A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation™ Abdominal Stent Graft System
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Sponsor: TriVascular, Inc.

TriVascular, Inc. Ovation™ Abdominal Stent Graft System 
 
 
Protocol #771-0006, Rev. J 
TriVascular Proprietary Information 
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CONFIDENTIALITY STATEMENT 
The information contained in this document is a confidential communication.  Acceptance of this 
document constitutes an agreement by the recipient(s) that no unpublished information contained 
herein will be published or disclosed without the sponsor’s prior written approval, except that 
this document may be disclosed to appropriate Institutional Review Boards/Ethics Committees 
under condition that they are also requested to maintain confidentiality. 
 
 
 
 
A Pivotal Clinical Study to Evaluate the Safety and 
Effectiveness of the  
Ovation™ Abdominal Stent Graft System 
 
 
 
 
Protocol Number 771-0006 
 
 
 
 
 
 
 
 
 
Revision:  
 
J (July 7, 2011) 
 
 
Sponsor Name:  
TriVascular, Inc. 
 
Address:   
 
3910 Brickway Blvd. 
 
 
 
Santa Rosa, CA 95403 
 
 
 
 
 
 
 
 
NCT Number: NCT01092117 

TriVascular, Inc. Ovation™ Abdominal Stent Graft System 
 
 
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Protocol Signature Page 
 
 
 
A Pivotal Clinical Study to Evaluate the Safety and Effectiveness 
of the Ovation™ Abdominal Stent Graft System 
Protocol Number 771-0006 
 
 
Revision: 
 
J 
 
Sponsor Name: 
TriVascular, Inc. 
Address: 
 
3910 Brickway Blvd. 
 
 
 
Santa Rosa, CA 95403 
 
I have read this protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described.  I will personally oversee the 
conduct of the study as outlined herein, in accordance with FDA regulations 21 CFR 812, Good 
Clinical Practice (GCP) and the Declaration of Helsinki. 
 
I will provide all study personnel under my supervision with access to this document and all 
pertinent information provided by TriVascular, Inc.  I will discuss this material with them to 
ensure that they are fully informed regarding the investigational device, the safety and efficacy 
parameters, and the conduct of the study in general.  I understand that I am responsible for 
providing adequate supervision of those to whom protocol-related tasks are delegated and that I 
am accountable for regulatory violations from failure to adequately supervise the conduct of the 
clinical study. I agree to provide all subjects with informed consent forms, as required by 
government and ICH regulations.  I agree to report to TriVascular any adverse experiences in 
accordance with the terms of this protocol. Furthermore, I am aware that, prior to the 
commencement of this study, the Institutional Review Board responsible for such matters must 
approve this protocol for the clinical facility where it will be conducted. 
 
 
Site Principal Investigator: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator Name (Printed)  
 
 
Signature 
 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
TABLE OF CONTENTS ............................................................................................................................................ 4 
PROTOCOL SUMMARY .......................................................................................................................................... 6 
1.0 
STUDY GOAL ............................................................................................................................................... 9 
2.0 
BACKGROUND AND RATIONALE ....................................................................................................... 10 
2.1 
CONVENTIONAL TREATMENT OF ABDOMINAL AORTIC ANEURYSM .......................................................... 10 
3.0 
INDICATIONS ............................................................................................................................................ 14 
4.0 
DEVICE DESCRIPTION ........................................................................................................................... 15 
5.0 
STUDY DESIGN ......................................................................................................................................... 18 
5.1 
ELIGIBILITY CRITERIA ............................................................................................................................... 18 
5.2 
STUDY POPULATION .................................................................................................................................. 19 
5.3 
WITHDRAWAL AND LOST-TO-FOLLOW-UP ................................................................................................ 19 
5.4 
DURATION OF STUDY ................................................................................................................................ 20 
6.0 
STUDY PROCEDURES ............................................................................................................................. 21 
6.1 
PATIENT SCREENING ................................................................................................................................. 21 
6.2 
PRE-PROCEDURE EVALUATION .................................................................................................................. 21 
6.3 
TREATMENT PERIOD (IMPLANT/SURGICAL PROCEDURE) ............................................................................ 21 
6.4 
PRE-DISCHARGE ........................................................................................................................................ 22 
6.5 
POST-TREATMENT FOLLOW-UP PERIOD ..................................................................................................... 22 
6.6 
UNSCHEDULED FOLLOW-UP VISITS ........................................................................................................... 23 
6.7 
ANNUAL FOLLOW-UP VISITS ...................................................................................................................... 23 
6.8 
DISCONTINUATION FROM STUDY ............................................................................................................... 23 
7.0 
STUDY OBJECTIVES ............................................................................................................................... 24 
7.1 
PRIMARY OBJECTIVES ............................................................................................................................... 24 
8.0 
DEFINITIONS ............................................................................................................................................ 25 
8.1 
ENDOLEAK ................................................................................................................................................ 25 
8.2 
MIGRATION ............................................................................................................................................... 25 
8.3 
PATENCY ................................................................................................................................................... 25 
8.4 
LOSS OF STENT GRAFT INTEGRITY ............................................................................................................ 25 
8.5 
AAA ENLARGEMENT ................................................................................................................................ 25 
8.6 
SURGICAL CONVERSION ............................................................................................................................ 25 
8.7 
IMAGING CORE LAB .................................................................................................................................. 25 
8.8 
EXPLANT EVALUATION ............................................................................................................................. 26 
8.9 
ADVERSE EVENTS ..................................................................................................................................... 26 
8.10 
SERIOUS ADVERSE EVENTS (SAE) ............................................................................................................ 27 
8.11 
MAJOR ADVERSE EVENTS (MAE) ............................................................................................................. 28 
8.12 
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) ................................................................................ 28 
8.13 
CONVERSION TO OPEN SURGICAL REPAIR ................................................................................................. 28 
8.14  
TECHNICAL FAILURES ............................................................................................................................... 29 
8.15 
DEATHS ..................................................................................................................................................... 29 
8.16 
EXPLANTS ................................................................................................................................................. 29 
9.0  
ENDPOINTS AND TECHNIQUES FOR MEASUREMENT ................................................................ 30 
9.1 
PRIMARY ENDPOINTS ................................................................................................................................ 30 

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9.2 
SECONDARY ENDPOINTS ........................................................................................................................... 30 
10.0  
STATISTICAL CONSIDERATIONS ....................................................................................................... 32 
10.1 
PRIMARY ENDPOINTS AND HYPOTHESES ................................................................................................... 32 
10.2 
STATISTICAL SAMPLE SIZE JUSTIFICATIONS .............................................................................................. 32 
10.3  
STATISTICAL METHODS FOR PRIMARY ENDPOINTS ................................................................................... 33 
10.4  
SECONDARY STATISTICAL ENDPOINTS ...................................................................................................... 33 
10.5 
ASSUMPTION VERIFICATION ..................................................................................................................... 34 
10.6 
STUDY RETENTION AND HANDLING OF MISSING DATA ............................................................................ 34 
10.7 
POOLABILITY ............................................................................................................................................ 34 
10.8 
SUBJECT POPULATIONS FOR ANALYSIS ..................................................................................................... 35 
10.9 
DETAILED STATISTICAL ANALYSIS PLAN .................................................................................................. 35 
10.10 
STATISTICAL REFERENCES ........................................................................................................................ 35 
11.0  
RISK ANALYSIS ........................................................................................................................................ 36 
12.0  
STUDY RESPONSIBILITIES ................................................................................................................... 38 
12.1  
RESPONSIBILITIES OF SPONSOR ................................................................................................................. 38 
12.2  
FDA AND IRB APPROVAL ......................................................................................................................... 38 
12.3  
SELECTION OF INVESTIGATORS ................................................................................................................. 38 
12.4  
SELECTION OF MONITORS ......................................................................................................................... 38 
12.5  
ACCOUNTABILITY AND CONTROL OF DEVICE ........................................................................................... 38 
12.6  
OBTAINING AGREEMENTS .......................................................................................................................... 38 
12.7  
INFORMING INVESTIGATORS ...................................................................................................................... 38 
12.8  
MONITORING INVESTIGATIONS ................................................................................................................. 39 
12.9  
RESPONSIBILITIES OF INVESTIGATORS ....................................................................................................... 39 
12.10 
SOURCE DOCUMENTATION ........................................................................................................................ 39 
12.11 
MAINTAINING RECORDS ............................................................................................................................ 40 
12.12 
STUDY DEVIATIONS .................................................................................................................................. 41 
12.13 
TERMINATION OF STUDY ........................................................................................................................... 41 
13.0 
STUDY COMMITTEES ............................................................................................................................ 43 
13.1  
DATA SAFETY MONITORING ..................................................................................................................... 43 
13.2  
CLINICAL EVENTS COMMITTEE ................................................................................................................. 43 
14.0 
TRAINING .................................................................................................................................................. 44 
15.0 
INFORMED CONSENT ............................................................................................................................ 45 
 
LIST OF APPENDICES 
Appendix I: 
References 
 
Appendix II:  References Related to Complications 
 
Appendix III:  ASA Classification System 
 
Appendix IV: Schedule of Activities 
 
Appendix V:  Informed Consent Template 
 
Appendix VI:  CT Scanning Techniques 
 
Appendix VII: Explant Procedure 

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PROTOCOL SUMMARY 
Sponsor 
TriVascular, Inc. 
Protocol Title 
A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the 
Ovation Abdominal Stent Graft System 
Study Description A prospective, consecutively enrolling, non-randomized multi center 
clinical evaluation of the safety and efficacy of the Ovation Abdominal 
Stent Graft System when used in the treatment of patients with AAA.  
Study Objectives 
The primary objectives of this study are to determine whether the Ovation 
Abdominal Stent Graft System is a safe and effective method of treating 
AAA’s in those patients considered to be suitable candidates for open 
surgical repair.   
 
The safety of the Ovation Abdominal Stent Graft System will be 
determined by evaluating the proportion of subjects that experience a 
Major Adverse Event. The Major Adverse Event rate will be compared to 
a performance goal.   
 
The effectiveness of the Ovation Abdominal Stent Graft System will be 
determined by evaluating the proportion of subjects that achieve 
Treatment Success at 12 months post-procedure.  The Treatment Success 
rate will be compared to a performance goal. 
Study Primary 
Endpoints 
The primary safety endpoint is defined as the proportion of subjects who 
experience a Major Adverse Event within 30 days of the initial 
procedure. 
 
The primary effectiveness endpoint is proportion of subjects that achieve 
Treatment Success. Treatment Success is a composite endpoint assessed 
at 12 months that requires the following criteria to be met: 
 
- 
Technical Success, defined as successful delivery and deployment of 
one aortic body and two iliac limbs. 
- 
Freedom from Type I & III endoleaks at 12 months 
- 
Freedom from stent graft migration at 12 months 
- 
Freedom from AAA enlargement at 12 months 
- 
Freedom from AAA rupture and conversion to open repair through 12 
months 

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PROTOCOL SUMMARY 
Study Secondary 
Endpoints 
The secondary safety endpoints are: 
• Mortality rates at 30 days and 12 months  
• AAA related mortality at 30 days and 12 months 
• Major Adverse Events (MAE) through 12 months 
• AAA rupture through 12 months  
• Conversion to open repair through 12 months 
 
The secondary effectiveness endpoints will be evaluated through 12 
months:  
• Technical success, defined as successful delivery and deployment 
of one aortic body and two iliac limbs. 
• Freedom from Type I & III endoleaks  
• Freedom from stent graft migration 
• Freedom from AAA enlargement 
• Freedom from loss of device integrity 
 
The secondary Clinical Utility endpoints will be evaluated: 
• Blood loss 
• Duration of procedure 
• Length of hospital stay 
• Type of anesthesia 
• Type of vascular access 
Subject 
Population 
Primary Study Phase - 150 subjects 
Continued Access Phase – 100 subjects 
Follow-Up 
Intervals 
Follow up intervals will consist of 1, 6, and 12 months following the 
initial implant procedure, then annually through 5 years.   
Follow- Up 
Activities 
Follow up activities will consist of: 
• Physical exam 
• Ankle Brachial Index (ABI) at Hospital Discharge 
• Contrast Enhanced Spiral Abdominal/Pelvic CT  
• Abdominal X-ray (KUB), including AP, lateral, left oblique and 
right oblique views  
• Device/aneurysm assessment based on imaging  
• Laboratory Assessment  
• Assessment of Adverse Events  
 

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PROTOCOL SUMMARY 
Investigational 
Sites 
Maximum of 40 sites 
 
Anatomic 
Criteria 
Proximal Neck Diameter: 
16-30mm (ID) 
Proximal Neck Length: 
>7mm 
Juxtarenal Aortic Angle: 
< 45 degrees if <10mm neck length 
 
≤ 60 degrees if  >10mm neck length 
Iliac Diameter: 
8-20mm 
Iliac Length: 
>10mm 
(Distal Seal Zone) 
Treatment Length: 
13-19cm  
Principal 
Investigators: 
Dr. Manish Mehta 
Albany Medical Center 
Data Safety 
Monitoring 
Board (DSMB) 
Axio Research Acquisition Co. LLC  
2601 4th Avenue, Suite 200  
Seattle, WA 98121  
Phone: 206-547-2829  
Fax: 206-547-4671  
Monitoring 
TriVascular, Inc. 
3910 Brickway Blvd. 
Santa Rosa, CA 95403 
Electronic Data 
Capture (Host) 
Phase Forward  
880 Winter Street  
Waltham, MA 02451  
Phone: 781-890-7878  
Fax: 781-890-4848  
Core Lab 
M2S, Inc.  
12 Commerce Avenue  
West Lebanon, NH 03784 USA  
Phone: 603-298-5509  
Fax: 603-298-5055  
 
 

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PROTOCOL 
 
A list of all articles referenced in this protocol is contained in Appendix I: References. 
1.0 
STUDY GOAL  
The goal of this study is to evaluate the performance of the Ovation Abdominal Stent Graft 
System in subjects with Abdominal Aortic Aneurysms.  The specific goals of the study are to: 
1. Evaluate the safety of the Ovation Abdominal Stent Graft System at 30, 180, 365-days 
and annually for 5 years post-implant. 
2. Evaluate the ability to deliver the Ovation Abdominal Stent Graft System within the 
abdominal aorta. 
3. Evaluate the ability of the Ovation Abdominal Stent Graft to exclude the abdominal 
aortic aneurysm. 

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2.0 
BACKGROUND AND RATIONALE  
Abdominal aortic aneurysms (AAA) are the most commonly encountered aneurysm of the 
arterial system.  Several factors are thought to contribute to the development of AAA’s such as: 
advanced age, gender, previous family history of AAA, chronic obstructive pulmonary disease, 
hypertension, smoking, connective tissue disorders and atherosclerotic disease.  Males are 
affected by aneurysmal disease more often than females.   
The presentation of a AAA usually depends upon whether complications or symptoms have 
occurred.  Many asymptomatic patients are diagnosed with a AAA upon routine examination by 
a physician for another problem or as a result of increased patient awareness through public 
screening programs.  Symptoms such as acute onset of abdominal, back, or flank pain are a result 
of expansion of the aneurysm.  Such symptoms can be an indication of impending rupture which 
may follow at a time that is unpredictable.  Rupture of a AAA is a life-threatening clinical event 
necessitating emergent intervention.  Many patients with a ruptured AAA die before reaching the 
hospital.  Of the patients that do reach the hospital, about half of those patients survive.  
Fortunately, the rate of detecting and diagnosing AAA has increased in recent years.  Improved 
imaging techniques and public screening programs for the aging population have contributed to 
this increase1.  
The overall objective in treating AAA is to prevent rupture and subsequent death.  The natural 
history of untreated AAA is to progressively enlarge and consequently rupture.  Although it is 
difficult to predict, it is generally accepted that the greater the diameter of a AAA, the greater the 
risk of rupture.  According to a study of 300 patients over a 6-year time period, Guirguis et al2  
determined that the risk of rupture of abdominal aortic aneurysms with a diameter less than 5.0 
cm is significantly lower than the risk of rupture of AAA’s with a diameter of 5.0 cm or more.  
More recently, Brewster et al3 reported in 2003 the risk of rupture for females having a 5 cm 
diameter AAA is equivalent to that of a male having a 6 cm diameter AAA. 
2.1 
Conventional Treatment of Abdominal Aortic Aneurysm 
The current (standard) treatments for abdominal aortic aneurysms include “watchful waiting,” 
surgical repair of the aorta using a fabric substitute, and endovascular repair of the aorta. 
2.1.1  Watchful Waiting 
If the AAA is small and not causing symptoms, the treating physician may perform a CT or 
MRI scan every 6 months to assess changes in the size or shape of the aneurysm.  This 
method is usually used for aneurysms that are smaller than about 5 cm in diameter. 
If the AAA is large, grows quickly, or is causing symptoms, it will require prompt treatment 
to prevent rupture.  The active treatments for AAA are open surgical aneurysm repair and 
endovascular stent graft repair. 
2.1.2  Open Surgical Repair 
Until the early 1990’s, open surgical repair was the only standard treatment for AAA.  
Significant inherent mortality and morbidity risks are associated with open surgical repair 
due to the invasive nature of this surgery.  The standard surgical procedure involves resection 
of the diseased segment of the aorta and replacement with a synthetic graft.  This surgical 
technique necessitates general anesthesia, aortic cross-clamping, and significant blood loss 
with associated transfusions.   
Improvements in mortality and morbidity rates for open surgical repair have been noted in 
the last several decades4.  The rate of early operative mortality for open surgical repair varies 

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greatly, (between 3-6%) throughout the published literature.  In a prior FDA Health 
Notification, the reported range for early mortality rates in population-based series for 
elective open surgical repair was between 3-5% at 30 days1.  In a literature review study 
conducted in 2001 by Hallin5, the mortality rate for elective surgical repair was noted to be 
approximately 5%, and approximately 50% for emergent surgical repair.  In a recent multi-
center AAA clinical trial evaluation of open versus endovascular treatment conducted by W. 
L. Gore & Associates, Matusmura6 reports the rates of major adverse events were 
significantly lower in the endovascular group (14%) than those in the control group (57%).  
Patients in the endovascular treatment group experienced less blood loss, a reduction in need 
for transfusions and a shorter length of hospital stay. 
Significant mortality and morbidity have been associated with the surgical repair of AAAs, 
particularly in elderly patients with multiple comorbid medical conditions.  Surgical 
complications have mainly been associated with the surgical incision, patient co-morbidities, 
cardiopulmonary bypass, and anticoagulation.  Postoperative complications have included 
bleeding, renal insufficiency, paraplegia, stroke, and the need for prolonged ventilatory 
support.  The literature demonstrates mortality rates for elective surgery to be 0–6.1%, with 
2.7% as the average.  The following outlines morbidities associated with elective 
conventional surgery. 
Complication 
Range 
Average* 
All Cardiac (includes myocardial infarction, congestive 
heart failure, and new cardiac arrhythmias) 
0.8 – 21% 
12% 
Pulmonary (includes pneumonia and pulmonary 
insufficiency, does not include atelectasis) 
0 – 23% 
8.4% 
Renal Failure (chronic and acute) 
0 – 9% 
4.2% 
Cerebrovascular Accident  
0 – 11% 
1.9% 
Paraplegia or Paraparesis 
0 – 0.6% 
<0.1% 
Vascular 
0 – 5.7% 
1.1% 
Thrombotic/embolic 
0 – 5.0% 
1.8% 
Gastrointestinal 
0 – 14% 
4.2% 
Impotence 
0 – 1.8% 
0.2% 
Hematoma 
0 – 1.8% 
0.2% 
Bleeding/coagulopathy 
0 – 44% 
5.9% 
Wound healing/infection 
0 – 7.1% 
2.2% 
*Averages are unweighted from a review of the literature listed in Appendix II: References Related to 
Complications. 
 
2.1.3  Endovascular Stent Graft Repair 
Since the early 1990’s, endovascular abdominal aortic repair (EVAR) has evolved as an 
alternative treatment for AAA.  In 1991 Parodi was one of the first to introduce endovascular 
aneurysm treatment as a less invasive procedure.  Since that time, systems for performing 
endovascular repair of AAA have been developed, improved upon, clinically tested, and 
approved by FDA for commercial use.  The availability of this less invasive technique has 

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afforded the treatment of patients with multiple co-morbidities.  These patients may have 
otherwise been excluded from treatment with open surgical repair7. 
Endovascular grafts, often stented for support, are designed to provide an alternate conduit 
for blood flow and should exclude the aneurysm from this flow and the associated 
hemodynamic pressure.  Exclusion of the aneurysm is presumed to significantly reduce its 
potential for rupture. 
Endovascular repair of AAA involves the placement of a stent graft at the location of the 
aneurysm without the need for performing an open surgical procedure.  This technique is less 
traumatic for the patient by eliminating the need for aortic clamping, thereby eliminating or 
reducing the risks associated with decreased blood flow to vital organs and to the lower 
extremities.  Additionally, anesthetic and ventilation time during these procedures are 
reduced.  An endovascular approach also eliminates a significant amount of postoperative 
pain and discomfort associated with that of open surgical repair and allows a shorter recovery 
time for the patient.  The length of hospital stay is reduced, thus, allowing patients to more 
rapidly resume their normal activities of daily living.   
During the last 10 years, systems for performing endovascular repair of AAA have been 
developed, clinically tested, and approved for use.  At the present time, there are 
approximately five (Excluder, Zenith, Powerlink, Talent, AneuRx) devices approved for use 
in the United States, six to eight devices approved for use in Europe, and several devices 
approved for use in Australia.  The following outlines morbidities associated with 
endovascular repair. 
 
Complication 
Range 
Average* 
All Cardiac (includes myocardial infarction, congestive 
heart failure, and new cardiac arrhythmias) 
0 – 12% 
4.9% 
Pulmonary (includes pneumonia and pulmonary 
insufficiency, does not include atelectasis) 
0 – 7.7% 
2.6% 
Renal Failure (chronic and acute) 
0 – 6.5% 
3.0% 
Cerebrovascular Accident  
0 – 2.8% 
0.3% 
Paraplegia or Paraparesis 
0 – 0.2% 
<0.1% 
Access/Deployment Failure 
0 – 11% 
5.0% 
Endoleak 
6.5 – 47% 
21% 
Vascular 
0 – 14% 
5.1% 
Thrombotic/embolic 
0.9 – 18% 
7.7% 
Gastrointestinal 
0 – 4.8% 
1.4% 
Impotence 
0% 
0% 
Hematoma/bleeding/coagulopathy 
0 – 24% 
5.7% 
Wound healing/infection 
0 – 14% 
3.0% 
*Averages are unweighted from a review of the literature listed in Appendix II: References Related to 
Complications. 
 

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The literature demonstrates mortality rates for endovascular repair to be 0–7.5%, with 3.4% 
as the average.  This rate is inflated, to some extent, by the utilization of endovascular repair 
in patients who are not candidates for surgical repair because of co–morbidities that 
dramatically increase the risk associated with the surgical procedure.  For the systemic 
morbidities (cardiac, pulmonary, renal, cerebrovascular, and gastrointestinal), the rates for 
endovascular repair appear to be lower than for surgical repair.  The statistical significance of 
this observation, however, has not been assessed. 
During the clinical evaluation of the AneuRx Stent Graft System for AAA repair, patients in 
the endovascular repair group had lower blood loss, fewer days in the ICU, and a shorter 
hospitalization in comparison to the patients in the surgical control group.  The difference for 
each of these measures was statistically significant.  Similarly, the clinical evaluation of the 
ANCURE System demonstrated that the endovascular repair group experienced a statistically 
significant lower blood loss and a shorter hospitalization than the patients in the surgical 
control group. 

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3.0 
INDICATIONS 
The Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm 
in the abdominal aorta having vascular morphology suitable for endovascular repair, including: 
• Adequate iliac/femoral access compatible with vascular access techniques, devices, 
and/or accessories, 
• Non-aneurysmal proximal aortic neck: 
o with a length of at least 7 mm proximal to the aneurysm, 
o with an inner wall diameter of no less than 16 mm and no greater than 30 mm, 
and 
o with an aortic angle of <60 degrees if proximal neck is ≥10 mm and <45 degrees 
if proximal neck is <10 mm, 
• Non-aneurysmal distal iliac landing zone: 
o with a length of at least 10 mm, 
o with an inner wall diameter of no less than 8 mm and no greater than 20 mm. 
 

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4.0 
DEVICE DESCRIPTION 
The TriVascular Ovation™ Abdominal Stent Graft System is a low-profile endovascular device 
delivered via catheter to treat abdominal aortic aneurysms (AAAs).  The stent graft is designed to 
reline the diseased vasculature, providing an alternate endovascular blood conduit for isolating 
the aneurysm from the high pressure flow of blood, thereby reducing or eliminating the risk of 
rupture.  The stent graft is a modular configuration comprised of an aortic body section, iliac 
limbs, and iliac extensions as required (Figure 1).   
 
The aortic section is comprised of a proximal stent for supra-renal fixation and a low-
permeability PTFE graft.  The stent is designed with small anchors to enable fixation to the 
aortic wall.  For delivery, the stents are in a compressed state within the catheter.  When released 
from the compressed state, the stent expands to engage the vessel wall.  The nitinol stents are 
radiopaque and the implant contains radiopaque markers adjacent to the graft edges.  These 
markers serve as positioning aids during placement of the device and allow the stent to be 
located so that it will not obstruct the renal arteries.  To seal the proximal end of the graft and to 
provide support into which the iliac limbs are deployed, the graft body contains a network of 
inflatable rings that are filled with a liquid polymer which solidifies during the deployment 
procedure.  The graft has a fill port that connects the fill network of the graft to the delivery 
catheter.   
 
The iliac limbs and extensions are comprised of nitinol stents encapsulated in PTFE.  The limbs 
are deployed into the limb section of the aortic body.  Radiopaque markers allow the physician to 
visualize the appropriate iliac limb - aortic body overlap or iliac extension – iliac limb overlap 
during a catheter-based deployment.  Stent radial force provides both fixation and sealing of the 
interface between the aortic body and each iliac limb, between the iliac limb and iliac extension, 
and between the iliac limb/extension and its landing zone in the iliac artery. 
 
 
Figure 1. Schematic of Deployed Ovation Abdominal Stent Graft System 
 
To facilitate device introduction into the access vessel, the aortic body, the iliac limbs and the 
iliac extensions are preloaded into low-profile delivery catheters (14F-15F OD, 13F–15F OD, 
and 13F-14F OD respectively; Figures 2 and 3).  The aortic body is deployed via the aortic body 
delivery catheter.  The aortic body delivery catheter has a lumen that allows for the use of a 
guidewire to help deliver the stent graft to the deployment site.   
 
During stent graft deployment, the device is positioned and the sheath is retracted.  The proximal 
stent is then deployed using release knobs on the handle.  The fill polymer is then delivered 
through the fill connector port using an auto injector (supplied).   

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The contralateral and ipsilateral iliac limbs are deployed via iliac limb delivery catheters.  After 
deployment of the aortic body, a guidewire is placed from the contralateral access site into the 
contralateral distal leg of the aortic body.  The contralateral iliac limb is then advanced into 
position and deployed into the aortic body by retracting the catheter sheath with the catheter in 
the appropriate location.  After the fill material cures within the sealing rings, the aortic body 
delivery catheter is disengaged from the fill port of the graft and withdrawn from the vasculature.  
The ipsilateral limb is then advanced over the ipsilateral guide wire and deployed using the 
method described above for the contralateral limb. 
 
If an iliac extension is required, the delivery system is advanced over the guide wire and 
deployed using the method described above for contralateral and ipsilateral iliac limbs. 
 
 
 
 
Figure 2. Schematic of TriVascular Ovation Stent Graft aortic body delivery catheter 
 
 
 
 
 
Figure 3. Schematic of TriVascular Ovation Stent Graft iliac limb/extension delivery 
catheter 
 
The fill polymer is comprised of three components and is supplied in kit form as shown in Figure 
4.  Upon mixing and injection into the graft, the components form a robust radiopaque polymer 
network that is durable in vivo.  Once inside the PTFE channels in the wall of the aortic body 
graft, the fill polymer forms conformable “gasket-like” sealing rings.  The fill polymer 
radiopacity dissipates over time and may not be visible on fluoroscopy beyond 1-2 months post-
implant.   

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Just prior to use, the two valves on the kit are opened and the fill polymer is mixed by alternately 
depressing the two syringe plungers for a total of 15 strokes.  Thereafter, the full syringe is 
disconnected from the connection tube, slipped out of the syringe support and connected to the 
fill polymer injection port on the catheter handle.  The syringe plunger is then inserted into the 
autoinjector (Figure 5) and the syringe given a quarter-turn to lock it in place.  The autoinjector 
applies controlled pressure to inject the fill polymer into the graft without requiring continuous 
attention from the operator. 
 
 
Figure 4 – TriVascular Fill Polymer Kit 
 
 
 
Figure 5–TriVascular Autoinjector 
 

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5.0 
STUDY DESIGN 
This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical 
evaluation of the safety and effectiveness of the TriVascular Stent Graft when used in the 
treatment of patients with AAA.  
A total of 150 subjects will be enrolled during the primary study phase with an additional 100 
subjects enrolled during the continued access phase at up to 40 institutions.  No one institution 
may enroll more than 30 subjects.   
5.1 
Eligibility Criteria 
5.1.1  Inclusion Criteria 
All patients must meet all of the following inclusion criteria to be eligible for enrollment into 
this study: 
1. Patient is > 18 years of age 
2. Patients who are male or non-pregnant female (females of child bearing potential must 
have a negative pregnancy test prior to enrollment into the study) 
3. Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form 
4. Patient is considered by the treating physician to be a candidate for elective open surgical 
repair of the AAA (i.e., category I, II, or III per American Society of Anesthesiology 
(ASA) classification; refer to Appendix III: ASA Classification System).  ASA 
category IV patients may be enrolled provided their life expectancy is greater than 1 year. 
5. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the 
following: 
• Abdominal aortic aneurysm >5.0 cm in diameter  
• Aneurysm has increased in size by 0.5 cm in last 6 months.  
• Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an 
adjacent non-aneurysmal aortic segment 
6. Patient has patent iliac or femoral arteries that allow endovascular access with the 
TriVascular Ovation Abdominal Stent Graft System. 
7. Patient has a suitable non–aneurysmal proximal aortic neck length of > 7 mm inferior to 
the most distal renal artery ostium. 
8. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of >10 mm. 
The resultant repair should preserve patency in at least one hypogastric artery.  
9. Patient has a suitable non–aneurysmal proximal aortic neck luminal diameter between 16 
and 30 mm.  
10. Patient has suitable non–aneurysmal distal iliac luminal diameters between 8 and 20 mm. 
11. Patient meets the following anatomic criteria:  the distance from the most distal renal 
artery to most superior internal iliac artery measurement is at least 13 cm.   
12. Patient has juxtarenal aortic neck angulation < 60º if proximal neck is ≥10 mm and < 45º 
if proximal neck is <10 mm.  
13. Patient must be willing to comply with all required follow-up exams. 
 

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5.1.2  Exclusion Criteria 
Patients that meet ANY of the following are not eligible for enrollment into the study: 
1. Patient has a dissecting aneurysm  
2. Patient has an acutely ruptured aneurysm 
3. Patient has an acute vascular injury 
4. Patient has a need for emergent surgery  
5. Patient has a known thoracic aortic aneurysm or dissection. 
6. Patient has a mycotic aneurysm or has an active systemic infection  
7. Patient has unstable angina (defined as angina with a progressive increase in symptoms, 
new onset at rest or nocturnal angina, or onset of prolonged angina) 
8. Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 
months. 
9. Patient has a major surgical or interventional procedure planned ≤30 days of the AAA 
repair. 
10. Patient has history of connective tissue disease (e.g., Marfan’s or Ehler’s–Danlos 
syndrome). 
11. Patient has history of bleeding disorders or refuses blood transfusions.  
12. Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0 mg/dl 
13. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast 
media that is not amenable to pre-treatment. 
14. Patient has a known allergy or intolerance to polytetrafluorethylene (PTFE), PEG-based 
polymers, fluorinated ethylene propylene (FEP) or nitinol. 
15. Patient has a body habitus that would inhibit X–ray visualization of the aorta 
16. Patient has a limited life expectancy of less than 1 year 
17. Patient is currently participating in another investigational device or drug clinical trial  
18. Patient has other medical, social or psychological conditions that, in the opinion of the 
investigator, preclude them from receiving the pre-treatment, required treatment, and 
post-treatment procedures and evaluations.  
5.2 
Study Population 
5.2.1  Subject Selection 
Adult male and female patients will be consecutively screened for the study.  Eligible 
patients must meet all of the inclusion criteria and none of the exclusion criteria.   
 
The study includes 150 subjects enrolled during the primary study phase with an additional 
100 subjects enrolled during the continued access phase.     
5.3 
Withdrawal and Lost-to-Follow-Up 
Subjects may be withdrawn from the study for any of the following reasons:   
• Lost-to-follow up despite exhaustive attempts to contact.  A minimum of three (3) 
attempts to contact such subjects must be made.  One such attempt must include a 
registered return receipt requested letter. All attempts to contact the subjects must be 
documented.  

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• Subjects may voluntarily decide to withdraw from the study. All reasonable attempts 
should be made to ascertain the reason for voluntary withdrawal. 
 
All subject withdrawals must be documented on the Study Completion/Exit Case Report Form 
(eCRF). 
5.4 
Duration of Study 
Subject follow-up visits will occur at one, six, and 12 months post implant procedure then 
annually through five years.  Lifelong follow-up by the physician is required after subjects have 
completed the study. 

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6.0 
STUDY PROCEDURES 
Treatment of subjects enrolled in this study will include tests and procedures listed in Appendix 
IV: Schedule of Activities.  Placement of the AAA stent graft will be performed in accordance 
with the IFU.   
6.1 
Patient Screening 
Prospective candidates are evaluated in a consecutive manner for eligibility for the study at the 
time they are considered to be candidates for AAA repair.  Initial screening may include 
diagnostic testing (e.g., imaging, angiogram, laboratory testing) performed as part of routine 
medical care.   
 
The following steps outline the process to determine patient eligibility for enrollment and 
subsequent shipment of the device(s): 
1. Ensure that patient has signed an IRB approved Informed Consent Form, per Institutional 
policies 
2. Complete the Eligibility Verification Worksheet form  
3. Complete the AAA Pre-Operative Sizing Worksheet  
4. Fax #2 and #3 (above) to TriVascular Clinical Department (888-706-1617) 
5.  Submit contrasted spiral CT images to Core Lab obtained within 6 months of anticipated 
treatment. 
Refer to Manual of Operations for Core Lab Imaging Guidelines. 
6.2 
Pre-procedure evaluation 
The following assessments will be performed no more than one month prior to the 
implant/surgical procedure:   
• Patient demographics  
• Medical/surgical history 
• Physical exam 
• Ankle-Brachial Index (ABI) measurement 
• Laboratory testing, which includes renal and coagulation assessment, as well as serum 
pregnancy for female patients of childbearing potential.  
 
If the patient is eligible to be enrolled into the study, the results of these screening assessments 
are recorded on the Baseline eCRF. If a patient does not qualify for enrollment into the study, 
the baseline screening worksheets will be retained, together with the patient’s signed/dated 
consent(s).    
6.3 
Treatment period (implant/surgical procedure) 
The following assessments and data collection will be performed at the time of the 
implant/surgical procedure: 
• Investigational device accountability- documentation of product information (e.g., lot 
number, serial number, and expiration date).  
• Type and length of anesthesia 
• Anticoagulation 
• Description of delivery system access on both ipsilateral and contralateral sides (e.g. 
femoral cut down, percutaneous access, closure device) 

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• Type and volume of contrast used 
• Total fluoroscopy time during procedure 
• Estimated blood loss and replacement requirements 
• Adjunctive procedures (e.g. stent placement) 
• Investigator assessment of AAA device performance as it relates to: 
o Access success/failure, delivery/deployment success, evidence of endoleak, 
device integrity issues  
• Procedural times  (time of initial arterial access, stent graft deployment start and stop 
time, polymer mix completion time, delivery system removal time, and time of closure of 
arterial access) 
• Adverse events  
6.4 
Pre-Discharge  
The following assessments and testing will be performed post-procedure, prior to discharge: 
• Physical exam 
• Ankle-Brachial Index (ABI) measurement 
• Laboratory testing, which includes renal and optional coagulation assessment  
• Length of hospital stay 
• Abdominal X-ray (KUB), including AP, lateral, left oblique and right oblique views. This 
X-ray will serve as the baseline for all future evaluations of device integrity and can be 
performed within 7 days following hospital discharge. 
• Concomitant medications (anticoagulants, antiplatelets and antibiotics only) 
• Adverse events  
• Other relevant data as indicated on the CRF, including optional wound assessment. 
The above assessments are recorded in the Hospital Discharge eCRF. In some instances, 
subjects may experience a prolonged hospitalization post procedure.  In those cases, the above 
assessments should be performed no more than two (2) weeks post procedure. 
6.5 
Post-Treatment follow-up period 
The following assessments and tests will be performed at the following intervals: 
 
Time period post-treatment 
Acceptable visit timeframe allowance 
1 Month (30 days) 
± 14 days 
6 Months (180 days) 
± 30 days 
12 Months (365 days) 
± 60 days 
Annually from 2 to 5 years 
± 60 days 
 
• Physical exam 
• Laboratory testing, which includes renal and optional coagulation assessment  
• Contrast Enhanced Spiral Abdominal/Pelvic CT 
• Abdominal X-ray (KUB), including AP, lateral, left oblique and right oblique views 
Device/aneurysm assessment based on imaging (endoleak, migration, integrity, patency, 
AAA dimensions)  
• Concomitant medications (anticoagulants, antiplatelets and antibiotics only) 
• Adverse events  
• Other relevant data as indicated on the CRF including optional wound assessment. 
 

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The above assessments are recorded in the appropriate Follow-up Visit eCRF.  Note that in the 
event the subject is unable to tolerate a contrast-enhanced spiral CT, a duplex ultrasound and 
non-contrast spiral CT should be completed as an alternative assessment. 
6.6 
Unscheduled Follow-up visits 
In the event that a subject visit occurs outside the protocol-specified time frames (i.e., Pre-
discharge, 1 month, 6 month, 12 month) sites are required to record data from that visit, if that 
visit is specifically associated with the device, procedure or aneurysmal disease.  Possible 
reasons for unscheduled visit data collection may be: 
• Subject experiences new symptomatology and/or an adverse event 
• Surveillance of an existing adverse event 
 
The Unscheduled visit information would be recorded in the Follow-up Visit eCRF where the 
reason for the unscheduled visit will be specified. 
 
If a subject is seen in the office or clinic for other reasons than listed above, information from 
that visit would be recorded on the next protocol-specified visit in the appropriate Follow-Up 
CRF.    
6.7 
Annual follow-up visits 
Subjects who have completed 12 months of follow-up will continue annual follow-up exams  
(+/- 2 months) for 5 years.  
 
The following assessments and tests will be performed at annual visits through 5 years: 
 
• Physical exam 
• Laboratory testing, which includes renal and optional coagulation assessment  
• Contrast Enhanced Spiral Abdominal/Pelvic CT 
• Abdominal X-ray (KUB), including AP, lateral, left oblique and right oblique views  
• Device/aneurysm assessment based on imaging (endoleak, migration, integrity, patency, 
AAA dimensions)  
• Concomitant medications (anticoagulants, antiplatelets and antibiotics only) 
• Adverse events  
• Other relevant data as indicated on the CRF, including optional wound assessment. 
6.8 
Discontinuation from study 
Subjects who choose to discontinue participation in the study prior to study completion will be 
requested to undergo a final assessment by the investigator at the time notification is made of 
their decision to discontinue.  If the subject notifies the clinical site of discontinuation by mail or 
phone, subject will be requested to have a final assessment by the investigator.   
 
The final assessment will be recorded in the Follow-up Visit and Study Completion/Exit 
eCRFs. 

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7.0 
STUDY OBJECTIVES 
The purpose of this pivotal clinical trial is to evaluate the safety and effectiveness of the Ovation 
Abdominal Stent Graft in the treatment of subjects with abdominal aortic aneurysms (AAA). 
7.1 
Primary Objectives 
The primary objective of this study is to determine whether the Ovation Abdominal Stent Graft 
System is a safe and effective method of treating AAAs in those subjects considered to be 
suitable candidates for open surgical repair.   
 
The safety of the Ovation Abdominal Stent Graft System will be determined by proportion of 
subjects with major adverse events. 
 
The effectiveness of the Ovation Abdominal Stent Graft System will be determined by the 
proportion of subjects that achieve treatment success. 

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8.0 
DEFINITIONS 
8.1 
Endoleak 
Endoleak is defined by the persistence of blood flow outside the lumen of the endovascular graft 
but within the aneurysm sac and can be classified as: 
Type I – Ineffective seal at either the proximal or distal sealing zones 
Type II – Retrograde blood flow from lumbar arteries, the inferior mesenteric artery, or other 
collateral vessels into the aneurysm sac 
Type III – A leak caused by fabric tears or disruption, component disconnection, or graft 
disintegration 
Type IV – Blood flow through an intact fabric. 
8.2 
Migration 
Migration is defined as evidence of proximal or distal movement of the stent graft >10mm 
relative to fixed anatomic landmarks. Spiral CT images will be used to determine migration at 
regularly scheduled follow-up visits.  The 1 month image will be used as the baseline 
assessment. 
8.3 
Patency 
Patency is defined as the absence of complete occlusion of the treated vessel.  This may be 
evidenced by: CT, angiography, ultrasound or other imaging modality, or pathological analysis. 
8.4 
Loss of Stent Graft Integrity 
The integrity of the stent graft will be evaluated by abdominal x-rays at regularly scheduled 
follow-up visits.  Any fractured stents, and any other issues compromising the integrity of the 
stent graft will be reported. 
8.5 
AAA Enlargement 
Aneurysm enlargement is defined as a greater than 5 mm (diameter) increase in the aneurysm 
size.  Spiral CT images will be used to determine aneurysm enlargement at regularly scheduled 
follow-up visits.  The 1 month image will be used as the baseline assessment. In addition, 
aneurysm volume will be assessed by the Core Lab and reported in the data analysis, but 
diameter is considered the relevant characteristic for the study endpoint evaluations. 
8.6 
Surgical Conversion 
Surgical conversion occurs when a subject implanted with an Ovation Abdominal Stent Graft 
undergoes open surgical repair with explantation of the stent graft. The follow-up for subjects 
who are converted to open surgical repair include collection of the following data: Physical 
Exam and assessment of Adverse Events.  The visits are to occur at 1 month post open 
conversion and 1 year post open conversion.   
8.7 
Imaging Core Lab 
TriVascular will utilize an independent imaging Core Lab to analyze device performance 
specifically related to study endpoints such as: device integrity, endoleaks, migration, and 
aneurysm dimensions (e.g., length, diameter, volume).  Clinical sites will submit all CT and X-
ray images to the Core Lab for all required study visits.   
 

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Study Visit 
Images* Required to be submitted to Core lab 
Baseline 
(pre-op) 
Contrast Enhanced Spiral Abdominal/Pelvic CT  
Discharge 
(post-op) 
Abdominal X-rays (AP, lateral, left oblique and 
right oblique views ) 
1 month 
(16 - 44 days) 
Abdominal X-rays (AP, lateral, left oblique and 
right oblique views ) 
Contrast Enhanced Spiral Abdominal/Pelvic CT 
6 month 
(150 - 210 days) 
Abdominal X-rays (AP, lateral, left oblique and 
right oblique views ) 
Contrast Enhanced Spiral Abdominal/Pelvic CT 
12 month 
(305 - 425 days) 
Abdominal X-rays (AP, lateral, left oblique and 
right oblique views ) 
Contrast Enhanced Spiral Abdominal/Pelvic CT 
*Refer to Appendix VI: CT Scanning Techniques and Manual of Operations 
for Core Lab imaging requirements. 
8.8 
Explant Evaluation 
TriVascular is committed to understanding the effects of the human in vivo environment on the 
stent graft over time.  To this end, all explanted devices should be returned to TriVascular for 
evaluation by a Pathologist at an independent Explant Laboratory.  Refer to Appendix VII: 
Explant Procedure and the Manual of Operations for specific instructions for managing the 
removal, shipping, and handling of the explanted AAA device.  
8.9 
Adverse Events 
An adverse event is any new, undesirable medical occurrence or change (worsening) of a pre-
existing condition that occurs in a subject, whether or not considered to be associated with the 
product.  Elective hospitalizations for pre-existing conditions (e.g., elective cosmetic procedures) 
are not adverse events.   
 
Requirements for reporting AEs are dependent upon the reviewing IRB policy. Adverse events 
will be reviewed by a Clinical Events Committee (CEC).  The CEC will meet periodically, a 
minimum of annually. 
 
Adverse Event information is recorded in the Adverse Event eCRF. 
For purposes of this study, the following events are not considered adverse events, because they 
are expected to occur in conjunction with the index procedure or are associated with customary, 
standard care of subjects undergoing endovascular AAA repair procedures: 
 Early post-operative pain (within 24 hours of index procedure) at the access site 
and/or related to position on procedure table 

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 Post-anesthesia/conscious sedation emesis, nausea, or headache (within 24 hours of 
index procedure) 
 Electrolyte imbalance without clinical sequelae following index procedure, even if 
requiring correction 
 Low grade temperature increase (< 101.0 °F) 
 Hematocrit decrease from baseline of less than 6 points (2 grams of hemoglobin) that 
remains above 30% and is not associated with hemodynamic changes and does not 
require transfusion 
 Blood loss not requiring transfusion and not resulting in decreased hematocrit. 
 Minor, localized tenderness, swelling, induration, bruising, erythema, hematoma etc. 
at vascular access site that does not require surgical intervention, evacuation, 
transfusion, or antibiotics 
 Prophylactic administration of atropine 
 Prophylactic pacing 
 Isolated, non-sustained PVCs/PACs 
 Non-sustained, arrhythmia not requiring treatment or intervention 
 Hypotension or hypertension not requiring treatment or intervention 
 Atelectasis not requiring treatment 
 
The Investigator and/or IRB may require that these events are reported as adverse events.  In this 
case, the Investigator should report these observations based on their medical judgment and 
requirements of the IRB. 
 
Device-related adverse events should be reported to the sponsor within 24 hours of 
knowledge of the event. 
 
8.10 
Serious Adverse Events (SAE) 
A serious adverse event (SAE) defined as one that suggests a significant hazard or side effect, 
regardless of the investigator or sponsor’s opinion on the relationship to the investigational 
product.  This includes, but may not be limited to, any event that: 
• Is fatal 
• Is life-threatening 
• Requires or prolongs  (>48 hours) inpatient hospitalization 
• Is a persistent or significant disability or incapacity 
• Is considered an important medical event 
 
Important medical events may be considered serious by the investigator although they may not 
be immediately life threatening or result in death or prolong hospitalization.  Such important 
medical events are those that may jeopardize the subject, require intervention to prevent one of 
the outcomes listed above, or result in urgent investigation.  Examples include, but are not 
limited to, allergic bronchospasm, convulsions, and blood dyscrasias. 

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Serious Adverse Events will be recorded in the Adverse Event CRF and the event is to be 
reported by telephone or fax to the Sponsor within 24 hours of knowledge of the event.  
Sites are also required to adhere to the reviewing IRB requirements for reporting of SAE’s. 
8.11 
Major Adverse Events (MAE) 
The following specific events will be considered major adverse events (MAE) for the purpose of 
evaluating the primary (30 day) and secondary (1 year) safety endpoints: 
 
Major adverse events (MAE) are defined as any one of the following events: 
• Death 
• Myocardial Infarction 
• Stroke (excludes TIA) 
• Renal Failure (excludes renal insufficiency) 
• Respiratory Failure (excludes COPD or pulmonary complications) 
• Paralysis (excludes paraparesis) 
• Bowel Ischemia 
• Procedural Blood Loss (≥1,000 cc) 
 
A major adverse event (MAE) may or may not be considered related to the device. Mortality will 
be reported as “all cause” and “AAA related.” All deaths occurring in the first 30 days post-
index procedure are considered “AAA related.” 
 
The Clinical Events Committee (CEC) shall determine which adverse events are considered 
Major Adverse Events (MAE) for evaluation of the primary (30 days) and secondary (1 year) 
safety endpoints.   
8.12 
Unanticipated Adverse Device Effect (UADE) 
An unanticipated adverse device effect means 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.  
 
Unanticipated Adverse Device Effect (UADE) are to be recorded in the Adverse Event CRF 
and the event is to be reported by telephone or fax (see above contact information) to the 
Sponsor within 24 hours of knowledge of the event.  Sites are also required to adhere to the 
reviewing IRB requirements for reporting of any UADE. 
8.13 
Conversion to Open Surgical repair 
Conversion to open surgical repair may occur either at the initial implant procedure or 
subsequent to the initial procedure.  Information regarding the surgical conversion will be 
recorded on the Open Surgical Conversion eCRF and the Adverse Event eCRF.    
 
In the event that a subject requires conversion from endovascular to open surgical repair, the 
explanted device should be sent to TriVascular for examination.  Refer to the Manual of 

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Operations for specific instructions for managing the removal, shipping and handling of the 
explanted device.  Explant information will be recorded on the Explant eCRF. 
 
Surgical conversions must be reported by telephone or fax to the Sponsor within 24 hours of 
knowledge of the event. 
 
The Follow-up visit schedule for surgically converted subjects is at one month and one year post 
open conversion.  
8.14  Technical Failures   
In the event that an AAA stent graft could not be deployed due to a technical failure, contact 
TriVascular Clinical Affairs to obtain device return information. Device failure information will 
be captured on the Device Failure eCRF. 
8.15 
Deaths 
Any deaths that occur during the conduct of the study must be reported by telephone or fax to the 
Sponsor within 24 hours of knowledge of the event.  Sites are also required to adhere to the 
reviewing IRB requirements for reporting of deaths.  In addition, subjects with an implanted 
device who expire before completing the study should have the device explanted and sent to 
sponsor whenever possible for examination.  Additional information to be submitted to sponsor 
may include such documents as: death certificate, autopsy report, summary of death report, 
hospital records, explant reports and copy of IRB notification of the event. 
8.16 
Explants 
Specific instructions for managing the removal, shipping and handling of the explanted device 
can be found in Appendix VII: Explant Procedure and Manual of Operations.  Explant 
information will be recorded on the Explant eCRF. 

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9.0  
ENDPOINTS AND TECHNIQUES FOR MEASUREMENT 
For the purpose of this study, the information below provides definitions and measurement 
criteria in determining each endpoint. The endpoints (primary and secondary) specified below 
and Statistical Considerations outlined in Section 10 may appear in the product labeling to 
support clinical results. Information not included in the endpoint list below or the statistical 
considerations will not appear in the labeling to support clinical results. 
9.1 
Primary Endpoints 
9.1.1  Safety 
The primary safety endpoint is the rate of major adverse events (MAE) at 30 days post 
procedure. The following specific events will be considered major adverse events: 
 
Major adverse events (MAE) are defined as any one of the following events: 
• Death 
• Myocardial Infarction 
• Stroke (excludes TIA) 
• Renal Failure (excludes renal insufficiency) 
• Respiratory Failure (excludes COPD or pulmonary complications) 
• Paralysis (excludes paraparesis) 
• Bowel Ischemia 
• Procedural Blood Loss (≥1,000 cc) 
 
A major adverse event (MAE) may or may not be considered related to the device. Mortality 
will be reported as “all cause” and “AAA related.” All deaths occurring in the first 30 days 
post-index procedure are considered “AAA related.” 
 
9.1.2  Efficacy 
The primary effectiveness endpoint is the proportion of subjects that achieve treatment 
success. Treatment success is a composite endpoint assessed at 12 months that requires all of 
the following criteria to be met in order for a subject to be considered a treatment success: 
 
• Technical Success, defined as successful delivery and deployment of one aortic body and 
two iliac limbs. 
• Freedom from Type I & III endoleak at 12 months 
• Freedom from stent graft migration at 12 months 
• Freedom from AAA enlargement at 12 months 
• Freedom from AAA rupture and conversion to open repair through 12 months 
9.2 
Secondary Endpoints 
9.2.1  Safety 
The following secondary safety endpoints will be assessed: 
 
• All-cause mortality at 30 days and 12 months 
• AAA Related Mortality at 30 days and 12 months 
• Major Adverse Events (MAE) through 12 months 
• AAA rupture through 12 months 

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• Surgical conversion through 12 months 
 
All deaths that occur in the study will be adjudicated by the CEC.  AAA related death is any 
death determined by the CEC to occur as a result of the initial procedure (first 30 days), AAA 
rupture, conversion to open surgical repair, or any AAA related secondary intervention. 
 
 
9.2.2  Stent Graft Efficacy   
The following secondary efficacy endpoints will be assessed. 
1)  Technical Success   
The physician was able to insert the delivery catheter and deliver an aortic graft and two 
iliac limbs to the treatment site. 
2)  AAA Enlargement 
Any increase in aneurysm diameter (>5 mm) from the one month (baseline) post-
operative measurement will be considered AAA enlargement, as determined by Core 
Lab.   
3)  Migration 
Migration is defined as evidence of proximal or distal movement of the stent graft >10 
mm relative to fixed anatomic landmarks.  Spiral CT images will be used by Core Lab to 
determine migration from the one month (baseline) CT image. 
4)  Type I and III Endoleak 
Type I and III endoleaks will be assessed by the Core Lab using Spiral CT images.   
5)  Device Integrity 
The integrity of the stent graft will be evaluated from X-ray images by the Core Lab using the 
discharge X-ray as the baseline.  Any fractured stents or other issues compromising the integrity 
of the stent graft will be reported. 
9.2.3  Clinical Utility Assessment 
The following secondary endpoints associated with the procedure will also be assessed: 
• Procedure time  
• Amount of blood loss 
• Days spent in hospital 
• Type of Anesthesia 
• Type of Vascular access 
 

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10.0  STATISTICAL CONSIDERATIONS 
10.1 
Primary Endpoints and Hypotheses 
10.1.1  Primary Safety Endpoint and Hypothesis: Major Adverse Event Rates 
This study is designed to compare the rate of major adverse events following abdominal 
aortic aneurysm repair with the Ovation Abdominal Stent Graft System to a target 
performance goal.  The proportion of subjects receiving the Ovation Abdominal Stent Graft 
who experience one or more events meeting the definition of a major adverse event within 30 
days of the initial procedure is the rate of interest.   The null and alternative hypotheses are 
given below: 
 
H0: π T ≥ 21%  
 
H1: π T  <  21% , where 
πT is the expected proportion of subjects undergoing AAA repair with the Ovation 
Abdominal Stent Graft System who experience a major adverse event at 30 days. The target 
performance goal rate of 21% is that based on the 11% rate (plus 10% ”non-inferiority” 
margin) of major adverse events at 30 days reported for the Medtronic Talent device 
(reported in the Medtronic Talent Summary of Safety and Effectiveness Data 2008). 
 
10.1.2  Primary Effectiveness Endpoint and Hypothesis:  Treatment Success at 12 
Months 
Treatment success is the primary effectiveness endpoint for the study.  The proportion of 
subjects who are treatment successes at 12 months is the rate of interest.  The null and 
alternative hypotheses are as follows: 
 
H0: π  ≤ 80%  
 
H1: π  >80%, where 
 
π is the expected rate of treatment success.  The Ovation Abdominal Stent Graft is 
considered to be effective if this study’s result verifies that the lower limit of the one-sided 
95% confidence interval for π is above 80%. 
10.2 
Statistical Sample Size Justifications for the Primary Study Phase  
Should the rate of major adverse events be 11%, n=150 primary study subjects would provide 
96% power to test the primary safety hypothesis at the one-sided 5% significance level. 
 
It is anticipated that attrition through the 12 month visit may be approximately 15%.  Hence 150 
primary study subjects less 15% attrition would yield approximately 130 subjects with data 
available to assess the primary effectiveness endpoint at 12 months. Should the rate for the 
primary effectiveness composite endpoint equal 88.2%, then 130 subjects would provide 80% 
power to test the primary effectiveness hypothesis at the one-sided 0.05 alpha level. Sample size 
calculations were performed using the normal approximation in nQuery Advisor 6.02. 
 

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10.3  Statistical Methods for Primary Endpoints 
10.3.1  Primary Safety Endpoint: Major Adverse Events: 
Let n be the sample size and z1-α denote the upper (1-α) quantile of the standard normal 
distribution.  If the upper limit of the one-sided confidence interval for the true rate of Major 
Adverse Events is less than 21%, then the null hypothesis for safety will be rejected in favor 
of the alternative hypothesis.  Therefore, the primary safety endpoint will be considered met 
if the upper bound of the 95% confidence interval for the measured value is less than the 
performance goal (21%), based on the major adverse event rate. An accurate estimate of the 
upper limit of a binomial proportion is presented by Agresti and Coull (Agresti 1998).1 The 
Agresti-Coull upper limit of a one-sided 95% confidence interval for the true rate of major 
adverse events is estimated by Formula 1, where 
 
Formula 1: 
 
)
(
2
)
1(
4
)
2
(
2
05
.0
2
05
.0
05
.0
2
05
.0
Z
n
p
pn
Z
Z
Z
np
U
+
−
+
+
+
=
   , where 
 
p is the observed rate of Major Adverse Events and Zu is the upper u-th 
percentile of the standard normal distribution. Hence Z.05 = 1.645.  
 
10.3.2  Primary Efficacy Endpoint: Treatment Success 
Let n be the sample size and z1-α denote the upper (1-α) quantile of the standard normal 
distribution.  If the lower limit of the one-sided confidence interval for the true rate for 
treatment success is greater than 80%, then the null hypothesis defined in Section 10.1.2 will 
be rejected in favor of the alternative hypothesis.  Using the same approach to calculate the 
confidence interval as used for the primary safety endpoint, the corresponding formula for 
the lower limit of the confidence interval is: 
 
Formula 2: 
 
)
(
2
)
1(
4
)
2
(
2
05
.0
2
05
.0
05
.0
2
05
.0
Z
n
p
pn
Z
Z
Z
np
L
+
−
+
−
+
=
   , where 
 
p is the observed rate of treatment success and Zu is the upper u-th percentile of the standard 
normal distribution. Hence Z.05 = 1.645.   
10.4 
Secondary Statistical Endpoints 
No hypothesis testing will be performed for secondary endpoints. 
 
10.4.1  Secondary Safety Endpoints 
Rates for all-cause mortality, AAA related mortality, major adverse events, AAA rupture, 
and surgical conversion will all be calculated at 30 days and 12 months.  The Kaplan-Meier 
estimates will be presented with 95% confidence intervals. 
 
 
 

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10.4.2  Assessment of Clinical Utility 
 
Estimation of Mean Volume of Blood Loss 
For each subject, the amount of blood loss is the outcome variable.  The mean and standard 
deviation of blood loss values and 95% confidence intervals will be provided. 
 
Estimation of Mean Duration of Procedure, Overall Hospital Stay  
The objective is to estimate mean duration of procedure (minutes), mean time from hospital 
admission to discharge (days) and duration of anesthesia (minutes).   For each outcome the 
mean, median, standard deviation and 95% confidence interval will be provided.  
 
Anesthesia Type 
The objective is to estimate the rate of general anesthesia use. 
 
Vascular Access Type 
The objective is to assess the rate of femoral vs. percutaneous access used.  The rates will be 
presented as a percent with 95% confidence interval. 
 
10.4.3  Effectiveness 
All secondary effectiveness endpoints are categorical in nature.  Technical success is only 
measured peri-operatively and will be presented as a percent with 95% confidence interval.  
All the remaining effectiveness endpoints will be presented by visit, as percents with 95% 
confidence intervals. Endoleak will be reported by type. 
10.5 
Assumption Verification 
Visual inspection and statistical tests will be used to determine if the study variables are 
consistent with the assumptions of statistical tests proposed.  For continuous variables, test of 
normality will be done by Shapiro-Wilks test or equivalent. 
10.6 
Study Retention and Handling of Missing Data 
Every effort will be made to collect all data points in the study. The sponsor plans to minimize 
the amount of missing data by appropriate management of the prospective clinical trial, proper 
screening of study subjects, and training of participating investigators, monitors and study 
coordinators.  Primary analyses will be performed on an intent-to-treat basis.  All partial data that 
is available on subjects who drop out during the course of the study will be included.   
 
In order to evaluate the effect of missing data on the primary outcomes a sensitivity analysis will 
be performed.  The sensitivity analysis will include evaluating the primary outcomes using a 
best-case scenario (assuming missing data for the subjects are successes) a worse-case analysis 
(assuming all missing data for the subjects are failures), and a tipping point analysis as described 
by Yan 2009.2  A multiple imputation analysis will also be performed using logistic regression to 
further evaluate the effect of missing data on the primary outcome (Little 2001).3 
10.7 
Poolability 
Data will be pooled from multiple study sites for this analysis.  The justification for pooling is 
made on a clinical basis (Meinert, 1986).4  This study will be conducted such that: 1) the same 
protocol will be used at each site; 2) site investigators and personnel will receive uniform 
training; and 3) central data management and monitoring will be applied with equal rigor at all 

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sites.  The diversity of hospital and clinical practice settings will add to the scientific validity and 
generalizability of the findings.  Rates for the primary efficacy and safety endpoints will also 
be reported by clinical centers. 
10.8 
Subject Populations for Analysis 
Primary analysis will be performed on an intent-to-treat basis.  The intent to treat group will 
include all subjects in which the delivery system is inserted into the access vessels. 
10.9 
Detailed Statistical Analysis Plan 
Prior to database lock a detailed statistical analysis plan will be written to provide a detailed 
description of the statistical analysis to be used in the final analysis.  This plan will incorporate 
lists of relevant variables to be included in multiple imputations analysis and will incorporate any 
protocol changes that would affect the analysis. 
10.10 Statistical References 
1. 
Agresti, A and Coull, B A (1998). Approximate is better than “exact” for interval 
estimation of bionomial proportions.  The American Statistician, 52:119-126. 
2. 
Yan, Xu, Lee, Shiowjen and Li, Ning (2009).  Missing Data Handling Methods in 
Medical Device Clinical Trials.  Journal of Biopharmaceutical Statistics, 19: 6, 
1085-1098. 
3. 
Little, R. and D Rubin (2001).  Statistical Analysis with Missing Data.  John Wilen 
and Sons, New York. 
4. 
Meinert, C. (1986). Clinical Trials: Design, Conduct, and Analysis.  Oxford 
University Press, New York. 

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11.0  RISK ANALYSIS 
Treatment of an AAA with both endovascular and open surgical repair poses significant inherent 
risks to the subject.  The mortality risk of open surgical repair of an AAA is greater for those 
subjects with significant surgical risk factors, such as age and comorbidities (e.g., cardiac, renal 
and pulmonary).1   
 
Endovascular treatment of a AAA has been shown to be an effective, less invasive procedure that 
may result in reduced early mortality and factors related to morbidities, reduced time for 
anesthesia, need for blood products, shorter hospital stays and recovery time, as well as 
improved quality of life in the early postoperative period.   
 
Risks to subjects are minimized initially by including those patients that are considered to be 
suitable candidates for open surgical repair and by selecting qualified investigators/institutions 
with endovascular experience to participate in the study.  In order for patients to participate in 
this study, they must agree to adhere to a strict follow-up schedule to continuously monitor their 
long term safety.  
 
The risks associated with the use of this study device are not currently known.  Although the 
adverse events associated with the use of the Ovation Abdominal Stent Graft System may be less 
than for standard open surgical repair, inherent risks exist, as with many medical procedures.  
However, risks that have been associated with repair of AAAs with this type of device in clinical 
trials or that are currently marketed include, but may not be limited to: 
• Cardiac events such as congestive heart failure (CHF), volume overload, arrhythmias, 
myocardial infarction (MI), chest discomfort or angina, elevations in creatinine 
phosphokinase (CPK), hypotension 
• Pulmonary events such as pulmonary insufficiency, pneumonia, respiratory 
depression or failure, pulmonary edema, pulmonary embolism 
• Cerebral events such as cerebrovascular accident (hemorrhagic or embolic), 
reversible ischemic neurologic deficit, transient ischemic attacks (TIA) 
• Acute and chronic renal insufficiency or failure, renal microembolism 
• Operative and post–operative bleeding disorders, hemorrhage and coagulopathy 
• Insertion and other vascular access site complications such as infection, bleeding, 
delayed healing, hematoma, dehiscence, seroma, nerve injury/damage, neuropathy, 
neuralgia, vasovagal response 
• Vascular injury including damage to blood vessels and surrounding tissues, vessel 
dissection, perforation, plaque dissection, collateral vessel occlusion, tissue loss, 
arterial fistula, limb loss, gangrenous disease, worsened or new onset claudication, 
edema 
• Neurological complications, such as paralysis (temporary or permanent),  paraplegia, 
monoplegia, paresis, spinal cord ischemia, hemiplegia, bowel or bladder incontinence 
• Multi-system organ failure 
• Embolic and thrombotic events such as deep vein thrombosis, thromboembolism, 
microembolism, thrombophlebitis, phlebothrombosis, pulmonary embolism, air 
embolism 
• Gastrointestinal events such as ischemia, paralytic or adynamic ileus, obstruction, 
fistulas 

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• Impotence, erectile dysfunction 
• Radiation injury, late malignancy 
• Allergic reaction, such as flushing, nausea, vomiting, itching, hives, and/or  
anaphylactoid response to device materials (including polytetrafluorethylene [PTFE], 
PEG-based polymers, fluorinated ethylene propylene [FEP] or nitinol) and/or x–ray 
contrast dye  
• Generalized inflammatory response that may be associated with elevated levels of 
systemic mediators of inflammation, elevated temperature 
• General discomfort related to the procedure or tests, sore throat, pain 
• Infection–urinary tract, systemic or localized, sepsis, endograft 
• Device events such as endograft occlusion, migration, dislodgement, endoleak, and/or 
stent fracture 
• Branch vessel occlusion 
• Renal artery occlusion 
• Aneurysm rupture 
• Conversion to open surgical repair 
• Death 
 
Potential benefits of the Ovation Abdominal Stent Graft System compared to open surgical 
aneurysm repair may include, but are not limited to: 
 Not having open surgery; 
 Less time under general anesthesia and/or the ability to use other forms of anesthesia that 
do not require mechanical ventilation; 
 Reduction of complications; and 
 Reduction in hospitalization and recovery time. 
 
Potential benefits of the Ovation Abdominal Stent Graft System compared to other commercially 
available endovascular AAA repair devices may include, but are not limited to: 
 More robust seal between the graft and aorta, possibly reducing the risk that the graft will 
develop Type I or III endoleaks or migrate over time and; 
 Lower risk of injury to the access vessels due to the low profile and more flexible delivery 
system compared to the commercially available devices. 

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12.0  STUDY RESPONSIBILITIES 
12.1  Responsibilities of Sponsor 
Sponsors are responsible for selecting qualified investigators and providing them with the 
information needed to properly conduct the investigation, ensure proper monitoring, IRB review 
and approval are obtained, submitting IDE application to the FDA and ensuring that reviewing 
IRBs and FDA are promptly informed of significant new information about the study. 
The sponsor, the FDA, or other regulatory bodies with responsibilities similar to FDA for clinical 
sites outside the United States, retain the right to terminate the study and remove all study 
materials from the investigational site at any time.  Specific instances, which may precipitate 
study termination, are: 
• Unsatisfactory subject enrollment with regard to quality and quantity. 
• Deviations from protocol, without prior approval from the sponsor. 
• Inaccurate, incomplete, and/or untimely data recording on a recurrent basis. 
• The incidence and/or severity of adverse experiences in this or other studies indicating a 
potential health hazard caused by the device. 
12.2  FDA and IRB approval 
A sponsor shall not begin an investigation until an IRB and FDA have both approved the IDE 
12.3  Selection of Investigators 
A sponsor shall select investigators qualified by training and experience to investigate the device. 
12.4  
Selection of Monitors 
A sponsor shall select monitors qualified by training and experience to monitor the study in 
accordance with applicable FDA regulations. 
12.5  
Accountability and Control of Device 
Sponsor shall ship investigational devices only to qualified investigators participating in the 
study.  The investigator shall maintain adequate records of the receipt and disposition of all 
investigational devices.  The investigator shall return any unused devices to sponsor with a 
completed device disposition record.  The disposition record shall include:  the devices being 
returned and the method of return. Devices shall be maintained in a secure, limited–access 
storage area.   
12.6  
Obtaining agreements 
A sponsor shall obtain a signed agreement from each participating investigator which includes a 
Curriculum Vitae (CV) with relevant experience, as well as an explanation of any research that 
was terminated. 
12.7  
Informing Investigators 
A sponsor shall supply all investigators with copies of the investigational plan and inform them 
of any new relevant safety information obtained during the course of this investigation. 

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12.8  
Monitoring Investigations 
Monitoring visits to the clinical sites will be made periodically during the study, to ensure that 
the clinical trial is being conducted in strict accordance with the protocol/amendment(s) and in 
compliance with Good Clinical Practice as defined by the Food and Drug Administration (FDA) 
and by ICH Harmonized Tripartite Guidelines, and that the clinical data can be validated against 
source documentation at the investigative site.  Original source documents will be reviewed for 
verification of data recorded on the eCRFs and in the electronic database.  The 
Investigator/institution guarantees direct access to original source documents by TriVascular 
personnel, their designees, and appropriate regulatory authorities.  In the event that the original 
medical record cannot be obtained for a subject that is seen by a non-study physician at a non-
study institution, photocopies of the original source documents must be made available for 
review. 
 
Sponsors may discontinue shipments of devices and terminate the investigator’s participation if 
determination has been made that the investigator is not compliant with the signed agreement, 
the protocol, conditions imposed by the reviewing IRB, or the applicable FDA regulations.   
12.9  
Responsibilities of Investigators 
An investigator is responsible for ensuring that the study is conducted in accordance with the 
signed agreement, the protocol, IRB and FDA regulations and requirements. An investigator is 
also responsible for adhering to regulations associated with obtaining informed consent.  An 
investigator shall permit an investigational device to be used only with subjects under the 
investigator’s supervision.  An investigator shall disclose to the sponsor accurate financial 
information required per 21 CFR, Part 54.  Investigator shall return unused devices to the 
sponsor, or dispose of device as directed by sponsor. 
 
TriVascular Clinical Field Specialists will be in attendance during the implant of the study device to 
provide technical assistance to the investigators. These field specialists will be supervised by the 
investigator to eliminate the potential for biasing the outcome of studies, affecting the quality of 
research data, and/or compromising the rights and welfare of human subjects.  
 
Additionally, investigators are responsible for maintaining accurate, complete and current 
records pertaining to correspondence, device accountability, each subject case history, including 
evidence of informed consent.  Reports of any IRB withdrawal, unanticipated adverse device 
effects, deviations from the protocol, use of a device without obtaining subject consent, as well 
as progress reports to IRB (annually at minimum) are also the responsibility of the investigator. 
12.10 Source Documentation 
Investigators are responsible for maintaining information in the study subjects’ medical records 
that corroborate data entered into the CRF.  The following documents will be maintained and 
made available as required by the sponsor’s designated monitors and/or regulatory inspectors: 
 
1. Medical and surgical history/physical condition of the subject prior to participation in 
the study in order to verify protocol entry criteria. 
2. Dated and signed notes in the subjects’ medical record that verify that informed 
consent was obtained. 
3.  Dated and signed notes from each subject visit with reference to the data collected. 

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4.  Description of device implantation procedure (date, time, medications, AEs, duration 
of procedure, etc) 
5.  Notations on abnormal lab results and their resolution. 
6.  Dated printouts of diagnostic reports of assessments (CT, X-ray, etc) 
7.  Adverse event reporting and follow-up of the AE. 
8.  Subjects condition upon completion of or withdrawal from the study. 
12.11 Maintaining Records 
TriVascular will maintain hard or electronic copies of correspondence, data, shipment of devices, 
adverse device effects, and other records related to the clinical trial.  All Core Labs and clinical 
sites will maintain study records for two (2) years after study completion.   
It is the responsibility of the investigator and the study staff to maintain a comprehensive and 
centralized filing system of all relevant study documentation which may include: 
• Subject Files – which substantiate the data entered in the electronic Case Report Forms 
for all required tests and procedures. 
• Subject Identification Log – a list correlating all subject names, appropriate identifying 
information, etc., to the TriVascular assigned subject number. 
• Screening Log – which should reflect the reason any subject was screened for the study 
and found to be ineligible. 
• Monitoring Visit Log – which lists dates of monitor/sponsor visits. 
• IRB Correspondence – includes approval letter(s), and any adverse event reporting or 
other correspondence with the IRB. 
• Sponsor Correspondence –letters, e-mails, or faxes sent to the investigator or study 
coordinator at the investigational site. 
• Site Correspondence – letters or fax sent to the sponsor from the investigator or study 
coordinator at that site. 
• Signed Informed Consent for each subject 
• Informed Consent Log – lists version of consent(s) signed by each subject screened and 
enrolled into the study 
• Device Inventory Log – includes a list of any devices received by the site, used in a case 
and/or returned to the sponsor. 
All Study Documentation pertaining to the conduct of the study must be kept on file by the 
investigator for a minimum of two (2) years after being notified by the sponsor of either PMA 
approval or discontinuation of the Sponsor’s IDE. 
In compliance with current regulatory guidelines regarding the monitoring of clinical studies, it 
is requested that the investigator permit the study monitor to review and duplicate information in 
the subject’s medical record that is directly related to the study.  This information may include  
relevant study documentation, including the subject’s medical history, to verify eligibility, 
laboratory test results to verify transcription accuracy, x–ray reports, admission and discharge 
summaries for hospital or outpatient admissions occurring while the subject is participating in 
the study, charges and billing, and autopsy reports for deaths occurring during the study (if 
available). 
As part of the required content of informed consent, the subject must be informed that his/her 
medical record will be reviewed and, possibly, duplicated by the sponsor, or the sponsor’s 

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authorized representative or government regulatory authorities.  Should access to the medical 
record require a separate waiver or authorization, it is the investigator’s responsibility to obtain 
such permission from the subject in writing before the patient subject is entered into the study. 
12.12 Study Deviations 
A study deviation is defined as an event where the investigator or site personnel did not conduct 
the study according to the investigational plan, protocol or the investigator agreement.  
Investigators shall be required to obtain prior approval from TriVascular clinical study 
management before initiating deviations from the protocol, except where necessary to protect the 
life or physical well being of a subject in an emergency.  Such approval shall be documented in 
writing and maintained in clinical study management and investigator files.  Prior approval is 
generally not expected in situations where unforeseen circumstances are beyond the investigators 
control (e.g., missed visits or tests); however, the event is still considered a deviation and will be 
collected on the Deviation eCRF.  Investigators are responsible for reporting deviations in 
accordance with the reviewing IRB policies. 
 
FDA regulations require that investigators maintain accurate, complete, and current records, 
including documents showing the dates of and reasons for each deviation from the protocol.  The 
following information outlines requirements for the reporting of protocol deviations: 
 
Type of Deviation 
Investigator to notify: 
Reporting timeline 
Emergency 
procedures to 
protect the life or 
physical well-being 
of a subject  
TriVascular and 
reviewing IRB 
Within 5 days of event 
Changes in or 
Deviations from 
the investigational 
plan  
Prior approval from: 
TriVascular, IRB and 
FDA 
Prior to use 
Non-urgent 
protocol deviation 
TriVascular, IRB (if 
required) 
Upon CRF completion.  
Deviations directly related to the 
study endpoints will be 
summarized and submitted in an 
annual report to the FDA 
12.13 Termination of Study 
The sponsor or the FDA retains the right to terminate the study and remove all study materials 
from the investigational site at any time.  Specific instances, which may precipitate study 
termination, are: 
1. Unsatisfactory subject enrollment with regard to quality and quantity. 
2. Deviations from protocol, without prior approval from the sponsor. 
3. Inaccurate, incomplete, and/or untimely data recording on a recurrent basis. 

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4. The incidence and/or severity of adverse experiences in this or other studies indicating a 
potential health hazard caused by the device. 
5. Submission of fraudulent data. 

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13.0 
STUDY COMMITTEES 
13.1  Data Safety Monitoring 
A Data Safety & Monitoring Board (DSMB) committee shall be used to review the progress of 
the clinical study.  The committee will be responsible for reviewing the data associated with the 
device and the subjects.  It will provide independent recommendations to the sponsor based on 
its review of the data and input from the Clinical Events Committee (CEC).  The DSMB shall 
meet annually, at a minimum. 
13.2  Clinical Events Committee 
The Clinical Events Committee (CEC) shall be used to review and adjudicate all device related 
adverse events (AE) and all serious adverse events (SAE) regardless of the relatedness to the 
device.  The CEC shall also determine which adverse events are considered Major Adverse 
Events (MAE) for evaluation of the primary (30 days) and secondary (1 year) safety endpoints.  
The committee shall consist of at least three (3) physicians representing multiple specialties 
familiar with abdominal aortic aneurysm repair.  The CEC will provide their review to the 
DSMB and shall meet annually, at a minimum. 

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14.0 
TRAINING 
TriVascular will provide technical training and support.  Physician training may involve a 
didactic review of the research team’s study responsibilities and hands on device implantation in 
a simulated anatomic model.  The emphasis during physician training will include: protocol and 
study compliance, compliance with applicable regulations, subject selection criteria, sizing of the 
stent graft, mechanics of the Ovation Abdominal Stent Graft System and its deployment, as well 
as the essential ancillary equipment necessary to perform the implant procedure with the device.  

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15.0 
INFORMED CONSENT  
All subjects must provide written informed consent in accordance with the reviewing IRB policy 
and procedures.  The process of obtaining informed consent must be documented in the subject’s 
medical record.  If changes to the TriVascular informed consent template are to be made, these 
changes must be submitted and approved by TriVascular prior to IRB submission.  Each clinical 
site must provide TriVascular with a copy of the IRB approval letter, which states the study 
name, protocol revision being approved as well as the approval date.  A copy of the approved 
informed consent must also be submitted to TriVascular.  A template for the Informed Consent is 
provided in Appendix V: Informed Consent Template. Clinical sites are responsible for 
maintaining annual approval (as appropriate) and submitting the annual approval letters to 
TriVascular.  
 

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APPENDIX I: REFERENCES 
1. Hallin, A., Bergqvist, Holmberg, L.  Literature Review of Surgical Management of 
Abdominal Aortic Aneurysm.  Eur J Vasc Surgery 2001; 22:197-204. 
 
2. Guirguis, E. M., Barber, G. G., The Natural History of Abdominal Aortic Aneurysms. 
Am J of Surgery 1990; 162:481-483 
 
3. Brewster, D. C., Cronenwett, J. L., Hallett, J. W. Jr., Johnston, K.W., Krupski, W. C., 
Matsumura, J. S.  Guidelines for the Treatment of Abdominal Aortic Aneurysms. J 
Vascular Surgery 2003; 37:1106-1116 
 
4. Menard, M. T., Chew, D. K.W., Chan, R. K., Conte, M. S., Donaldson, M. C., Mannick, 
J. A., Whittemore, A. D., Belkin, M.  Outcome in Patients at high risk after open surgical 
repair of abdominal aortic aneurysm.  J Vascular Surgery 2003; 37:285-292. 
 
5. FDA Public Health Notification:  Updated Data on Mortality Associated with Medtronic 
AVE AneuRx® Stent Graft System.  December 17, 2003 
 
6. Matsumura, J. S., Brewster, D. C., Makaroun, M. S., Naftel, D. C. A multicenter 
controlled clinical trial of open versus endovascular treatment of abdominal aortic 
aneurysm.  J Vascular Surgery 2003; 37:262-271. 
 
7. Buth, J., van Marrewijk, C. J., Harris, P. L., Hop, W. C. J., Riambau, V., Laheij, R. J. F.  
Outcome of endovascular abdominal aortic aneurysm repair in patients with conditions 
considered unfit for an open procedure: A Report on the EUROSTAR experience. J 
Vascular Surgery 2002; 35: 
 
8. Lavori, P.W., Dawson, D., Shera, D. “A Multiple Imputation Strategy for Clinical Trials 
with Truncation of Patient Data.” Statistics in Medicine, Vol 14, (1995):1913-1925.]

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APPENDIX II: REFERENCES RELATED TO COMPLICATIONS 
 
1) 
AbuRahma, A. F., Robinson, P. A., Boland, J. P., Lucente, F. C., Stuart, S. P., Neuman, 
S. S., Hall, M. D., Hoak, B. A..  Elective resection of 332 abdominal aortic aneurysms in 
a southern West Virginia community during a recent 5-year period.  Surg 1991; 109 (3) 
Part I: 244-251.  
2) 
Bernstein, E. F., Dilley, R. B., Randolph III, H. F.  The improving long-term outlook for 
patients over 70 years of age with abdominal aortic aneurysms.  Ann Surg 1988; 207 (3): 
318-322.  
3) 
Brewster, D. C., Geller, S. C., Kaufman, J. A., Cambria, R. P., Gertler, J. P., LaMuraglia 
G. M., Atamian S., Abbott W. M.  Initial experience with endovascular aneurysm repair: 
Comparison of early results with outcome of conventional open repair.  J Vasc Surg 
1998; 27 (6): 992-1005.  
4) 
Buth, J., Laheij, R. J. F. Early complications and endoleaks after endovascular abdominal 
aortic aneurysm repair: Report of a multicenter study.  J Vasc Surg 2000; 31 (1), Part I: 
134-146. 
5) 
Chuter, T. A., Risberg, B., Hopkinson, B. R., Wendt, G., Scott, A. P., Walker, P. J., 
Viscomi, S., White, G.  Clinical experience with a bifurcated endovascular graft for 
abdominal aortic aneurysm repair.  J Vasc Surg 1996; 24 (4): 655-666.  
6) 
Diehl, J. T., Cali, R. F., Hertzer, N. R., Beven, E. G.  Complications of abdominal aortic 
reconstruction: An analysis of perioperative risk factors in 557 patients.  Ann Surg 1983; 
197 (1): 49-56.  
7) 
May, J., White, G. H., Yu, W., Ly, C. N., Waugh, R., Stephen, M. S., Arulchelvam, M., 
Harris, J. P.  Concurrent comparison of endoluminal versus open repair in the treatment 
of abdominal aortic aneurysms: Analysis of 303 patients by life table method.  J Vasc 
Surg 1998; 27 (2): 213-221.  
8) 
May, J., White, G., Waugh, R., Stephen, M. S., Chaufour, X., Yu, W., Harris, J. P.  
Adverse events after endoluminal repair of abdominal aortic aneurysms: A comparison 
during two successive periods of time.  J Vasc Surg 1999; 29 (1): 32-39.  
9) 
Mialhe, C., Amicabile, C., Becquemin, J.  Endovascular treatment of infrarenal 
abdominal aneurysms by the Stentor system: Preliminary results of 79 cases.  J Vasc Surg 
1997; 26 (2): 199-209.  
10) 
Perry, M. O., Calcagno, D.  Abdominal aortic aneurysm surgery: The basic evaluation of 
risk.  Ann Surg 1998; 208 (6): 738-742.  
11) 
Richardson, J. D., Main, K. A.  Repair of abdominal aortic aneurysms: A statewide 
experience.  Arch Surg 1991; 126 (5): 614-616.  
12) 
Stelter,W., Umscheid, T., Ziegler, P.  Three-year experience with modular Stent graft 
devices for endovascular AAA treatment.  J Endovasc Surg 1997; 4: 362-369. 
13) 
Zarins, C. K., White, R. A., Schwarten, D., Kinney, E., Dietrich, E. B., Hodgson K. J., 
Fogarty, T.J.  AneuRx Stent graft versus open surgical repair of abdominal aortic 
aneurysms: Multicenter prospective clinical trial.  J Vasc Surg 1999; 29 (2): 292-308. 
14) 
Nayak, K. R., White, A. A., Cavendish, J. J, Barker, C. M., Kandzari, D. E. 
Anaphylactiod Reactions to Radiocontrast Agents:  Prevention and Treatment in the 
Cardiac Catheterization Laboratory. J Invasive Cardiol 2009; 21:548-551. 
15) 
Canter, L. M. Anaphylactiod Reactions to Radiocontrast Media. Allergy and Asthma 
Proc 2005; 26:199-203. 

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16) 
Honari, G., Ellis, S. G., Wilkoff, B. L., Aronica, M. A., Svensson, L. G., Taylor, J. S. 
Hypersensitivity reactions associated with endovascular devices. Contact Dermatitis 
2008; 59:7-22. 

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APPENDIX III: ASA CLASSIFICATION SYSTEM 
 
American Society of Anesthesiologists Classification System 
 
The American Society of Anesthesiologists (ASA) presents a graded scale assessing a patient’s 
risk of undergoing anesthesia.  The scale represents the significance of the patient’s underlying 
illnesses prior to anesthesia. 
 
The following provides a description of the four grades of the ASA scale: 
 
ASA I 
Healthy individual without any systemic disease, undergoing elective surgery.  Patient not at 
extremes of age.  (Note: Age is sometimes ignored as affecting operative risk; however, patients 
at either extreme of age are thought to represent increased risk.)  Some examples are a fit man 
with an inguinal hernia, and a fibroid uterus in an otherwise healthy woman. 
 
ASA II 
Individual with one system, well-controlled disease.  Disease does not affect daily activities.  
Other anesthetic risk factors, including mild obesity, alcoholism, and smoking can be 
incorporated here.  Examples include non-limiting or only slightly limiting organic heart disease, 
essential hypertension, anemia, or mild diabetes. 
 
ASA III 
Individual with multiple system disease or well controlled major system disease.  Disease does 
limit daily activities.  No immediate danger of death from any individual disease.  Examples 
include severe organic heart disease, severe diabetes with vascular complications, moderate to 
severe degrees of pulmonary insufficiency, angina or healed myocardial infarction. 
 
ASA IV 
Individual in imminent danger of death.  Surgery is viewed to be last resort at salvaging life.  
Individual not expected to live through the next 24 hours.  In some cases, the individual may be 
healthy prior to catastrophic event that led to the current medical condition.  Examples include 
ruptured abdominal aortic aneurysm with profound shock, major cerebral trauma with rapidly 
increasing intracranial pressure, massive pulmonary embolus. 
 
Reference: Composite from different editions of: 
 Sabiston, 
DC, 
Textbook 
of 
Surgery.  
Philadelphia: W.B. Saunders Company 
 

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APPENDIX IV: SCHEDULE OF ACTIVITIES 
 
 
 
1X-ray images should include: AP, lateral, left oblique and right oblique views.  
2PT, PTT and INR are optional after Baseline. 
3Baseline med/surg history, physician exam/ABIs, and laboratory assessments performed no more than 
one month prior to the implant/surgical procedure. Serum pregnancy HCG required for females 
of child-bearing potential only. 
4Baseline contrast enhanced CT must be obtained within 6 months of anticipated treatment date. 
5Only the device will be assessed at discharge as no CT is performed at that visit. 
 
 
Procedure 
Baseline 
Treatment 
Discharge 
1 Month 
Follow-Up 
6 Month 
Follow-Up 
12 Month 
Follow-Up  
Annual  
Follow-Up 
Medical/Surgical 
History 
X3 
 
 
 
 
 
 
Physical Exam   
X3 
 
X 
X 
X 
X 
X 
ABI 
X 
 
X 
 
 
 
 
Spiral Contrast 
Enhanced CT 
X4 
 
 
X 
X 
X 
X 
Abdominal X-ray1 
 
 
X 
X 
X 
X 
X 
Laboratory 
Assessment (BUN, 
creatinine, PT, PTT, 
INR)2 
X3 
 
X 
X 
X 
X 
X 
Adverse Event 
Assessment 
 
X 
X 
X 
X 
X 
X 
Concomitant 
Medication 
Assessment 
(anticoagulants, 
antiplatelets, 
antibiotics only) 
X 
X 
X 
X 
X 
X 
X 
Device/aneurysm 
assessment based on 
imaging (endoleak, 
migration, integrity, 
patency) 
 
X5 
 
X 
X 
X 
X 

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APPENDIX V: INFORMED CONSENT TEMPLATES 
 
DRAFT SCREENING INFORMED CONSENT 
 
Study Title: 
A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of 
the Ovation Abdominal Stent Graft System 
 
Trial Number:   
771-0006 
 
Researcher:   
Investigator Name 
Site Name 
Site Address 
Site Address 
Investigator Telephone:  
 
Sponsor:  
TriVascular, Inc. 
3910 Brickway Blvd. 
Santa Rosa, CA 95403 
Telephone: +1 707.543.8811 
 
 
Patient Name: _________________________ 
  
 
 
I, ___________________________________, an adult, voluntarily consent to release my 
medical records for screening evaluations for possible participation in a clinical research study 
sponsored by TriVascular, Inc. The TriVascular Pivotal Clinical Study is to evaluate the Safety 
and Effectiveness of the Ovation Abdominal Stent Graft System for the treatment of abdominal 
aortic aneurysms. 
 
I understand that in order to determine my eligibility to participate in the study, medical 
information from my CT scans and/or x-rays whichever is deemed appropriate and available, 
will be evaluated by the study sponsor and an independent laboratory appointed by the study 
sponsor, who will read the scans/x-rays and take anatomical measurements. 
 
I have been informed that my name may appear on the films (x-rays) that will be sent to the 
sponsor. All personal information taken and recorded will be treated in strict confidence. I 
understand that my personal identity will not be used by the sponsor for any public disclosure. 
 
I understand that my consent is for screening only and is not my consent to participate in the 
study. I understand that the CT scans or x-rays are part of the standard evaluation for abdominal 
aortic aneurysms and are not taken specifically for research study purposes. 
 
I hereby authorize my physician to release the information from my CT scans or x-rays to the 
study sponsor and the independent core laboratory to evaluate and determine my eligibility to 
participate in research. 

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________________________________________________________________ 
Participant’s (or representative) printed full name 
 
 
_______________________________________  
__ __ / __ __ / __ __ __ __ 
Participant’s (or representative) signature 
Date (dd/mm/yyyy) (written by the participant 
or his/her representative) 
 
________________________________________________________________ 
Impartial witness (full name) (Witness signature required only in the event the patient cannot read and/or 
sign the Informed Consent; for instance, if the patient is illiterate or blind) 
 
_______________________________________  
_______________________ 
Signature of the impartial witness (if required)   
Date (dd/mm/yyyy) (written by the witness) 
 
 
____________________________________ 
__ __ / __ __ / __ __ __ __ 
Principal Investigator or Authorized Designee 
 
Date (dd/mm/yyyy) 
 

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DRAFT INFORMED CONSENT 
 
Study Title: 
A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of 
the Ovation Abdominal Stent Graft System 
 
Trial Number:   
771-0006  
 
Researcher:   
Investigator Name 
Site Name 
Site Address 
Site Address 
Investigator Telephone:  
 
Sponsor:  
TriVascular, Inc. 
3910 Brickway Blvd. 
Santa Rosa, CA 95403 
Telephone: +1 707.543.8620 
 
 
Patient Name: _________________________ 
Patient #:  ______________ 
 
WHAT IS INFORMED CONSENT? 
When researchers ask for your consent, they are asking for your voluntary agreement to take part 
in a test, procedure, or clinical research trial.  Informed consent means more than signing a 
printed consent form.  To be informed, you need to know about benefits and risks of the clinical 
research trial and how it may affect you, your family, and society.  The following document is 
called a consent form and describes the clinical research trial and what your role will be as a 
study participant. 
 
This consent form may contain words that you do not understand.  Please ask the doctor in 
charge of the study, your own doctor, or the staff involved with the clinical research trial to 
explain any words that you do not understand before signing this form.  You may also contact 
the organizations listed in the Section below entitled “Persons To Contact For Research 
Questions” for any questions you may have regarding this research study.  You will be given a 
copy of the signed consent form. 
PURPOSE OF THE STUDY 
You have been asked to consider participating in a clinical research study designed to determine 
the safety and effectiveness of the Ovation Abdominal Stent Graft System, an investigational 
device used in the treatment of abdominal aortic aneurysms (AAA).  This study will be 
conducted at approximately 40 clinical sites and will enroll up to 150 subjects during the initial 
study phase with an additional 100 subjects enrolled during the continued access phase. 
 
An abdominal aortic aneurysm is a bulge in the aorta (the main artery leaving the heart) caused 
by a weakening in the artery wall.  If left untreated, this bulge may continue to grow larger and 
ultimately rupture (break open), resulting in serious internal bleeding.  The information collected 

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from this study will be used to evaluate how well patients do when treated with the Ovation 
Abdominal Stent Graft System both immediately after surgery and over a long period of time.  If 
you decide to participate in this study, your medical condition will be carefully monitored. 
 
Treatment of your AAA with the Ovation Abdominal Stent Graft System involves the placement 
of specially designed grafts (fabric tubes) in your aorta.  The main graft looks like a pair of pants 
with very short legs.  The top of the pants will be placed in your aorta.  Then, two or more 
smaller grafts are used to extend from the main graft into your iliac arteries (the main arteries 
supplying blood to your abdomen and legs) to form the legs of the pair of pants.  Each graft is 
enclosed in a small catheter (a long, flexible tube) that is inserted into your aorta through the 
femoral artery in your groin (top of your leg).  The grafts are then placed in the correct position 
in your aorta by releasing them from the catheters.  Once the grafts are attached inside your 
aorta, they will reinforce the area of your aorta that is weakened and bulging from your 
aneurysm.  This procedure is called an endovascular aneurysm repair because the grafts are 
delivered through your blood vessels.   
 
In standard surgical aneurysm repair, the surgeon makes a large incision in your abdomen and 
actually cuts into your aorta and sews a graft in place.  There are other endovascular AAA repair 
devices that are approved for use by the Food and Drug Administration (FDA) in the United 
States (U.S.).  You have the choice of having your treatment with the investigational Ovation 
Abdominal Stent Graft System or with any other AAA repair device which is already FDA 
approved.  You also have the choice of having your treatment with standard surgery or choosing 
to have no treatment for your aneurysm.  
EXPLANATION OF PROCEDURES 
In preparation for this research study, you will have a physical examination by the study doctor, 
an evaluation of your medical history and any risk factors, and a check of the blood pressures in 
your arms and legs.  You will also have approximately 2 tablespoons, or 30 milliliters, of blood 
drawn from a vein using a needle, so that tests of your kidney function and your body’s blood-
clotting abilities can be performed.  If you are a female with child bearing potential, you will also 
have a blood pregnancy test performed to make sure you are not pregnant. Since your doctor has 
already diagnosed your aneurysm, you may have already had a special x-ray, called a CT scan.  
If you have not had a CT scan, or if the CT scan information is not detailed enough to let your 
doctor evaluate your aneurysm, you will be required to have a CT scan. These same tests would 
be done if you were scheduled to undergo standard surgery to repair your aneurysm or if you 
were going to have an endovascular AAA repair using another device. 
 
As the procedure begins, you will receive a drug in your hand or arm to help sedate you, or you 
might receive general anesthesia depending upon your particular circumstance.  Your surgeon 
will clean your skin and shave hair around the place where the device will be inserted through a 
catheter (flexible tube) into your body.  Your surgeon will then make an incision (cut) into the 
skin in order to get access to the femoral artery in your groin (top of leg). Your surgeon will then 
thread a very thin wire into your artery to guide it to the aneurysm. Because you have no nerve 
endings inside your arteries, you will not feel the wires or catheters as they move through your 
body. You may feel a slight pressure or a sensation of mild tugging during this part of the 
procedure.  
 

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The main catheter containing the first piece of the graft will be advanced through your femoral 
artery up to a level in the aorta above the aneurysm, but below the arteries that go to your 
kidneys.  The graft will be released from the catheter and the catheter will be pulled away.  A 
special material will be inserted into tubes inside the wall of the main graft to ensure it is tight 
against the artery wall.  Then, catheters are used to place the two or more smaller grafts into your 
iliac arteries to complete the procedure.  All the catheters will be removed leaving the graft in 
place inside your aorta.  The incisions in your groin arteries and in your skin will be closed by 
your doctor. 
 
After the procedure has been completed and you have had time to recover from the sedation, you 
will be kept in the hospital until your doctor allows you to go home.  Prior to your discharge 
from the hospital, you will have physical examinations, the blood pressure in your arms and legs 
will be checked, an X-Ray of your abdomen and you will have blood tests that will require 
approximately 2 tablespoons, or 30 millimeters, of blood to be drawn.  
FOLLOW-UP EVALUATIONS 
If you decide to participate in this research study, you will be required to return to your doctor 
for follow-up evaluations at one (1) month, six (6) months, and twelve (12 months) after the 
procedure, as well as every year thereafter until five (5) years after the procedure. 
 
At each of the follow-up visits, you will have a physical exam, CT scan, X-Ray of your 
abdomen, and blood tests that will require approximately 2 tablespoons, or 30 millimeters, of 
blood to be drawn.  If you experience any problems with your grafts, your physician may ask to 
see you more frequently and additional tests may be done. 
 
It is very important to complete these follow-up visits even if you are feeling well and not having 
any symptoms.  These visits are important for documenting how well the treatment has worked. 
It is also very important that you contact your doctor if you have any symptoms that may be 
related to the treatment that you received so that your condition can be properly checked. 
ALTERNATIVE TREATMENTS 
Alternative procedures to repair your AAA include standard surgical aneurysm repair and 
endovascular repair using a commercially available endovascular AAA repair device.  In 
standard surgical aneurysm repair, the surgeon makes a large incision in your abdomen and 
actually cuts into your aorta and sews a graft in place.  The procedure with a commercially 
available endovascular AAA repair device is very similar to the procedure with the Ovation 
Abdominal Stent Graft System, by placing the device through your groin (femoral) arteries. 
RISKS 
The risks associated with the use of this study device are not currently known.  Although the 
adverse events associated with the use of the Ovation Abdominal Stent Graft may be less than 
for standard open surgical repair, inherent risks exist, as with many medical procedures.  
However, risks that have been associated with repair of AAAs with this type of device in clinical 
trials or that are currently marketed include, but may not be limited to: 
 hematoma (deep bruise) or lymphatic problems (infection) at the access sites in the groin;  
 damage to the iliac or femoral arteries during device deployment;  

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 fracture of the metallic components of the implant; 
 endoleak (leakage of blood around the graft into the aneurysm sac and/or blood flow into 
the aneurysm sac from vessels connected to the aorta); 
 continued enlargement of your aneurysm; 
 failure to deploy the graft resulting in the need to stop the procedure and/or convert to 
open surgical repair; 
 twisting of the implanted graft; 
 migration of the some or all of the device parts; 
 separation of implant parts; 
 aortic occlusion (blockage or the blood flow in your aorta) from blood clots;  
 kinking or twisting of the graft and iliac artery occlusion (blockage of blood flow in the 
blood vessels that supply blood to your legs) from blood clots, kinking or twisting of the 
legs of the graft; and 
 allergic reaction to the device fill material, if injected into the bloodstream, as well as 
device materials. 
 
Complications common to all patients undergoing standard surgical aneurysm repair or 
endovascular repair include, but may not be limited to:  
 allergic reaction to x-ray contrast dye; 
 procedural bleeding; 
 post-procedure bleeding;  
 hematoma (deep bruise);  
 bleeding disorders;  
 respiratory failure;  
 pneumonia;  
 pulmonary embolism (blood clots in the lung);  
 myocardial infarction;  
 congestive heart failure;  
 irregular heart beat requiring therapy;  
 kidney failure; wound infection;  
 bowel complications such as paralysis of the bowel; blockage of the bowel; or decreased 
blood flow to the bowel tissue; 
 mild or severe blockage of blood flow to your legs or arms due to blood clots or damage 
to the blood vessels;  
 amputation;  
 stroke;  

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 impotence;  
 blood clots or infection in the graft; graft dilatation (stretching);  
 development of a hole between the aorta and the intestines or the aorta and the vena cava 
(major blood vessel carrying blood to the heart);  
 separation of the walls of the aorta;  
 a false aneurysm developing at the fixation point of the graft; 
 re-operation (additional surgery); and  
 death.   
Your doctor will make every effort to minimize the risks and discomforts of the procedures.  
Most of the complications and discomforts listed above can be treated with medications or 
surgery that can be given to you if your doctor feels it is needed.  In the event of a serious 
complication or injury, it may be necessary to surgically remove the study device. In that case, 
TriVascular requests that the removed study device be returned to them for examination. 
POTENTIAL BENEFITS 
Potential benefits of the Ovation Abdominal Stent Graft System compared to open surgical 
aneurysm repair may include, but are not limited to: 
 Not having open surgery; 
 Less time under general anesthesia and/or the ability to use other forms of anesthesia that 
do not require mechanical ventilation; 
 Reduction of complications; and 
 Reduction in hospitalization and recovery time. 
 
Potential benefits of the Ovation Abdominal Stent Graft System compared to other commercially 
available endovascular AAA repair devices may include, but are not limited to: 
 More robust seal between the graft and your aorta, possibly reducing the risk that the graft 
will develop leaks or move over time and; 
 Lower risk of injury to the vessels in your legs because this catheter is smaller and more 
flexible than the commercially available devices. 
Any potential benefits cannot, however, be guaranteed. There may be no direct benefit to you 
from your participation in this study, but it is hoped that the information gained from your 
participation in this study may benefit others with a condition similar to yours. 
CONFIDENTIALITY 
The information obtained about you due to taking part in this study will be kept confidential to 
the extent allowed by law.  Total confidentiality cannot be guaranteed. However, all medical 
records and research materials that would identify you will be held confidential. Your identity 
will remain confidential unless the law requires disclosure. By signing this consent, you grant 
permission for medical information about you obtained during this study to be made available to 

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authorized representatives of the FDA and other government agencies. You also grant 
permission for this medical information to be made available to the following people: 
• TriVascular, the Sponsor—the manufacturer of the Ovation Abdominal Stent Graft 
System and the company funding the Study, and its employees (e.g., Clinical Field 
Specialists who are in attendance during the procedure to provide technical assistance to 
your physician) who are involved in the conduct of the study. 
• Employees of a Contract Research Organization, a company contracted by TriVascular to 
supervise/validate the clinical information obtained in the Study.  
• The local Institutional Review Board (IRB). 
The results of this research study may be published or used for teaching purposes; however, 
patients will not be identified by name in those publications or teaching materials.  You will be 
assigned a special study code that will not reveal your name or personal identity.   
 
You will be asked to review and sign a special document, along with this informed consent form, 
that describes the privacy law, Health Insurance Portability and Accountability Act (HIPAA), so 
that the researchers can use or disclose your protected health information for research purposes. 
RIGHT OF REFUSAL AND STUDY TERMINATION 
Your participation in this study is voluntary.  Your refusal to participate will not prejudice your 
future treatment or benefits.  You are free to stop participation in the study at any time without 
fear of penalty or loss of medical care. You will be asked to come in for a final study visit. 
 
Your doctor may also terminate your participation in this study, if in his or her medical judgment 
it is in your best interest not to continue.  You will be informed, if important new findings 
develop during the study that may affect your willingness to continue. 
COSTS OF TREATMENT AND STUDY PARTICIPATION 
You and/or your third party payer (Medicare or other health insurance company) will be 
responsible for the costs of your treatment procedures and follow-up examinations which are 
considered standard of care for endovascular AAA repair.  The cost of any test or examination 
which is not considered standard of care or reimbursable by your third party payer (insurance) 
will be covered by the study sponsor.   
PAYMENT FOR STUDY PARTICIPATION 
You will not be compensated or paid for your participation in this study.  Any reasonable costs 
you incur traveling to your physician for required follow-up visits will be reimbursed by the 
sponsor, TriVascular, Inc., if agreed to in advance of your visit.  Please contact ____________, 
the Research coordinator for this study at __________________ <insert institution name> to 
arrange for reimbursement. 
RESEARCH RELATED INJURIES 
If physical injury occurs that is directly related to your involvement in this research, you will 
receive any medical treatment that is necessary to assist your recovery from the injury.   The 
costs of medical care associated with injuries related to your participation in this study will be 
provided by the sponsor, TriVascular, Inc, provided that the injury is a direct result of the use of 

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the investigational device in accordance with the Protocol. You will not receive any 
compensation for this injury. This agreement to provide free medical treatment does not include 
treatment for any illness you might experience during the course of this study if the illness is not 
the result of direct participation in the research study. 
PERSONS TO CONTACT FOR RESEARCH QUESTIONS 
If you have any questions about the research or experience an adverse reaction (any unusual 
symptoms) or injury, and if emergency medical treatment is required, you should immediately 
contact your study doctor, Dr. __________ at _____________.    
 
If you have questions about your rights as a research participant at this institution, you may call 
the Institutional Review Board at ________<insert contact information for IRB>. 
STUDY PARTICIPANT’S BILL OF RIGHTS 
Persons who participate in a medical experiment are entitled to certain rights.  These rights 
include but are not limited to the subject's right to: 
 Be informed of the nature and purpose of the experiment; 
 Be given an explanation of the procedures to be followed in the medical experiment, and 
any drug or device to be utilized; 
 Be given a description of any attendant discomforts and risks reasonably to be expected; 
 Be given an explanation of any benefits to the subject reasonably to be expected, if 
applicable; 
 Be given a disclosure of any appropriate alternatives, drugs, or devices that might be 
advantageous to the subject, their relative risks, and benefits; 
 Be informed of the avenues of medical treatment, if any, available to the subject after the 
investigational procedure if complications should arise; 
 Be given an opportunity to ask questions concerning the experiment or the procedures 
involved; 
 Be instructed that consent to participate in the medical experiment may be withdrawn at 
any time and the subject may discontinue participation without prejudice; 
 Be given a copy of the signed and dated consent form; and 
 Be given the opportunity to decide to consent or not to consent to a medical experiment 
without the intervention of any element of force, fraud, deceit, duress, coercion, or undue 
influence on the subject's decision. 
CONSENT AND SIGNATURES 
PATIENT OR LEGALLY AUTHORIZED REPRESENTATIVE 
I voluntarily consent to participate in this study.  The purpose and procedures of this study have 
been fully explained to me by the study investigator listed above.  All of my questions about the 
study have been satisfactorily answered.  I am free to not participate in this research study or to 
withdraw at any time, and that my current medical care will not be affected by this decision. 
 

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I agree that my primary physician will be informed of my participation in this trial.  I authorize 
the release of my medical records to TriVascular, agents of TriVascular, the Food and Drug 
Administration in the United States, other governmental agencies, and the (Insert name of 
IRB/EC). 
 
By signing and dating this consent form, I have not waived any of the legal rights that I would 
have if I were not a participant in a clinical research study. I will receive and may keep a copy of 
this signed and dated consent form. 
 
 
 
________________________________________________________________ 
Participant’s (or representative) printed full name 
 
 
___________________________________ 
 
__ __ / __ __ / __ __ __ __ 
Participant’s (or representative) signature 
Date (dd/mm/yyyy) (written by the participant 
or his/her representative) 
 
________________________________________________________________ 
Impartial witness (full name) (Witness signature required only in the event the patient cannot read and/or 
sign the Informed Consent; for instance, if the patient is illiterate or blind) 
 
_____________________________________ 
 
_______________________ 
Signature of the impartial witness (if required)   
Date (dd/mm/yyyy) (written by the witness) 
 
 __________________________________ 
 
__ __ / __ __ / __ __ __ __ 
Principal Investigator or Authorized Designee 
 
Date (dd/mm/yyyy) 
 
AUTHORIZATION OF USE AND DISCLOSURE 
PROTECTED HEALTH INFORMATION 
FOR RESEARCH PURPOSES 
(Sample HIPAA authorization) 
 
The privacy law, Health Insurance Portability & Accountability Act (HIPAA), requires me to 
sign an agreement called an Authorization so that the researchers can use or disclose my 
protected health information for research purposes. 
I authorize Dr.  <insert name>   and his research staff, and the Sponsor of this study, 
TriVascular, Inc., to use and disclose my protected health information for the purposes described 
below in the study titled, “A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of 
the Ovation Abdominal Stent Graft System”. 
 
I authorize the following individuals or groups to use or disclose my Protected Health 
Information: 
 <Insert Name of Hospital>; 
 My doctor(s) who care for me during this research.  These doctors include my primary 
care doctor and other doctors who may take care of me while I am part of this research. 

TriVascular, Inc. Ovation™ Abdominal Stent Graft System 
 
 
Protocol #771-0006, Rev. J 
TriVascular Proprietary Information 
Page 61 of 65 
 
The health information that may be used and disclosed includes: 
 All information collected during the research described in the Informed Consent Form; 
and 
 Health information in my medical records that is relevant to the research described in the 
Informed Consent Form. 
The Researchers may: 
 Use and share my health information to conduct the research; 
 Disclose my health information to the Sponsor of the research, TriVascular, Inc. and its 
agents; 
 Disclose my health information as required by law; 
 Disclose my health information to representatives of government organizations and other 
persons who are required to watch over the safety and effectiveness of medical products 
and therapies and the conduct of research; and 
 Remove from my health information my name and other information that could be used to 
identify me. 
TriVascular, Inc. may: 
 Use and share my health information to conduct the research; 
 Use my health information for additional purposes, such as other medical research, 
development of other study protocols, development of new medical products or 
procedures, system analysis and other business purposes, except where prohibited by law; 
• Disclose my health information as required by law; 
• Disclose my health information to representatives of government organizations and other 
persons who are required to watch over the safety and effectiveness of medical products 
and therapies, and the conduct of research; and  
• Remove from my health information my name and other information that could be used 
to identify me. 
 
The Researchers may share my health information with: 
 <Insert Name of Institutional Review Board>; 
 <Insert Name of Hospital Clinical Research Department>; 
 Government representatives, when required by law; 
 <Insert any names of hospital representatives, as applicable>; 
 TriVascular, Inc., as the Sponsor of the study, or its agents, such as data management 
groups, research monitoring groups, or contract research organizations; 
 <Insert> Other medical centers/institutions/Investigators outside of the name of hospital; 
 Your health insurer or payer, if necessary, in order to secure their payment for any covered 
treatment not paid for through the research. 
 

TriVascular, Inc. Ovation™ Abdominal Stent Graft System 
 
 
Protocol #771-0006, Rev. J 
TriVascular Proprietary Information 
Page 62 of 65 
Once my health information has been disclosed to a third party, federal privacy laws may no 
longer protect it from further disclosure.  The Researchers and TriVascular agree to protect my 
health information by using and disclosing it only as permitted by me in this Authorization and 
as directed by state and federal law.  Once information that could be used to identify me has been 
removed, the information that remains is no longer subject to this Authorization and may be used 
and disclosed by the Researchers and TriVascular as permitted by law.  No publication about the 
research will reveal my identity without my specific written permission. 
 
I do not have to sign this Authorization.  If I decide not to sign the Authorization: 
 It will not affect my treatment or my eligibility for health benefits. 
 I will not be able to participate in the research study. 
 
After signing the Authorization, I can change my mind and: 
 Not let the Researcher disclose or use my protected health information (revoke the 
Authorization), except for the information already collected for the study. 
 If I wish to revoke the Authorization, I will send a written letter to _________<insert 
Name and address of Investigator>. 
 If I revoke the Authorization, I can no longer participate in the study. 
Expiration: 
This Authorization expires at the conclusion of all work related to this research study, which 
could be as long as six years or until the study is completed, whichever is longer. 
 
If I have not already received a copy of the Notice of Privacy Practices, I may request one.  If I 
have questions or concerns about my privacy rights, I should contact <insert name and contact 
information for this person>. 
Authorization: 
I have read this information, and I will receive a copy of this form after it is signed. 
 
 
 
______________________________________ 
 
Patient’s Printed Name 
 
 
______________________________________ 
______________ 
Patient’s Signature 
Date 
 

TriVascular, Inc. Ovation™ Abdominal Stent Graft System 
 
 
Protocol #771-0006, Rev. J 
TriVascular Proprietary Information 
Page 63 of 65 
APPENDIX VI: CT SCANNING TECHNIQUES 
 
Reminders: 
• TriVascular requires contrast enhanced Spiral CT data for reconstruction. 
o Data must be uncompressed DICOM 
o Patient motion should be avoided during scan. If possible, avoid scanning non-
patient objects in field of view. Do not change patient position, table height, or field 
of view during scan. If patient moves, repeat the study in its entirety.  
• Entire Exam sent to M2S via: Direct transfer of data via FTP or on optical disc sent via a 
traceable method. 
 
Minimum Protocol 
(Required) 
High Resolution Protocol 
(Recommended) 
Scan Mode 
Helical  
Helical  
Scan Parameters 
110-140kVp, Auto mAs or 
170-400 mA scan time of 0.5sec 
110-140kVp, Auto mAs or 
170-400 mA scan time of 0.5sec 
Slice Thickness 
 3mm 
0.625 – 2mm 
Slice Interval 
 3mm 
0.625 – 2mm 
Pitch 
0.984:1 
0.984:1 
Superior Extent AAA 
2 cm above celiac artery origin 
2 cm above celiac artery origin 
Inferior Extent AAA 
Pre-op: Lesser trochanter of femurs to 
include femoral bifurcations 
 
Post-op: At least 2cm distal to the 
lowest hypogastric artery origin 
Pre-op: Lesser trochanter of femurs to 
include femoral bifurcations 
 
Post-op: At least 2cm distal to the 
lowest hypogastric artery origin 
Contrast 
Standard per Radiology Department 
Standard per Radiology Department 
Volume 
80ml contrast with 40ml saline flush 
or Standard Contrast Volume with 
Saline Flush per Radiology 
Department 
80ml contrast with 40ml saline flush 
or Standard Contrast Volume with 
Saline Flush per Radiology 
Department 
Rate 
4 ml/sec 
4 ml/sec 
Scan Delay 
ROI – threshold 90-100 HU in aorta 
ROI – threshold 90-100 HU in aorta 
Field of View 
Large Body 
Large Body 
Reconstruction 
Algorithm 
Standard 
Standard 
 
 

TriVascular, Inc. Ovation™ Abdominal Stent Graft System 
 
 
Protocol #771-0006, Rev. J 
TriVascular Proprietary Information 
Page 64 of 65 
APPENDIX VII: EXPLANT PROCEDURE 
 
Explant During Surgical Conversion 
The objective of device removal is to minimize trauma or damage to the device at the time of 
surgical excision from the subject, while maintaining the subject’s safety.  It is also important to 
minimize surrounding tissue disturbance so that a thorough pathological evaluation can be made. 
1. If possible, a swab should be used to obtain material for microbial culture prior to removal of 
the explant. 
2. Attempt to identify all components including their orientation so that they may be maintained 
in the same relative position as they were in situ. 
3. Attempt to remove the specimen en bloc from superior to the proximal stent to inferior to the 
distal stent. 
4. The residual blood should be rinsed from the explant surfaces utilizing physiological 
solutions such as Ringer’s lactate or normal saline avoiding disturbance to the inside surface 
of the explant. 
5. All samples should be fixed in 10% neutral buffered formalin. 
6. Prior to the explant, please contact TriVascular to obtain shipping instructions. 
7. Please alert the sponsor within 24-hours of the explant and the shipment of the device. 
8. Explant case report forms should be completed at this time 
9. An operative report and a separate report from the examining pathologist should be sent to 
the sponsor, if available. 
 
Explant During Autopsy 
The objective of device removal is to excise en bloc from superior to the proximal stent to 
inferior to the distal stent.  The abdominal aorta and iliacs should not be opened nor should any 
endovascular device manipulation be done.  Photos should be taken in anterior-posterior as well 
as oblique and lateral views.  The external characteristics and the relationship to surrounding 
viscera should be noted based on the guidelines on the case report forms.  Adhesions to viscera 
as well as evidence of fistula formation by erosion of the endograft through the arterial wall 
should be noted.  Any problems or abnormalities of this type should be photographed in situ, if 
possible. 
1. If possible, a spiral CT scan with 3-D reconstruction should be obtained of the endograft 
prior to explantation of the device.  Spiral CT should be performed before immersion of the 
specimen in fixative. 
2. Attempt to identify all components including their orientation so that they may be maintained 
in the same relative position as they were in situ. 
3. Attempt to remove the specimen en bloc from superior to the proximal stent to inferior to the 
distal stent. 
4. All samples should be fixed in 10% neutral buffered formalin. 
5. Prior to the explant, please contact TriVascular to obtain shipping instructions. 
6. Please alert the sponsor within 24-hours of the explant and the shipment of the device. 
7. An autopsy report and a separate report from the examining pathologist should be sent to the 
sponsor, if available. 
 
*These guidelines have been furnished by the Lifeline Registry of Endovascular Aneurysm 
Repair. 

TriVascular, Inc. Ovation™ Abdominal Stent Graft System 
 
 
Protocol #771-0006, Rev. J 
TriVascular Proprietary Information 
Page 65 of 65 
Revision History 
Rev 
DCO # 
Date 
Description of Change 
Initiator 
A 
2176 
18Nov09 
Initial Version of Document 
L. Mack 
B 
2311 
07Jan10 
Revision of Juxtarenal aortic neck length from 7-
9 mm to <10 mm. 
L. Mack 
C 
2350 
21Jan10 
Addition of Protocol Signature Page, Clinical 
Utility endpoint, and Revision of Statistical 
Section 10.0. 
L. Mack 
D 
2412 
10Feb10 
Addition of Protocol Approval Page; deletion of 
references to “roll-in patients”; revisions to 
Imaging Core Lab and Schedule of Activities 
tables to be consistent with schedule of 
procedures discussed in body of protocol; 
clarification of visit timeframe allowances; 
correction of protocol title on screening informed 
consent and informed consent templates; 
specification of number of patients and exit visit 
procedure on informed consent template; and 
minor spelling corrections. 
L. Mack 
E 
3238 
13Aug10 
Update verbiage based on DSMB’s request in 
response to UADE. 
M. Carr 
F 
3551 
20Oct10 
Clarification of allowable window for baseline 
procedures; incorporation of suggested 
investigator responsibilities as per “Guidance for 
Industry: Investigator Responsibilities” issued by 
the FDA in October of 2009. Update PI and 
product name. Added optional wound assessment 
at FU.  Removed ABI after Hospital Discharge. 
Made coagulation labs optional after Baseline. 
Requested site notification within 24 hours of 
device-related AEs. Modifications in response to 
FDA Conditional Approval letter dated 30 July 
2010. 
 
L. Mack 
G 
3732 
22Nov10 
The Device Description and Patient Informed 
Consent were revised to include the use of iliac 
extensions. 
C. Campbell 
H 
3759 
23Nov10 
Minor change to rename Section 1.0 of Protocol – 
Study Goal 
L. Mack 
I 
3917 
10Jan11 
Revise to incorporate provisions for the continued 
access phase. 
C. Campbell 
J 
4759 
15Aug11 
Revise number of additional subjects, modify 
follow-up periods, clarify sample size 
justification and remove DSMB wording added in 
previous revision. 
J German