Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Sponsor: Medtronic Cardiovascular

 
ENGAGE Post Approval Study 
 
Investigational Plan # 10012289:  Version 1D 
 
Confidential 
Date: June 11, 2013 
 
 
 
 
 
 
 
POST APPROVAL STUDY PROTOCOL 
 
 
 
POST APPROVAL STUDY EVALUATING THE LONG 
TERM SAFETY AND EFFECTIVENESS OF THE 
ENDURANT STENT GRAFT SYSTEM 
 (ENGAGE PAS) 
 
 
 
 
 
 
DEVICE: 
                 
ENDURANT STENT GRAFT SYSTEM 
 
PROTOCOL VERSION: 
VERSION # 1D 
 
 
 
      
JUNE 11, 2013 
INVESTIGATIONAL PLAN  
 
NUMBER: 
 
 
10012289 
 
FDA#:  
 
 
P100021/SXXX 
 
SPONSOR: 
 
 
MEDTRONIC VASCULAR, INC. 
3576 UNOCAL PLACE 
SANTA ROSA, CA 95403 
 
 
 
 
 
 
 
 
 
 
May not be reproduced without written permission from 
Medtronic Vascular 
 

 
ENGAGE Post Approval Study 
 
Investigational Plan # 10012289:  Version 1D 
 
Confidential 
Date: June 11, 2013 
 
Page ii 
 
Investigational Plan Signature Page 
 
 
 
POST APPROVAL STUDY EVALUATING THE LONG 
TERM SAFETY AND EFFECTIVENESS OF THE 
ENDURANT STENT GRAFT SYSTEM 
(ENGAGE PAS) 
 
Investigational Plan Version 1D: June 11, 2013 
  
 
 
 
 
Investigational Plan Compliance:  I have read the above named Investigational Plan 
and agree to conduct the study as indicated. 
 
 
 
 
 
Investigator (Please Print) 
 
 
 
 
 
Investigator Signature 
Date 
 
 
 
 
Institution 
 
 
 
 
 
 
 
Sponsor: 
 
Medtronic Vascular, Inc. (a.k.a. Medtronic Vascular) 
 
3576 Unocal Place 
 
Santa Rosa, CA 95403 
 
 
 
 
 
Simona Zannetti, MD 
Date 
Vice President, Clinical and Medical Affairs 
Endovascular Innovations 
 
 
 
SIGN

 
ENGAGE Post Approval Study 
 
Investigational Plan # 10012289:  Version 1D 
 
Confidential 
Date: June 11, 2013 
 
Page iii 
TABLE OF CONTENTS 
ENGAGE POST-APPROVAL STUDY SYNOPSIS ............................................................................... VI 
1. 
INTRODUCTION ............................................................................................................................... 9 
2. 
BACKGROUND ................................................................................................................................ 10 
3. 
INTENDED USE OF THE DEVICE ............................................................................................... 12 
4. 
DESCRIPTION OF THE DEVICE ................................................................................................. 13 
4.1. ENDURANT STENT GRAFT COMPONENTS ........................................................................................... 13 
4.1.1 
Bifurcated Stent Graft ............................................................................................................ 14 
4.1.2 
Contralateral Limb ................................................................................................................ 16 
4.1.3 
Iliac Extension ....................................................................................................................... 16 
4.1.4 
Aortic Extension .................................................................................................................... 16 
4.1.5     Aorto -Uni-Iliac Stent Graft………………………………………………………………………… 17 
4.2. ENDURANT DELIVERY SYSTEM .......................................................................................................... 17 
4.2.1 
Endurant Aortic Delivery System .......................................................................................... 18 
4.2.2 
Endurant Iliac Delivery System ............................................................................................. 19 
5. 
STUDY OBJECTIVES ...................................................................................................................... 21 
5.1. 
STUDY PURPOSE AND CLINICAL OBJECTIVE ............................................................................... 21 
 
 
5.3. 
SCOPE AND DURATION OF THE CLINICAL STUDY ........................................................................ 21 
6. 
CLINICAL STUDY DESIGN ........................................................................................................... 22 
7. 
STATISTICAL METHODS AND ANALYSES ............................................................................. 24 
7.1. 
DESCRIPTION OF THE STUDY PRIMARY ENDPOINT ...................................................................... 24 
7.2. 
LITERATURE DERIVED PERFORMANCE GOAL (PG) ..................................................................... 25 
7.3. 
SAMPLE SIZE CALCULATIONS ..................................................................................................... 26 
7.4. 
ADDITIONAL MEASURES ............................................................................................................. 26 
7.5. 
ACUTE PROCEDURAL AND HOSPITAL EXPERIENCE ..................................................................... 28 
7.6. 
ANALYSIS METHODS................................................................................................................... 28 
7.6.1 
Data Analysis Subsets ............................................................................................................ 28 
7.6.3 
Analysis of the Additional Measures ..................................................................................... 29 
7.6.4 
Analysis of the Acute Procedural and Hospital Experience Endpoints ................................. 29 
7.6.5 
Analysis of Baseline Variables .............................................................................................. 29 
7.6.6 
Subset Analyses ..................................................................................................................... 29 
7.6.7 
Time Window Conventions Used in Analysis of Endpoints ................................................... 30 
7.6.8 
Patient Withdrawal and Missing Data .................................................................................. 30 
8. 
CLINICAL STUDY PREPARATION PROCEDURES ................................................................ 32 
8.1. 
SELECTION OF CLINICAL INVESTIGATORS ................................................................................... 32 
8.2. 
INSTITUTIONAL REVIEW BOARD REQUIREMENTS ....................................................................... 32 
8.3. 
INFORMED CONSENT ................................................................................................................... 33 
8.4. 
STUDY TRAINING ........................................................................................................................ 33 
8.5. 
REQUIRED EQUIPMENT ............................................................................................................... 34 
8.6. 
SITE ACTIVATION AND SUPPLY OF STUDY MATERIALS .............................................................. 35 
9. 
CLINICAL STUDY PROCEDURES............................................................................................... 36 
9.1. 
ELIGIBILITY CRITERIA ................................................................................................................ 38 
9.1.1 Inclusion Criteria ........................................................................................................................ 38 
9.1.2 Exclusion Criteria ....................................................................................................................... 38 
9.2. 
PATIENT SCREENING, ENROLLMENT, AND PRE-IMPLANT PROCEDURES ...................................... 38 
9.3. 
IMPLANT PROCEDURES ............................................................................................................... 40 
9.4. 
HOSPITAL DISCHARGE PROCEDURES .......................................................................................... 41 
9.5. 
REQUIRED FOLLOW-UP EVALUATIONS ....................................................................................... 41 
9.6. 
UNSCHEDULED VISITS ................................................................................................................ 42 
9.7. 
PROTOCOL DEVIATIONS .............................................................................................................. 43 

 
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9.7.1 
Deviations Requiring Prior Approval ................................................................................... 43 
9.7.2 
Non-Urgent Deviations ......................................................................................................... 43 
9.8. 
TECHNICAL OBSERVATIONS ........................................................................................................ 43 
9.9. 
ADVERSE EVENTS ....................................................................................................................... 44 
9.10. 
PATIENT DEATH .......................................................................................................................... 44 
9.11. 
EXPLANTED DEVICES .................................................................................................................. 45 
9.12. 
STUDY EXIT ................................................................................................................................ 46 
9.13. 
STRATEGIES FOR MAINTAINING LONG-TERM SUBJECT FOLLOW-UP COMPLIANCE ....................... 47 
9.14. 
SUBJECT CONFIDENTIALITY ........................................................................................................ 48 
9.15. 
DEVICE TRACKING ...................................................................................................................... 48 
9.16. 
STUDY TERMINATION ................................................................................................................. 48 
9.17. 
STUDY CLOSURE ......................................................................................................................... 48 
10. 
ADVERSE EVENT DEFINITIONS AND EXPEDITED REPORTING ...................................... 49 
10.1. 
DEFINITIONS ............................................................................................................................... 49 
10.2. 
EXPEDITED ADVERSE EVENT REPORTING ................................................................................... 50 
10.3. 
MEDICAL DEVICE REPORTING .................................................................................................... 51 
11. 
DATA MANAGEMENT PROCEDURES ....................................................................................... 53 
11.1. 
CASE REPORT FORMS ................................................................................................................. 53 
11.2. 
SOURCE DOCUMENTATION ......................................................................................................... 53 
11.3. 
TRANSMISSION OF DATA ............................................................................................................. 54 
11.4. 
DATA QUERIES ........................................................................................................................... 54 
12. 
MONITORING AND AUDITING PROCEDURES ....................................................................... 55 
12.1. 
MONITORING .............................................................................................................................. 55 
12.2. 
RESPONSIBILITIES OF THE CLINICAL INVESTIGATOR ................................................................... 55 
12.3. 
RESPONSIBILITIES OF THE SPONSOR ............................................................................................ 56 
12.4. 
MONITORING VISITS ................................................................................................................... 56 
12.4.1 
Prestudy Qualification Visit .............................................................................................. 56 
12.4.2 
Initiation Visit ................................................................................................................... 57 
12.4.3 
On-Site Interim Monitoring Visits .................................................................................... 57 
12.4.4 
Audits ................................................................................................................................ 57 
12.4.5 
Final Monitoring Review .................................................................................................. 57 
13. 
RECORDS AND REPORTS ............................................................................................................ 58 
13.1. 
INVESTIGATOR RECORDS ............................................................................................................ 58 
13.2. 
INVESTIGATOR REPORTS ............................................................................................................. 58 
13.3. 
SPONSOR RECORDS ..................................................................................................................... 60 
13.4. 
SPONSOR REPORTS ...................................................................................................................... 60 
13.5. 
INSTITUTIONAL REVIEW BOARD RECORDS ................................................................................. 62 
14. 
STUDY COMMITTEES ................................................................................................................... 63 
14.1. 
CLINICAL EVENTS COMMITTEE ................................................................................................... 63 
15. 
RISK ANALYSIS .............................................................................................................................. 64 
15.1. 
POTENTIAL RISKS ....................................................................................................................... 64 
15.2. 
POTENTIAL BENEFITS .................................................................................................................. 66 
16. 
PUBLICATION POLICY ................................................................................................................. 67 
17. 
INSURANCE ...................................................................................................................................... 68 
18. 
REFERENCES CITED ..................................................................................................................... 69 
 
 
 
 
 

 
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LIST OF FIGURES 
Figure 1: Endurant Stent Graft Components .................................................................... 14 
Figure 2: Endurant Stent Graft Aortic Proximal Configuration. ...................................... 15 
Figure 3: Endurant Stent Graft Limb Distal Configuration. ............................................. 15 
Figure 4: Endurant Aortic Delivery System ..................................................................... 17 
Figure 5: Endurant Aortic Delivery System – Tapered Tip Detail. .................................. 18 
Figure 6: Endurant Aortic Delivery System - Tapered Tip Detail in Open configuration 19 
Figure 7: Endurant Aortic Delivery System – Back-End Detail....................................... 19 
Figure 8: Endurant Iliac Delivery System. ....................................................................... 20 
 
 
LIST OF TABLES 
Table 1: Projected milestones for the study ...................................................................... 23 
Table 2: Projected monthly subject enrollment and site activation (for ENGAGE PAS De 
Novo subjects) .................................................................................................................. 23 
Table 3: Windows for analysis of noncompliant or missing data. .................................... 30 
Table 4: Overview of the study procedures and data collection requirements. ................ 37 
Table 5: Required postoperative follow-up schedule and windows. ................................ 42 
Table 6: Expected and unavoidable adverse events related to the surgical procedure. .... 44 
Table 7: Investigator Reporting Responsibilities. ............................................................. 59 
Table 8: Medtronic Vascular Reporting Responsibilities. ................................................ 61 
 

 
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ENGAGE POST-APPROVAL STUDY SYNOPSIS 
Study Device 
Endurant Stent Graft and Delivery System 
Study Title  
Post approval Study Evaluating the Long term Safety and Effectiveness of the 
Endurant Stent Graft System (ENGAGE PAS)  
Sponsor 
Medtronic Vascular 
3576 Unocal Place 
Santa Rosa, CA 95403 
Study Design 
This is a multicenter, post market, non-controlled, non-randomized, two arm, 
prospective post approval study.  
Study Purpose 
The purpose of the study is to demonstrate the long term safety and effectiveness of the 
Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal 
aortic or aortoiliac aneurysms in a post-approval environment, through the endpoints 
established in this protocol.  
Post-Approval 
Study (PAS) 
Objectives 
The clinical objective of the study is to evaluate the long term safety and effectiveness 
of the Endurant Stent Graft System assessed at 5 years through freedom from 
Aneurysm-Related Mortality (ARM). 
 
 
 
 
 
  
 
 
 
Indications for 
Use  
The Endurant Stent Graft System is indicated for the endovascular treatment of 
infrarenal abdominal aortic aneurysms or aortoiliac aneurysms having the following 
characteristics.  
 
Morphology suitable for endovascular repair. 
 
Adequate iliac/femoral access that is compatible with vascular access techniques, 
devices or accessories 
 
Proximal neck length ≥ 10 mm  
 
Infrarenal angulation ≤ 60°.   
 
Non-aneurysmal aortic neck diameter of 19-32 mm.  
 
Iliac diameters of 8-25 mm.  
 
Bilateral distal fixation length of ≥ 15mm for the bifurcated stent graft or unilateral 
distal fixation length of ≥ 15mm for the Aorto-Uni-Iliac (AUI) stent graft.  
Primary Endpoint 
Primary Safety Endpoint: 
Freedom from Aneurysm-related Mortality Rate (ARM) at 5 years (1826 days).   
 
ARM is defined as death from rupture of the abdominal aortic aneurysm or from any 
procedure intended to treat the AAA. If a death occurred within 30 days of any 
procedure intended to treat the AAA, then it is presumed to be aneurysm related unless 
there is evidence to the contrary. Deaths occurring after 30 days of any procedure 
intended to treat the AAA that are procedure-related should be aneurysm related. 
 
All deaths will be adjudicated by a Clinical Events Committee (CEC) to determine 
device, procedure and/or AAA relatedness.  
Additional 
Measures 
The following metrics will be evaluated:  
1. Technical Success 
2. Major Adverse Events (MAE) rates within 30 days of the initial or secondary 

 
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procedures, including:  
a. All-cause mortality 
b. Bowel ischemia 
c. Myocardial infarction 
d. Paraplegia 
e. Procedural blood loss ≥ 1000cc  
f. Renal failure 
g. Respiratory failure 
h. Stroke 
3. At 12 months and subsequent 4 yearly follow-ups, the following will be reported:  
a. All-cause mortality  
b. Aneurysm-related mortality 
c. Aneurysm rupture 
d. Aneurysm expansion 
e. Conversions to open repair 
f. Stent graft migration (>10 mm compared to the 1 month CT) 
g. Stent graft patency 
h. Endoleaks 
i. 
Secondary endovascular procedures 
j. 
Technical observations 
k. Adverse events, as follows:  
i. Clinical sequelae caused by or directly associated with the 
Endurant device, the index procedure or any secondary 
endovascular procedure (including conversion to open repair) and 
technical observation. 
ii. Those adverse events that meet the definition of Major Adverse 
Event (MAE). 
iii. Those adverse events directly associated with the death of the 
subject.  
iv. Adverse events meeting Medical Device Reporting (MDR) 
criteria.  
v. Serious adverse events within 30 days of index procedure. 
 
 
Subject 
population 
Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered 
candidates for endovascular repair, per the FDA approved Instructions For Use (IFU). 
Number of 
subjects 
This study incorporates the Test Group from the Endurant Stent Graft System US 
Clinical Study’s Bifurcated Arm, consisting of 150 subjects and the Test Group for the 
Endurant Stent Graft System US Clinical Study’s AUI arm, consisting of 44 subjects. 
In addition, 178 new bifurcated subjects will be prospectively enrolled to complement 
the PMA bifurcated arm subjects. All subjects are followed for a total of 5 years 
following initial implantation.    
Number of sites 
Up to 30 investigational sites in the United States may participate 
Analysis Sets 
The primary analysis set will consist of the Intent-to-Treat (ITT) population.  This 
analysis set is defined as all subjects who were enrolled, i.e. when vessel access is 
achieved through a cut down or percutaneous approach with the intention of 
implanting the Endurant Stent Graft System.  The ITT analysis set will be used for all 
analyses. 

 
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Follow-up 
schedule 
Subjects will have required follow-up evaluations at these time points: 
 1 month following the index procedure. 
 12 months following the index procedure. 
Annually thereafter, for a total of 5 years from the index procedure.    
Clinical Events 
Committee (CEC) 
A CEC will be used to adjudicate all subject deaths and unanticipated adverse device 
effects through 5 years and MAEs through 30 days. 
Monitoring 
Monitoring will be performed per the ENGAGE PAS Monitoring Plan 
 
 
 
 
 
 
 

 
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1. INTRODUCTION 
 
This clinical investigational plan describes the Post Approval Study requirements for the 
Endurant Stent Graft and Delivery System (hereafter referred to as the Endurant Stent 
Graft System). The purpose of the study is to demonstrate the performance of the 
Endurant Stent Graft System in the post-approval environment.  The United States (US) 
study will be conducted using a common protocol at up to 30 centers. The information 
collected will be submitted at regular 6 month intervals to the FDA for the first 2 years 
and annually thereafter for an additional 3 years. A final post approval study report will 
be submitted at the completion of the study.  
 
As the Sponsor of this clinical study, Medtronic Vascular has the overall responsibility 
for the conduct of the study, including assurance that the study will be performed 
according to the Investigational Plan and the US Food and Drug Administration (FDA) 
regulations.  During this study, Medtronic Vascular will have certain direct 
responsibilities and may delegate other responsibilities to, for example, a Data 
Monitoring Committee, Clinical Events Committee, and/or CROs.  Medtronic Vascular 
and/or its designees will conform to the US Code of Federal Regulations (CFR) 
including: 
 
Investigational 
Device 
Exemptions 
(21 
CFR 
812), 
Electronic 
Records/Electronic Signatures (21 CFR 11), Protection of Human Subjects (21 CFR Part 
50), and Institutional Review Boards (21 CFR 56). 
 
 

 
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2. BACKGROUND 
Abnormal bulging of the abdominal aorta, called an abdominal aortic aneurysm (AAA), 
is a potentially serious condition that can lead to death if the aneurysm ruptures.  
Endovascular aneurysm repair (EVAR) has gained an increasingly important role in the 
management of AAA since its introduction in the early 1990s.  The past 15 years have 
been marked by continuing progress in the diagnosis, management, timing of treatment, 
and assessment of EVAR versus conventional open surgical repair, which was the 
original gold standard for treatment of AAA. 
 
Endovascular aneurysm repair provides substantial clinical benefit for the patient.  This 
minimally-invasive approach using endoluminal placement of a stent graft is a less 
invasive alternative to standard open surgical repair and is associated with a lower rate of 
morbidity and more rapid patient recovery.1-9  The physiologic insult is clearly reduced 
with endovascular techniques as compared to open surgical repair, resulting in less time 
in the intensive care unit, shorter length of hospital stay, and earlier return to normal 
activities.3,4,10,11  In addition, endovascular devices make it possible to treat patients 
whose co-morbidities would otherwise make conventional open repair difficult or 
impossible.10 
 
The technology of EVAR for treating AAAs has progressed rapidly and the approach has 
been demonstrated to be safe and effective.10-14 Over the years, endovascular stent grafts 
and their delivery systems have undergone substantial improvement, resulting in better 
operator handling of the device and patient outcomes.  Initial success with the original 
endoluminal stent graft encouraged worldwide study of the technology.  Although the 
initial endografts were relatively simple aorto-aortic tube grafts with balloon-expandable 
stents stitched to the end, a better understanding of the extent of the disease triggered the 
development of devices that could be implanted in one or both iliac arteries.15,16   
 
Since the mid-1990s, commercially produced, modular systems have been available.  
Multiple companies have worked on the refinement of both the stent graft and its delivery 
system.  The profile/size of the stent graft delivery system has decreased leading to fewer 
traumas to the vessel wall and enabling placement in patients with smaller iliac/femoral 
access arteries.  Devices with uncovered suprarenal stents also were introduced.  This 
development should lead to a more secure anchor to the perirenal aorta and reduce the 
tendency for distal migration.15 Delivery systems have also evolved in regard to tip 
design, flexibility, sheaths and other features that hold the proximal stent graft, while 
allowing a controlled release resulting in improved deliverability and placement 
accuracy.10  
 
When selecting the specific stent graft to be used for EVAR, the characteristics of the 
graft must be considered in light of the patient’s anatomical and physiological 
characteristics.  Endovascular devices vary in the type of stent used.17 For example, 
longer, stiffer stents make navigation of angulated proximal implantation zones more 
challenging and may contribute to proximal attachment site endoleaks or kinking of the 
stent graft if it is deployed in tortuous vessels.  It is well recognized that the most limiting 
consideration for the feasibility of EVAR is the anatomy of the proximal neck.18 Many 

 
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patients are precluded from EVAR because of marked neck angulation and shorter neck 
lengths.   
 
The Endurant Stent Graft System is a next-generation modular system for endovascular 
repair of AAA.  The system was designed with the following features:  
 
1. Designed for high flexibility and conformability to adapt straight and tortuous 
anatomies:  
a. The M-shaped proximal stent is specifically designed for improved wall 
apposition, minimizing the risk of in-folding and providing a 10mm seal 
zone 
b. The anchor pins on the suprarenal stent provide secure fixation to the 
aortic wall. 
c. Limb stents and stent spacing designed to prevent kinking in anatomies 
with increased iliac tortuosity. 
 
2. Accuracy and control with simple and controlled deployment: Controlled release 
of suprarenal stent with anchor pins achieved by:  
a. The tip capture mechanism allows for precise positioning adjustments post 
deployment of the suprarenal stent. 
b. Rotation of the back-end wheel provides controlled release of the 
suprarenal stent with anchor pins. 
c. Proximal radiopaque markers facilitate accurate positioning in relation to 
the renal arteries, and the ‘e’ marker assists with the anterior/posterior 
view. 
 
3. A delivery system with a lower outer diameter profile and hydrophilic coating (on 
the graft cover surface) allows it to more easily access and track in small and 
tortuous anatomies.  
 
Medtronic Vascular submitted a Pre-Market Application (PMA) to the FDA on June 3 
2010, and received market approval for the Endurant Bifurcated Stent Graft System on 
December 16, 2010. As a condition of approval, the FDA requested a post approval 
study. Medtronic therefore designed a post-approval study (PAS), in collaboration with 
the FDA, to document the performance of the Endurant Bifurcated Stent Graft System 
under a post-market setting. This study is referred to as ENGAGE PAS. This document 
describes the methodology of the ENGAGE PAS trial. 
 
Medtronic Vascular submitted a Pre-Market Application Supplement (PMA-S) to the 
FDA on October 10, 2012, and received market approval for the Endurant II AUI Stent 
Graft System on April 16, 2013. Medtronic committed that the Endurant AUI cohort will 
be incorporated as a separate arm into the existing ENGAGE PAS clinical study for 
follow-up through 5 years.     
 

 
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3. INTENDED USE OF THE DEVICE 
 
The Endurant Stent Graft System is indicated for the endovascular treatment of infrarenal 
abdominal aortic or aortoiliac aneurysms having the following characteristics.  
 Morphology suitable for endovascular repair. 
 Adequate iliac/femoral access that is compatible with vascular access 
techniques, devices or accessories 
 Proximal neck length ≥ 10 mm  
 Infrarenal angulation ≤ 60°.   
 Non-aneurysmal aortic neck diameter of 19-32 mm.  
 Iliac diameters of 8-25 mm.  
 Bilateral distal fixation length of ≥ 15mm for the bifurcated stent graft or 
unilateral distal fixation length of ≥ 15mm for the AUI stent graft. 
 

 
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4. DESCRIPTION OF THE DEVICE  
 
The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic or 
aortoiliac aneurysms using an endovascular approach.  When placed within the 
aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative 
conduit for blood flow within the patient’s vasculature by excluding the aneurysmal sac 
from blood flow and pressure.   
 
The Endurant Stent Graft System is comprised of 2 key components:  the Endurant Stent 
Graft and the Endurant Delivery System.  The stent graft is constrained by the delivery 
system outer sheath (graft cover).  The preloaded stent graft is advanced to the aneurysm 
location over a guidewire.  As deployment occurs, the stent graft self-expands due to the 
superelastic properties of the nitinol stents.  Upon deployment, the proximal and distal 
ends of the stent graft conform to the shape and size of the proximal and distal seal zones 
due to the radial force of the stents. 
 
4.1. ENDURANT STENT GRAFT COMPONENTS 
 
The Endurant Stent Graft (Figure 1) is a modular device comprised of 2 primary 
components:  an aorto-iliac bifurcated component and a contralateral limb component. 
The Aorto-Uni-Iliac (AUI) stent graft component is intended for the treatment of patients 
whose vessel anatomy precludes the use of a bifurcated stent graft. Additional 
components include aortic and iliac extensions. After the placement of the stent graft, 
each additional component is introduced separately into the vessel and is mated in vivo to 
the components already in situ.   
 
All components are composed of nitinol stents sewn to a fabric graft.  The suprarenal 
stents with anchor pins on the proximal end are laser cut from a nitinol tube.  The 
bifurcated body component includes seal, body, contour, and limb stents formed from 
nitinol wire.  The stents are formed in a ring with opposing ends terminating together in 
crimp sleeves.  The suprarenal stents are sewn to the multifilament polyester (PET – 
Polyethylene Terephthalate) graft fabric using ultra high-molecular weight polyethylene 
suture.  The wire formed stents are sewn to the graft fabric using polyester suture. 
 
Radiopaque markers are sewn onto each component of the stent graft to facilitate 
visualization and accurate placement.  Radiopaque markers are located at the proximal 
and distal ends of each stent graft component, and at the bifurcation of the bifurcated 
stent grafts to help visualize the edges and locations of the stent grafts.  The nitinol stents 
can also be visualized under fluoroscopy. 
 
 
 
 
 
 

 
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                             8   
 
 
 
 
 
 
 
 
Figure 1: Endurant Stent Graft Components 
Note : Graphical representation not to scale. 
 
 
1. Radiopaque Marker 
2. ‘e’ Marker 
3. Radiopaque Gate Marker 
4. Aortic Extension 
5. Bifurcated Component 
6. Iliac Extension 
7. Contralateral Limb 
8. Aorto-Uni-Iliac  (AUI) Component 
 
 
4.1.1 Bifurcated Stent Graft 
 
The proximal section of the bifurcated stent graft component is deployed into the 
proximal neck and upper section of the aneurysm.  All stents on the proximal aortic 
section of the bifurcated component are sewn to the outside of the graft fabric.  The 
proximal stent (suprarenal) of the aortic section is not covered with graft fabric.  As such, 
this bare stent design allows the Endurant Stent Graft to be fixed above the renal arteries 
without obstructing them with graft fabric.  Refer to Figure 2 for a representation of the 
proximal configuration.  The suprarenal stent has anchor pins to fix the stent graft in 

 
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place.  The suprarenal stent is joined to the proximal edge of the graft by ultra high- 
molecular weight polyethylene suture.   
 
 
 
 
 
 
 
 
 
 
 
 
 
Distally, the aortic section bifurcates into 2 smaller tubes:  an ipsilateral single iliac limb 
and a short contralateral stub leg.  In the ipsilateral limb of the bifurcated stent graft 
component, the stents are sewn to the outside of the graft fabric providing a smooth inner 
lumen.  In the contralateral (stub) leg of the bifurcated stent graft component, the stents 
are sewn to the inside of the graft fabric providing additional friction to give higher 
disjunction (separation) forces with the contralateral limb component.  Refer to Figure 3 
for a schematic of the ipsilateral limb distal configuration of the Endurant Stent Graft 
Component. 
 
 
 
 
 
 
 
 
 
 
 
 
 
The diameters of the available proximal aortic section of the bifurcated stent graft 
components range from 23 - 36 mm, and the covered length of the bifurcated stent graft 
components ranges from 124 - 166 mm.  In use, all stent graft components are oversized 
to fix the stent graft components in place and to provide sealing for the exclusion of the 
aneurysm.  The aortic sections of the bifurcated stent graft components should be 
oversized approximately 10% - 20% in relation to the actual measured vessel inner 
diameter.  The available aortic section sizes are able to be used in aortas with diameters 
ranging from 19 - 32 mm.  The dimensions of the ipsilateral distal limb portion of the 
bifurcated stent graft components range in diameter from 13 - 20 mm and can be used in 
iliac arteries with diameters ranging from 10 - 18 mm.  If a larger range of limb sizes is 
 
Figure 2: Endurant Stent Graft Aortic Proximal 
Configuration. 
Note: Graphical representation not to scale 
 
Figure 3: Endurant Stent Graft Limb Distal Configuration. 
Note: Graphical representation not to scale 

 
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necessary, then refer to the iliac extension section of the Instructions for Use (Appendix 
A).   
 
4.1.2 Contralateral Limb  
 
The proximal end of the tube-like contralateral limb component is deployed within the 
short contralateral stub leg of the bifurcated stent graft component, while the contralateral 
limb component’s distal end is deployed in the contralateral iliac artery.  The proximal 
section of the contralateral limb component uses an open web configuration, which 
contains no graft material in the stent valleys of its proximal stent.  This is designed to 
reduce the chance of an endoleak.  The available distal diameter of contralateral limb 
components ranges from 10 - 28 mm with lengths ranging from 82 - 124 mm.  The 
contralateral limb component should be oversized by approximately 10% - 25% in 
relation to the vessel inner diameter and can be used in iliac arteries ranging from 8 - 25 
mm. 
 
4.1.3 Iliac Extension  
 
When additional distal length of the stent graft is required, iliac extension components are 
available.  The iliac extension component has a proximal end open web configuration 
similar to the contralateral limb component.  The diameter of the iliac extension 
components ranges from 10 - 28 mm with a covered length of 82 mm.  Similar to the 
contralateral limb component, the iliac extension component is designed for oversizing of 
approximately 10% - 25% and can be used in iliac arteries ranging from 8 - 25 mm in 
diameter.  
 
4.1.4 Aortic Extension 
 
When additional proximal length of the stent graft is required, aortic extension 
components are available.  The aortic extension components use the same proximal bare 
suprarenal stent with anchor pin design as the proximal stent of the aortic section of the 
bifurcated component.  The diameters of available aortic extension components range 
from 23 - 36 mm with the aortic extension having a covered length of either 49 mm or 70 
mm.  The aortic extension component should be oversized approximately 10% - 20% in 
relation to the actual measured vessel inner diameter, and can be used in aortic arteries 
ranging from 19-32 mm in diameter.  
 
4.1.5 Aorto-Uni-Iliac Stent Graft  
  
The proximal section of the Aorto-Uni-Iliac (AUI) stent graft component in use is 
deployed into the proximal neck and upper section of the aneurysm.  All stents on the 
proximal aortic section of the AUI component are sewn to the outside of the graft fabric.  
The proximal stent (suprarenal) of the aortic section is not covered with graft fabric.  As 
such, this bare stent design allows the Endurant Stent Graft to be fixed above the renal 
arteries without obstructing them with graft fabric.  Refer to Figure 1 for a representation 
of the proximal configuration.  The suprarenal stent has anchoring pins to fix the stent 

 
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graft in place.  The suprarenal stent is joined to the proximal edge of the graft by ultra 
high-molecular weight polyethylene suture. 
 
Distally, the aortic section tapers down to a smaller diameter tube.  In the distal end of the 
tapered AUI stent graft, the stents are sewn to the inside of the graft fabric providing 
additional friction for higher disjunction (separation) forces with the contralateral limb 
component.  
 
The diameters of the available proximal aortic section of the AUI stent graft components 
range from 23 - 36 mm, and the covered length of the AUI stent graft component is 105 
mm.  In use, all stent graft components are oversized to fix the stent graft components in 
place and provide sealing for the exclusion of the aneurysm.  The aortic sections of the 
AUI stent graft components should be oversized approximately 10% - 20% in relation to 
the actual measured vessel diameter.  The available aortic sections sizes can be used in 
aortas with diameters ranging from 19 - 32 mm.  The diameter of the distal end of the 
AUI stent graft component is 14 mm. 
 
 
4.2. ENDURANT DELIVERY SYSTEM 
 
The Endurant Stent Graft is loaded and held inside the Endurant Delivery System, which 
facilitates placement of the stent graft via the arterial vasculature, e.g., femoral arteries.  
Using fluoroscopic guidance, the Endurant Delivery System is properly positioned within 
the patient’s vasculature and the stent graft is deployed.  
 
The Endurant Delivery System consists of a single use, disposable catheter with an 
integrated handle to provide accurate and controlled deployment.  The catheter assembly 
is flexible and compatible with a 0.035-inch (0.89 mm) guidewire.  There are 2 kinds of 
Endurant Delivery Systems.  The Endurant Aortic Delivery System is for delivering the 
Aortic components, i.e., aortic extensions, bifurcated stent grafts and AUI stent grafts. 
The Endurant Iliac Delivery System is for delivering the Endurant contralateral limb and 
iliac extension stent grafts. 
 
 
Figure 4: Endurant Aortic Delivery System 
Note: Graphical representation not to scale 

 
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4.2.1 Endurant Aortic Delivery System 
 
The Endurant Aortic Delivery System (Figures 4 to 7) is constructed of 4 concentric 
single lumen shafts:  an outer polymer with a hydrophilic coated graft cover, a stainless 
steel spindle-tube shaft, a polymer middle member shaft, and a guidewire lumen 
containing a nitinol inner member.  A stent stop (not shown in figures) is attached to the 
distal end of the middle member shaft to ensure the position of the Aortic Stent Graft 
Component during deployment.  
 
The tapered tip attached to the distal end of the nitinol inner member, is depicted in 
Figures 5 and 6.  A metallic spindle (as shown in Figure 6) is attached to the distal end of 
the spindle-tube to hold the proximal end of the suprarenal stent axially stationary before 
release.  An atraumatic tapered polymeric tip is attached at the distal end of the inner 
member to facilitate tracking through tortuous and calcified vessels.  Attached to the 
proximal end of the polymeric tip is a metallic sleeve that holds the suprarenal stent 
constrained on the spindle.  The polymeric tapered tip, stent stop, and ring marker on the 
distal end of the graft cover are radiopaque and aid in fluoroscopic visualization.  
Hemostasis is maintained by various components within the delivery system to prevent 
excessive blood loss during the procedure. 
 
Retraction of the graft cover, while the suprarenal stent is held by the spindle and the 
metallic sleeve of the tapered tip allows for accurate positioning and partial deployment 
of the body of the aortic stent graft component. 
Note: Graphical representation not to scale 
 
Figure 5: Endurant Aortic Delivery System – Tapered Tip Detail. 

 
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The back-end wheel can be rotated clockwise to advance the tapered tip, thereby moving 
the metallic sleeve forward to release the anchor pins of the suprarenal stent from the 
spindle.  After release of the suprarenal stent, the physician should rotate the back-end 
wheel counter clockwise to reseat the tip of the delivery system before retracting the tip 
into the graft cover through the deployed stent graft component in the process of 
removing the delivery system from the body. For detailed instructions on delivery and 
deployment of the Endurant Stent Graft, refer to the Instructions for Use in Appendix A.  
 
4.2.2 Endurant Iliac Delivery System 
 
The Endurant Iliac Delivery System (Figure 8) is constructed of 3 concentric single 
lumen shafts:  an outer polymer with a hydrophilic coated graft cover, a polymer middle 
member shaft, and a guidewire stainless steel inner member lumen.  A stent stop is 
attached to the distal end of the middle member shaft to maintain the position of the Iliac 
components during deployment.  A polymeric, atraumatic tapered tip is attached at the 
distal end of the inner member to facilitate tracking through tortuous and calcified 
vessels.  The tapered tip, stent stop, and ring marker on the distal end of the graft cover 
 
Figure 6: Endurant Aortic Delivery System - Tapered Tip Detail in Open configuration 
Note: Graphical representation not to scale 
 
Figure 7: Endurant Aortic Delivery System – Back-End Detail. 
Note: Graphical representation not to scale

 
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are radiopaque and aid in fluoroscopic visualization.  Hemostasis is maintained by 
various components within the delivery system to prevent excessive blood loss during the 
procedure.  The deployment of the self-expanding stent graft components is facilitated by 
the retraction of the graft cover.  After deployment of the stent graft component, the 
physician should retract the tip of the delivery system into the graft cover before 
removing the delivery system from the body. 
 
 
Figure 8: Endurant Iliac Delivery System. 
Note: Graphical representation not to scale 

 
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5. STUDY OBJECTIVES 
 
5.1. STUDY PURPOSE AND CLINICAL OBJECTIVE 
 
The purpose of this study is to examine, through the endpoints established in this 
protocol, the long-term safety and effectiveness of the Endurant Stent Graft System, in a 
post-approval environment. Patients diagnosed with abdominal aortic or aortoiliac 
aneurysm who meet the eligibility criteria for the study may be enrolled (see Section 9.1 - 
Eligibility Criteria).  A primary endpoint has been defined for the study. The results of 
females and non-whites having undergone EVAR, and a literature review and study 
outcome description of both females and non-whites will be provided as part of the subset 
analyses with each regular post-approval study update. In addition, results of acute 
procedural and hospital experience-related endpoints will be evaluated.  Sample size 
estimates are based on the primary endpoint, and the expected subject dropout rate (based 
on previous Medtronic EVAR trial experience). Details in regard to the endpoints and 
statistical methods are provided in Section 7 – Statistical Methods and Analyses. 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 

 
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6. CLINICAL STUDY DESIGN 
 
The post-approval performance of the Endurant Stent Graft System will be evaluated in a 
two-arm, non-controlled, non-randomized, and multi-center clinical study. Subjects must 
be diagnosed with an abdominal aortic or aortoiliac aneurysm, considered candidates for 
endovascular repair, and fulfill the study Eligibility Criteria (Section 9.1 – Eligibility 
Criteria).  
 
The Endurant Test Groups from the Bifurcated Arm of the PMA (P100021) and the AUI 
Arm of the PMA (P100021/S021) will be rolled into the post-approval study cohort. The 
newly enrolled Bifurcated (De Novo) subjects and the Bifurcated Arm Test Group will be 
combined for the analysis of the Endurant Bifurcated Stent Graft. The AUI Arm from the 
PMA-S will be analyzed separately. 
 
The post-approval study for Endurant Stent Graft System started enrollment in the United 
States in the summer of 2011. Initially, 20 sites were enrolled in the study. As many as 30 
investigational sites may participate.  All sites used the same investigational plan.  The 
enrollment period was estimated to be 16 months. Investigators at any one site may not 
enroll more than 20% (35 subjects) of the new subject enrollment population. Data from 
178 patients, who undergo AAA treatment with the Endurant Stent Graft System with 
complete 5 year follow-up, were combined with the data from the 150 subject Endurant 
Bifurcated Test Group from the Endurant US IDE PMA submission yielding a cohort of 
328 subjects for analysis and summary of the long term safety and performance of the 
bifurcated device. The 44 AUI subjects from the Endurant US IDE PMA-S were 
analyzed separately. By-gender and by-race analyses were performed separately for the 
bifurcated group and AUI group as well.  
 
Data from the study was submitted at 6 month intervals for the first two years, and 
annually thereafter. The duration of the clinical study from first enrollment through final 
follow-up and close-out is expected to be 6 years 5 months. To permit collection of long-
term safety and effectiveness data on the stent graft system, patients will be followed for 
a total of 5 years post implantation under this same clinical protocol. When all enrolled 
patients have been followed for 5 years post index procedure, or have exited, the study 
will be closed. An estimated timeline of key milestones for the study is shown in Table 1. 
The projections for monthly subject enrollment and sites activated with IRB approvals 
are shown in Table 2.    
 
 
 
 
 
 
 
 
 
 

 
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Table 1: Projected milestones for the study 
 
Key Study Milestones 
Projected Dates
Six Month Progress Report 
16-Jun-2011
Six Month Progress Report 
16-Jun-2011
12 Month Progress Report 
16-Dec-2011
18 Month Progress Report 
16-Jun-2012
Last Patient Enrollment 
15-Dec-2012
24 Month Progress Report 
16-Dec-2012
Last Patient Follow Up 
15-Dec-2017
Study Close-out Report 
15-Mar-2018
 
 
 
Table 2: Projected monthly subject enrollment and site activation (for ENGAGE PAS De Novo 
subjects) 
 
 
Month/Year 
Subject Enrollment 
Site Activation 
Aug-2011 
2 
1 
Sep-2011 
5 
2 
Oct-2011 
7 
3 
Nov-2011 
8 
3 
Dec-2011 
10 
3 
Jan-2012 
8 
2 
Feb-2012 
13 
2 
Mar-2012 
11 
2 
Apr-2012 
11 
2 
May-2012 
13 
2 
Jun-2012 
12 
2 
Jul-2012 
15 
2 
Aug-2012 
16 
2 
Sep-2012 
15 
2 
Oct-2012 
16 
 
Nov-2012 
16 
 
Total 
178 
30 

 
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7. STATISTICAL METHODS AND ANALYSES 
 
This is a prospective, multi-center, two-arm trial to evaluate the performance of the 
Endurant Stent Graft System in a post approval environment. A total of 178 subjects will 
be prospectively enrolled to receive the Endurant Bifurcated stent graft. The Endurant 
Bifurcated Arm test group, consisting of 150 subjects from the FDA approved Endurant 
US PMA submission, will be rolled into the prospectively enrolled cohort, resulting in a 
total cohort of 328 subjects for the Bifurcated Arm. The Endurant AUI Arm test group, 
consisting of 44 subjects, will be rolled in but analyzed separately. The primary statistical 
analysis will be based on freedom from Aneurysm Related Mortality (ARM) at 5 years. 
For the bifurcated arm, it will be compared to a Performance Goal (PG), determined from 
literature. This comparison will be performed based on a Kaplan-Meier (KM) analysis of 
the ARM. For the AUI group, the KM estimate of freedom from ARM will be calculated 
without a hypothesis testing. By-sex/gender and by-race (white vs. non-white) subset 
analyses will be performed on the freedom from ARM rate at 5 years separately for the 
bifurcated arm (328 subjects) and the AUI arm (44 subjects).. 
 
In general, the number and percentage of subjects reaching each of the additional 
measures will be given, along with confidence intervals for those percentages.  
 
Those acute procedural and hospital experience-related outcomes that are categorical will 
be reported in frequency and percentage.  The outcomes that are continuous will be 
reported by giving the number of observations, mean, standard deviation, median, 
minimum and maximum.  
 
The primary analysis set used for these analyses will be the ITT population, which 
consists of all subjects enrolled in the study.  For the purposes of this definition, a subject 
is enrolled at the point when vessel access is achieved through a cut down or 
percutaneous approach with the intention of implanting the stent graft. 
 
7.1. DESCRIPTION OF THE STUDY PRIMARY ENDPOINT 
 
The primary endpoint is freedom from ARM, measured at 5 years (1826 days). For the 
bifurcated arm, it will be compared to the Performance Goal (PG), determined from the 
literature as described in Section 7.2.  ARM is defined as 
 
ARM is defined as death from rupture of the abdominal aortic aneurysm or from any 
procedure intended to treat the AAA. If a death occurred within 30 days of any 
procedure intended to treat the AAA, then it is presumed to be aneurysm related 
unless there is evidence to the contrary. Deaths occurring after 30 days of any 
procedure intended to treat the AAA that are procedure-related should be aneurysm 
related. 
 
 
 
 

 
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The null hypothesis that will be tested is: 
 
H0:  ARMF5 ≤ 92 %, 
 
where ARMF5 is the 5-year freedom from ARM rate in the population of patients treated 
with the Endurant Bifurcated Stent Graft System and 92.0% is the PG. 
 
The alternative hypothesis is: 
 
H1:  ARMF5 > 92 %, 
 
where ARMF5 is as above. 
 
This comparison will be performed based on a Kaplan-Meier (KM) analysis of the ARM. 
All deaths will be adjudicated by a CEC to determine device, procedure and/or AAA 
relatedness. 
 
This study primary endpoint will be also analyzed for the AUI arm descriptively, 
calculating the KM estimate of 5-year freedom from ARM along with a 2-sided 95% 
confidence interval. 
 
7.2. BIFURCATED LITERATURE DERIVED PERFORMANCE GOAL (PG) 
 
A comprehensive literature review of the journal articles reporting ARM rates, calculated 
by Kaplan-Meier analysis or life-table analysis for Endovascular Aneurysm Repair 
(EVAR) through five years from the period of 2004 to 2010 was performed using the 
PubMed search engine.  
 
The key words (as single words or in combination) such as “Abdominal aortic aneurysm 
and aneurysm-related death” and “EVAR and aneurysm-related death” were employed. 
These chosen key words were deliberately broad, to include as many articles as possible 
for review. Articles that appeared relevant based on title and abstract were reviewed in 
detail.  
 
Criteria for inclusion into the PG analysis were: 
 
 An ARM rate calculated by either Kaplan-Meier analysis or life-table analysis, 
with the ARM rate clearly indicated by either chart or text. 
 The definition of ARM must be either explicitly stated or could be deduced from 
the article.  
 The rate must be specific for the time frame to be analyzed (i.e., rates were not 
extended outwards to later time frames, but were within the specified time frame 
of the study and study analysis). 
 
On the basis of the above search criteria, 13 articles with KM estimates for 5 year 
freedom from ARM were found and their citations are shown in Appendix L. A total of 

 
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6385 subjects treated with EVAR were accounted for in the 13 journal articles reviewed 
for this analysis.  
 
A definition of ARM inclusive of a death related to the implant procedure <30 days from 
implantation or >30 days after implantation if the death is deemed procedure related in 
the medical opinion of the Clinical Events Committee. 
 
After reviewing the articles, the weighted average freedom from ARM by population size 
(as reported in EVAR literature) is 95.99% (or 96%) at 5 years. With a clinical acceptable 
margin and variations reported in the literature, the PG for freedom from ARM at 5 year 
is set to be 92% with inputs from both clinician and FDA.  
 
7.3. SAMPLE SIZE CALCULATIONS 
 
The sample size calculation is based on the primary analysis for the bifurcated arm as 
analysis for the AUI arm is descriptive. 
 
The statistical analysis of the 5-year post approval safety endpoint assumes a 97.3% 
freedom from ARM at 5 years and a 15% annual attrition rate. These assumptions are 
based on: 
 The current Vitality post-approval study results (P070027/R015), which show a 
96.9% freedom from ARM at 5 years as outlined in the 2012 study Annual 
Progress Report, and 
 The 2012 ENGAGE post-approval study report (P100021/R005), which shows  a 
99.7% freedom from ARM at 3 years, and an 8.5% annual attrition rate during the 
first 3 years of follow-up for the Endurant Bifurcated Test Group.  
 
The planned sample size of 328 subjects, including 150 rollover subjects in the bifurcated 
arm of the IDE trial and 178 De Novo subjects, will yield approximately 170 evaluable 
subjects at the 5th year and this will provide a minimum of 90% statistical power for a 1-
sided test at a 0.05 statistical significance level against the Performance Goal (PG). 
Therefore, according to these assumptions, enrolling additional 178 De Novo subjects 
will provide a sufficient sample size for the statistical hypothesis test on the 5-year post 
approval safety endpoint. 
 
7.4. ADDITIONAL MEASURES 
 
The following metrics will be evaluated: 
1. Technical Success 
a. Technical success of the Endurant Stent Graft System (assessed intra-
operatively) is defined as:  
 

 
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Successful delivery and deployment of the stent graft in the planned location and with no 
unintentional coverage of both internal iliac arteries (in the case of AUI, unintentional coverage 
of the ipsilateral internal iliac artery) or any visceral aorticbranches and with the removal of the 
delivery system 
 
2. Major adverse event (MAE)  rates within 30 days of the initial or secondary 
procedures, including: 
a. All-Cause Mortality 
b. Bowel Ischemia 
c. Myocardial Infarction 
d. Paraplegia 
e. Procedural Blood Loss ≥ 1000 cc  
f. Renal Failure 
g. Respiratory Failure 
h. Stroke 
3. At 12 months and subsequent 4 yearly follow-ups, the following will be 
reported: 
a. All-cause mortality 
b. Aneurysm-related mortality 
c. Aneurysm rupture 
d. Aneurysm expansion 
e. Conversions to open repair 
f. Stent graft migration (>10mm compared to the first post-implant CT) 
g. Stent graft patency 
h. Endoleaks 
i. Secondary endovascular procedures 
j. Stent-graft integrity 
k. Adverse Events, as follows: 
i. Clinical sequelae caused by or directly associated with the 
Endurant device, the index procedure or any secondary 
endovascular procedure (including conversion to open repair) and 
technical observation. 
ii. Those adverse events that meet the definition of a Major Adverse 
Event (MAE). 
iii. Those adverse events directly associated with the death of the 
subject 
iv. Adverse events meeting Medical Device Reporting (MDR) 
criteria 
v. Serious adverse events within 30 days of index procedure. 
 
 

 
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7.5. ACUTE PROCEDURAL AND HOSPITAL EXPERIENCE 
 
The following acute procedural and hospital experience-related outcomes will be 
summarized using descriptive statistics.   
1. Mean duration (min) of procedure. 
2. Proportion of subjects who underwent general anesthesia. 
3. Mean volume (cc) of estimated blood loss. 
4. Proportion of subjects requiring blood transfusions. 
5. Mean length of time (hours) in intensive care unit. 
6. Mean length of time (days) of overall hospital stay (from index procedure to 
discharge).  
 
7.6. ANALYSIS METHODS 
 
Statistical analyses for this post-approval study will take place after the final subject’s 5 
year follow-up. The study will be conducted in a way to minimize the incidence of study 
deviations and missing data, and all subjects with assessable data will be accounted for. 
Statistical analyses will be performed using the Statistical Analysis System (SAS) for 
Windows (Version 9.1 or higher) or other validated statistical or graphical software. 
 
Data generated from the clinical study will be analyzed as specified in the following 
sections. Subject data listings, tabular, and graphical representations will be provided. In 
general, for categorical variables, frequency and percentage will be presented as 
descriptive statistics. For continuous variables, number of observations, mean, standard 
deviation, median, minimum, and maximum will be reported. 
 
7.6.1 Data Analysis Subsets 
 
All analyses will be constructed using an Intent-to-Treat (ITT) population. This analysis 
set is defined as all subjects who were enrolled, i.e. when vessel access is achieved 
through a cut down or percutaneous approach with the intention of implanting the 
Endurant Stent Graft System.  The ITT analysis set will be used for all safety and 
effectiveness analyses.   
 
 
7.6.2 Analysis of the Primary Study Endpoint 
 
In the bifurcated arm, the statistical hypothesis will be tested by calculating a 1-sided 
95% confidence limit for the 5-year KM estimate and comparing it to the Performance 
Goal (PG).  The confidence limit will be based on the Greenwood standard error and 
using a normal approximation. If the lower confidence limit is greater than the 
Performance Goal (PG), then the null hypothesis (see Section 7.1) will be rejected in 
favor of the alternative hypothesis and a higher than 92% freedom from ARM rate at 5 
year will be concluded. 
 
In the AUI arm, a KM estimate will be calculated along with a 2-sided 95% confidence 
interval for the freedom from ARM at 5 years.  

 
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Subjects who die from aneurysm-related death as determined by the CEC will be 
considered as having the event.  The time from the initial implant to the time of death is 
the time to event. Other subjects will be considered censored at the date of last follow-up 
visit / contact or the date of death due to other reasons.  
 
7.6.3 Analysis of the Additional Measures 
 
For these additional measures, which are all proportions, a 2-sided 95% confidence 
interval will be constructed based on the binominal distribution, i.e., using the exact 
method.  Because these confidence intervals are strictly descriptive, i.e., no statistical 
hypothesis to be tested, no multiplicity adjustment of the confidence level will be 
performed.  
 
7.6.4 Analysis of the Acute Procedural and Hospital Experience Endpoints 
 
All analyses on acute procedural and hospital experience outcomes are considered as 
additional to that for the primary and secondary endpoints. For duration of procedure, 
volume of estimated blood loss, length of time in intensive care unit (ICU) and length of 
time in hospital (from admission to discharge) will be summarized using mean, standard 
deviation, median, min and max. For proportion of subjects undergoing general 
anesthesia and proportion of subjects requiring blood transfusion, the number and 
percentage of subjects in each category will be presented. All ITT subjects with available 
data will be included in the analysis. 
 
 
7.6.5 Analysis of Baseline Variables 
 
All clinically relevant baseline variables will be tabulated. Categorical variables, 
including binary variables, will be reported by giving the number and percentage of 
subjects in each category. Continuous variables will be reported by presenting the mean, 
standard deviation, median, minimum, and maximum value for each. All ITT subjects 
with available data will be included in the analysis.  
 
7.6.6 Subset Analyses 
 
By-sex/gender and by-race (white vs. non-white) subset analyses will be performed on the 5-
year ARM rate separately for the bifurcated arm and AUI arm. A 2-sided 95% confidence 
interval based on a KM estimate of the rate will be calculated for each arm using the 
Greenwood standard error and normal approximation. In addition, this study will also attempt 
to better understand the overall outcomes in females and non-whites undergoing 
endovascular repair (EVAR) with the Endurant device. The study report will summarize the 
current research results of females and nonwhites having undergone EVAR, and a literature 
review and study outcome description of both females and non-whites will be provided with 
each regular post-approval study update. Publications to be examined will include single-
center experiences and multicenter trials. Specifically, descriptive statistics will be used to 
summarize literature derived outcomes in patients with the EVAR therapy, literature-derived 

 
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Endurant specific outcomes, and the post-approval study outcomes. These summaries will be 
conducted to the level of detail available in both the literature and the post-approval study 
trial subsets, including device safety and effectiveness measures such as aneurysm-related 
mortality, endoleaks, aortic ruptures, etc. 
 
7.6.7 Time Window Conventions Used in Analysis of Endpoints 
 
Throughout this study, all attempts will be made to collect complete and compliant data.   
Thus, the majority of data are expected to be within the protocol-specified timeframes for 
follow-up visits.  However, in practice, it may not be possible to achieve this completely.  
For example, an unscheduled visit may take place and then the patient may miss the next 
follow-up or withdraw.  For these exceptions, and to take into account all available data, 
the following rules and time windows will be applied in the statistical analyses (Table 3).  
 
Table 3: Windows for analysis of noncompliant or missing data. 
 
Study Visit 
Target Day 
Time Window 
Implant 
0 days 
Day 0 
1 Month 
30 days 
1 – 90 days 
12 Months 
365 
305 – 548 Days 
2 Year 
731 
549 – 913 Days 
3 Year 
1096 
914 – 1278 Days 
4 Year 
1461 
1279 – 1644 Days 
5 Year 
1826 
1645 – 2009 Days 
 
 
If there are 2 or more assessments in the same time window, then the assessment closest 
to the target day will be used in the analysis. 
 
For an adverse event or death, date of onset will be defined as the time when the event 
occurred.  In cases where the date of onset is incomplete, the 15th day of the known 
month or July 1st of the known year will be used. Furthermore, adverse events or death 
may be observed at any time during the study, so no time windows will be applied.  An 
event that occurs “within 1 month” is an event that takes place between Days 0 to Day 30 
inclusive.  The same applies to events such as adverse events or death within 1 year, i.e., 
Day 0 – Day 365 inclusive. 
 
7.6.8 Patient Withdrawal and Missing Data 
 
Intent-to-treat analysis allows for the evaluation of all subjects who enrolled the study, 
even though some may not complete the study (e.g., subjects who are, for any reason, lost 
to follow-up, drop-outs, or terminated by investigator).  The intent-to-treat principle 
means that analysis will be based on observed results of all subjects for the treatment as 
they are enrolled to receive. Imputation of missing data will not be performed in the 

 
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intent-to-treat analysis, unless otherwise specified.  For example, to determine the rate of 
MAEs within 365 days, only following subjects with observations will be counted for the 
rate: 
 
The numerator consists of:  
 
 The number of subjects that experienced an MAE during Day 0 and Day 365, 
inclusive. 
 
The denominator consists of: 
 
 The number of subjects evaluated during the analysis window (i.e., last day in 
study>=304), plus 
 Any subjects not evaluated during the analysis window, but that had an MAE 
during Day 0 and Day 303, inclusive. 
 
Note that subjects that were followed less than 305 days and no MAE reported during the 
follow-up period will be excluded from the analysis of this rate because no complete 
observations were made to these subjects due to withdrawal or lost to follow-up. 
 
For the analysis of primary endpoint, freedom from ARM rate at 5 years, the KM 
analysis will be applied. Subjects who lost to follow-up or withdraw consent will be 
considered censored at the date of withdrawal.  Therefore, no subjects in the intent-to-
treat analysis set will be excluded from the analysis. Vital status of other subjects at 5 
years will be determined.  For the purposes of analyzing ARM, subjects who die of 
unrelated causes will be considered censored at time of death.    
 
 

 
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8. CLINICAL STUDY PREPARATION PROCEDURES 
 
8.1. SELECTION OF CLINICAL INVESTIGATORS 
 
Investigators selected will be responsible for fulfilling the clinical study requirements 
specified in this investigational plan.  The study center must have the necessary resources 
to comply with the requirements.  The following criteria will be used to select 
investigators for participation in the ENGAGE PAS clinical study. 
 
 Investigator is qualified by training and expertise in endovascular repair of 
abdominal aortic and aortoiliac aneurysms. 
 Investigator and clinical research staff have experience with US IDE studies and 
have the time to conduct the study in accordance with the investigational plan. 
 Agreement to comply with the investigational plan and regulatory requirements. 
 Adequate volume of potential patients who meet the eligibility criteria, i.e., at 
least 1 patient per center per month. 
 Number of simultaneous competing clinical studies that might interfere with 
patient enrollment or study conduct. 
 Appropriate facilities, resources, and equipment. 
 An expressed desire to participate in the study. 
 Willing to undergo required study training. 
 Willing and able to complete study initiation activities in a timely manner (2-3 
months).   
 
All investigators will sign the appropriate study-related agreements (Form of Investigator 
Statement, Clinical Research Agreement) before they are added to the clinical study. 
 
8.2. INSTITUTIONAL REVIEW BOARD REQUIREMENTS 
 
No clinical study activities will begin without documented approval of the investigational 
plan and the informed consent documentation by an Institutional Review Board (IRB) 
affiliated with the study center.  The IRB has the authority and responsibility to review 
and approve the study and its conduct in accordance with Title 21, Part 56—Institutional 
Review Boards, US Code of Federal Regulations.  The primary purpose of the IRB is to 
protect the rights and welfare of the patients enrolled in the clinical study. 
 
Information required by the IRB will be supplied to the investigators and the investigator 
is responsible for providing all materials to the IRB.  The investigator will notify 
Medtronic Vascular when IRB approval is granted.  An approval letter from the IRB 
addressed to the investigator is required, and a copy of this letter must be provided to 
Medtronic Vascular prior to any studies activities related to enrollment of the first patient.  
This approval letter must reference the name of the study and specific version of the 
Endurant Post Approval Study Investigational Plan and the Informed Consent document.  

 
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Investigators are also responsible for ensuring that the IRB reviews the study according 
to the timeframes designated by the IRB.  A renewal/approval letter based on continuing 
review by the IRB must also be provided to Medtronic Vascular annually. 
 
A roster of the IRB committee members or a General Assurance number is required and 
must be maintained with the clinical study files at the site and Medtronic Vascular.  An 
updated roster should be provided to Medtronic Vascular on an annual basis.  If an 
investigator is a member of the IRB, then written documentation must be provided by the 
IRB stating that the investigator did not participate in the approval process (voting) for 
this study. 
 
8.3. INFORMED CONSENT 
 
To protect the rights and welfare of study patients, the Endurant Stent Graft System 
clinical study will be conducted in conformance with Title 21, Part 50—Protection of 
Human Subjects, US Code of Federal Regulations.  Obtaining informed consent in 
accordance with the policy of the IRB, this investigational plan, and the US IDE 
regulations is mandatory for patient participation.  The patient informed consent 
document(s) must be provided in a language that the patient reads and understands.  All 
patients must provide voluntary, written informed consent. 
 
Medtronic Vascular and the IRB must approve the informed consent documentation and 
any modifications to the consent materials prior to use.  Required elements of an 
informed consent document and a sample informed consent form are provided in 
Appendices E and F, respectively.  The approved informed consent documentation must 
have a version number.  It is also recommended that the document carry an IRB approval 
stamp.  The informed consent process (including time and date of discussion), should be 
documented in the patient’s medical record and signed/dated by the individual 
(investigator or designee) who recorded it.  A copy of the signed informed consent 
documentation should be given to the subject.   
 
8.4. STUDY TRAINING 
 
Prior to the start of the study, the investigator and study staff at each site will undergo 
training to provide in-depth information about the use of the device, the clinical 
investigational plan, and study requirements.  Medtronic Vascular personnel (or 
designees) will conduct the training.  Training of study personnel will be documented on 
the appropriate training record form and maintained with the site and Medtronic Vascular 
study files.  Clinical research staff will be supplied with the investigational plan, 
instructions for use, case report form instructions, and other supporting materials.   
 
 

 
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Topics to be covered at the training include the following. 
 
 Study plan overview and study timeframes 
 Role of Clinical Events Committee  
 Subject eligibility criteria 
 Informed consent procedure and documentation in the subject’s medical record  
 HIPAA regulations and patient confidentiality 
 Screening procedures 
 Data collection schedule 
 Imaging requirements and guidelines 
 Study-specific assessments  
 Device disposition, inventory, storage requirements and packing slips 
 Instructions for use and implantation procedures  
 Device complaints and returns 
 Adverse event reporting 
 Source document requirements  
 CRF completion instructions and corrections 
 Monitoring procedures 
 IRB policies and procedures  
 Regulatory and other study document completion and maintenance 
 Study correspondence with sponsor, monitor and data management 
 Regulatory requirements and compliance 
 Overview of Good Clinical Practices 
 Identification of potential issues that might arise in regard to clinical study site 
management  
 
Medtronic personnel (or designees) may be present for the first implant at a site.  Also, an 
Investigators’ Meeting may be conducted prior to the start of the study for the purpose of 
study-related training. 
 
8.5. REQUIRED EQUIPMENT 
 
The Endurant Stent Graft System is commercially available in the United States and will 
be used in this study.  The commercial version of the Instructions for Use is provided in 
Appendix A. Final product labeling is found in Appendix G.   
 
The Endurant Stent Graft Systems are composed of the following components. 
 
 Endurant Bifurcated Stent Graft 
 Endurant Contralateral Limb 
 Endurant Iliac Extension 
 Aortic Extension 
 Endurant Aortic Delivery System 
 Endurant Iliac Delivery System 
 

 
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Each Endurant Stent Graft component (bifurcated, contralateral limb, aortic and iliac 
extensions) is individually contained within an Endurant Delivery System.  Endurant 
Delivery Systems are sterilized using E-beam and are supplied sterile for single use only.  
The system should be stored at room temperature in a secured, dark, dry place.  Ancillary 
required and recommended equipment associated with implantation of the Endurant Stent 
Graft System is listed in the Endurant Stent Graft System Instructions for Use—Section 
9:  Clinician Use Information (Appendix A – Instructions For Use and as provided 
electronically on www.medtronic.com/manuals or may be provided in hard-copy format 
upon request). 
 
8.6. SITE ACTIVATION AND SUPPLY OF STUDY MATERIALS 
 
Before a patient is enrolled at a study site, the investigator must receive a “Go Letter” 
from Medtronic Vascular.  In addition, the following documentation must be on file at 
Medtronic Vascular.  
 
 IRB approval letter for the investigational plan and informed consent 
documentation 
 IRB membership list or General Assurance number 
 Executed Clinical Research Agreement  
 Executed budget agreement 
 Site Investigator Qualification Form 
 Delegation of Authority Form 
 Form of Investigator Statement (templates provided in Appendix H) 
 Executed Non-Disclosure Agreement 
 Curriculum Vitae (investigator, sub-investigators, research coordinator) 
 Training Records (device, investigational plan, GCP) 
 
Medtronic Vascular will control the supply of case report form materials, return shipment 
containers for explanted devices, and other items required to conduct the clinical study.  
Investigators will be provided with the post-approval study plan, procedures, informed 
consent information and templates, case report form instructions, and other supportive 
documents required for the study. 
 
 

 
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9. CLINICAL STUDY PROCEDURES 
 
Clinical data will be collected preoperatively to establish eligibility, at baseline, during 
implantation of the Endurant Stent Graft, throughout the hospital stay, and 
postoperatively. Each patient will continue to be followed after the 12-month evaluation 
on an annual basis to collect a total of 5 years’ experience.  When all enrolled patients 
have been followed for 5 years post index procedure or have previously exited from the 
study, the study will be closed and the final report generated.     
 
Information for the case report forms will be collected using an electronic data capture 
system (EDC).  The clinical investigators will use EDC to review, sign, and date the case 
report forms.  Medtronic Vascular monitors (or designees) will review all electronic case 
report forms.  Sample case report forms and information for required assessments are 
provided in Appendices I and J. 
 
Any source documentation (procedure reports, imaging studies, lab reports, death 
certificates, etc.) that is sent to the sponsor or reviewing committees should have all 
patient identifiers removed and replaced with the subject’s study ID. 
 
The data collection schedule is summarized in Table 4.     
 

 
 
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Table 4: Overview of the study procedures and data collection requirements. 
 
Data 
Screening/ 
Baseline 
Procedure
1-Month 
FU +15 
days 
12-Month 
FU + 56 
Days 
24-Month 
FU 
+ 56 Days 
36-Month 
FU + 56 
Days 
48-Month 
FU + 56 
Days 
60-Month 
FU + 56 
Days 
Informed Consent 
 
 
 
 
 
 
 
 
Physical Examination 
 
 
 
 
 
 
 
 
Pregnancy Test (for female of child-
bearing potential) 
 
 
 
 
 
 
 
 
Medical History  
 
 
 
 
 
 
 
 
CT/MRA with contrast 
 
 
 
 
 
 
 
 
CT non contrast and Color Duplex 
Ultrasound (only for subjects with 
renal insufficiency) 
 
 
 
 
 
 
 
 
INR 
 
 
 
 
 
 
 
 
Serum Creatinine 
 
 
 
 
 
 
 
 
Current Health Status & Risk 
Factors 
 
 
 
 
 
 
 
 
Preimplant Adjunctive Procedures 
 
 
 
 
 
 
 
 
Angiogram of Abdomen & Pelvis 
 
 
 
 
 
 
 
 
Device and Procedure Information 
 
 
 
 
 
 
 
 
Hospital Discharge Information 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abdominal X-Ray (4-view, KUB) 
 
 
 
 
 
 
 
 
Adverse Event Assessment 
 
 
 
 
 
 
 
 

 
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9.1. ELIGIBILITY CRITERIA 
 
The study population will include those patients who are appropriate candidates for 
endovascular repair of abdominal aortic aneurysms (evidenced by screening contrast-
enhanced CT or MRA) and who fulfill all of the following eligibility criteria.  Data will 
be recorded on the Inclusion and Exclusion Criteria Form. 
 
9.1.1 Inclusion Criteria  
 
 Age ≥18 years  
 Indication for elective surgical repair of AAA with an endovascular stent graft in 
accordance with the applicable guidelines on endovascular interventions and the 
Instructions for Use of the Endurant Stent Graft System  
 Signed consent form. The subject or legal representative has been informed of the 
nature of the trial and has consented to participate and authorized the collection 
and release of his medical information 
 Intention to electively implant the Endurant Stent Graft System 
 Ability and willingness to comply with the Clinical Investigational Plan (CIP). 
 
9.1.2 Exclusion Criteria  
 
 High probability of non-adherence to physician’s follow-up requirements 
 Current participation in a concurrent trial which may confound study results 
 Female of childbearing potential in whom pregnancy cannot be excluded or who 
is lactating. 
 
9.2. PATIENT SCREENING, ENROLLMENT, AND PRE-IMPLANT 
PROCEDURES 
 
Investigators will assess potential patients with an abdominal aortic or aortoiliac 
aneurysm for their suitability for enrollment in the study.  Initially, patient eligibility will 
be determined by the investigator based on the diagnosis of AAA as evidenced on 
screening contrast-enhanced CT/MRA.   If the patient appears to meet the eligibility 
criteria, then the investigator will discuss the study with the patient and provide 
information relating to the potential risks and benefits, and required follow-up procedures 
per the informed consent process (Section 8.3 – Informed Consent).  After the patient 
voluntarily has signed and dated the informed consent document, the patient will be 
considered a study candidate, i.e., subject, and move on to the screening phase of the 
enrollment process.  If a patient does not sign the informed consent document, then 
screening procedures for the ENGAGE PAS clinical study must not proceed.  To avoid 
subject selection bias, consecutive screening and enrollment will be expected. Subjects 
will be screened consecutively for stent graft implantation and enrollment into ENGAGE 
PAS. Consecutive enrollment is strongly encouraged in order to minimize selection bias.  

 
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Screening assessments and collection of baseline information can take place only after 
the patient has given voluntary, documented informed consent. The following 
information will be collected in the respective forms:  
 
 Informed consent information and Inclusion/Exclusion Criteria in Subject 
Enrollment and Inclusion/Exclusion Criteria Form.  
 Screening dates, patient demographics, current health status, laboratory analyses, 
Aneurysm imaging results/dimensions in Screening Form.  
 Medical history, ASA Physical Status Classification and risk factors in Medical 
History Form.  
 
  
 
 
 
 
 
 
 
Test results that are within the timeframes specified below may be used even though the 
actual test was done prior to a patient’s informed consent.  This may be done only for 
standard of care tests with the intent to minimize stress and discomfort to the patient and 
reduce costs.   Required screening evaluations include the following. 
 
 Physical examination (within 1 month of index procedure). 
 Pregnancy test (for female patients of childbearing potential).  Test must be 
completed at the time of screening (prior to) the index procedure.  Results must be 
negative. 
 CT or MRA with contrast of the abdomen and pelvis (celiac to external iliac 
arteries) completed within 4 months prior to the index procedure.  This will be 
used to visualize and assess the characteristics, length, and diameters of the AAA 
and the surrounding anatomy.   
 Laboratory tests (completed within 1 month prior to the index procedure) to 
include serum creatinine and INR. 
 
Those patients who sign and date the informed consent document, meet all of the study 
eligibility criteria, and complete and pass the screening evaluations will be eligible for 
enrollment into the clinical study.  
 
The subject will be considered to be enrolled when vessel access is achieved through 
a cut down or percutaneous approach with the intention of implanting the Endurant 
Stent Graft System.   
 
Percutaneous approach: A needle is used to access the vessel followed by the 
introduction of a wire through the lumen of the needle. It is over this wire that other 

 
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catheter can be placed into the blood vessel and this technique is known as the modified 
Seldinger technique. Following access the wire and sheaths are removed and hemostasis 
is gained with either pressure or with a percutaneous closure device or other means of 
closure. 
 
Subjects who do not qualify for enrollment after the screening procedure and an informed 
consent voluntarily signed, will be documented as ineligible on the Subject Enrollment 
and Inclusion/Exclusion Form.    
 
9.3. IMPLANT PROCEDURES 
 
Information pertaining to any preoperative adjunctive procedures and data collected 
during the procedure will be recorded on the Endovascular Procedure Form.  The 
anesthesia and general surgical protocol (administration of prophylactic antibiotic 
therapy, technique for access and closure of the arterial site, use of systemic heparin, etc.) 
will be left to the discretion of the implanting physician and the standard medical practice 
at the hospital.  The Endurant Stent Graft System Instructions for Use, which is provided 
electronically (www.medtronic.com/manuals) or can be provided in hard copy format 
upon request, must be followed for implantation of the stent graft system. 
 
Verification of the dimensions and characterization of the AAA and pertinent arteries will 
be documented using angiography at the time of the procedure and prior to the insertion 
of the Endurant Stent Graft System.  Use of an angiographic catheter with calibrated 
radiopaque marking is preferred.  The investigator will verify dimensions and 
characterizations of the subject’s anatomy in relation to the Endurant Stent Graft System.   
 
Fluoroscopic guidance will be used for placement of the stent graft throughout the 
endovascular procedure.  Total fluoroscopic time will be documented.  All devices should 
be deployed following the steps outlined in the Instructions for Use (IFU), which is 
provided with the packaged device (also Appendix A).  Upon completion of the index 
procedure, a final run-off angiography should be performed to document the status of the 
Endurant device(s), the aneurysmal sac, and the surrounding vasculature. 
 
Information to be recorded on the Endovascular Procedure Form includes the 
following. 
 
 Adjunctive procedures performed prior to the index procedure 
 Date of hospital admission prior to the index procedure 
 Date of the index procedure 
 General procedural information 
 Success of Endurant implantation 
 Additional procedures performed  
 Volume of contrast used, fluoroscopy time 
 Blood loss, was transfusion required 
 Occurrence of adverse events or Technical Observation 
 

 
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Identification and/or serial numbers for all investigational components of the Endurant 
Stent Graft System used during the index procedure will be recorded on the Device 
Disposition Form.   
 
Report adverse events on the Adverse Event Form as specified in Section 9.9 - Adverse 
Events.   
 
Inability to implant the Endurant Stent Graft following arterial access due to deployment 
issues or entrapment of the delivery system will be considered a treatment failure.  The 
appropriate case report forms should be completed.  These subjects will be followed 
through the 1-month follow-up time point and then exited from the study. 
 
The Conversion to Open Repair Form should be completed for any conversion, as 
appropriate.  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.   
 
9.4. HOSPITAL DISCHARGE PROCEDURES 
 
Information pertaining to the patient’s hospital experience and discharge will be recorded 
on the Hospital Discharge Form.  Data will include the following. 
 
 Date of hospital discharge 
 Duration of stay in the ICU, if applicable 
 Aneurysm-related imaging, serum creatinine (if done)  
 Occurrence of adverse events 
 
 
 
Imaging is not required at the time of hospital discharge.  However, if done, the Site 
Image Report Form should be completed by the site for each film that can provide 
information relating to the aneurysm treatment.  The electronic de-identified copies of the 
films should be sent to Medtronic in a timely manner and the Site Image Report Form 
completed in a timely manner through the 5 year follow-up time point.   
 
9.5. 
 REQUIRED FOLLOW-UP EVALUATIONS 
 
Patient follow-up visits are required subsequent to the implantation of the Endurant Stent 
Grafts at 1 month, 12 months, and annually thereafter for a total of 5 years of follow-up 
experience for each patient.  After implantation of the Endurant Stent Graft, the study site 
will be informed of the target date and required follow-up window time- frames for each 
patient.  Follow-up window timeframes are summarized in Table 5.  All data required for 
the follow-up must be collected within the window for that scheduled visit, not 
necessarily on the same day. 
 
 

 
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Table 5: Required postoperative follow-up schedule and windows. 
 
Follow-Up Visit 
Window Start Day 
Target Day 
Window Close Day 
1 month (± 15 days) 
15 
30 
45 
12 Months (±56 days) 
309 
365 
421 
24 Months (±56  days) 
675 
731 
787 
36 Months (±56  days) 
1040 
1096 
1152 
48 Months (±56  days) 
1405 
1461 
1517 
60 Months (±56 days) 
1770 
1826 
1882 
   
The following data are required at each follow-up evaluation and will be recorded on the 
corresponding Clinical Follow-Up Form.   
 
 Date of follow-up visit/data collection 
 Serum creatinine value 
 Occurrence of adverse events 
 
 
 
An imaging report (Site Image Report Form) should be completed for each imaging 
study that can provide information relating to the aneurysm treatment (guidelines for 
imaging are provided in Appendix J).  The electronic de-identified copies of the films 
should be sent to Medtronic in a timely manner and the Site Image Report Form 
completed in a timely manner through the 5 year follow-up time point. 
 
If a subject requires a secondary procedure that results in explant of the Endurant Stent 
Graft, then the patient will be followed for 1 month and exited from the study.  The 
Secondary Endovascular Procedure Form and Adverse Event Forms should be 
completed, as appropriate. 
 
Subjects who do not respond will be documented as having missed visits.  The 
investigator will keep a record of documented follow-up attempts in the subject’s study 
file.  In addition, a Protocol Deviation Form will be completed.  Refer to Section 9.7 – 
Protocol Deviations for additional information. 
 
9.6. UNSCHEDULED VISITS 
 
No data are required from unscheduled follow-up evaluations other than aneurysm-
related imaging studies and information pertaining to adverse events.  If an unscheduled 
visit occurs, then data should be recorded on the Clinical Follow-Up Form.   
 
The Site Imaging Report Form should be completed by the site for each film that can 
provide information relating to the aneurysm treatment. The electronic de-identified 
copies of the films should be sent to Medtronic in a timely manner and the Site Image 
Report Form completed in a timely manner through the 5 year follow-up time point. 
 
 

 
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9.7. PROTOCOL DEVIATIONS 
 
A protocol deviation occurs when a clinical investigator and/or study site personnel do 
not conduct the study according to the clinical investigational plan.  All deviations are 
recorded on a Protocol Deviation Form.  Depending upon the nature of the protocol 
deviation, expedited reporting and prior approval from Medtronic Vascular may be 
required.  All deviations will be summarized and submitted in regular progress reports, 
and the final study report to FDA. 
 
If Medtronic Vascular finds that an investigator is not complying with the executed study 
agreements, the investigational plan, the FDA regulations, or the requirements of the 
reviewing IRB, prompt action will be taken to secure compliance.  Additional 
information is provided in Section 9.16– Study Termination. 
 
9.7.1 Deviations Requiring Prior Approval  
 
An investigator is required to obtain prior approval from clinical study management at 
Medtronic Vascular and the IRB before initiating deviations from the Investigational Plan 
that affect the scientific soundness of the plan, or the rights, safety, and welfare of the 
subjects (non-emergent situation).  However, prior approval is not required in situations 
where unforeseen circumstances are beyond the investigator’s control, e.g., subject did 
not attend scheduled follow-up visit, laboratory test was performed incorrectly, and test 
equipment did not operate properly. 
 
9.7.2 Non-Urgent Deviations  
 
Protocol deviations which do not have the urgency associated with expedited notification 
or prior Medtronic Vascular/ IRB approval (as discussed in the above paragraphs) will be 
reported upon discovery, such as during completion of eCRFs or a monitoring visit.   
 
9.8. TECHNICAL OBSERVATIONS 
 
A technical observation is a defect, malfunction, or failure of the Endurant Stent Graft 
System.  Also, this may pertain to the device or system not functioning according to its 
design intent.  These might include (but not be limited to) anchor pin fracture, migrations, 
and device access difficulties.  Technical observations may or may not be related to an 
adverse event in a subject.  Technical observations that are not associated with any 
untoward medical occurrence in a subject will be reported on the appropriate forms: Site 
Image Report Form, Procedure Form and/or Conversion to Open Repair Form.  If 
adverse events occurred as a result of the technical observation, then the appropriate 
adverse events forms must be completed as well. 
 
 
 
 

 
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9.9. ADVERSE EVENTS 
 
Potential (anticipated) adverse events that may be associated with endovascular 
implantation of an abdominal aortic stent graft are listed in Section 15 - Risk Analysis.  
Events reported should reflect actual diagnoses/syndromes and not merely clinical signs 
or symptoms, if possible.  For example, if chest pain is recorded as an adverse event and 
the diagnosis is actually Myocardial Infarction, then the event should be reported as a 
Myocardial Infarction.  Events reported should represent a new onset or increase in the 
severity of the condition from the time of enrollment in the study (the subject is 
considered to be enrolled when vessel access is achieved through a cut down or 
percutaneous approach with the intention of implanting the Endurant Stent Graft System). 
 
Adverse events will be reported to Medtronic Vascular on the Adverse Event Form.  
Source documentation for adverse events must be collected and filed with the subject’s 
hospital chart.  Refer to Section 10 – Adverse Event Definitions and Expedited Reporting 
for additional information. 
 
Adverse events that are inherent to a surgical procedure and expected to occur in most 
subjects for a projected duration according to the opinion of the investigator may be 
considered unavoidable.  Such events include, but are not limited to, those listed in Table 
6.  These adverse events should not be reported during this study. 
 
 
Table 6: Expected and unavoidable adverse events related to the surgical procedure. 
Description of the Event 
Time Frame from the Index Procedure 
 
Endoleaks observed and resolved during the index 
procedure 
Resolved by the time the subject leaves the OR 
Anesthesia-related nausea and/or vomiting 
Within 24 hours  
Low-grade fever (< 100° F or < 37.8° C)  
Within 48 hours 
Back pain related to laying on OR table 
Within 48 hours 
Incisional pain (pain at access site) 
Within 72 hours 
Sleep problems or insomnia 
Within 72 hours 
Mild to moderate bruising or ecchymosis 
Within 168 hours 
 
9.10. PATIENT DEATH 
 
The investigator is responsible for reporting the death of a subject to Medtronic Vascular 
and the IRB.  The procedures and reporting timeframes detailed in Section 10 – Adverse 
Event Definitions and Expedited Reporting must be followed.  All deaths will be 
reviewed and adjudicated by the Clinical Events Committee.   
 
Patient deaths must be documented on the Study Exit Form.  A copy of the death 
summary report (as dictated by the physician) and death certificate should be sent to 
Medtronic Vascular.  If an autopsy is conducted, then the autopsy report also should be 

 
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submitted.  When the death occurs at a non-investigational site, it is the investigative 
center’s responsibility to attempt to retrieve information about the death.  If the death 
does not occur in an institution, then the investigator must submit a summary of the 
known events surrounding the death. All patient deaths will be classified according to the 
following definitions of mortality.   
 
Aneurysm-Related Death 
Aneurysm-Related Death is defined as death from rupture of the abdominal aortic 
aneurysm or from any procedure intended to treat the AAA. If a death occurred within 30 
days of any procedure intended to treat the AAA, then it is presumed to be aneurysm 
related unless there is evidence to the contrary. Deaths occurring after 30 days of any 
procedure intended to treat the AAA that are procedure-related should be aneurysm 
related. 
 
Perioperative Death 
Any death that occurs intraoperatively or within 30 days of the primary procedure.  In 
addition, any death that occurs beyond 30 days while the patient is still hospitalized 
following the index procedure will be considered a perioperative death. 
 
“Within 30 days” is defined as within 30 days of the procedure or at hospital discharge, 
whichever is longer.  
 
In the event of a patient death, the Endurant Stent Graft should be explanted (when 
feasible) and returned to Medtronic Vascular for analysis.  Refer to Section 9.11 - 
Explanted Devices.   
 
9.11. EXPLANTED DEVICES 
 
All explanted devices should be returned to Medtronic Vascular for analysis.  
Information pertaining to the explant procedure should be recorded on the Endovascular 
Procedure Form or Conversion to Open Repair Form.  Relevant information should 
also be recorded on associated case report forms, e.g., Adverse Event Form, Study Exit 
Form. 
 
Detailed instructions are provided in Appendix K for explant of the device and its return. 
An overview of the explant procedure follows. 
 
 Notify Medtronic Vascular when an explant has occurred.  Medtronic 
Vascular will provide a shipping container for the explanted product, which 
includes instructions and a return shipping label. 
 Before the device is explanted, if possible, obtain an in situ photograph of the 
stent graft.  At the time of removal, care should be taken to avoid excessive 
manipulation with metallic instruments at the proximal and distal fixation 
sites.  Leave the stent graft as intact as possible and avoid deforming the 
device. 
 

 
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 When the explant is performed as part of an autopsy or a postmortem 
procedure, the device should be carefully excised with at least 1 cm of host 
tissue adjacent to the proximal and distal fixation sites.  Do not disturb the 
inside surface of the stent graft. 
 Record the location of the site of the tissue removal relative to the position of 
the stent graft. 
 If possible, immediately after its removal, make photographic records of the 
explanted device and the explant site. 
 Clearly identify all components relative to surgical placement and orientation.  
Identify the proximal and distal ends.  The anterior portion of the stent graft 
should also be labeled.  Surgical clips and sutures can be used to label the 
explanted device.  A complete record of labeling methodology should be 
made at the time of the explant procedure and be included with the explanted 
product and any relevant reports. 
 Complete the Explant Form (non-CRF: located in Appendix K).  Labels are 
provided in the explant kit. 
 The subject undergoing explant as a secondary procedure will be followed for 
1 month subsequent to removal of the device. 
 A summary of the explant findings will be provided to the investigator. 
 
9.12. STUDY EXIT 
 
The Study Exit Form should be completed at the time a 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. 
 Physician requests that patient be withdrawn to protect the welfare of the 
patient. 
 Patient is lost to follow-up. 
 Other (specify). 
 
A subject may elect to withdraw from the study at any time.  The subject should notify 
the investigator.  The investigator and research staff should encourage all subjects to 
return for required follow-up visits.  A subject is considered lost to follow-up if by the 
five year time point the subject who missed earlier consecutive visits has not come in for 
their final follow-up visit. Only at this time should the subject be exited from the trial.   
 
The site research staff should make every effort to contact the patient at each scheduled 
follow-up visit, despite any lack of contact on any previous occasions.  The clinical 
objective may be jeopardized if a large number of subjects are lost to follow-up or 
withdraw consent.   
 

 
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A subject may be considered lost to follow-up for a particular visit if 3 documented 
attempts are made to make contact with the subject, one by certified mail.   
 
9.13. STRATEGIES FOR MAINTAINING LONG-TERM SUBJECT FOLLOW-UP 
COMPLIANCE 
 
Medtronic will be work with each site to maintain compliance of implanted subjects in 
order to assess the long-term performance of the Endurant Stent Graft. The following are 
strategies for increasing that compliance. 
 
1. During site training, Medtronic will emphasize to the site the importance of study 
follow-up, and that the site should communicate this importance to each subject. 
2. Medtronic Clinical Research Associates (CRAs) will continue to contact sites 
prior to the next follow-up visit to ensure a visit has been scheduled. After the 
anticipated visit takes place, the CRA will again contact the site to ensure the 
subject was seen. 
3. Sites will be informed to promptly reschedule any missed patient visits, and to 
reinforce the necessity of a follow-up visits to confirm proper stent graft function. 
4. If a scheduled visit is missed due to patient illness, transportation issues, or travel, 
the site will be advised to: 
 
a. Reinforce the necessity of follow-up visits; 
 
b. Identify alternate transportation sources 
c. Identify alternate investigational sites to perform required imaging for device 
assessment 
5. For lost-to-follow-up subjects, sites will be requested to examine the Social 
Security Death Index to determine subject status (only the status will be sent to 
Medtronic, excluding subject identifying information). 
 
In addition to the aforementioned steps executed at the site level, Medtronic will evaluate 
follow-up compliance at each site, on a quarterly basis, as the electronic data capture 
system can provide regular reports on site / subject follow-up compliance rates. Those 
sites which have reported several missed visits will be contacted to determine a root 
cause of the noncompliant visits. Once this cause is determined, CRAs will work with the 
site to help reinforce the importance of follow-up visits. If the site continues to deviate 
from the follow-up schedule, additional training will take place at the site level. Repeated 
follow-up compliance violations within the site’s control may result in further actions, 
including but not limited to withdrawal of permission to enroll subjects at a particular 
site, or denial of future study participation. 
 
Medtronic is committed to patient safety and realizes that follow-up visits are essential in 
determining any device-related issues.   By taking the steps listed above, Medtronic 
anticipates improved subject follow-up and site compliance with the follow-up 
requirements of the protocol. 
 
 

 
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9.14. 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 patient identifiers from 
clinical study documents.  For this purpose, a unique subject identification code (site 
number, subject number and subject initials) 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. 
 
Medtronic Vascular recommends that the study sites comply with the subject 
confidentiality provisions of the Health Insurance Portability and Accountability Act 
(HIPAA) issued by the U.S. Department of Health and Human Services (HHS).  Sites 
should maintain patient privacy in accordance to federal regulations (45 CFR Parts 160 
and 164), local regulations, and institutional requirements. 
 
9.15. DEVICE TRACKING 
 
The investigator also is required to maintain adequate records of the Endurant Abdominal 
Stent Graft Systems used in trial subjects. This information is recorded in the Device 
Disposition Form. 
 
Explanted product should be returned to Medtronic Vascular (see Appendix K).   
 
9.16. STUDY TERMINATION 
 
Medtronic Vascular and/or the US FDA have the right to terminate this study at any time 
and remove all study materials from the site.  Regardless of the underlying reason for 
terminating the study, all subjects that have been enrolled up to the point of study 
termination will continue to be followed out to the 5 year follow-up time frame. 
 
9.17. STUDY CLOSURE 
 
Upon completion (when all patients enrolled have completed the 5-year follow-up visit or 
previously exited the study, and the CRFs and queries have been completed) or 
termination (closure that occurs prior to meeting defined endpoints) of the study, 
Medtronic Vascular and/or its designees will notify the site.  Study closeout visits will be 
performed.  All unused study devices and any unused study materials and equipment will 
be collected and returned to Medtronic Vascular and/or its designees.  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.  Other issues that will be 
reviewed at this visit include:  discussing record retention requirements (refer to Section 
13.1—Investigator Records), device accountability, possibility of site audits, publication 
policy, and notifying the IRB of study closure, etc. 

 
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10. ADVERSE EVENT DEFINITIONS AND EXPEDITED 
REPORTING 
 
The following adverse events will be collected for the study:  
 Clinical sequelae caused by or directly associated with the Endurant device, the 
index procedure or any secondary endovascular procedure (including 
conversion to open repair) and technical observation. 
 Those adverse events that meet the definition of Major Adverse Event (MAE). 
 Those adverse events directly associated with the death of the subject.  
 Adverse events meeting Medical Device Reporting (MDR) criteria.  
 Serious adverse events within 30 days of index procedure. 
 
A list of potential adverse events is provided in Section 15 - Risk Analysis.  Adverse 
event definitions and reporting schedules are defined in the following sections.  
Definitions for “Adverse Event” and “Serious Adverse Event” are not specified in the US 
FDA IDE regulations (21 CFR 812) and so are based on those in the EN ISO 14155:2011 
document, entitled, Clinical investigation of medical devices for human subjects – Part 1:  
General requirements (ISO 14155-1:2003E).23   
    
10.1. DEFINITIONS 
 
Adverse Event20 
  Specific adverse event definitions are provided in Appendices B-D. 
 
Adverse Event (AE) (ISO14155:2011) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device. 
NOTE 1    This definition includes events related to the investigational medical 
device or the comparator. 
NOTE 2    This definition includes events related to the procedures involved. 
NOTE 3    For users or other persons, this definition is restricted to events related to 
the investigational medical device. 
 
Major Adverse Event 
Major adverse events include the occurrence of any of the following and are defined in 
Appendix B. 
 
All-Cause Mortality 
 
Bowel Ischemia 
 
Myocardial Infarction 

 
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 
Paraplegia 
 
Procedural Blood Loss ≥ 1000 cc 
 
Renal Failure 
 
Respiratory Failure 
 
Stroke 
 
Serious Adverse Event20 
Serious Adverse Event (SAE) (ISO14155:2011) 
Adverse event that  
a) 
led to a death. 
b) 
led to a serious deterioration in the health of the subject that either resulted in  
1) 
a life threatening illness or injury, or 
2) 
a permanent impairment of a body structure or a body 
function, or 
3) 
in-patient hospitalization or prolongation of existing 
hospitalization, or 
4) 
medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body 
structure or a body function  
c) 
led to fetal distress, fetal death or a congenital abnormality or birth defect  
 
NOTE     Planned hospitalization for a pre-existing condition, or a procedure required 
by the CIP, without serious deterioration in health, is not considered a serious adverse 
event  
 
Unanticipated Adverse Device Effect20 
An unanticipated adverse event is defined as any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if 
that effect, problem, or death was not previously identified in nature, severity, or degree 
of incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects.   
 
10.2. EXPEDITED ADVERSE EVENT REPORTING  
  
Investigators are responsible for reporting all adverse events to Medtronic Vascular as 
described in Section 9.9 – Adverse Events.  The investigator should follow the reporting 
requirements of the reviewing IRB for all adverse events (including serious events). In 
addition, Medtronic requires that the following timeframes be used for the reporting of 
adverse events.     
 
Adverse Events 
The investigator must report to Medtronic Vascular any adverse event as soon as possible  
In addition, the investigator must report the adverse event to the reviewing IRB according 
to its policies and procedures. 

 
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Information should be submitted on the Adverse Event Form.   
 
Documentation of the IRB and Medtronic notification should be maintained in the site’s 
clinical study files.  It is recommended that acknowledgement of receipt from the IRB be 
maintained in the study file as well. 
 
Serious Adverse Events 
The investigator must report to Medtronic Vascular any serious adverse event as soon as 
possible, but in no case later than 3 working days after the investigator first learns of the 
event.  In addition, the investigator must report the serious adverse event to the reviewing 
IRB according to its policies and procedures. 
  
 
Information should be submitted on the Adverse Event Form.  All relevant source 
documentation should be faxed to the Medtronic Vascular Clinical Affairs Department at 
(763) 367-3214. 
 
Documentation of the IRB and Medtronic notification should be maintained in the site’s 
clinical study files.  It is recommended that acknowledgement of receipt from the IRB be 
maintained in the study file as well. 
 
Unanticipated Adverse Device Effect 
The investigator must report to Medtronic Vascular any unanticipated adverse device 
effect as soon as possible, but in no case later than 3 working days after the investigator 
first learns of the event.  The investigator’s report to the reviewing IRB must be 
completed within 10 working days of the investigator’s knowledge of the event (per 21 
CFR 812.150).   
 
Information should be submitted on the Adverse Event Form.  All relevant source 
documentation should be faxed to the Medtronic Vascular Clinical Affairs Department at 
(763) 367-3214. 
 
Documentation of the IRB and Medtronic notification should be maintained in the site’s 
clinical study files.  It is recommended that acknowledgement of receipt from the IRB be 
maintained in the study file as well.  Questions about reporting of adverse events may be 
directed to the ENGAGE PAS clinical study team.  
 
 
10.3. MEDICAL DEVICE REPORTING 
 
The products used in this study are market approved and will be used within current 
indications for use as specified in the product labeling. If there should be any alleged 
device related death, serious injury/illness, device malfunction, or complaint reported, the 
event will be reported through Medical Device Reporting (MDR) per FDA regulations 21 
CFR 803, subpart C. 
 

 
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Manufacturers must report device-related deaths, serious injuries/illnesses and 
malfunctions to the FDA whenever they become aware of information that reasonably 
suggests that the reportable event occurred (one of their devices has or may have caused 
or contributed to the event).  
 
A device complaint is defined as any (written, electronic or oral communication that 
alleges) deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of a device after it is released for distribution. 
 
A device malfunction is defined as failure of a device to perform as claimed by the 
manufacturer. This includes all performance specifications and all claims made in the 
instruction for the device. 
 
Serious injury/ Serious illness is defined as an injury or illness that 
 is life threatening. 
 results in permanent impairment of a body function or permanent damage to a 
body structure; or 
 necessitates medical or surgical intervention to preclude permanent impairment of 
a body function or permanent damage to a body structure. 
 
All device complaints, malfunctions and serious injuries/illnesses will be documented on 
the eCRF as soon as possible but in no case later than 3 working days after the 
Investigator, or other site personnel authorized to participate in the study, become aware 
of the event, and reported to the IRB within the IRB timeframe if required. 

 
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11. DATA MANAGEMENT PROCEDURES 
 
Medtronic Vascular will oversee all data management functions.  Medtronic Vascular 
will be responsible for database development, system maintenance, user training, data 
queries, and report generation.  A contract research organization will be responsible for 
the electronic data capture system.   
 
11.1. CASE REPORT FORMS 
 
Medtronic Vascular will use an electronic data capture (EDC) system to collect patient 
data.  The electronic case report forms (eCRFs) are the primary component of EDC and 
are based on the sample forms shown in Appendix I.  Training on use of the system will 
be provided to the study site personnel.  Instructions for completion of the eCRFs also 
will be provided. 
 
The eCRFs must be completed, saved, and locked via electronic signature by the 
Investigator using a unique ID and password.  This ID and password are for the use of the 
investigator only and may not be used by any other person.  Because of the potential for 
errors or inaccuracies in transcribing data into eCRFs, source documentation must be 
maintained in each subject’s hospital chart and/or electronic medical record.  The eCRFs 
and source documentation must be available at all times for inspection by the study 
monitors or regulatory inspectors. 
 
Changes made to eCRFs will be electronically recorded in a complete audit trail that 
cannot be changed, but can be accessed by authorized personnel at anytime.  All data are 
transmitted via the Internet in an encrypted fashion.  When received at the server site, the 
data are decrypted and stored.  Data can be extracted for Medtronic Vascular review and 
analysis at any time. 
 
11.2. SOURCE DOCUMENTATION 
 
Regulations require that an investigator maintain information in the study subject’s 
medical records to corroborate data collected on the eCRF.  To comply with these 
regulatory requirements, the following information will be maintained and made 
available as required by Medtronic Vascular and/or its designees and/or regulatory 
inspectors.  Shadow charts are not appropriate or adequate source documentation.  
Complete medical (clinical and hospital) records include the following documentation.   
 
 Medical history/physical condition of the patient before involvement in the study 
sufficient to verify clinical protocol entry criteria. 
 Description of device implantation procedure (material used, drugs administered 
during the procedure, device identification information and disposition, date, 
time, angiographic and clinical findings, etc.). 
 
 

 
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 Signed notes in the subject’s medical record on the enrollment day that identify 
and include:  the subject’s date of enrollment, procedure date, the study sponsor 
(Medtronic Vascular), clinical site name, the subject-assigned identification 
number, the subject- assigned enrollment number, and documentation and 
confirmation that the appropriate informed consent was obtained. 
 Dated and signed notes for each subject’s study visit. 
 Lab results.   
 All ECG, angiogram, CT, Ultrasound and MRI reports, etc.   
 Dated printouts or reports of special assessments (ECG report, imaging report, 
etc.). 
 Adverse event reporting and follow-up of the adverse events.  Information in the 
medical chart should include at a minimum the following:  event description, 
severity, seriousness, onset date, date site became aware of event, duration, 
relation to study device, treatment, and outcome of the adverse event. 
 Study subject’s condition upon completion of or withdrawal from the study. 
 
11.3. TRANSMISSION OF DATA  
 
Required data will be recorded on the appropriate eCRF at the time of or as soon as 
possible after the patient visit.  The eCRFs and any requested supporting source 
documents must be sent to Medtronic Vascular and/or retrieved from the investigator 
during monitoring visits.  Questions about completion of the eCRFs may be directed to 
the ENGAGE PAS clinical study team. 
 
11.4. DATA QUERIES  
 
During monitoring visits, the Monitor will perform review as per the Monitoring plan on 
variables, i.e., demography, inclusion/exclusion criteria, safety, effectiveness, on the 
eCRFs with each subject’s source documents. Any discrepancies will be queried by 
Medtronic Vascular or its designee and must be resolved by the investigational site staff 
and investigator in a timely manner.  Queries also will be generated by Medtronic 
Vascular data management personnel during routine review of the data on the electronic 
data capture system. 
 
 
 
 

 
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12. MONITORING AND AUDITING PROCEDURES 
 
12.1. MONITORING 
 
This study will be monitored in accordance with the protocol, International Conference 
on Harmonization (ICH) Guidelines, Good Clinical Practices and applicable regulations 
and guidelines governing clinical study conduct and the ethical principles that have their 
origin in the Declaration of Helsinki, including Title 21 CFR Parts 11, 50, 54, and 56. 
 
A monitor is an individual designated by a sponsor or contract research organization to 
oversee the progress of an investigation.  The monitor may be an employee of a sponsor 
or a consultant to the sponsor, or an employee of or consultant to a contract research 
organization.  The monitor will be trained on the device, investigational plan, informed 
consent, instructions for use, applicable Medtronic Vascular procedures, electronic data 
capture system, and regulatory requirements.  The monitor will periodically check and 
report on the progress of the clinical study at an investigational site or other data 
gathering organization, e.g., other Medtronic facility. 
 
All Case Report Forms will be reviewed for completeness and clarity.  Source 
verification of study data and the schedule for monitoring visits to the sites will be 
performed per the study's Monitoring Plan.  Missing or unclear data will be requested as 
necessary throughout the study.  Additional documentation such as Discharge Summaries 
or Death Certificates may be requested when adverse events are observed.     
 
The monitors for this study are responsible for securing compliance with the signed 
clinical study agreement, the investigational plan, applicable FDA regulations, or any 
conditions of approval imposed by the reviewing IRB or FDA.   
 
12.2. RESPONSIBILITIES OF THE CLINICAL INVESTIGATOR 
 
This clinical study is subject to regulations of the U.S. Food and Drug Administration 
(FDA).  Therefore, the Investigator is responsible for ensuring that the investigation is 
conducted according to the signed clinical study agreement, the investigational plan and 
all applicable FDA regulations, for protecting the rights, safety, and welfare of subjects 
under the investigator's care, and for the control of devices under investigation. The 
investigator is also responsible for ensuring that informed consent is properly obtained 
per 21 CRF Part 50 of the FDA's regulations. 
 
The Investigator is also responsible for the following: 
 
 Awaiting Approval:  The Investigator is responsible for determining whether 
potential subjects would be interested in participating in an investigation, but 
not requesting the written informed consent of any subject to participate and 
not allowing any subject to participate before obtaining IRB and FDA 
approval. 
 

 
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 Compliance: The Investigator is responsible for conducting the investigation 
in accordance with the signed clinical study agreement with Medtronic, the 
Investigational Plan, and any applicable FDA regulations and any conditions 
of approval imposed by the IRB or FDA. 
 
 
12.3. RESPONSIBILITIES OF THE SPONSOR 
 
Medtronic is the Sponsor of this clinical study.  As the Sponsor, Medtronic is responsible 
for selecting qualified investigators and providing them with the information they need to 
conduct the clinical study properly, ensuring proper monitoring of the investigation, 
ensuring that IRB review and approval are obtained, and ensuring that any reviewing IRB 
and FDA are promptly informed of significant new information about the clinical study. 
 
12.4. MONITORING VISITS 
 
Scheduled visits to the clinical investigational site may occur at the following times:  
prior to the start of the clinical study (pre-study qualification visit), at initiation of the 
study and interim visits throughout the clinical study as required, annually, and upon 
completion of the clinical study. 
 
12.4.1 Pre-study Qualification Visit 
 
A pre-study visit may be conducted by Medtronic Vascular personnel (or designees) to 
review the clinical investigational plan and regulatory requirements with the investigator 
and the study personnel to assure that they:  
 
 Understand the investigational status of the device and the requirements 
for its use and accountability. 
 Understand the clinical investigational plan. 
 Understand the requirements for an adequate and well-controlled clinical 
study. 
 Understand and accept the obligation to conduct the clinical 
investigation in accordance with the national regulations. 
 Understand and accept the obligation to obtain informed consent in 
accordance with the national regulations. 
 Understand and accept the obligation to obtain IRB approval before the 
clinical study is initiated, ensure continuing review of the study by the 
IRB, and keep Medtronic Vascular informed of IRB approval and 
actions concerning the clinical study. 
 Have access to an adequate number of eligible patients to participate in 
the study (1/center/month). 
 Have adequate facilities and resources to conduct the study.  This 
includes resources appropriate for use of electronic data capture systems. 
 Have sufficient time from other obligations to carry out the 
responsibilities of the clinical study. 

 
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 Sign the Investigator Agreement and study contracts (prior to enrollment 
of patients). 
 
A report of the pre-study qualification visit will be completed.  Resolution of any 
concerns or completion of any appropriate follow-up activities stemming from the pre-
study visit also will be documented. 
 
12.4.2 Initiation Visit 
 
Medtronic Vascular clinical personnel (or designees) will provide assistance for both 
technical concerns and study management issues during the initiation visit.  First implant 
may or may not coincide with this visit.  Any observations will be documented and issues 
requiring follow-up will be identified on a monitoring report.  Training of study 
personnel also will be documented. 
 
12.4.3 On-Site Interim Monitoring Visits 
 
On-site monitoring visits will be made on an as-required basis (and at least annually) to 
assess adherence to the clinical investigation plan, IRB review of study progress, 
maintenance of records and reports, and selected review of source documents for 
accuracy, completeness, legibility, and omissions.  The monitors will acquire information 
to assess the progress of the study (toward meeting study objectives) and identify any 
concerns that stem from observation of device performance and/or review of the 
investigator's patient records, study management documents, and patient informed 
consent documents.  Monitoring reports will be generated along with communications to 
the investigator, which document the result of the monitoring visit and any recommended 
actions.  Resolution of concerns and completion of assigned tasks will be documented. 
 
12.4.4 Audits 
 
An on-site audit may be completed periodically throughout the study at each clinical site 
by an independent group.  The purpose of the audit will be to ensure compliance to the 
investigational plan and regulatory requirements, e.g., written informed consent was 
documented, information recorded on the case report forms is complete and accurate as 
compared to source documentation, protocol deviations are noted, and device 
accountability is accurate and complete.  A randomly selected number of patient records 
and other supporting documents will be compared to the case report forms.  A record of 
the findings and recommended actions to correct deficiencies will be documented on the 
audit report. 
 
 
12.4.5 Final Monitoring Review 
 
Depending upon the status of the study at each center, a close-out or final visit may be 
conducted.  Any ongoing responsibilities will be discussed with the investigator and the 
study center coordinator.  A final monitoring report, which includes, at a minimum, 
disposition of any unused devices, will be completed. 
 
 
 

 
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13. RECORDS AND REPORTS 
 
Throughout the course of this clinical study, Medtronic Vascular, the investigators, and 
reviewing IRBs are responsible for the records and reports detailed in the following 
sections.   
 
13.1. INVESTIGATOR RECORDS 
 
Records must be maintained by the investigator in compliance with national regulations.  
Investigator records are subject to regulatory inspection (and Medtronic Vascular) and 
copying, and must be retained for a period of 2 years after the investigation is completed 
or terminated, or, 2 years after the records are no longer required to support the 
application to market the device (whichever date is later). 
 
The investigator is responsible for the preparation (review and signature) and retention of 
the records cited below. 
 
 All correspondence with another investigator, IRB, Medtronic Vascular, a 
monitor, or FDA, including required reports and study documents which 
pertain to the investigation. 
 Records of receipt, use, and final disposition of a device.    
 Records of each subject's case history and exposure to the device.  Case 
histories include the case report forms and supporting source data (signed and 
dated informed consent forms, medical records, e.g., progress notes of the 
physician, patient’s hospital chart, nursing notes).   
 The clinical investigational plan, with documents showing the dates of and 
reasons for each deviation from the protocol.  
 Any other records that FDA requires to be maintained by regulation or by 
specific requirement for a category of investigations or a particular 
investigation. 
13.2. INVESTIGATOR REPORTS 
 
The investigator is responsible for the preparation and submission of the reports cited in 
Table 7.  Reports must be prepared in complete, accurate and timely manner.  These 
reports may be subject to regulatory inspection (and Medtronic Vascular) and copying, 
and the retention requirements described above for Investigator Records.  In addition to 
the reports listed in the following table, FDA or the reviewing IRB may request reports 
pertaining to any aspect of the clinical study. 
 
 
 
 

 
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Table 7: Investigator Reporting Responsibilities. 
 
REPORT 
SUBMIT TO 
DESCRIPTION/CONSTRAINTS 
Unanticipated 
Adverse Device 
Effects 
Sponsor & IRB 
The report must be submitted to Medtronic Vascular within 3 working 
days after the investigator first learns of the effect.   
Notification to the IRB should be made according to the reporting 
requirements of the reviewing IRB, but no later than 10 working days 
after the investigator first learns of the effect. 
Serious  Adverse 
Events 
Sponsor & IRB 
The report must be submitted to Medtronic Vascular within 3 working 
days after the investigator first learns of the event.   
Notification to the IRB should be made according to the reporting 
requirements of the reviewing IRB. 
Adverse Events  
Sponsor & IRB 
The report must be submitted to Medtronic Vascular as soon as 
possible Notification to the IRB should be made according to the 
reporting requirements of the reviewing IRB. 
Withdrawal of IRB 
Approval 
Sponsor 
The investigator must report a withdrawal of the reviewing authority 
within 5 working days.  
Deviation from 
Investigation Plan 
(Emergency) 
Sponsor & IRB 
Notification must be made within 5 working days if the deviation was 
made to protect the life or physical well-being of a subject. 
Deviation from 
Investigation Plan 
(Other – Non 
Emergent) 
Sponsor & IRB 
If the deviation may affect the scientific soundness of the plan or the 
rights, safety and welfare of the subjects (and is not an emergency), 
then the deviation must be approved by Medtronic Vascular and the 
reviewing authority prior to its implementation.  If the deviation does 
not affect these issues (study soundness, rights, safety, etc.) then only 
Medtronic Vascular must approve it, (except in cases which are 
beyond the control of the investigator—see Section 9.7 – Protocol 
Deviations). 
Failure to Obtain 
Informed Consent 
Sponsor & IRB 
The Investigator must notify Medtronic Vascular and the reviewing 
authority within 5 working days after device use.  The report must 
include a brief description of the circumstances justifying the failure 
to obtain informed consent. 
Final Report 
Sponsor & IRB 
This report must be submitted within 3 months after termination or 
completion of the investigation. 

 
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13.3. SPONSOR RECORDS 
 
Medtronic Vascular will maintain the following study-related records. 
 
 All correspondence with another sponsor, a monitor, an investigator, an IRB, or 
FDA, including required reports.    
 Signed investigator agreements will be required to be collected under 21 CFR 
812.43.  
 Records concerning adverse events related to the device (whether anticipated or 
unanticipated) and complaints.  
 Any other records that FDA requires to be maintained by regulation or by specific 
requirement for a category of investigation or a particular investigation. 
 
13.4. SPONSOR REPORTS 
 
Medtronic Vascular is responsible for the reports cited in Table 8.  These reports are 
subject to regulatory retention and inspection requirements.  In addition to the reports 
listed in the following table, FDA or the reviewing IRB may request reports pertaining to 
any aspect of the clinical study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table 8: Medtronic Vascular Reporting Responsibilities. 
 
 
 
 
 
REPORT 
SUBMIT TO 
DESCRIPTION 
Unanticipated Adverse 
Device Effects 
Regulatory authorities and all 
participating IRBs and 
investigators 
Medtronic Vascular will report on unanticipated 
adverse event within 10 working days after 
receiving notice of the effect. 
Medical Device Reporting 
FDA 
Medtronic Vascular will report Deaths, Serious 
injuries, Malfunctions and Product complaints 
within 30 days of becoming aware of a reportable 
event.     
Informed Consent 
Regulatory authorities 
Medtronic Vascular will submit a copy of any 
report from an investigator of use of the device 
without obtaining informed consent within 5 
working days of receipt of notice of such use. 
Withdrawal of IRB 
Approval 
IRBs, investigators, and 
regulatory authorities, as 
appropriate 
Notification will be made within 5 working days 
after receipt of the withdrawal of approval. 
Withdrawal of Regulatory 
Approval 
All IRBs and investigators 
Notification will be made within 5 working days of 
receipt of notice of the withdrawal of approval. 
Progress Report 
Regulatory authorities and IRBs  
A progress report will be submitted at least 
annually. 
Recall and Device 
Disposition 
Regulatory authorities, IRBs, and 
investigators 
Notification will be made within 30 working days 
and will include the reasons for any request that an 
investigator return, repair or otherwise dispose of 
any devices. 
Final Report 
Regulatory authorities, IRBs, and 
investigators 
Medtronic Vascular will notify reviewing 
authorities within 30 working days of the 
completion or termination of the investigation.  A 
final report will be submitted within 6 months of 
completion or termination. 

 
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13.5. INSTITUTIONAL REVIEW BOARD RECORDS 
 
Each reviewing IRB should maintain the following records.  Records are subject to 
regulatory (and Medtronic Vascular) inspection and copying, and must be retained for a 
period of 3 years after completion of the study.  Additional information may be found in 
21 CFR 56. 
 
 Research proposals reviewed and accompanying documentation 
 Continuing review of ongoing studies 
 Correspondence between IRB and investigator 
 Membership roster 
 Written procedures 
 Meeting minutes 
 Approved informed consent documents 
 Statements of significant new findings 
 Record retention 
 Progress reports submitted by investigators 
 Reports of adverse events 
 
 

 
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14. STUDY COMMITTEES 
 
14.1. CLINICAL EVENTS COMMITTEE 
 
A Clinical Events Committee (CEC) is a group of physicians independent of the clinical 
study with expertise and experience in the area of AAA stent grafts.  The members may 
be interventional cardiologists, vascular surgeons, cardiothoracic surgeons, or 
interventional radiologists.  The CEC will review and adjudicate all major adverse events 
(refer to Appendix B), (except procedural blood loss) through thirty days post-procedure.  
The CEC will review and adjudicate all deaths and any unanticipated adverse device 
effects that occur during the five year follow-up period.  The CEC will also review and 
adjudicate any datapoints pertaining to stent graft occlusions, device migrations, type I 
and III endoleaks and AAA sac enlargement that require further clarification. The CEC 
will review events when the MCRI (Medtronic Clinical Research Institute) Clinical 
Safety forwards the relevant documentation to the members. These events are reviewed 
by the CEC members and adjudicated as being device related, procedure related and/or 
aneurysm related.  
 
The CEC will meet periodically and follow specific criteria to classify and adjudicate the 
aforementioned events and patient deaths.   A Manual of Operations will be developed 
that will detail the operations of the committee.  Results of the adjudication process will 
be recorded by the CEC members on the CEC Event Adjudication Form. 
 
 
 
 
 

 
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15. RISK ANALYSIS 
15.1. POTENTIAL RISKS 
 
Following is a list of potential (expected) risks that may be associated with use of the 
Endurant Stent Graft Systems.  The occurrence of the listed complications may lead to a 
repeat endovascular intervention and/or open surgical repair.  Since the Endurant Stent 
Graft System is a significant risk device, all risks may not be known..   These risks are 
believed to be similar to those associated with the existing commercial endovascular 
devices available as well as the risks associated with standard open surgical repair of 
AAA. 
 
All efforts will be made to minimize these risks by selecting investigators who are 
experienced and skilled in using endoluminal aortic devices and who have been 
adequately trained.  Also, risk minimization activities were performed during 
development and design verification tests of the device.  Activities intended to minimize 
risks include the following. 
 Investigator and study personnel training will be conducted to share information 
regarding the design of the Endurant Stent Graft System, its application and pre-
clinical results. 
 Adherence to eligibility criteria and screening procedures will ensure that 
appropriate patients are enrolled.   
 Adherence to the Endurant Stent Graft System Instructions for Use packaged with 
the device (Appendix A). 
 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. 
 
 
Detailed study procedures are provided in Section 9 - Clinical Study Procedures. 
 
The following potential risks may be associated with use of the Endurant Stent Graft 
System. 

 
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 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 
transient or 
permanent ischemia 
or infarction 
 Endoleak 
 Femoral-femoral 
artery bypass 
thrombosis 
 Fever and localized 
inflammation 
 Genitourinary 
complications and 
subsequent attendant 
problems (e.g., 
ischemia, erosion, 
fistula, incontinence, 
hematuria, infection) 
 Hepatic failure 
 Impotence 
 Infection of the 
aneurysm, device 
access site, including 
abscess formation, 
transient fever and 
pain 
 Lymphatic 
complications and 
subsequent attendant 
problems (e.g., 
lymph fistula) 
 Neurologic local or 
systemic 
complications and 
subsequent attendant 
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 subsequent 
attendant problems 
(e.g., artery 
occlusion, contrast 
toxicity, 
insufficiency, 
failure) 
 Stent graft: improper 
component 
placement; 
incomplete 
component 
deployment; 
component 
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 
subsequent attendant 
problems (eg, 
dehiscence, 
infection, hematoma, 
seroma, cellulitis)  

 
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15.2. POTENTIAL BENEFITS 
 
The potential benefits of the Endurant Stent Graft Systems 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 
repair.4-9  Stent graft repair also provides a treatment option for patients 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 
 
 

 
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16. PUBLICATION POLICY 
 
Publications based on the results of the ENGAGE Post Approval Study will follow the 
process outlined in the Clinical Research Agreement.  A publication committee may be 
formed to oversee the preparation of manuscripts and identify first authors and writers for 
primary and ancillary publications of the study results.   
 
At the conclusion of the study, a multicenter manuscript may be prepared for publication 
in a peer-reviewed, scientific journal.  The manuscript will be made available for review 
by all co-authors, including Medtronic Vascular personnel, prior to submission. 
 
Publication of the primary results from any single site experience within the study will 
not be allowed until the multicenter results are published.  Exceptions to this rule will 
require the prior approval of Medtronic Vascular.   
 
Secondary or ancillary manuscripts also are anticipated.  For the purposes of timely 
abstract presentation and publication, such publications will be delegated to the 
appropriate principal author(s).  Final analysis and review of the manuscript for all 
multicenter publications will require the approval of Medtronic Vascular. 
 
As owners of the Endurant Stent Graft System Study database, Medtronic Vascular has 
the discretion to determine who will have access to the data.  This includes raw as well as 
summary data.  Complete study data, which may contain health information that could be 
identified with a subject, will be made available only for study-related/business-related 
activities, or to regulatory authorities and other government bodies.     
 

 
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17. INSURANCE 
 
Medtronic Vascular has umbrella insurance in an amount common in the medical device 
industry to cover significant exposures.  Medtronic Vascular will comply with local 
regulatory requirements concerning insurance coverage.   
 

 
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18. REFERENCES CITED 
 
1. Faries PL, Dayal R, Lin S, Trociolla S, Rhee J, Craig Kent K. Endovascular stent 
graft selection for the treatment of abdominal aortic aneurysms. J Cardiovasc Surg 
2005;46:9-17.  
 
2. Zarins CK, White RA, Schwarten D, et al. AneuRx stent graft versus open 
surgical repair of abdominal aortic aneurysms: multicenter prospective clinical 
trail. J Vasc Surg 1999;29:292-308.  
 
3. Brewster DC, Geller SC, Kaufman JA, et al. Initial experience with endovascular 
aneurysm repair: comparison of early results with outcome of conventional open 
repair. J Vasc Surg 1998;27:992-1005.  
 
4. 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.  
 
5. Salartash K, Sternbergh III WC, York JW, Money SR. A comparison of open 
transabdominal AAA repair with endovascular AAA repair in reduction of 
postoperative stress response. Ann Vasc Surg 2001;15:53-59.  
 
6. Cuypers WM, Gardien M, Buth J, et al. Randomized study comparing cardiac 
response in endovascular and open abdominal aortic aneurysm repair. Br J Surg 
2001;88:1059-1065. 
 
7. EVAR trial participants.  Endovascular aneurysm repair versus open repair in 
patients with abdominal aortic aneurysm (EVAR trial 1):  randomized controlled 
trial.  Lancet 2005;365:2179-2186. 
 
8. 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. 
 
9. Prinssen M, Buskens E, Blankensteijn JD.  The Dutch Randomized Endovascular 
Aneurysm Management (DREAM) trial.  Background, design and methods.  J 
Cardiovasc Surg (Torino). 2002;43:379-384. 
 
10. 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. 
 

 
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11. Chahwan S, Comerota AJ, Pigott JP, Scheuermann BW, Burrow J, Wojnarowski 
D.  Elective treatment of abdominal aortic aneurysm with endovascular or open 
repair: The first decade. J Vasc Surg 2007;45(2):258-62. 
 
12. Albertini JN, Perdikidess T, Soong CV, et al. Endovascular repair of abdominal 
aortic aneurysms in patients with severe angulation of the proximal neck using a 
flexible stent-graft: European Multicenter Experience. J Cardiovasc Surg 
2006;44:229-236. 
 
13. Sicard GA, Zwolak RM, Sidawy AN, White RA, Siami FS.  Endovascular 
abdominal aortic aneurysm repair: long-term outcome measures in patients at high 
risk for open surgery. J Vasc Surg 2006;44:229-236.  
 
14. Du Toit DF, Saaiman JA, Carpenter JP, Geldenhuys KM. Endovascular aortic 
aneurysm repair by a multidisciplinary team: lessons learned and six-year clinical 
update. Cardiovasc J South Africa 2005;16:36-47. 
 
15. Rose J. Stent-grafts for unruptured abdominal aortic aneurysms: current status. 
Cardiovasc Intervent Radiol. 2006;29:332-43. 
 
16. Faries PL, Briggs VL, Rhee JY, et al. Failure of endovascular aortoaortic tube 
grafts: a plea for preferential use of bifurcated grafts. J Vasc Surg. 2002;35:868-
73. 
 
17. Faries PL, Dayal R, Rhee J, Trocciola S, Kent KC. Stent graft treatment for 
abdominal aortic aneurysm repair: recent developments in therapy. Curr Opin 
Cardiol 2004;19:551-557.  
 
18. Carpenter JP, Baum RA, Barker CF, et al. Impact of exclusion criteria on patient 
selection for endovascular abdominal aortic aneurysms repair. J Vasc Surg 
2001;34:1050-54. 
 
19. Ng TH.  Issues of simultaneous tests for noninferiority and superiority.  J 
Biopharm Stats, 2003;13(4):629-639. 
 
20. United States Code of Federal Regulations, Title 21, Part 812—Investigational    
      Device Exemptions, Subpart A—General Provisions, Definitions (21CFR812.3).   
      Revised April 1, 2006.