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



 
 
 
 
Clinical Investigation Plan 
 
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Table of Contents 
A 
SYNOPSIS ....................................................................................................................................... 5 
B 
GENERAL INFORMATION ............................................................................................................10 
B.1 
Introduction ........................................................................................................................10 
B.2 
Device Information .............................................................................................................11 
B.2.1 Device Description ................................................................................................................11 
B.2.2 Indications for Use ................................................................................................................15 
C 
STUDY PLAN .................................................................................................................................16 
C.1 
Study objectives .................................................................................................................16 
C.1.1 Primary objectives .................................................................................................................16 
C.1.2 Secondary objectives ............................................................................................................16 
C.2 
Clinical Endpoints ..............................................................................................................16 
C.2.1 Primary Endpoints .................................................................................................................16 
C.2.2 Secondary Endpoints ............................................................................................................16 
C.2.3 Additional Observations ........................................................................................................17 
C.3 
Study Hypothesis ...............................................................................................................17 
C.4 
Study population ................................................................................................................17 
C.5 
Study design .......................................................................................................................17 
C.6 
Randomization and blinding .............................................................................................18 
C.7 
Sample size .........................................................................................................................18 
C.8 
Number of investigational sites and study duration .......................................................18 
D 
SUBJECT SELECTION ..................................................................................................................18 
D.1 
Inclusion criteria .................................................................................................................19 
D.2 
Exclusion criteria ................................................................................................................19 
E 
STUDY PREPARATION PROCEDURES.......................................................................................20 
E.1 
Investigator / Investigational site selection ......................................................................20 
E.1.1 Investigator selection criteria .................................................................................................20 
E.1.2 Investigational site selection criteria ......................................................................................20 
E.1.3 Clinical Trial Agreement ........................................................................................................21 
E.1.4 Curriculum Vitae....................................................................................................................21 
E.2 
Ethics ...................................................................................................................................21 
E.2.1 EC/IRB approval ...................................................................................................................21 
E.2.2 Informed consent process .....................................................................................................21 
E.2.3 Revisions in Informed Consent Form ....................................................................................22 
E.2.4 Regulatory submission ..........................................................................................................22 
E.3   Regulatory compliance .......................................................................................................22 
E. 4  Training requirements .........................................................................................................23 

 
 
 
 
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E. 5  Clinical study materials .......................................................................................................23 
E. 6  Study device/product traceability ......................................................................................23 
E.6.1 Supply of investigational devices/products ............................................................................23 
E.6.2 Storage and handling of investigational devices/products .....................................................23 
E.6.3 Device explant and return procedures/products ....................................................................23 
E.6.4 Device/product disposition requirements ..............................................................................23 
F 
STUDY METHODS .........................................................................................................................23 
F.1 
Point of Enrollment ............................................................................................................23 
F.2 
Implant and Follow up ........................................................................................................24 
F.2.1 Index Procedure ....................................................................................................................24 
F.2.2 Hospital Discharge ................................................................................................................25 
F.2.3 Follow-Up Visits and Procedures ..........................................................................................25 
F.3 
Data Collection Requirements ..........................................................................................26 
F.4 
Role of the sponsor representatives ................................................................................28 
F.5 
Source documents .............................................................................................................28 
F.6 
Adverse Events ...................................................................................................................28 
F.6.1 Definitions / Classifications ...................................................................................................29 
F.6.2 Recording and reporting of Adverse Events ..........................................................................30 
F.6.3 Recording and reporting of Device Deficiencies ...................................................................30 
F.6.4 Adverse Event and Device Deficiency review process ..........................................................30 
F.6.5 Clinical Event Committee ......................................................................................................31 
F.6.6 Emergency contact details in case of serious AEs ................................................................31 
F.7 
Subject accountability ........................................................................................................31 
F.7.1 Criteria and procedures for exit from study ...........................................................................31 
F.7.2 Study Withdrawal ..................................................................................................................31 
F.7.3 Missed follow-up ...................................................................................................................31 
F.7.4 Lost-to-follow-up ...................................................................................................................32 
F.7.5 Conversion to open repair .....................................................................................................32 
F.7.6 Medical care after study exit .................................................................................................32 
F.8 
Study/Protocol deviations and CIP changes ...................................................................32 
F.8.1 Request for approval of study deviations ..............................................................................32 
F.8.2 Reporting requirements for study deviations .........................................................................33 
F.8.3 Amendments to the Clinical Investigation Plan .....................................................................33 
G 
QUALITY CONTROL PROCEDURES ...........................................................................................33 
G.1 
Procedures for database management ............................................................................33 
G.1.1 Data collection ......................................................................................................................33 
G.1.2 Source data to be directly recorded on the Case Report Forms ...........................................34 
G.1.3 Time windows for completion and submission of Case Report Forms ..................................34 

 
 
 
 
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G.1.4 Data review and processing ..................................................................................................34 
G.2 
Monitoring procedures ......................................................................................................34 
G.2.1 Accessibility of investigation site staff and study materials ...................................................34 
G.2.2 Audits and investigation site inspections ...............................................................................34 
G.3 
Study suspension or early termination ............................................................................35 
G.3.1 Early study suspension or termination ..................................................................................35 
G.3.2 Early investigation site suspension or termination .................................................................35 
G.3.3 Subject follow-up in case of termination ................................................................................35 
G.4 
Study close out ...................................................................................................................35 
H 
DATA ANALYSIS AND REPORTING ............................................................................................36 
H.1 
Analysis of clinical data .....................................................................................................36 
H.2 
Publication Policy ..............................................................................................................37 
I 
STUDY MANAGEMENT .................................................................................................................37 
I.1 
Study Contact .....................................................................................................................37 
I.2 
Advisory committees .........................................................................................................37 
I.2.1 Clinical Event Committee (CEC) ...........................................................................................37 
I.2.2 Data Monitoring Committee ..................................................................................................38 
I.2.3 Publication Committee ..........................................................................................................38 
I.2.4 Imaging Core Lab..................................................................................................................38 
I. 3 Records and reports ..............................................................................................................38 
I.3.1 Investigator records ...............................................................................................................38 
I.3.2 Investigator reporting responsibilities ....................................................................................38 
I.3.4 Sponsor reporting responsibilities .........................................................................................39 
I. 4 Miscellaneous .........................................................................................................................40 
I.4.1 Insurance ..............................................................................................................................40 
I.4.2 Subject compensation and indemnification ...........................................................................40 
I.4.3 Subject confidentiality ...........................................................................................................41 
J 
RISKS AND BENEFITS .................................................................................................................41 
J.1 
Potential Risks ....................................................................................................................41 
J.2 
Potential Benefits ...............................................................................................................41 
J.3 
Risk-to-Benefit Rationale ...................................................................................................42 
K 
REFERENCES ...............................................................................................................................42 
L 
APPENDICES ................................................................................................................................44 
L.1 
Abbreviations .....................................................................................................................44 
L.2 
Definitions ...........................................................................................................................45 
L.4 
Imaging Technique and Sensitivity ..................................................................................49 
L.5 
Imaging Device Assessment Reporting Decision Tree ..................................................50 
L.6 Table of changes & rationale CIP version 7 compared to version 6 .................................51 
 

 
 
 
 
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A 
SYNOPSIS 
 
Protocol Number 
10173339DOC 
Title 
Endurant Evo International Clinical Trial 
Investigational 
Device 
EndurantTM Evo AAA Stent Graft System 
Study Design 
The Endurant Evo International Clinical Trial is a prospective, multi-center, pre- 
market, non-randomized, single-arm trial. 
Purpose 
The purpose of the Endurant Evo International Clinical Trial is to evaluate the 
safety and effectiveness of the Endurant Evo AAA stent graft system for 
endovascular treatment of subjects with infrarenal abdominal aortic or aortoiliac 
aneurysms.  
Primary Objective 
The primary safety objective is to evaluate 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 evaluate successful delivery and 
deployment of the Endurant Evo AAA stent graft system with successful removal 
of the delivery system during the index procedure. 
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: 
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. 
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 
30, 183 and 365 days 
• 
Secondary endovascular procedures within 30, 183 and 365 days 
• 
Serious adverse events within 30, 183 and 365 days 
• 
Aneurysm rupture within 30, 183 and 365 days 
• 
Conversion to open surgery within 30, 183 and 365 days 
• 
Major adverse events within 183 and 365 days 
• 
Stent graft migration at 12-month follow-up visit (as compared to 
1- month imaging) 
• 
Aneurysm expansion > 5 mm at 12-month follow-up visit (as 
compared to 1-month imaging) 
• 
All endoleaks based on imaging findings at 1- month, 6-month and 

 
 
 
 
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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 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 

 
 
 
 
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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 
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 
aneurysms.5 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 
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 

 
 
 
 
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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 International Clinical Trial was 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 Investigator’s Brochure. 
 
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. 
 
Endurant Evo Stent Graft 
The Endurant Evo stent graft is comprised of the following stent graft configurations: 
• 
Bifurcated component 
• 
Limb component 
• 
Aorto-Uni-Iliac (AUI) 
• 
Aortic extensions 
• 
Iliac extensions 
Each stent graft component is introduced separately into the vessel and is mated in vivo to the 
components already in situ. All components are constructed by sewing the self-expanding nitinol 
stents to a fabric graft. The suprarenal stents with anchor pins on the proximal end of the bifurcated 
component, the AUI component and the aortic extension are laser cut from a nitinol tube and all 
other stents are wire-formed. The stents are formed in a ring with opposing ends being terminated 
together in crimp sleeves. The suprarenal and wire formed stents are sewn to the polyester (PET) 
graft fabric using ultra high molecular weight polyethylene (UHMWPE) suture. 

 
 
 
 
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• 
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. 
 
C 
STUDY PLAN 
 
C.1 
Study objectives 
The purpose of the Endurant Evo International Clinical Trial is to evaluate the safety and 
effectiveness of the Endurant Evo AAA stent graft system for endovascular treatment of subjects 
with infrarenal abdominal aortic or aortoiliac aneurysms.. 
 
C.1.1 Primary objectives 
The primary safety objective is to evaluate 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 evaluate successful delivery and deployment of the 
Endurant Evo AAA Stent graft system with successful removal of the delivery system during the 
index procedure. 
(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 
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 
C.2.2 Secondary Endpoints 
The following secondary endpoints will be evaluated: 
 

 
 
 
 
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Subjects will have required follow-up evaluations at the following time points: 
 
• 
1 month following the index procedure 
• 
6 months following the index procedure 
• 
12 months following the index procedure 
• 
Annually thereafter, until 5 years post index procedure 
 
Given the DDs with SAE potential that have occurred within the Endurant Evo trials, the Data 
Monitoring Committee (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. 
 
In addition to the 40 subjects enrolled to support regulatory approval, approximately 30 additional 
subjects may be enrolled to support geography-specific regulatory requirements. For these 
subjects, all inclusion/exclusion criteria, study methods, follow-up schedule and data-collected will 
be identical to the first 40 subjects enrolled. 
 
Number of devices being used within this trial 
For subjects that are treated with the bifurcated stent graft minimal 3 pieces will be implanted in 
the target segment; one bifurcated stent graft component and 2 limb stent graft components. For 
subjects that are treated with the AUI component approximately 2 pieces will be implanted in the 
target segment; the AUI stent graft component and one limb stent component. Additional stent 
graft extensions might be needed to cover the complete target lesion length. 
 
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 
A sample of 40 subjects will be enrolled consecutively and analyzed to support regulatory approval. 
The sample size of 40 subjects is considered adequate to assess the primary safety endpoint, 
which is defined as the proportion of subjects experiencing a MAE within 30 days post-implantation. 
Considering the reported MAE rate from the ENGAGE Post-Approval Study (PAS), which evaluated 
the long-term safety and effectiveness of the Endurant Stent graft system in 328 subjects18, it is 
estimated that 2 of 40 (5%) subjects treated with Endurant Evo AAA stent graft system will 
experience a MAE. The precision of this assumed 5% point estimate can be assessed by 
calculating the difference from the 1-sided 95% upper confidence limit. This difference, or margin 
of error, is calculated to be < 10% for the Endurant Evo International Clinical Trial and is therefore 
considered adequate to assess the primary safety endpoint. 
 
C.8 
Number of investigational sites and study duration 
Approximately 10 sites will participate in the clinical study. For the initial 40 subjects to be analyzed, 
no more than 20% (i.e. 8 subjects) will be enrolled from a single investigational site. Enrollment 
will be halted at sites that reach the 20% enrollment cap. Following enrollment of the 40 subjects, 
a site where enrollment has been halted may resume enrolling until approximately 30 additional 
subjects have been reached in total. For the total cohort (approximately 70 subjects) again no 
more than 20% of the subjects will be enrolled from a single investigational site.1 
 
The total enrollment period is not expected to exceed 12 months. All enrolled subjects will be 
followed until 5 years post-implantation. Thus total study duration from first subject enrolled to final 
subject exit could approach 6 years. 
 
A list of names and addresses of the investigational sites and principal investigators in which the 
clinical study will be conducted will be kept separate from the clinical investigation plan and 
provided to the investigators. The sponsor will maintain an updated list. 
 
D 
SUBJECT SELECTION 
 

 
 
 
 
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D.1 
Inclusion criteria 
Candidates for the Endurant Evo International 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 
1 Given the DDs with SAE potential that have occurred within the Endurant Evo trials (transition 
stent fracture, partial suprarenal stent detachment, and suprarenal stent fracture), enrollment was 
terminated with a total enrollment of 69 subjects. 
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 
c) Mycotic 
d) Inflammatory 
e) Pseudoaneurysm 
f) 
Dissecting 
g) Ruptured 
h) Leaking but not ruptured 
5) Subject requires emergent aneurysm treatment 
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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 
 
 
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 ISO14155:2011 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 

 
 
 
 
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• 
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 Delegated Task List 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 
 
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, Investigator’s Brochure, 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 

 
 
 
 
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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. 
 
The date when the subject signed the Informed Consent From and the name of the clinical study 
for which the consent was signed should be documented in the medical records of each consented 
subject. 
 
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. 
 
If new information becomes available that can significantly affect the subject’s future health and 
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 International Clinical Trial will be conducted in compliance with the Declaration 
of Helsinki (October 2013). The international standard ISO 14155:2011 ('Clinical Investigation of 
medical devices for human subjects') and Medical Device Directive 93/42/EEC will be followed 
with the following two exceptions: 
• 
ISO 8.2.4.5 Routine on-site monitoring visits will be replaced by remote monitoring (see 
section (G2 and rationale in L5) 
• 
ISO6.4.1 Adverse events: Not all adverse events will be collected (see section F6 and 
rationale in L5) 
In addition, the study will be compliant with the laws and regulations of the countries in which the 
clinical study is conducted, including data protection laws, the clinical trial agreement and the 
clinical investigation plan. In addition, the study will be conducted in compliance with 21 CFR Part 
11 and 54 in all participating geographies. 
All principles of the Declaration of Helsinki have been implemented in this clinical study by means 
of the informed consent process, EC/IRB approval, study training, clinical trial registration, 
preclinical testing, risk benefit assessment and publication policy. 
The sponsor will avoid improper influence on, or inducement of the subject, monitor, and 
investigator(s) or other parties participating in, or contributing to, the clinical study by implementing 
the informed consent process, clinical trial agreements, and EC/IRB approval. 
 
This study will be publicly registered accordance with the Declaration of Helsinki on 
www.clinicaltrials.gov. 
 

 
 
 
 
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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, ISO 14155:2011, 
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 investigators 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 
investigator must be in receipt of an “Activation 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 Investigator’s Brochure and 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. 
 
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 
Tracking 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 Tracking Log. 
 
F 
STUDY METHODS 
 
F.1 
Point of Enrollment 

 
 
 
 
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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. 
 
• 
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 a 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. 
 
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 
International 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 

 
 
 
 
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of the investigator, it may be used to meet the 1-month follow-up visit CT/MR requirement and 
acquisition of an additional 1-month CT/MR with contrast would not be required.  
 
Abdominal X-rays should be completed via a four-view kidney, ureter, bladder (KUB) X-ray. 
Posterior/anterior (PA) and lateral images are recommended for visualization of the stent graft. 
Ensure the entire device is captured on images for assessment. 
 
If 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. Please 
refer to Device Explant and Returned Procedures/Products section, located in E.6.3 of the 
protocol. 
 
F.3 
Data Collection Requirements 
Clinical data will be collected preoperatively to establish eligibility, at baseline, during the index 
procedure, throughout the hospital stay, and postoperatively at the required (and any interim 
imaging) follow-up visits described in Section F.2. The data collection schedule is summarized in 
Table F-2. Imaging source data will be sent to  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 be 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. 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.5) must be reported on the 
applicable eCRF. Study data will be collected using electronic case report forms (eCRFs) as 
described in Section G.1. Clinical investigators must electronically review and approve all eCRFs. 
The monitoring strategy will be defined in the monitoring plan. 
 
 

 
 
 
 
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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. 
The investigator will clearly mark clinical records to indicate that the subject is enrolled in this 
clinical investigation. 
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) 
 
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, probable or causal relationship to the aneurysm (Excluding 
aneurysms in anatomic areas other than the Endurant grafted segment) 
• 
Adverse events with a possible, probable or causal relationship to the device 
• 
Adverse events with a possible, probable or causal relationship to the index 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.5. 
 
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.6.2 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 AEs as 
reportable/collectable per CIP 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.5. 
 
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. 
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. Please see guidance for reporting of Device Deficiency 
following image review in Appendix L.5. 
 
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. 
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 
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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), serious 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 
• 
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. 
 

 
 
 
 
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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. 
Relevant medical records may be made available by the investigational sites for the treating 
physician per local laws and regulations if needed for further subject treatment. As per local law 
and regulation the trial investigator may be contacted by the treating physician in case of questions 
related to the study device and treatment. 
 
F.8 
Study/Protocol deviations and CIP changes 
A study deviation is an event where the investigator or investigation site personnel did not conduct 
the clinical study according to the clinical investigation plan or clinical trial agreement. The 
investigator is not allowed to deviate from the above mentioned documents except with prior 
approval and/ or under emergency circumstances. All deviations shall be documented and 
explained, regardless of the reason for the deviation. 
Specific examples of deviations include but are not limited to: 
• 
Failure to obtain informed consent prior to participation 
• 
Incorrect version of the informed consent form used 
• 
No EC approval before the start of the study 
• 
Enrolled subject did not meet inclusion/exclusion criteria 
• 
CIP required testing and/or measurements not done or incorrectly done subject did 
not attend follow up visit or follow up visit outside window 
• 
Unauthorized use of investigational devices 
• 
Adverse event not reported by investigators in the required time frame as specified in 
the CIP 
• 
Control of study devices not maintained 
• 
Source data lost or unavailable 
• 
Enrollment of subjects during elapse of IRB/EC approval 
• 
Subject not implanted according to the Instructions for Use 
 
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. 
 
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 
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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. 
 
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 

 
 
 
 
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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. 
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 
 
It will be verified whether signed and dated informed consent forms have been obtained from each 
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. 
 
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. 
 
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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) 
• 
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. 
 
After study termination relevant medical records may be made available by the investigational sites 
for the treating physician per local laws and regulations if needed for further subject treatment. As 
per local law and regulation the trial investigator may be contacted by the treating physician in 
case of questions related to the study device and treatment. 
 
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 assure 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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For the primary endpoint, a one-sided 95% confidence interval based on binomial distribution will 
be constructed in addition to event count and frequency. Subset analysis will be performed by-sex 
for the primary endpoints descriptively and reviewed for clinical significant difference. All analysis 
will be performed on the intent-to-treat analysis set, which includes all enrolled subjects. Subjects 
will be considered as enrolled in the study as described in section F.1. 
 
The analysis for the regulatory submission will take place when 40 subjects have been implanted 
with the study device for at least 30 days except that a subject expires early.2 Endpoints as defined 
in Section C.2 will be analyzed for these 40 enrolled subjects. 
 
Interim Analysis: 
No interim analysis is planned prior to the regulatory submission. 
 
Annual Report: 
An annual report will be provided including all enrolled subjects at the time of reporting if required 
per local law and regulations. 
 
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. 
 
I 
STUDY MANAGEMENT 
 
I.1 
Study Contact 
The study is sponsored by the Medtronic Bakken Research Center B.V. based in the Netherlands. 
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. 
 

 
 
 
 
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2 Given the DDs with SAE potential that have occurred within the Endurant Evo trials (transition stent fracture, partial 
suprarenal stent detachment, and suprarenal stent fracture), enrollment was terminated with a total enrollment of 69 
subjects. 
 
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 
• 
Investigator’s Brochure and 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 
• 
Insurance certificates 
• 
Completed Delegated Task List and Curriculum Vitae of all investigational site personnel 
• 
Training documentation of all investigation site personnel 
• 
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 

 
 
 
 
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Adverse Events 
Sponsor, EC/IRB, 
and local regulatory 
authority, where 
applicable 
Refer to section F.6 for reporting requirements. 
Progress Report 
Sponsor and EC/IRB Provide if required by local law or IRB/EC. 
(ISO 14155:2011) 
Withdrawal of EC/IRB 
approval 
Sponsor 
Investigator will inform Medtronic in case EC/IRB 
approval is withdrawn. 
Final Report 
EC/IRB 
A copy of the Final Clinical Study Report will be 
provided to the EC/IRB. 
Deviations from Investigational Plan 
Emergency Use 
Sponsor, EC/IRB, 
regulatory authority, if 
applicable 
Investigator will report deviation as soon as 
possible to the sponsor, EC/IRB and regulatory 
authority if applicable. 
Planned deviation 
Sponsor, EC/IRB, 
regulatory authority, if 
applicable 
Prior approval from Medtronic must always be 
obtained from Medtronic. If the deviation affects 
scientific soundness of the clinical study or the 
rights, safety, or welfare of the subject and is not 
an emergency, prior approval must be obtained 
from the EC/IRB and regulatory authority. 
Other Deviations 
Sponsor, EC/IRB, 
regulatory authority, if 
applicable 
Deviations that are beyond the control of the 
investigator (such as subject who fails to return to 
follow-up visit) or deviations that do not affect the 
scientific soundness of the clinical study or the 
rights, safety, or welfare of the subject and are not 
an emergency, should be submitted as they are 
identified by the investigational site or Medtronic 
staff. 
 
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 
• 
Investigator Brochure and one copy of the Instructions for Use 
• 
Sample of labeling attached to the investigational device 
• 
Curriculum Vitae of investigators and investigational site personnel 
• 
Delegated Task Lists 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 
• 
Insurance certificates 
• 
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 
 
 
 

 
 
 
 
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Table I-2: Sponsor reporting responsibilities 
Report 
Submit to 
Description 
Adverse Events 
EC/IRB, 
Investigators, FDA 
and regulatory 
authorities, where 
applicable 
Medtronic will report adverse events as 
required and in compliance with local 
regulatory requirements, as applicable and 
as described in the Endurant Evo Safety 
Plan. 
Withdrawal of EC/IRB 
approval 
EC/IRB, 
Investigators, FDA 
and regulatory 
authorities, where 
applicable 
In case of withdrawal of EC/IRB approval 
Medtronic will suspend the clinical study as 
described below. 
Premature termination or 
suspension of study 
EC/IRB, 
Investigators, and 
regulatory 
authorities, where 
applicable 
Medtronic will provide prompt notification of 
termination or suspension and reason(s) to 
investigator and where required to EC/IRB 
and regulatory authorities. 
Progress Reports 
EC/IRB, regulatory 
authority (upon 
request) 
Progress reports will be submitted to the 
EC/IRB and/or Regulatory Authority only if 
required. 
Final Report 
Investigators, and 
regulatory 
authorities, where 
applicable 
Medtronic will provide all investigators with a 
copy of the Final Clinical Study Report of the 
clinical study. EC/IRBs and regulatory 
authorities will be informed when required. 
Study deviation 
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. 
Emergency Deviations from 
Investigational Plan 
Regulatory 
authorities, where 
applicable 
If required, Medtronic will inform regulatory 
authorities as soon as possible about any 
emergency deviations that affect scientific 
soundness of the clinical study or the rights, 
safety, or welfare of the subject. 
Significant new information 
EC/IRB and 
regulatory authority 
Ensure that the EC/IRB and Regulatory 
Authorities are informed of significant new 
information about the clinical investigation 
(ISO 14155:2011). 
 
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 
The Medtronic Bakken Research Center B.V. 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 local 
law and custom concerning specific insurance coverage. If required, a Clinical Trial Insurance 
statement/certificate will be provided to the EC/IRB and the regulatory authorities. 
 
I.4.2 Subject compensation and indemnification 
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and necessary travel expenses incurred by the subjects enrolled in the study including, but not 
limited to travel to/from the hospital, provided that such expenses are properly documented in the 
subject files and that the study evaluation is not performed under a regularly scheduled follow-up. 
These expenses will be payable to the institution/hospital upon receipt by Medtronic of a detailed 
invoice, which, however, shall not contain any identifying characteristics concerning the subjects. 
Finally the site in which the subject is treated shall be solely responsible for the reimbursement of 
expenses directly to the subject. 
 
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. 
 
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 

 
 
 
 
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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 
• 
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 DD with SAE 
potential (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 and the results are detailed in the Investigator Brochure. 
 
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. 

 
 
 
 
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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/R005 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. 
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 
IB 
Investigator Brochure 
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 and 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 
USADE 
Unanticipated Serious Adverse Device Effect  
WBC White Blood Cell 

 
 
 
 
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procedure performed following the completion of the operative initial 
implantation procedure (thus on subsequent occasion after final 
closure of the last artery access site) which involves the targeted 
vascular segment treated by the Endurant Evo AAA stent graft 
system, including access sites and bypasses of the targeted vascular 
segment in which there is either manipulation of the implanted 
Endurant Evo stent graft or implantation of any additional devices. 
(Procedures related to complications due to the use of a closure 
device are excluded from this definition) 
Aneurysm Expansion 
Aneurysm maximum diameter increase >5 mm as compared to the 
1- month contrast enhanced imaging measurements 
Aneurysm Rupture 
Rupture or perforation of the targeted abdominal aneurysmal sac as 
detected by angiography, CT scan, and/or direct observation at 
surgery or autopsy. 
Aneurysm rupture should be reported as either procedure-related 
aneurysm rupture, (i.e., perforation of the aneurysm during the 
course of the implantation procedure), or as a late aneurysm rupture 
that follows device deployment. 
Excluded are aneurysms in anatomic areas other than the targeted 
segment treated by the Endurant Evo AAA Stent graft system. 
Conversion to Open 
Surgery 
Conversion of the endovascular procedure to an open procedure 
required at the time of the index procedure (primary conversion) or at 
a time beyond the initial endovascular procedure (secondary 
conversion). 
Major Adverse Events 
Major Adverse Events include the occurrence of any of the following: 
• 
All-cause Mortality 
• 
Bowel Ischemia 
• 
Myocardial Infarction 
• 
Paraplegia 
• 
Procedural Blood Loss ≥1000 cc 
• 
Renal Failure 
• 
Respiratory Failure 
• 
Stroke 
Stent Graft Occlusion 
Defined as a 100% blockage of the lumen diameter of any implanted 
the stent graft component(s) as evidenced by CT, angiography, 
ultrasound, or other appropriate imaging modality, and/or operative 
or pathological analysis. 
Endoleak 
Defined by the presence of contrast-enhanced blood outside the 
lumen of the endoluminal graft but within the aneurysm sac. 
Type I - Endoleak resulting from an incomplete seal of the endograft 
proximally or distally; the endoleak is in continuity with the proximal 
anchoring site (proximal endoleak) or the distal anchoring site (distal 
endoleak) of the device reaching the aneurysm sac. 
Type I a - Leak at the proximal graft attachment site 
Type I b - Leak at the distal graft attachment site. 
Type I c - Leak around an occluding plug 
Type II - Endoleak resulting from a collateral vessel entering the 
aneurysmal sac resulting in retrograde filling (e.g. inferior mesenteric, 
middle sacral, hypogastric, accessory renal or lumbar arteries). 
Type III - Endoleak resulting from a defect of fabric or between the 
segments of the modular graft (junctional endoleak). 
Type III a – Endoleak between the segments of the modular 

 
 
 
 
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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.5 
Imaging Device Assessment Reporting Decision Tree 
 
 
 
 
 

 
 
 
 
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L.6 Table of changes & rationale CIP version 7 compared to version 6 
 
Section 
CIP Version 6 
CIP Version 7 
Rationale for change 
Throughout 
Document 
NA 
Administrative changes 
Correction of previous 
administrative errors and 
minor updates 
Synopsis 
Purpose 
the purpose of the Endurant Evo 
International Clinical Trial is to 
evaluate the safety and 
effectiveness of the Endurant 
Evo AAA stent graft system for 
endovascular treatment of 
subjects with infrarenal 
abdominal aortic or aortoiliac 
aneurysms. The clinical 
evidence collected as part of 
this trial is expected to be used 
to support regulatory approval 
and subsequent 
commercialization of the 
Endurant Evo AAA stent graft 
system in multiple international 
geographies. Data collected 
during this trial may also be 
used in conjunction with data 
collected during a concurrently 
enrolling IDE trial to support 
PMA approval of the Endurant 
Evo AAA stent graft system in 
the United States. 
Purpose 
The purpose of the Endurant 
Evo International Clinical Trial is 
to evaluate the safety and 
effectiveness of the Endurant 
Evo AAA stent graft system for 
endovascular treatment of 
subjects with infrarenal 
abdominal aortic or aortoiliac 
aneurysms. The clinical 
evidence collected as part of 
this trial is expected to be used 
to support regulatory approval 
and subsequent 
commercialization of the 
Endurant Evo AAA stent graft 
system in multiple international 
geographies. Data collected 
during this trial may also be 
used in conjunction with data 
collected during a concurrently 
enrolling IDE trial to support 
PMA approval of the Endurant 
Evo AAA stent graft system in 
the United States. 
 
C.1Study 
objectives 
Data collected during this trial 
may also be used in conjunction 
with data collected during a 
concurrently enrolling IDE trial 
to support PMA approval of the 
Endurant Evo AAA stent graft 
system in the United States. 
Data collected during this trial 
may also be used in conjunction 
with data collected during a 
concurrently enrolling IDE trial 
to support PMA approval of the 
Endurant Evo AAA stent graft 
system in the United States. 
 
E.3 Regulatory 
Compliance 
………….The international 
standard ISO 14155:2011 
('Clinical Investigation of 
medical devices for human 
subjects') Medical Device 
Directive 93/42/EEC laws and 
regulations of the countries in 
which the clinical study is 
conducted, including…………. 
…………The international 
standard ISO 14155:2011 
('Clinical Investigation of 
medical devices for human 
subjects') and Medical Device 
Directive 93/42/EEC will be 
followed with the following two 
exceptions: 
• 
ISO 8.2.4.5 Routine 
on-site monitoring visits will be 
replaced by remote monitoring 
(see section (G2 and rationale 
in L5) 
• 
ISO6.4.1 Adverse 
events: Not all adverse events 
will be collected (see section F6 
and rationale in L5) 
In addition, the study will be 
compliant with the laws and 
regulations of the countries in 
which the clinical study is 
conducted, 
including…………….. 
Rationale for the deviation to 
ISO8.2.4.5 is provided in row 
G2 of this table) 
 
Rationale for the deviation to 
ISO 6.4.1 is proviced in row 
F6 of this table) 

 
 
 
 
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F.2.3 Follow-Up 
Visits and 
Procedures 
At all required follow-up visits 
subjects will undergo the 
following assessments: 
•Physical Exam  
•CT/MR with contrast and non-
contrast (2 cm above the origin 
of the celiac artery through the 
bifurcation of the femoral 
arteries) 
•Abdominal X-ray (4-view, KUB) 
•EQ5D questionnaire (until 12 
months F/U only) 
•Adverse event assessment 
•Concomitant Medication  
At all required follow-up visits 
subjects will undergo the 
following assessments: 
•Physical Exam (to be reported 
in FUP eCRF until 24 months 
only) 
•CT/MR with contrast and non-
contrast (2 cm above the origin 
of the celiac artery through the 
bifurcation of the femoral 
arteries) 
•Abdominal X-ray (4-view, KUB) 
•EQ5D questionnaire (until 12 
months F/U only) 
•Adverse event assessment 
•Concomitant Medication (to be 
reported in FUP eCRF until 24 
months only) 
Clinical assessments remain 
to be done as per site 
standard of care but it is no 
longer required to report data 
from the physical exam and 
data from concomitant 
medications from 2 year 
follow up till the end of the 
study. 
In case of medications 
administrated for reportable 
adverse events the 
medications should be added 
in the description of the event 
if relevant 
 
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. Study data will 
be collected using electronic 
case report forms (eCRFs) as 
described in Section G.1. 
Clinical investigators must 
electronically review and 
approve all eCRFs. Medtronic 
monitors will perform source 
document verification of the 
eCRFs. The monitoring strategy 
will be defined in the monitoring 
plan. 
For test equipment critical for 
assessing endpoints (e.g., CT 
scan, Duplex Ultrasound, x-ray) 
maintenance and calibrations 
will be monitored periodically. 
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. Study data will be 
collected using electronic case 
report forms (eCRFs) as 
described in Section G.1. 
Clinical investigators must 
electronically review and 
approve all eCRFs. Medtronic 
monitors will perform source 
document verification of the 
eCRFs. The monitoring strategy 
will be defined in the monitoring 
plan. 
For test equipment critical for 
assessing endpoints (e.g., CT 
scan, Duplex Ultrasound, x ray) 
maintenance and calibrations 
will be monitored periodically. 
In protocol version 6, images 
were analyzed by both Core 
Lab and sites.  Moving 
forward, protocol version 7 
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. 
 
See section G.2 Monitoring 
Procedures on details 
regarding the monitoring 
process. 

 
 
 
 
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F.3 Data 
Collection 
Requirements  
 
Table F2 Data 
Collection 
Schedule 
Last column 
2-5 Yr. FU (±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) 
 
Last column 
2 5 Yr. FU (±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 
3-5 Yr. FU  (±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. 
Changes detailed in sections  
F.2.3 and F.3 are 
implemented in table F-2: 
schedule of assessments 
 
 
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)  
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, probable or causal 
relationship to the aneurysm 
(Excluding aneurysms in 
anatomic areas other than the 
Endurant grafted segment) 
• 
Adverse events with a 
possible probable or causal 
relationship to the device 
• 
Adverse events with a 
possible probable or causal 
relationship to the index 
procedure 
• 
Adverse events leading 
to subject’s death 
  
Secondary procedures 
performed as a result of any of 
the above adverse events must 
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. 
 

 
 
 
 
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be reported on the respective 
Adverse Event form. Please see 
guidance for reporting of 
adverse events following image 
review in Appendix L.5. 
F.6.2 Adverse 
Events  
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. 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. 
Adverse Event (AE) information 
will be collected throughout the 
study and reported to 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 AEs as 
reportable/collectable per CIP 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.5. 
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.5. 
L.5 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 
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 Investigation Plan 
 
Version 6.0 
16 NOV 2016 
10173339DOC Endurant Evo International Clinical Trial 
Medtronic Confidential 
Page 55 of 56 
T432 V4.0 
 
requested by the Sponsor if a 
concern arises with regards to 
compliance or data integrity. 
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.  
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.6 table of 
changes 
 
Added table of changes CIPv7 
versus CIPv6