and regulatory authority must also be obtained before implementation. The investigator 
shall timely contact the Clinical Study Manager for review of the proposed change/deviation. 
Prior approval is not always realistic in situations where unforeseen circumstances are beyond the 
investigator’s control. However, also in these cases, the event is considered a deviation, and shall 
be reported. 
 
In any emergency situation the investigator shall exercise his/her judgment to safeguard the subject’s 
interest. Such deviations from the clinical investigation plan do not require the prior approval of 
Medtronic. The investigator shall report the deviation as soon as possible to Medtronic and the 
reviewing EC/IRB, if applicable. Medtronic will inform the regulatory authorities, if required. 
 
F.8.2 
Reporting Requirements for Study Deviations 
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the CIP, additional training, terminate 
the study), such as those included in, but not limited to, the list below. Repetitive or serious 
investigator compliance issues may result in the need to initiate a corrective action plan, and in 
some cases freeze enrollment or ultimately terminate the investigator’s participation in the clinical 
study: 
• 
Non-compliance to obtain subject’s informed consent 
• 
Non-compliance to the inclusion/exclusion criteria 
• 
Failure to follow subjects per scheduled follow-ups 
• 
Failure to follow-up with findings on monitoring reports 
• 
IRB/ EC approval expiration 
• 
IRB/ EC suspension of the center 
 
If a center is terminated or suspended, no additional enrollments will be allowed at the center. 
Unused investigational product allocated to the center will be returned to Medtronic. 
Medtronic will provide site-specific reports to the investigators on a periodic basis summarizing 
information on deviations that occurred at the investigational site. 
The investigator shall adhere to EC/IRB requirements and procedures for reporting study deviations. 
 
F.8.3 Amendments to the Clinical Investigation Plan 
The investigator can propose any appropriate modification(s) of the clinical investigation plan or 
investigational device or investigational device use. Medtronic will review this proposal and decide 
whether the modification(s) will be implemented. 
 
Medtronic will submit any significant amendment to the clinical investigation plan, including a 
justification for this amendment, to the appropriate regulatory authorities and to the investigators to 
obtain approval from their EC/IRB. The investigator will only implement the amendment after approval 
of the EC/IRB, regulatory authority and Sponsor. Administrative amendments  to the clinical 
investigation plan will be submitted to the EC/IRB for notification. Furthermore investigators shall sign 
any approved amendment of the clinical investigation plan, if required per local regulation. 
 
 
 
 

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G 
QUALITY CONTROL PROCEDURES 
 
G.1 
Procedures for database management 
 
G.1.1 Data Collection 
The investigator must ensure accuracy, completeness and timeliness of the data reported in the 
eCRFs and in all other required reports. Data reported on the eCRFs which are derived from source 
documents must be consistent with the source documents and discrepancies need to be justified in 
a documented rationale, signed and dated by the principal investigator or co-investigator, and  filed 
in the subject’s medical file. 
 
Only authorized persons can complete eCRFs. The investigator (physicians only) shall sign eCRFs 
as specified on the Delegated Tasks List/ Delegation of Authority Form included in the Investigator 
Site File. 
 
The Electronic Data Capture (EDC) system maintains an audit trail on entries, changes, or corrections 
in eCRFs. If a person is only authorized to complete eCRFs or to make changes to an already 
signed eCRF, the investigator shall re-sign this eCRF. 
 
Any source documentation as well as any imaging (e.g., procedure reports, imaging material, lab 
reports, death certificates, autopsy reports) that is sent to the sponsor should have all subject 
identifiers removed and replaced with the subject’s study ID. 
 
A paper copy of the eCRFs as well as access to the EDC system will be provided to the investigation 
site prior to subject enrollment. 
 
G.1.2 Source Data to be Directly Recorded on the Case Report Forms 
All data reported on the eCRFs shall be derived from source documents and be consistent with 
these source, and any discrepancies shall be explained in writing. There are no data that will be 
recorded directly on the eCRF without corroborating source documentation. 
 
G.1.3 Time Windows for Completion and Submission of Case Report Forms 
All data entry should be completed as soon as possible after the visit takes place. Adverse event 
and device deficiencies should be reported as described in the section F.6. 
 
G.1.4 Data Review and Processing 
Data management will be done according to Medtronic SOPs and the Data Management Plan for 
this clinical study. These documents will be made available on request. 
All collected data will be reviewed for completeness, correctness and consistency. In case of 
issues, queries will be sent to the investigator or designee to complete, correct or comment the 
data. 
 
G.2 
Monitoring Procedures 
A site qualification visit may be conducted by Medtronic personnel (or designees) to review the 
clinical investigational plan and, regulatory and study requirements with the investigator and study 
personnel. A site initiation visit will be performed after it has been verified that the site is prepared 
for the study and that the site requirements for study participation are met. 
On-site monitoring visits will be conducted at the start and during the clinical study in accordance 
with Medtronic SOPs and the Monitoring Plan. Frequency and timing of monitoring visits shall be 
determined by the Sponsor for each site based on enrollment rate and volume, study compliance and 
findings from previous visits. 
It will be verified whether signed and dated informed consent forms have been obtained from each 

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subject before any clinical study related procedures are undertaken. Medtronic or designee will 
conduct site monitoring visits to monitor compliance with the protocol and adherence to the data 
collection procedures, to assess the accuracy and completeness of submitted clinical data, and to 
verify that records and documents are being properly maintained for the duration of the study. 
 
In-person monitoring visits will be replaced by telephone and email contact to the sites by the study 
team. The sponsor monitoring phone calls will include an assessment of the source documents to 
assure completeness of image submissions and event reporting and an assessment of the essential 
documents. In particular, the focus of these calls will be to ensure that safety data is entered and to 
verify that all relevant events are reported. Site monitoring visits will be requested by the Sponsor if 
a concern arises with regards to compliance or data integrity. 
 
G.2.1 Accessibility of Investigation Site Staff and Study Materials 
The principal investigator(s), his/her delegate(s), and the study coordinator(s) shall be accessible to 
Medtronic personnel or designee(s) and the Clinical Study Manager. This accessibility is of particular 
importance for reviewing data in the eCRF. Direct access to subject medical files for source data 
verification will need to be granted and prepared prior to any monitoring visits. If direct access cannot 
be provided per local laws and regulations, certified copies need to be made available or monitor 
needs to obtain access by reviewing alongside with study staff. 
 
G.2.2 Audits and Investigation Site Inspections 
In addition to regular monitoring visits, Medtronic may conduct audits at participating investigational 
sites. The purpose of an audit is to verify the adequate performance of the clinical study related 
activities, independent of the employees involved in the clinical study. Regulatory bodies may also 
perform inspections at participating investigational sites. Any regulatory authority inspection 
announcements shall be forwarded immediately to the Clinical Study Manager. 
The investigator and/or institution shall permit Medtronic and regulatory bodies direct access to 
source data and documents, taking into account any restrictions due to local law, to perform clinical 
study-related monitoring, audits, EC/IRB review, and regulatory inspections. 
 
G.3 
Study Suspension or Early Termination 
 
G.3.1 Early Study Suspension or Termination 
Medtronic or regulatory authority may decide to suspend or early terminate the clinical study (e.g. if 
information becomes available that the risk to study subject is higher than initially indicated, if 
interim analysis indicates that the results significantly differ from the study objectives or statistical 
endpoints). If the clinical study is terminated early or suspended, Medtronic shall promptly inform 
the investigators of the termination or suspension and the reason(s) for this. The investigator shall 
then promptly inform the reviewing EC/IRB and the study subjects. 
 
G.3.2 Early Investigation Site Suspension or Termination 
Medtronic, EC/IRB, or regulatory authority may decide to suspend or prematurely terminate an 
investigation site (e.g. in case of expiring approval of the reviewing EC/IRB, non-compliance to the 
Clinical Investigation Plan or lack of enrollment). 
If an investigation site is suspended or prematurely terminated: 
• 
Medtronic shall promptly inform the clinical investigator(s) of the termination or 
suspension and the reason(s) for this 
• 
The investigator shall then promptly inform the reviewing EC/IRB 
• 
The investigator shall then promptly inform study subjects 
• 
The investigator agreement will be terminated 
• 
The investigator will inform the institution (where required by applicable regulatory 
requirements) 

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• 
Medtronic will inform the regulatory authority(ies) (where required by applicable regulatory 
requirements) 
When the risks are found to outweigh the potential benefits or when there is conclusive proof of 
definite outcomes, investigators must assess whether to continue, modify or immediately stop the 
clinical study in the respective investigation site and immediately inform the sponsor and EC/IRB, if 
applicable. 
 
G.3.3 Subject Follow-up in Case of Termination 
If the study is terminated early, subjects will be followed as per routine standard of care by the 
investigational site or a treating physician which might be in line with the guidelines described in the 
Management of Abdominal Aortic Aneurysms Clinical Practice Guidelines of the European Society 
for Vascular Surgery19 or Society for Vascular Surgery practice guidelines for the care of patients 
with an abdominal aortic aneurysm20. 
 
G.4 
Study Close Out 
Prior to completion of study close out, all data must be entered and approved in the EDC system. 
Medtronic and/or its designees will notify the site of the intention to close the study. Remote study 
close out visits may be performed. The intent of these visits will be to assuring that the 
investigator’s regulatory files are up to date and complete and that any outstanding issues from 
previous visits have been resolved. Medtronic will notify and inform the site(s) that all requirements 
have been met with a study closure letter. 
If required, EC/IRB and/or regulatory authority will be informed by Medtronic about the study close 
out. 
 
 

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Physician Reviewer (IPR) and core imaging laboratory. 
 
At the data analysis stage, the data poolability will be reviewed for the primary endpoints. Results 
from Endurant Evo US Clinical Trial and Endurant Evo International Clinical Trial subjects will be 
presented separately for clinical review as well as tested using a Chi-square test. 
 
A poolability analysis among geographies/investigational sites will be assessed descriptively for the 
primary endpoints by geographic regions. Small investigational sites (less than 5 subjects) will be 
grouped with other nearby sites for the by-region analysis. 
 
H.2 
Publication Policy 
Publications and presentations referring to this clinical study will be coordinated by Medtronic to allow 
the use of all available data. The following publication policy will have to be adhered to by all 
participating investigational sites: 
 
Medtronic may use the study data for regulatory authority submission results, may publish the results 
in peer reviewed scientific journal(s) and present the data at major congresses. 
Authorship on any publication(s) resulting from this clinical study will be assigned according to 
substantial contributions to conception and design, acquisition of data, or analysis and interpretation of 
data, drafting the article or revising it critically for important intellectual content, and final approval of 
the version to be published. This is in accordance with the Vancouver principles (The Uniform 
Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical 
Publication, ICMJE, October 2008), as agreed upon by the editors of all major medical journals. 
The number of authors will be dependent on the regulations of the concerning journal with a 
maximum of 10 authors. Names of all participating investigators will appear in the Acknowledgment of 
the paper. 
 
Based on the principle that Medtronic owns the data of this clinical study, a single investigational 
site may access and use the data provided by itself for scientific publications  following prior approval 
by Medtronic. 
 
Pooling data from several investigational sites for publication purposes, national projects and 
international projects all require prior approval from Medtronic. 
 
Medtronic as the owner of the data can use the data and/or any results derived from the data or 
publications based on that data for marketing purposes, further research and development of devices 
or educational use. 
 
The study sponsor will collect data in such way that no subject can be identified. Participating 
subjects will not be identified by name in any published reports about the clinical study. 
 
 
 
 

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I 
STUDY MANAGEMENT 
 
I.1 
Study Contact 
The study is sponsored by Medtronic Aortic,Peripheral and Venous. Study staff contact details will be 
provided in the investigational site file. 
 
I.2 
Advisory Committees 
 
I.2.1 Clinical Event Committee (CEC) 
A clinical event committee (CEC) will be established. The CEC is an independent committee made up 
of clinicians (interventional and non-interventional) with pertinent expertise who are not participants in 
the study and who do not have any other real or potential conflicts of interest. Please refer to section 
F.6.5 for further details regarding the CEC. 
 
I.2.2 Data Monitoring Committee 
A Data Monitoring Committee (DMC) will be established. The DMC is composed of several members 
with pertinent expertise who are not participants or directly involved in the conduct of the study. 
The responsibility of the DMC is to evaluate safety data during the course of the study and to advise 
Medtronic about the continuing safety of the study, in order to ensure the well-being of the current 
participants and those yet to be enrolled as well as the continuing validity and scientific merit of the 
study. The DMC will review the study data after all subjects have reached the 1-month follow-up 
time point but might also be reviewed earlier. Thereafter, the study data will be reviewed on a 
periodic basis as defined in the DMC Charter. 
Based on the safety data, the DMC may recommend that Medtronic modify or stop the study. DMC 
composition, duties, procedures, deliberation rules, are detailed and documented in the DMC Charter. 
 
I.2.3 Publication Committee 
A publication committee will not be established for the Endurant Evo Clinical trial. The publication 
policy for this trial is described in section H.2. 
 
I.2.4 Imaging Core Lab 
An imaging Core Lab will be established to independently analyze images based on the imaging 
protocol/Core Lab guidelines. Imaging guidelines will be provided in the investigational site file. 
 
I.3 
Records and Reports 
 
I.3.1 
Investigator Records 
At a minimum, the following records must be kept by the investigator: 
• 
Clinical Investigation Plan and, if applicable, any amendments 
• 
1 copy of the Instructions for Use 
• 
Medtronic and EC/IRB approved Informed Consent Form 
• 
Regulatory authority approval or notification 
• 
Fully signed Clinical Trial Agreement and confidentiality agreement (if not included in the 
Clinical Trial Agreement) 
• 
Financial disclosures 
• 
Completed Delegation of Authority Form and Curriculum Vitae of all investigational site 
personnel 
• 
Training documentation of all investigation site personnel 

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• 
Relevant communications 
• 
Subject screening log and/or subject identification log 
• 
Signed, dated, and fully executed Informed Consent Forms 
• 
Fully executed eCRFs and corrections (in the EDC) 
• 
Reports of Adverse Events and Device Deficiencies 
• 
Device accountability records 
• 
IRB/EC correspondence 
 
I.3.2 Investigator Reporting Responsibilities 
Table I-1: Investigator Reporting Responsibilities 
Report 
Submitted to 
Description 
Adverse Events 
Sponsor, EC/IRB, and 
local regulatory authority, 
where applicable 
Refer to section F.6 for reporting requirements. 
Withdrawal of 
EC/IRB approval 
Sponsor 
An investigator shall report to the sponsor, 
within 5 working days, a withdrawal of 
approval by the reviewing IRB of the 
investigator's part of an investigation. (21 CFR 
812.150(a)(2)). 
Final investigator report Sponsor, IRB s and 
Relevant Authorities 
This report must be submitted within 3 months 
of study completion or termination of the 
investigation or the investigator’s part of the 
investigation. (21 CFR 812.150(a)(6)). 
Study deviations 
Sponsor and IRB 
Notice of deviations from the CIP to protect the 
life or physical well-being of a subject in an 
emergency shall be given as soon as possible, 
but no later than 5 working days after the 
emergency occurred. (21 CFR 812.150(a)(4)). 
Failure to obtain IC 
prior to 
investigational 
device use 
Sponsor and IRBs 
If an investigator uses a device without 
obtaining informed consent, the investigator 
shall report such use within 5 working days 
after device use. (21 CFR 812.150(a)(5)). 
Other 
IRB and FDA 
An investigator shall, upon request by a 
reviewing IRB, FDA or any other regulatory 
agency, provide accurate, complete, and 
current information about any aspect of the 
investigation. (21 CFR 12.150(a)(7)). 
 
I.3.3 Sponsor Records 
At a minimum, the sponsor will keep the following records: 
• 
All essential study documents and correspondence that pertains to the clinical study 
• 
CIP and, if applicable, any amendments 
• 
1 copy of the Instructions for Use 
• 
Sample of labeling attached to the investigational device 
• 
Curriculum Vitae of investigators and investigational site personnel 
• 
Delegation of Authority Form and training records of investigators and investigational site 
personnel 
• 
EC/IRB approvals/notifications/communication and regulatory approvals/notifications/ 
communication 
• 
Signed Clinical Trial Agreements and signed agreements with third parties 

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• 
Shipping records for investigational devices and clinical-investigation related documents 
and materials 
• 
Medtronic and EC/IRB approved Informed Consent Forms 
• 
Site qualification reports, site initiation reports and monitoring visit reports 
• 
Adverse event and Device Deficiency reports 
• 
Financial disclosure information 
• 
Fully executed eCRFs and corrections 
 
I.3.4 Sponsor Reporting Responsibilities 
Table I-2: Sponsor Reporting Responsibilities 
Report 
Submit to 
Description 
Adverse Events 
EC/IRB, 
Investigators, FDA and 
relevant authorities, 
where applicable 
Medtronic will report adverse events as 
required and in compliance with local 
regulatory requirements, as applicable and 
described in the Endurant Evo Safety Plan. 
Unanticipated Adverse 
Device Effect 
Investigators, IRB, FDA, 
and relevant authorities 
Notification within ten working days after the 
sponsor first receives notice of the effect. (21 
CFR 812.150(b)(1)). 
Withdrawal of EC/IRB 
approval 
Investigators, IRB, FDA, 
and relevant authorities 
Notification within five working days after 
receipt of the withdrawal of approval. (21 
CFR 812.150(b)(2)). 
Withdrawal of FDA 
approval 
Investigators, EC/IRB, and 
relevant authorities 
Notification within five working days after 
receipt of notice of the withdrawal of 
approval. (21 CFR 812.150(b)(3)). 
Investigator List 
FDA 
Submit at 6-month intervals, a current list of 
the names and addresses of all investigators 
participating in the investigation. (21 CFR 
812.150(b)(4)). 
Progress Reports 
EC/IRB and FDA 
Progress reports will be submitted at least 
annually. (21 CFR 812.150(b)(4)(5), 812.36(f) 
Recall and device 
disposition 
Investigators, EC/IRB, 
relevant authorities, and 
FDA 
Notification within 30 working days after the 
request is made and will include the reasons 
for any request that an investigator return, 
repair, or otherwise dispose of any devices. 
(21 CFR 812.150(b)(6)). 
Failure to obtain Informed 
Consent 
FDA 
Investigator’s report will be submitted to FDA 
within five working days of notification. (21 
CFR 812.150(b)(8)). 
Premature termination or 
suspension of study 
Investigators, IRB, and 
Relevant authorities 
Provide prompt notification of termination or 
suspension and reason(s). (ISO 
14155:2011), (MHLW Ordinance 36, Article 
32). 
Final Report 
Investigators, IRB, and 
regulatory authorities, 
where applicable and 
FDA 
Medtronic will notify FDA within 30 working 
days of the completion or termination of the 
investigation. A final report will be submitted 
to the FDA, investigators, and IRBs within six 
months after completion or termination of this 
study. (21 CFR 812.150(b)(7)). 
Study Deviations 
Investigators 
Ensure that all deviations from the CIP are 
reviewed with the appropriate clinical 
investigator(s), are reported on the case 
report forms and the final report of the clinical 
investigation. 
 

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I.3.5 Record Retention 
The investigator must retain the Investigator Site File, subject medical files and CRFs in accordance 
with local law and regulations for a minimum period of 2 years (or longer if local laws require) after 
market-release in his/her region and after study closure. The investigator should take measures to 
prevent accidental or early destruction of the clinical study related materials. 
 
I.4 Miscellaneous 
 
I.4.1 Insurance 
Medtronic Aortic and Peripheral Vascular is a wholly owned subsidiary of Medtronic Inc., which as the 
parent company of such entity maintains appropriate clinical study liability insurance coverage as 
required under applicable laws and regulations and will comply with applicable law and custom 
concerning specific insurance coverage. If required, a Clinical Trial Insurance statement/certificate will 
be provided to the EC/IRB. 
 
I.4.2 Subject Reimbursement and Indemnification 
Subjects will not receive any compensation for their participation in this study (including follow up); 
however, Medtronic may, at its option, provide reimbursement for participants who will incur 
extraordinary travel costs related to their participation in the study, including airfare, mileage or hotel 
expenses. Participating Institution will make such request(s) in writing to Medtronic (de-identified of 
participant information), detailing the unusual circumstances and the excessive costs that the 
participant will incur. Medtronic will evaluate requests on a case-by-case basis, and will notify the 
Participating Institution of its decision in writing. 
 
I.4.3 Subject Confidentiality 
Subject confidentiality will be maintained throughout the clinical study to the extent permitted by law. 
That is, every attempt will be made to remove subject identifiers from clinical study documents. For this 
purpose, a unique subject identification code (site number and subject number) will be assigned and 
used to allow identification of all data reported for each subject. This will also ensure that the 
information can be tracked back to the source data. 
Study data may be made available to third parties, e.g., in the case of an audit performed by regulatory 
authorities, provided the data are treated confidentially and that the subject’s privacy is guaranteed. 
The identity of a subject will never be disclosed in the event that study data are published. 

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J 
RISKS AND BENEFITS 
 
J.1 
Potential Risks 
Appendix L.3 shows a list of potential adverse events that may be associated with use of the Endurant 
Evo AAA stent graft system. The occurrence of the listed complications may lead to a repeat 
endovascular intervention and/or open surgical repair. Since the Endurant Evo AAA stent graft 
system is an investigational device, all risks may not be known. Risk mitigation activities were 
performed during development and design verification tests of the device. Activities intended to 
minimize risks during the conduct of the clinical trial include the following: 
• 
Investigator and study personnel will be trained to the design of the Endurant Evo AAA stent 
graft system, its application, and preclinical results. 
• 
Eligibility criteria and screening procedures will be followed to ensure that appropriate 
subjects are enrolled. 
• 
Investigator will adhere to the Endurant Evo AAA stent graft system IFU packaged with the 
device. 
• 
The subjects will be carefully monitored throughout the study period. 
• 
The investigator will evaluate the subject adverse events during the course of the 
study. 
• 
Data submitted from the investigative centers will be monitored during the course of the 
study. 
• 
Monitoring visits will be conducted to evaluate protocol compliance and data quality. 
• 
Safety and effectiveness data obtained during the course of the study will be shared with 
investigators in periodic reports to increase understanding of the device and potential 
adverse events. 
• 
A Data Monitoring Committee, Clinical Events Committee, and imaging Core Lab will be 
established to independently evaluate subject health status, device performance, and identify 
any safety concerns regarding subjects’ well-being. 
 
If a woman is pregnant or becomes pregnant, implantation of the trial device may involve risks to 
the embryo or fetus that are unknown at this time. Therefore, pregnant women will be excluded from 
the study. If a female subject becomes pregnant during the conduct of this clinical research study 
they need to inform the investigational site immediately. 
 
The risks will be continuously monitored, assessed and documented by the investigator. Any 
unanticipated or unforeseen complications will be reported by the investigator (or authorized 
designee) to the IRB/ EC and to Medtronic. Medtronic will in turn report any necessary findings to 
the appropriate regulatory agencies in each of the respective geographies. 
 
J.2 
Potential Benefits 
The potential benefits of the Endurant Evo AAA stent graft system have not been documented; 
nevertheless, they are expected to be similar to those associated with endovascular stent graft 
systems currently in clinical trials or commercially available. Endovascular treatment of AAA has 
been shown to be an effective, less invasive procedure that may result in a reduced rate of early 
mortality and comorbidities associated with open surgical repair12,21,22. Stent graft repair also provides 
a treatment option for subjects who would not otherwise be eligible for surgical repair. Additional 
potential benefits include the following: 
• 
Reduced operating room and anesthesia time 
• 
Reduced requirement for blood transfusions 
• 
Shorter time in intensive care 

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• 
Shorter length of hospital stay 
• 
Shorter recovery time and return to activities of daily living 
• 
Reduced access complications 
• 
Ability to treat subjects with smaller iliac anatomy 
• 
Ability to use percutaneous access for treatment 
 
J.3 
Risk-to-Benefit Rationale 
The benefits and risks associated with Medtronic’s AAA stent grafts are well-characterized through 
robust history of testing and successful clinical results. The Endurant Evo AAA stent graft system is 
Medtronic’s fourth generation AAA stent graft which is not only designed using established design 
characteristics and long term experience from previous generation Medtronic stent grafts but also 
uses the same principles of operation and technological characteristics. Furthermore, it has been 
demonstrated that implantation of AAA endovascular stent grafts can be performed safely, and that 
these devices provide benefits over surgical repair. 
 
Potential risks with this study are minimized by selecting qualified investigators, careful assessment 
of each subject prior to, during and after implantation. Medtronic has minimized the risks by 
completing product testing prior to the use of the device in this clinical study, implementing quality 
control measures into production processes, providing guidelines for subject selection and 
evaluation, and providing adequate instructions and labeling. However, to date, the UADE (transition 
stent fractures, partial suprarenal stent detachment, suprarenal stent fracture, and suprarenal 
anchoring pin fracture) observations reported have indicated that the Endurant Evo AAA stent graft 
system has associated risks with higher rates when compared to the associated risks of other 
commercially available devices. 
 
Because of these findings, there are risks associated with this trial which are worse than the risks 
normally associated with the use of the predicate device or other commercially available devices. 
Therefore, enrollment in the clinical study has been terminated and follow-up for the enrolled subjects 
will continue. 
 
Risk management for the Endurant Evo AAA stent graft system is performed in accordance with EN 
14971:2012. 
 
 

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K 
REFERENCES 
 
1. 
Li X, Zhao G, Zhang J, Duan Z, Xin S. Prevalence and trends of the abdominal aortic aneurysms 
epidemic in general population--a meta-analysis. PLoS One. 2013 Dec 2;8(12):e81260. 
2. 
Bengtsson H, Bergqvist D, Sternby NH. Increasing prevalence of abdominal aortic aneurysms. 
A necropsy study. Eur J Surg. 1992 Jan;158(1):19-23.3. 
3. 
Lederle FA, Johnson GR, Wilson SE, Ballard DJ et al. Prevalence and associations of abdominal 
aortic aneurysm detected through screening. Aneurysm Detection and Management (ADAM) 
Veterans Affairs Cooperative Study Group. Ann Intern Med. 1997 Mar 15;126(6):441- 9. 
4. 
SachsT, Landon B, Pomposelli F, Schermerhorn ML et al. Continued Expansion of EVAR for 
Intact and Ruptured Abdominal Aortic Aneurysm in the Medicare Population 1995-2008. JVS 
Volume 51, Issue 6, Supplement, Pages 22S–23S, June 2010.x 
5. 
Moll FL, Powell JT, Fraedrich G, Verzini F, Haulon S, Waltham M, et al. Management of 
abdominal aortic aneurysms clinical practice guidelines of the European society for vascular 
surgery. Eur J Vasc Endovasc Surg. 2011;41 Suppl 1:S1-S58. 
6. 
Gordon PA, Toursarkissian  B.  Treatment  of  Abdominal  Aortic  Aneurysms:  The Role of 
Endovascular Repair. AORN J. 2014 Sep;100(3):241-59 
7. 
Dubost C, Allary M, Oeconomos N. [Treatment of aortic aneurysms; removal of the aneurysm; 
re-establishment of continuity by grafts of preserved human aorta]. MemAcadChir (Paris). 
1951;77(12-13):381-3. 
8. 
Debakey ME, Cooley DA, Creech O, Jr. Surgical treatment of aneurysms and  occlusive disease 
of the aorta. Postgrad Med. 1954;15(2):120-7. 
9. 
Zwolak RM, Sidawy AN, Greenberg RK, Schermerhorn ML, Shackelton RJ, Siami FS. Lifeline 
registry of endovascular aneurysm repair: open repair surgical controls in clinical trials. 
JVascSurg. 2008;48(3):511-8. 
10. Volodos NL, Shekhanin VE, Karpovich IP, Troian,V.I., Gur'ev Iu A. [A self-fixing synthetic blood 
vessel endoprosthesis]. Vestn Khir Im I I Grek. 1986;137:123-5. 
11. Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal 
aortic aneurysms. AnnVascSurg. 1991;5(6):491-9. 
12. Jackson RS, Chang DC, Freischlag JA. Comparison of long-term survival after open vs 
endovascular repair of intact abdominal aortic aneurysm among Medicare beneficiaries. JAMA. 
2012;307(15):1621-1628. 
13. Mehta M, Cayne N, Veith FJ, et al. Relationship of proximal fixation to renal dysfunction in 
patients undergoing endovascular aneurysm repair. J Cardiovasc Surg 2004;45:367-74. 
14. Murray D, Ghosh L, Khwaja N, et al. Access for endovascular aneurysm repair.  J Endovascular 
Ther. 2006; 13(6): 754-61. 
15. Hobo R, Kievit J, Leurs LJ, Buth J. Influence of severe infrarenal aortic neck angulation on 
complications at the proximal neck following endovascular AAA repair: a EUROSTAR study. J 
Endovasc Ther 2007;14:1e11 
16. Bischoff MS, Peters AS, Meisenbacher K, Bockler D. Challenging access in endovascular repair 
of infrarenal aortic aneurysms. The Journal of cardiovascular surgery. 2014;55(2 Suppl 1):75- 
83. 
17. Chaikof et al. Identifying and grading factors that modify the outcome of endovascular aortic 
aneurysm repair . J Vasc Surg 2002;35:1061-6. 
18. PMA P100021/R_ 24-Month Interim Post Approval Study Status Report ENGAGE Post Approval 
Study Endurant Stent Graft System, 11Dec2012. 
19. Moll FL, Powell JT, Fraedrich G, et al. Management of Abdominal Aortic Aneurysms Clinical 
Practice Guidelines of the European Society for Vascular Surgery c, Eur J Vasc  Endovasc Surg 
(2011) 41, S1eS58 
20. Chaikof EL, Brewster DC, Dalman RL, MD, et al. SVS practice guidelines for the care of 
patients with an abdominal aortic aneurysm: Executive summary. JVascular Surgery 2009; 50 
(4):880-96. 

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21. Matsumura JS, Brewster DC, Makaroun MS, Naftel DC. A multicenter controlled clinical trial of 
open versus endovascular treatment of abdominal aortic aneurysm. J Vasc Surg 2003;37:262- 
271. 
22. Greenhalgh RM, Brown LC, Kwong GP, et al. Comparison of endovascular aneurysm repair 
with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative 
mortality results: randomized controlled trial. Lancet. 2004;364:843-848. 
 
 

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L 
APPENDICES 
 
L.1 
Abbreviations 
AAA 
Abdominal aortic aneurysm 
ADE 
Adverse Device Effect 
AE 
Adverse event 
ASA 
American Society of Anesthesiologists 
ASADE 
Anticipated serious adverse device effect 
AUI 
Aorto-uni-iliac 
CEC 
Clinical Event Committee 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
CT 
Computed Tomography 
CVA 
Cerebral Vascular Incident 
DD 
Device Deficiency 
DMC 
Data Monitoring Committee 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EVAR 
Endovascular Aneurysm Repair 
FDA 
Food and Drug Administration 
F/U 
Follow-up 
ICH-GCP 
International Conference on Harmonization – Good Clinical Practice 
ICU 
Intensive Care Unit 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
INR 
International Normalized Ratio 
IPR 
Independent physician reviewer 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
KUB 
Kidney, Ureter, Bladder 
MAE 
Major Adverse Event 
MI 
Myocardial Infarction 
MRA 
Magnetic Resonance Angiography 
MRI 
Magnetic Resonance Imaging 
PET 
Polyethylene terephthalate 
PMA 
Premarket Approval 
OD 
Outer Diameter 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SOP 
Standard operating procedure 
UADE 
Unanticipated Adverse Device Effect USADE
 
 Unanticipated Serious Adverse Device Effect                     
WBC 
White Blood Cell 
 
 

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L.3 
Potential Adverse Events 
Adverse events that may occur related to the index procedure and/ or device or that require 
intervention include, but are not limited to, the following: 
• 
amputation 
• 
anesthetic complications and subsequent attendant problems (e.g., aspiration) 
• 
aneurysm enlargement 
• 
aneurysm rupture and death 
• 
aortic damage, including perforation, dissection, bleeding, rupture, and death 
• 
arterial or venous thrombosis or pseudoaneurysm 
• 
arteriovenous fistula 
• 
bleeding, hematoma, or coagulopathy 
• 
bowel complications (e.g., ileus, transient ischemia, infarction, necrosis) 
• 
cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial 
infarction, congestive heart failure, hypotension, hypertension) 
• 
claudication (e.g., buttock, lower limb) 
• 
death 
• 
edema 
• 
embolization (micro and macro) with ischemia (transient or permanent) or infarction 
• 
endoleak 
• 
femoral-femoral artery bypass thrombosis 
• 
fever and localized inflammation 
• 
genitourinary complications and related problems (e.g., ischemia, erosion, fistula, 
incontinence, hematuria, infection) 
• 
hepatic failure 
• 
impotence 
• 
infection of the aneurysm or device access site, including abscess formation, transient 
fever, and pain 
• 
lymphatic complications and related problems (e.g., lymph fistula) 
• 
neurologic local or systemic complications and related problems (e.g., confusion, stroke, 
transient ischemic attack, paraplegia, paraparesis, paralysis) 
• 
occlusion of device or native vessel 
• 
pulmonary complications and subsequent attendant problems 
• 
renal complications and related problems (e.g., artery occlusion, contrast toxicity, 
insufficiency, failure) 
• 
stent graft: improper placement, incomplete deployment, migration, suture break, occlusion, 
infection, stent fracture, graft twisting or kinking, insertion and removal difficulties, graft 
material wear, dilatation, erosion, puncture, and perigraft flow 
• 
surgical conversion to open repair 
• 
vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, 
arteriovenous fistula, dissection 
• 
vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, 
death) 
• 
vessel damage 
• 
wound complications and related problems (e.g., dehiscence, infection, hematoma, seroma, 
cellulitis) 
 

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L.4 
Device Explant and Returned Product Instructions 
EXPLANT AND AUTOPSY PROCEDURE FOR ENDOVASCULAR PATIENTS 
SURGEON AND SITE RESPONSIBILITY 
NOTE: Priority should be given to patient health and safety at all times during the explant 
procedure. 
 
A. If the explant is part of a late conversion to an open-surgical procedure, consideration 
of the patient is foremost. The surgeon should remove ONLY the endovascular 
prosthesis, damaging or altering the device as little as possible yet providing optimal 
surgical care to the patient. 
B. If the explant is performed on a cadaver, the surgeon should carefully view the adjacent 
body organs and excise the intact aorta containing the endovascular prosthesis, 
including 1cm of tissue adjacent to the proximal and distal fixation sites to facilitate 
histological assessment. 
C. It is important that care be given during the collection, handling and examination of the 
implant to ensure that it is not damaged or altered. 
• 
Particular care should be taken to avoid applying force, traction, or torsion to the 
stent graft during the explant. 
• 
Care should be exercised to avoid excessive manipulation with metallic instruments 
at the proximal and distal fixation sites whenever possible. 
• 
Stent graft or post mortem specimen should be placed in formalin as is. Do not 
attempt to clean or remove organic debris. 
D. Using the Explant Procedure Observation Form (UC200103088EN), the physician 
should accurately and fully document the explant procedure and the stent graft ex situ. 
Any possible trauma applied to the device, e.g., clamping, twisting, torsion, or traction 
should also be documented. 
• 
Physician operation notes may also be used to document the procedure and the 
characteristics of the stent graft prior to and after explant from the body. 
• 
Mark components that separate during explant. Attach suture or hemoclip to 
anterior side and on the proximal end for proximal cuffs and distally for distal 
components. 
E. Follow procedures from Explant Return Instructions (UC200103091) included in the 
explant kit for packaging and return of device to Medtronic. 

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EXPLANT RETURN INSTRUCTIONS 
1.0 
Complete the following forms: 
Explant Procedure Observation Form (UC200103088EN) This form is to be completed at 
the time of the explant procedure. 
Explant Identification Peel-off Labels (UC200103089EN) Using permanent ink, complete 
the two labels provided in the kit. Place one completed label on the inner plastic container, 
place the second completed label on the outer metal container. 
Air bill (pre-printed)  Fill in shipper information. 
 
 
2.1 
Secure the explant in the explant kit for shipping. Note: Medtronic Monitors/Field 
Representatives are not authorized to handle formalin/formaldehyde. 
• 
Place the explanted device and any associated organic tissue into the labeled inner 
plastic container in a 10% neutral buffered formalin (3.7-4% Formaldehyde) solution to 
maintain tissue integrity. (To be completed by hospital staff only) 
Note: Any specimen too large for the provided inner container may be sent in any securely 
closed container and placed with provided packing in the metal container and box. 
• 
Seal the plastic container with red tape (provided in kit). The tape should be stretched 
clockwise around the cap and the container. Place plastic container into the absorbent bag. 
• 
Place the absorbent bag (with plastic container) inside the labeled metal container. Fold 
the top flaps of the absorbent lining over the top of the plastic container and secure the 
bag with a twist tie or cable tie (provided in kit). Place lid on metal can and seal with the 
locking ring provided. Place the can into the inner partition of the cardboard box, and 
push in the corner tabs on the top of the partition to retain the can. 
• 
Place the completed Explant Procedure Observation Form, implant and explant 
operative reports, and any radiology follow-up reports (if available), inside the moisture- 
resistant plastic bag provided, and place into the box. 
Note: A Record of Disclosure of Health Information for Public Purposes is included for your 
convenience and can be placed in the patients file. 
Securely seal the box with clear tape (provided in kit). Affix the shipping airbill to the 
outside of the box. 
• 
Arrange for pickup from Shipping Company. 
If you have questions about shipping the device, need additional information, or desire additional 
Explant Kits, please contact the Explant Department, at (707) 591-7672 or 1-800-465-5533, Option 3. 
 
Thank you for completing the Explant Forms and returning the device. Medtronic uses this information 
to meet FDA requirements and track product performance. 
 
 

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EXPLANT PROCEDURE OBSERVATION FORM 
 
PATIENT INFORMATION 
Patient IDE/ Study ID  
  
Name:  
 
DOB (Month/Day/Year):          /        /          
 
IMPLANT INFORMATION 
Date of Implant:         /_      /          
Implanting Physician:   
  
Implanting Hospital Name:   
  
City and State:  
 
Country:   
  
 
EXPLANT INFORMATION 
Date of Explant/Autopsy:         /        /          
Explanting Physician:   
 
Name of Hospital:   
  
Address:   
  
City and State:   
  
Country:   
  
Telephone: (      )  
   
 
REASON FOR EXPLANT 
 
 
 
 
 
 
 
 
 
 
 Planned Surgical Conversion 
 Emergent Conversion 
 Autopsy Date of Death: 
/ 
/  
 
 
Remarks about procedure:   
 
 
 
 
 
 
 
 
 
 
 
 
 

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Evidence of inflammation 
∆ Yes ∆ No 
Comments:  
 
  
Thrombosis present in the sealzones 
∆ Yes ∆ No 
Comments:  
 
  
Calcification present in the sealzones 
∆ Yes ∆ No 
Comments:  
 
  
 
 
How well was the device attached to the patient’s tissue? 
Proximally: ∆ Comes out easily from aortic vessel 
 Appears firmly attached to aortic vessel 
Mid body: 
∆ Comes out easily from aneurysm contents 
 Appears firmly attached to aneurysm contents 
Distally (L): ∆ Comes out easily from iliac/aortic vessel 
 Appears firmly attached to iliac/aortic vessel 
Distally (R): ∆ Comes out easily from iliac/aortic vessel 
 Appears firmly attached to iliac/aortic vessel 
 
Comments   
 
 
 
 
 
 
 
Successful Surgical Conversion: ∆ Yes ∆ No 
Patient Outcome:  ∆ Alive 
∆ Expired 
 
 

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EXPLANTED DEVICE INFORMATION 
 
 
DEVICE 
CATALOG NUMBER 
LOT NUMBER 
Bifurcated Body 
 Distal Left 
 Distal Right 
Contralateral Limb 
Iliac Extension 
 Left 
 Right 
Iliac Extension 
 Left 
 Right 
Iliac Extension 
 Left 
 Right 
Aortic Cuff 
AUI 
 Distal Left 
 Distal Right 
Thoracic, Proximal Main 
Thoracic, Distal Main 
Thoracic, Distal Main 
Thoracic, Proximal Extension 
Thoracic, Distal Extension 
Other (Specify) 
Additional Comments 
 
 
 
 
 
 
 
Form completed by:    
 
 
Title:   
 
 
Date:   
 
 

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Date of Disclosure: 
 
Recipient and Contact Information: 
 
Medtronic Vascular 
Quality Assurance 
Department 3576 Unocal 
Place 
Santa Rosa, California
 
95403 707-591-7672 
 
 
 
 
Description of Patient Information  Disclosed: 
 
Examples of descriptions to be written here include: 
 
• 
Information regarding the functioning of the patient’s AneuRx or Talent Stent Graft 
• 
Implant Operative Report, the Explant Operative Report, and surveillance 
radiology reports 
 
 
Purpose of Disclosure: 
 
The following language can be used on all Records of Disclosures: 
 
“For public health activities and purposes under Section 164.512(b)(1)(iii) of the HIPAA 
Privacy Rule, i.e. activities related to the quality, safety or effectiveness of FDA-regulated 
products or activities for which [Medtronic/Medtronic business unit] is responsible.” 
 
 
RECORD OF DISCLOSURE OF HEALTH INFORMATION FOR PUBLIC HEALTH 
PURPOSES 
To Custodian of Patient Information:  Federal privacy standards issued by the Department of 
Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 
1996 (HIPAA) require providers to record and, upon patient request, account for disclosures of 
patient information for public health purposes (except where disclosed pursuant to patient 
authorization or as part of a limited data set) (45 C.F.R. § 164.528(a)).  This Record of Disclosure 
may be appended to the medical record to facilitate an accounting of disclosures. 
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Clinical Investigational Plan 
 
Version 1E 
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Page 63 of 70 
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L.5 
Informed Consent Template 
THE INFORMED CONSENT TEMPLATE HAS BEEN REMOVED AS AN ATTACHMENT TO THE 
PROTOCOL AND WILL BE VERSION CONTROLLED AS AN INDEPENDENT DOCUMENT. 
 
 

Clinical Investigational Plan 
 
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L.8 
Imaging Device Assessment Reporting Decision Tree 
 
 
 
 

Clinical Investigational Plan 
 
Version 1E 
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Medtronic Confidential 
Page 67 of 70 
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•Concomitant 
Medication  
F.3 Data 
Collection 
Requirements  
Imaging source 
data will be sent 
to a Core Lab for 
analysis up to the 
60-month follow-
up visit. Any 
interim imaging of 
the stent graft 
region but not 
linked to a study 
visit should be 
recorded on the 
Interim Image e-
CRF (e.g. imaging 
performed as 
standard of care 
beyond the 
protocol required 
time points and/or 
when performed 
further to any 
issue observed at 
previous imaging 
Follow-up). 
Interim imaging 
performed, as 
recommended per 
the most recent 
DMC Surveillance 
and Management 
letter should also 
be reported on the 
interim imaging 
eCRF. 
Imaging source data will 
be sent to a the Core Lab 
for analysis up to the 60-
month follow-up visit. Any 
interim imaging of the 
stent graft region but not 
linked to a study visit 
should also be recorded 
on the Interim Image e
CRF sent to the Core Lab 
(e.g. imaging performed 
as standard of care 
beyond the protocol 
required time points 
and/or when performed 
further to any issue 
observed at previous 
imaging Follow-up). This 
also includes interim 
imaging performed as 
recommended per the 
most recent DMC 
Surveillance and 
Management letter.  
should also be reported on 
the interim imaging eCRF. 
All images taken from the 
stent graft region must be 
assessed by the site. Any 
findings that meet the 
requirements in the 
flowchart (Appendix L.8) 
must be reported on the 
applicable eCRF.  
In protocol version D, 
images were analyzed 
by both Core Lab and 
sites.  Moving forward, 
protocol version E will 
continue to require that 
the sites submit all 
images to the Core Lab 
for analysis, but the 
sites will not be required 
to report all data from 
imaging analysis. This is 
because the Core Lab 
will assure consistency 
between measurements 
of different sites. In 
addition, there is a 
discrepancy between 
the number of Device 
Deficiencies identified 
by the Core Lab and 
Sites. The Core Lab has 
proven more reliable at 
identifying Device 
Deficiencies as 
compared to the sites. 
For this reason, the 
Core Lab has 
demonstrated to be the 
most accurate and 
reliable data source for 
the image analysis. If in 
an incidental case, the 
site identifies a device 
deficiency that is not 
confirmed by the Core 
Lab, this finding will still 
be captured as the site 
continues to report such 
findings in the device 
deficiency or event 
eCRFs. For this reason, 
the decision to relieve 
sites from also entering 
this data into eCRF is 
not expected to affect 
overall data integrity. 
F.3 Data 
Collection 
Requirements  
 
Table F2 Data 
Collection 
Schedule 
Last column 
2-5 Yr. F/Ue (±56 days) 
• 
Physical 
examination 
• 
Medications 
• 
Adverse Event 
Assessment 
• 
CT/MR (2 cm 
above origin of 
celiac artery 
through 
bifurcation of 
Last column 
2-5 Yr. F/Ue (±56 days) 
• 
Physical examination 
• 
Medications 
• 
Adverse Event 
Assessment 
• 
CT/MR (2 cm above 
origin of celiac artery 
through bifurcation of 
femoral arteries) c 
• 
Abdominal X-Ray (4-
view, KUB) 
 
Column added 
Changes detailed in 
sections  F.2.3 and F.3 
are implemented in 
table F-2: schedule of 
assessments 
 
 

Clinical Investigational Plan 
 
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femoral 
arteries) c 
• 
Abdominal X-
Ray (4-view, 
KUB) 
 
3-5 Yr. F/Ue (±56 days) 
• 
Adverse Event 
Assessment 
• 
CT/MR (2 cm above 
origin of celiac artery 
through bifurcation of 
femoral arteries) c, f 
• 
Abdominal X-Ray (4-
view, KUB)f 
 
Footnote added 
f All Images (routine & interim) 
performed 3-5 years will be 
required to be submitted to the 
Core Lab for evaluation. Sites will 
continue to review images for 
clinical evaluation and detection of 
device deficiencies in accordance 
with Appendix L.8, but will not be 
required to complete imaging 
eCRF. 
F.6. Adverse 
Events 
Recording and 
Reporting of 
Adverse Events 
For the purpose of 
this clinical 
investigation 
Medtronic will 
define and 
classify the 
following events 
per 
ISO14155:2011 
and Title 21 CFR 
part 812.3.  
 
For the purpose of this 
clinical investigation 
Medtronic will define and 
classify the following 
events per 
ISO14155:2011 (followed 
for definitions of Adverse 
Events only) and Title 21 
CFR part 812.3.  
Adverse event reporting 
for the remaining follow up 
(3-5 years) will focus on 
the reporting of the below 
listed events:  
• 
Adverse events with a possible 
relationship to the aneurysm 
(Excluding aneurysms in 
anatomic areas other than the 
Endurant grafted segment) 
• 
Adverse events with a possible 
relationship to the device 
• 
Adverse events with a possible 
relationship to the procedure 
• 
Adverse events leading to 
subject’s death 
  
Secondary procedures performed 
as a result of any of the above 
adverse events must be reported 
on the respective Adverse Event 
form. Please see guidance for 
reporting of adverse events 
following image review in Appendix 
L.8. 
Because the Modular PMA was 
withdrawn, it was decided to 
focus on the collection and 
review of safety follow-up data 
for which the relationship to the 
aneurysm, device or procedure 
cannot be ruled out, for the 
remainder of the follow up 
period.  
This means that Medtronic will 
no longer require the reporting 
of events unrelated to the 
aneurysm, device, or procedure. 
This decision was deemed 
appropriate as the DMC has not 
reported any concerns with 
regards to events with no 
relationship to aneurysm, device 
or procedure.  If a relationship 
cannot be ruled out, sites are 
requested to report the event.  
To aid the sites in making a 
decision on reporting, an 
additional guidance flowchart 
was added in the protocol. 
 
F.6.2 Adverse 
Events  
Recording and 
Reporting of 
Adverse Events 
 
Adverse Event 
(AE) information 
will be collected 
throughout the 
study and 
reported to 
Adverse Event (AE) 
information will be 
collected throughout the 
study and reported to 
Medtronic on the Adverse 
Event eCRF. All Adverse 

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Medtronic on the 
Adverse Event 
eCRF. All 
Adverse Events 
(except the ones 
listed in table F-
3), regardless of 
relatedness or 
outcome, must be 
reported. The 
investigator is 
responsible for 
reporting all AE to 
Medtronic. See 
the Adverse Event 
eCRF for the 
information to be 
reported for each 
Adverse Event. 
Events (except the ones 
listed in table F-3), 
regardless of relatedness 
or outcome, must be 
reported. The investigator 
is responsible for reporting 
all AE to Medtronic. See 
the Adverse Event eCRF 
for the information to be 
reported for each Adverse 
Event. 
Please see guidance for 
reporting of Adverse 
Events following image 
review in Appendix L.8. 
F.6.3 Adverse 
Events  
Recording and 
Reporting of 
Device 
Deficiencies 
 
added at the end of the 
section: 
Please see guidance for 
reporting of Device 
Deficiency following image 
review in Appendix L.8. 
L.8 Imaging 
Device 
Assessment 
Reporting 
Decision Tree 
NA 
Added: 
Imaging Device Assessment 
Reporting Decision Tree. 
G.2. Monitoring 
Procedures   
 
Monitoring visits will 
be conducted at the 
start, during and at the 
closure of the clinical 
study in accordance 
with Medtronic SOPs 
and the Monitoring 
Plan. Frequency and 
timing of monitoring 
visits shall be 
determined by the 
Sponsor for each site 
based on enrollment 
rate and volume, 
study compliance and 
findings from previous 
visits. 
On-site monitoring visits will 
be conducted at the start and 
during and at the closure of 
the clinical study in 
accordance with Medtronic 
SOPs and the Monitoring 
Plan. Frequency and timing of 
monitoring visits shall be 
determined by the Sponsor for 
each site based on enrollment 
rate and volume, study 
compliance and findings from 
previous visits. 
(…) 
In-person monitoring visits will 
be replaced by telephone and 
email contact to the sites by 
the study team. The sponsor 
monitoring phone calls will 
include an assessment of the 
source documents to assure 
completeness of image 
submissions and event 
reporting and an assessment 
of the essential documents. In 
particular, the focus of these 
calls will be to ensure that 
safety data is entered and to 
verify that all relevant events 
are reported. Site monitoring 
visits will be requested by the 
Sponsor if a concern arises 
with regards to compliance or 
data integrity. 
To further mitigate the 
concern that sites could 
underreport safety 
events, it is noted that 
the following two 
procedures will remain 
to be in place: First, all 
sites will still be required 
to submit all images to 
Core Lab for analysis. 
The Core Lab will 
continue to analyze all 
site images for potential 
device deficiencies or 
other notable findings. 
Second, Medtronic will 
continue to monitor all 
source data received 
from the sites for any 
potential unreported 
adverse events (i.e. 
source data from 
adjudicable adverse 
events or source data 
requested by the DMC). 
Any findings from these 
additional verification 
procedures will be 
addressed with the site. 

Clinical Investigational Plan 
 
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G.4. Study 
Close Out 
Prior to completion of 
study close out, all 
data must be entered 
and monitored in the 
EDC system. 
Medtronic and/or its 
designees will notify 
the site of the 
intention to close the 
study. Study close out 
visits may be 
performed. 
During these visits, 
the monitors will 
ensure that the 
investigator’s 
regulatory files are up 
to date and complete 
and that any 
outstanding issues 
from previous visits 
have been resolved. 
Prior to completion of study 
close out, all data must be 
entered and monitored 
approved in the EDC system. 
Medtronic and/or its designees 
will notify the site of the 
intention to close the study. 
Remote sStudy close out visits 
may be performed. During 
these visits, the monitors will 
ensure that The intent of these 
visits will be to assure that the 
investigator’s regulatory files 
are up to date and complete 
and that any outstanding 
issues from previous visits 
have been resolved.  
H.1. Analysis of 
Clinical Data 
PMA Submission 
Based on the design 
similarities …//.... may 
be revisited with FDA 
at that time 
PMA Submission 
No analysis is scheduled 
related to PMA submission. 
Due to the UADEs, Medtronic 
has requested withdrawal of 
PMA submission, which was 
granted by the FDA in 
November 2016. 
Since PMA submission 
was withdrawn PMA 
submission related 
analyses is no longer 
applicable. The text in 
this section was 
replaced to clarify why it 
was removed from this 
protocol amendment 
J. 3 Risk-to-
benefit 
Rationale 
However, to date, 
the UADE 
(transition stent 
fractures, partial 
suprarenal stent 
detachment, and 
suprarenal stent 
fracture) 
observations 
reported have 
indicated that the 
Endurant Evo 
AAA stent graft 
system has 
associated risks 
with higher rates 
when compared 
to the associated 
risks of other 
commercially 
available devices. 
However, to date, the 
UADE (transition stent 
fractures, partial 
suprarenal stent 
detachment, and 
suprarenal stent fracture, 
and suprarenal anchoring 
pin fracture) observations 
reported have indicated 
that the Endurant Evo 
AAA stent graft system 
has associated risks with 
higher rates when 
compared to the 
associated risks of other 
commercially available 
devices. 
 
Text updated to include 
the new UADE, 
suprarenal anchoring 
pin fracture, to already 
listed UADEs in the 
previous version of the 
protocol.  
L.9. Overview of 
description of 
changes to for 
CIP Version 1D 
to 1E with 
rationale 
NA 
Added:  
Overview of description of 
changes from CIP Version 1D 
to 1E with rationale.