TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury
Phase: NA
Conditions: Thoracic Aorta, Thoracic Injuries, Blunt Injuries
Sponsor: Cook Research Incorporated

Cook Incorporated 
Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury 
Page 1 of 61 
 
 
COMPANY CONFIDENTIAL 
CIP 11-004-01 
 
 
CLINICAL INVESTIGATION PLAN 
 
 
 
 
Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury Clinical 
Study 
 
 
 
 
Global Clinical Number 11-004 
 
 
 
 
Manufacturer:  
William Cook Europe, ApS 
Sandet 6 
DK 4632  
Bjaeverskov, Denmark 
 
Sponsor:  
Cook Incorporated 
 
750 Daniels Way 
 
Bloomington, IN 47404 
 
USA 
 
 
Summary of Revisions 
Version # 
Description 
 
 
Date 
11-004-01 
Original version 
 
 
14 June 2012 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cook Incorporated 
Zenith® 
Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury 
Page 2 of6l 
CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
This clinical investigation will be conducted in compliance with the clinical investigation 
plan (CIP), GCP, ISO 14155,21 CFR 812, and other applicable requirements as appropriate. 
Signatures: 
Sponsor Contact 
Signature 
Printed Name 
COMPANY CONFIDENTIAL 
CIP 11-004-01 
Z-7 / 
2. O\t.. 
DD/MM/YYYY 
Ot!ec!t>t 
Title 

Jul. 9. 2012 11:58AM 
HMC 4MB 428. 8 
No. 0790 
P. 3/ 3 
Cook Incorporated 
. 
Zenith® TXt' Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury 
Page 3 of3 
CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
Coordinating Clinical Investigator . 
I hereby confirm that I approve of this Clinical Investigation Plan (CIP) and agree to comply 
with its terms as laid out in this document. 
Signature 
.. 
Printed Name 
COMPANY CONFIDENTIAL 
CIP 11·004·0 1 
Qq 1 01 I :1-.P L?_ 
DD/MMIYYYY 

Cook Incorporated 
Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury 
Page 4 of 61 
 
 
COMPANY CONFIDENTIAL 
CIP 11-004-01 
 
CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
 
 
Principal Clinical Investigator  
 
I hereby confirm that I approve of this Clinical Investigation Plan and agree to comply with 
its terms as laid out in this document. 
 
 
 
 
 
 
Signature 
 
DD/MM/YYYY 
 
 
 
 
 
 
Printed Name 
 
Title 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cook Incorporated 
Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury 
Page 5 of 61 
 
 
COMPANY CONFIDENTIAL 
CIP 11-004-01 
CONFIDENTIALITY STATEMENT 
 
 
 
 
 
 
 
 
 
This document shall be treated as a confidential document for the 
sole information and use of the clinical investigation team and the 
Ethics Committee/IRB. 
 
 

Cook Incorporated 
Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury 
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COMPANY CONFIDENTIAL 
CIP 11-004-01 
TABLE OF CONTENTS 
 
1.0 
Clinical Investigation Plan Overview .........................................................................8 
2.0 
Summary of Preliminary Investigations ....................................................................9 
2.1 
Preclinical Testing ..............................................................................................9 
2.2 
Previous Clinical Experience ..............................................................................9 
2.3 
Justification for the Investigation .......................................................................9 
3.0 
Objectives of the Clinical Investigation ...................................................................10 
3.1 
Primary Objectives ...........................................................................................10 
3.2 
Secondary Objectives .......................................................................................10 
3.3 
Specific Hypothesis to be Accepted or Rejected by Statistical Data ...............11 
4.0 
Product Description and Intended Use ....................................................................11 
4.1 
 General Product Description ...........................................................................11 
4.2 
Intended Use .....................................................................................................13 
4.3 
Product Identification and Tracking .................................................................13 
4.4 
Instructions for Use ..........................................................................................14 
4.5 
Summary of Necessary Training and Experience ............................................14 
4.6 
Description of the Necessary Medical or Surgical Procedures ........................14 
5.0 
Design of the Clinical Investigation ..........................................................................14 
5.1 
Type of Investigation ........................................................................................14 
5.2 
Endpoints ..........................................................................................................14 
5.3 
Variables to be Measured to Demonstrate Achievement of Endpoints ............15 
5.4 
Measures to be Taken to Avoid or Minimize Bias ...........................................15 
5.5 
Study Criteria ....................................................................................................16 
5.6 
Point of Enrollment ..........................................................................................18 
5.7 
Enrollment Objective ........................................................................................18 
6.0 
Methods .......................................................................................................................19 
6.1 
Subject Assessment and Screening...................................................................19 
6.2 
Subject Consent ................................................................................................19 
6.3 
Medications ......................................................................................................20 
6.4 
Pre-procedure ....................................................................................................20 
6.5 
Procedure ..........................................................................................................20 
6.6 
Peri-operative....................................................................................................21 
6.7 
Post-operative Treatment of Endoleaks ............................................................21 
6.8 
Secondary Interventions ...................................................................................21 
6.9 
Follow-up..........................................................................................................21 
6.10 
Criteria and Procedures for Study Termination ................................................22 
7.0 
Statistical Considerations ..........................................................................................22 
7.1 
Sample Size Calculations .................................................................................22 
7.2 
Performance Goals ...........................................................................................22 
7.3 
Site-level Poolability ........................................................................................23 
7.4 
Missing Data .....................................................................................................23 
7.5 
Future Use of Study Data .................................................................................24 

Cook Incorporated 
Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury 
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COMPANY CONFIDENTIAL 
CIP 11-004-01 
8.0 
Risk Analysis and Risk Assessment .........................................................................25 
8.1 
Risks and Foreseeable Adverse Device Effects ...............................................25 
8.2 
Methods to Minimize Risk ...............................................................................27 
9.0 
Safety Monitoring and Event Reporting ..................................................................27 
9.1 
Data Safety Monitoring Board .........................................................................27 
9.2 
Clinical Events Committee ...............................................................................27 
9.3 
Adverse Event Reporting..................................................................................27 
10.0 
Administrative ............................................................................................................28 
10.1 
Data Collection .................................................................................................28 
10.2 
Data Management and Quality Assurance .......................................................28 
10.3 
Data Reporting ..................................................................................................29 
10.4 
Emergency Situations and Vulnerable Subjects ...............................................29 
10.5 
Criteria and Procedures for Withdrawal ...........................................................29 
10.6 
Deviations from Clinical Investigation Plan ....................................................29 
10.7 
Early Termination or Suspension of the Investigation .....................................29 
10.8 
Limitations of the Investigation ........................................................................30 
10.9 
Publication Policy .............................................................................................30 
10.10 Approvals and Agreements ..............................................................................30 
10.11 General Information .........................................................................................30 
11.0 
Bibliography ...............................................................................................................31 
 
 
 
Appendices  
Contact Information  ................................................................................................ Appendix A 
Written Procedures for Monitoring Investigations  ................................................. Appendix B 
Definitions ............................................................................................................... Appendix C 
Short-Form and Telephone Consent Templates ...................................................... Appendix D 
Mortality Rate Literature Review  ........................................................................... Appendix E 
 

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COMPANY CONFIDENTIAL 
CIP 11-004-01 
1.0 
Clinical Investigation Plan Overview 
This study will be conducted as a prospective, nonrandomized, noncomparative, single-arm 
study enrolling a total of 50 patients at up to 30 global centers. The purpose of this study is to 
assess the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft in 
the treatment of patients with blunt thoracic aortic injury (BTAI).   
A patient is deemed suitable for inclusion in the study if the patient has blunt thoracic aortic 
injury of the descending thoracic aorta and is suitable for treatment with the Zenith® TX2® 
Low Profile Endovascular Graft and 16 Fr, 18 Fr, or 20 Fr Z-Trak Plus® Introduction 
System. The study flow diagram is presented in Figure 1. 
 
 
Patient has blunt thoracic aortic injury of the descending thoracic aorta AND is suitable for treatment with  
the Zenith® TX2® Low Profile Endovascular Graft and 16 Fr, 18 Fr, or 20 Fr Z-Trak Plus® Introduction 
System
 
 
 
 
 
 
Physician reviews available medical history and imaging and considers patient candidate for enrollment 
 
 
 
 
 
 
Informed consent is obtained (see Section 6.2) 
 
 
 
 
Pre-procedural CTA, blood tests, clinical exam1 
 
 
 
 
Patient meets all inclusion and no exclusion criteria 
 
 
 
 
 
 
Endovascular repair with procedural angiography 
 
 
 
 
Post-procedural (within 7 days) blood tests, clinical exam 
 
 
 
 
30-day: CTA, clinical exam 
 
 
 
6-month: CTA, clinical exam 
 
 
 
12-month and yearly thereafter to 5 years:  
CTA, clinical exam
 
Figure 1.  Study flow diagram 
 
                                                     
1 Data collected prior to the patient’s signing of an Informed Consent are acceptable if they are standard of care 
at the investigative site. 

Cook Incorporated 
Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury 
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COMPANY CONFIDENTIAL 
CIP 11-004-01 
2.0 
Summary of Preliminary Investigations 
2.1 
Preclinical Testing 
Non-clinical tests were conducted in accordance with Good Laboratory Practice 
requirements, or performed in compliance with verified methods and standard operating 
procedures to maintain the integrity of the results.  In vitro testing has established reasonable 
safety of the device for the expected duration of the study and in the trial population to be 
studied.  Please reference the Clinical Investigator Brochure for a summary of non-clinical 
testing. 
 
2.2 
Previous Clinical Experience 
Please reference the Clinical Investigator Brochure for a complete description of the previous 
clinical experiences with the device or other similar devices, if applicable. 
 
2.3 
Justification for the Investigation 
Endovascular repair has been reported as an independent predictor of survival for patients 
with blunt thoracic aortic injury (BTAI).1  A meta-analysis performed by the Society for 
Vascular Surgery (SVS) showed a mortality rate of 9% with endovascular treatment as 
compared to 19% with open surgical repair.  These findings led the SVS committee to 
preferentially recommend endovascular repair of traumatic thoracic aortic injuries over open 
surgical repair or nonoperative management.2,3  
However, limited endovascular treatment options are available for patients with blunt 
thoracic aortic injury.  Furthermore, several publications have noted the need for devices 
with better arch conformability to accommodate the steep curvature of the aortic arch.3,4  
Device infolding and collapse were also noted to be issues, often resulting from excessive 
oversizing at the site of fixation.3,4,5  As patients with BTAI are on average much younger6 
than those treated for thoracic aortic diseases such as aneurysms,7 smaller diameter 
endovascular grafts with better arch conformability are needed to treat this patient 
population.   

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Page 10 of 61 
 
 
COMPANY CONFIDENTIAL 
CIP 11-004-01 
The Zenith® TX2® Low Profile Endovascular Graft has multiple design features that address 
the challenges of treating BTAI.  The availability of the Zenith® TX2® Low Profile 
Endovascular Graft in smaller sizes and in smaller profile delivery systems will allow 
physicians to treat patients with smaller aortic anatomy and therefore eliminate the need to 
treat patients with larger endografts that are not suitable for their anatomy.  Furthermore, the 
Zenith® TX2® Low Profile Endovascular Graft features a bare alignment stent in 
combination with a curved cannula on the introduction system to help ensure adequate 
proximal conformability.  The Zenith® TX2® Low Profile Endovascular Graft device has 
been designed to accommodate a radius of curvature of 20 mm, whereas the currently 
available Zenith® TX2® TAA Endovascular Graft accommodates a radius of curvature of 
35 mm.  Based on these device design features and the clinical need for devices to treat 
BTAI, the clinical study to evaluate the safety and performance of the Zenith® TX2® Low 
Profile Endovascular Graft in patients with BTAI is justified. 
 
3.0 
Objectives of the Clinical Investigation 
3.1 
Primary Objectives 
The objectives of the study are to evaluate the safety and effectiveness of the Zenith® TX2® 
Low Profile Endovascular Graft for the treatment of patients with BTAI.  The primary safety 
endpoint will be all-cause and aortic-injury-related mortality (see Appendix C, Definitions) at 
30 days.  The primary effectiveness endpoint will be device success (see Appendix C, 
Definitions) at 30 days. 
 
3.2 
Secondary Objectives 
Additional objectives for descriptive purposes include assessment of the following: 
procedural time and clinical utility measures at the intra-operative and post-procedure time 
points (see Appendix C, Definitions); major adverse events (see Appendix C, Definitions), 
injury healing (as determined by maximum transverse diameter at the site of injury), 
secondary interventions, endoleak, device migration, device patency, device integrity, and 
device collapse through the 5-year time point.  
 
 

Cook Incorporated 
Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury 
Page 11 of 61 
 
 
COMPANY CONFIDENTIAL 
CIP 11-004-01 
3.3 
Specific Hypothesis to be Accepted or Rejected by Statistical Data 
The primary and secondary endpoints of this study will be analyzed using only descriptive 
statistics, and will not be analyzed for the purpose of statistical inference. 
 
4.0 
Product Description and Intended Use 
The Zenith® TX2® Low Profile Endovascular Graft is currently under clinical investigation 
for the treatment of patients with descending thoracic aortic aneurysms/ulcers.  The treatment 
of BTAI uses the same proximal main body component as that intended for the treatment of 
aneurysms/ulcers.  While the system that is available for the treatment of aneurysms/ulcers 
also has an overlapping distal component in order to provide the added coverage often 
needed, the available system for the treatment of BTAI will include only a proximal 
component, as the aortic segment requiring coverage is expected to be much more focal than 
that for an aneurysm/ulcer.   
 
4.1 
General Product Description 
As depicted in Figure 2, the proximal component is constructed of self-expanding nitinol 
stents sewn to polyester graft material with braided polyester and monofilament 
polypropylene sutures.  At the proximal end there is an uncovered stent and an internal 
sealing stent with fixation barbs that protrude through the graft material.  All other stents are 
external to the graft material, except for the distal-most stent, which is located internal to the 
graft material.  There are radiopaque markers at the proximal and distal edges of the graft.  
The proximal component will be available in multiple diameters and lengths and can be 
either straight or tapered, as shown in Table 1.   
 
 

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18 
20 
22 
24 
26 
28 
30 
32 
34 
36 
38 
40 
42 
44 
46 
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105 
109 
109 
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113 
113 
117 
117 
121 
125 
125 
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NFIDENTIAL
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Cook Incorporated 
Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury 
Page 13 of 61 
 
 
COMPANY CONFIDENTIAL 
CIP 11-004-01 
with a precurved inner cannula and a single trigger-wire release mechanism, which attaches 
the proximal and distal ends of the stent-graft to the delivery system following withdrawal of 
the sheath, until released by the operator. 
 
 
Figure 3.  Zenith® TX2® Low Profile Endovascular Graft proximal component Z-Trak Plus® 
Introduction System 
 
4.2 
Intended Use 
The Zenith® TX2® Low Profile Endovascular Graft with the Z-Trak Plus® Introduction 
System is indicated for the endovascular treatment of patients with blunt thoracic aortic 
injury of the descending thoracic aorta having vascular morphology suitable for endovascular 
repair, including: 
 Adequate iliac/femoral access compatible with the required delivery systems, 
 Aortic segments (fixation sites) proximal and distal to the blunt thoracic aortic injury: 
 with a length of at least 20 mm and 
 with a diameter measured outer-wall to outer-wall of no greater than 42 mm and 
no less than 15 mm. 
Please reference the Instructions for Use (IFU) for details regarding intended use. 
 
4.3 
Product Identification and Tracking 
The identification and labeling of the products under investigation are outlined in the Clinical 
Investigator Brochure and Instructions for Use. 
Products under investigation will be tracked throughout the course of the study through use 
of a Product Log, upon which lot numbers, quantity, and disposition of product will be 
recorded.  Product Logs will be maintained by the sites.  Additionally, the quantity(s), 
size(s), and lot number(s) of products used in patients will be recorded on the case report 
forms. 

Cook Incorporated 
Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury 
Page 14 of 61 
 
 
COMPANY CONFIDENTIAL 
CIP 11-004-01 
 
4.4 
Instructions for Use  
Please reference the manufacturer’s Instructions for Use for complete instructions including 
implantation, storage and handling requirements, preparation for use, pre-use checks for 
safety and performance, and precautions to be taken after use. 
 
4.5 
Summary of Necessary Training and Experience 
Please reference the manufacturer’s Instructions for Use for a complete summary of the 
necessary training and experience required for use of this product. 
 
4.6 
Description of the Necessary Medical or Surgical Procedures 
Please reference the manufacturer’s Instructions for Use for a complete description of the 
procedures involved in the use of this product. 
 
5.0 
Design of the Clinical Investigation 
5.1 
Type of Investigation 
The current investigation is a prospective, nonrandomized, noncomparative, single-arm 
clinical study.  Enrollment is expected to be completed within 24 months of initiating the 
study. 
 
5.2 
Endpoints 
The primary safety endpoint will be all-cause and aortic-injury-related mortality at 30 days.   
The primary effectiveness endpoint will be device success, defined as technical success (i.e., 
successful access of the injury site and deployment of the Zenith® TX2® Low Profile 
Endovascular Graft in the intended location, and endovascular graft patency upon completion 
of deployment) with none of the following at 30 days:  
 Device collapse;  
 Type I or type III endoleak requiring reintervention; or  
 Conversion to open surgical repair.   
 

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COMPANY CONFIDENTIAL 
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The secondary endpoints include an assessment of the following:   
 At the intra-operative and post-procedure time points: 
o Procedural time and clinical utility measures (see Appendix C, Definitions); 
 Through the 5-year time point: 
o Major adverse events (see Appendix C, Definitions), 
o Injury healing (as determined by maximum transverse diameter at the site of 
injury), 
o Secondary interventions,  
o Endoleak, 
o Device migration, 
o Device patency,  
o Device integrity, and  
o Device collapse. 
 
5.3 
Variables to be Measured to Demonstrate Achievement of Endpoints 
To evaluate deployment characteristics, procedural outcome, and follow-up, the following 
data points will be collected: 
1) Assessment of system performance including: deployment issues, ease of insertion, 
visualization, and ease of removal; 
2) Clinical utility measures such as days to discharge from hospital; 
3) Complications including major adverse events during procedure and at follow-up; 
4) Device integrity findings at completion of procedure and follow-up: device migration, 
patency, stent fracture, and graft kinks; 
5) Type and sources of endoleaks at procedure and follow-up; and  
6) Secondary interventions performed. 
 
5.4 
Measures to be Taken to Avoid or Minimize Bias 
This study is not randomized or blinded. It is intended to prospectively collect information 
regarding the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft. 
The study will utilize uniform definitions for study endpoints, event adjudication by an 
independent clinical events committee, and imaging data analysis by a centralized core 
laboratory.  Study results will be analyzed in accordance with a prospectively defined 
analysis plan. 

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COMPANY CONFIDENTIAL 
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5.5 
Study Criteria 
Assessment of entry criteria will be based upon data available pre-operatively.  Data obtained 
peri-operatively and post-operatively (including the results from core laboratory analysis of 
pre-procedure imaging) may contradict pre-operative assessment.  However, such 
contradiction is not considered a violation of the Clinical Investigation Plan and should not 
be construed as evidence of inadequate or inaccurate pre-operative assessment with respect to 
the enrollment criteria or evidence of inappropriate enrollment.  Enrollment is to be based 
upon best available pre-operative data.  Some criteria relate to subjective assessment while 
other criteria are considered absolute and able to be determined definitively.  Variability in 
assessment between centers, investigators, and observers is expected with several criteria.  
5.5.1 Inclusion Criteria 
All patients must meet all of the following inclusion criteria to be eligible for enrollment into 
this study: 
1) Blunt thoracic aortic injury of the descending thoracic aorta 
2) Suitable for treatment with the Zenith® TX2® Low Profile Endovascular Graft and 
16 Fr, 18 Fr, or 20 Fr Z-Trak Plus® Introduction System 
3) Treatment with the Zenith® TX2® Low Profile Endovascular Graft can be performed 
within 14 days of the blunt thoracic aortic injury 
4) Age ≥ 16 years 
5) Proximal fixation site length measuring ≥ 20 mm between the left common carotid 
artery and most proximal extent of the injury site (covering left subclavian artery is 
acceptable) 
6) Distal fixation site length measuring ≥ 20 mm between the distal-most aspect of 
aortic injury and most distal extent of graft 
7) No previous placement of a thoracic endovascular graft 
8) No prior open surgical repair involving the descending thoracic aorta including 
suprarenal aorta and/or arch 
9) Proximal neck diameter, measured outer-wall to outer-wall on a sectional image or 
multiplanar reconstruction (CT), ≥ 15 mm and ≤ 42 mm 
10) Distal neck diameter, measured outer-wall to outer-wall on a sectional image or 
multiplanar reconstruction (CT), ≥ 15 mm and ≤ 42 mm 
11) Ability to preserve the left common carotid artery and celiac artery 
12) Willing and able to comply with the follow-up schedule 

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COMPANY CONFIDENTIAL 
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13) Informed consent given by the patient or a legally authorized representative [Note: 
For pediatric patients, in addition to obtaining permission from their parents or 
guardians, assent from the patients may need to be obtained based on IRB 
requirements.  See Section 6.2 for further information.] 
 
5.5.2 Exclusion Criteria 
Patients must be excluded if any of the following general, medical, or anatomical exclusion 
criteria are true:  
General Exclusion Criteria 
1) Injury severity score (see Appendix C, Definitions) at the time of initial hospital 
admission is 75 
2) Aortic injuries classified as grade 18 (see Appendix C, Definition of Traumatic Aortic 
Injury) 
 
Medical Exclusion Criteria 
1) Pregnancy 
2) Known allergy to polyester, polypropylene, nitinol, or gold 
3) Allergic reaction to contrast, which in the opinion of the investigator, cannot be 
adequately premedicated 
4) Aortic dissection 
5) Systemic infection (e.g., sepsis) 
6) Degenerative connective tissue disorder (e.g., Marfan’s disease) 
7) Bleeding diathesis, uncorrectable coagulopathy, or refusal of blood transfusion 
8) Simultaneously participating in another investigative device or drug study  (The 
patient must have completed the primary endpoint of any previous study at least 
30 days prior to enrollment in this study and not enroll in another study until 30 days 
after blunt thoracic aortic injury repair in this study) 
 
 
 

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COMPANY CONFIDENTIAL 
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Anatomical Exclusion Criteria 
1) Treatment length (i.e., length of aortic injury including proximal and distal fixation 
sites) along greater curvature: 
> 105 mm for 18 mm to 26 mm diameter grafts 
> 109 mm for 28 mm to 32 mm diameter grafts 
> 113 mm for 34 mm to 36 mm diameter grafts 
> 117 mm for 38 mm to 40 mm diameter grafts 
> 121 mm for 42 mm diameter grafts 
> 125 mm for 44 mm to 46 mm diameter grafts 
2) Aortic arch radius of curvature < 20 mm (only if the device is intended to be deployed 
in the aortic arch) 
3) Tortuosity, calcification, occlusive disease, or arterial diameter of the intended access 
vessels (e.g., iliac and/or femoral arteries), measured inner-wall to inner-wall on a 
sectional image, that are not conducive to placement of the introducer sheath (16 Fr 
for 18 mm to 30 mm diameter grafts, 18 Fr for 32 mm to 38 mm diameter grafts, 
20 Fr for 40 mm to 46 mm diameter grafts) – use of an access conduit is acceptable 
4) Prohibitive calcification, occlusive disease, or tortuosity of intended fixation sites 
5) Circumferential thrombus in region of intended fixation sites 
6) Aneurysm or angulation in the distal thoracic aorta that would preclude advancement 
of the introduction system 
 
5.6 
Point of Enrollment 
Point of enrollment will be based on the intent-to-treat population, and is defined to include 
any patient in whom the treatment procedure is initiated.  More specifically, once a procedure 
has begun (i.e., cutdown or percutaneous access initiated), the patient will be included in the 
intent-to-treat population.  The patient’s informed consent will be obtained and assessment of 
the patient’s conformance to the inclusion/exclusion criteria will occur prior to the procedure. 
 
5.7 
Enrollment Objective 
Fifty patients will be enrolled to provide greater assurance of the study results and to also 
account for possible loss to follow-up or withdrawal from the study.  Up to 30 centers in the 
US and outside the US may participate. 
 

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COMPANY CONFIDENTIAL 
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6.0 
Methods 
6.1 
Subject Assessment and Screening 
Patients will be screened prior to the procedure to ensure they meet all of the inclusion and 
none of the exclusion criteria. 
 
6.2 
Subject Consent 
Patients who meet all of the inclusion and none of the exclusion criteria will be invited to 
participate in this investigation.  All patients eligible for entry into the investigation will have 
the clinical investigation plan explained to them, as well as potential risks and benefits of 
their participation in the investigation.   
Informed consent from the patient or a legally-authorized representative will be obtained (in 
accordance with 21 CFR 50) prior to the procedure or any study-specific testing.   
A short-form consent document, in accordance with 21 CFR 50.27, may be developed, to 
allow for oral presentation of the elements of the informed consent to the patient.  Because in 
many instances the patient may not be able to provide consent and the legally-authorized 
representative may not be able to be present at the hospital immediately, approval for 
telephone consent (wherein treatment options are discussed with the legally-authorized 
representative over the phone, and a consent form is then either faxed or emailed to the 
individual so the individual can sign and return the consent form via fax or email) may be 
sought from the IRBs/ECs (see Appendix D for short-form and telephone consent templates). 
For pediatric patients, in addition to obtaining permission from the parents or guardians of 
the patient, assent from the patient may be necessary based on the requirements of the IRB.  
Patients will not be treated with the Zenith® TX2® Low Profile Endovascular Graft in 
emergency situations where prior consent of the patient or the patient’s legally-authorized 
representative in accordance with 21 CFR Part 50.24 is not possible. 
This study will not be conducted as emergency research under 21 CFR 50.24.  Use of study 
devices in an emergent situation, wherein a patient or a legally-authorized representative is 
unable to provide consent, must be reported according to applicable FDA and IRB/EC 
requirements. 
 
 

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COMPANY CONFIDENTIAL 
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6.3 
Medications 
The hospital’s standard protocol should be followed with respect to medications. 
 
6.4 
Pre-procedure 
Grafts are sized based on pre-operative radiologic findings, using computerized tomography 
(CT).  Please reference the Instructions for Use for details regarding the suggested imaging 
studies to be obtained and sizing guidelines.     
Because patients with traumatic aortic injury most often have other serious concomitant non-
aortic injuries, endovascular repair of the aortic injury may be postponed until other injuries 
have been treated.  
 
6.5 
Procedure 
Standard techniques for placement of arterial access sheaths, guiding catheters, angiographic 
catheters, and wire guides should be employed during use of the Zenith® TX2® Low Profile 
Endovascular Graft.  The Zenith® TX2® Low Profile Endovascular Graft is compatible with 
0.035 inch diameter wire guides. 
Reference the institutional protocols and SVS guidelines relating to anesthesia, 
anticoagulation, access technique, spinal drainage, and monitoring of vital signs.  Coverage 
of the left subclavian artery is acceptable; however, revascularization of the left subclavian 
artery should be considered.3   
Reference the Instructions for Use for complete details regarding use of the Zenith® TX2® 
Low Profile Endovascular Graft.  Fluoroscopic guidance and angiography should be used 
throughout the procedure to verify positioning of the device with respect to the patient’s 
anatomy. 
 
 

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COMPANY CONFIDENTIAL 
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6.6 
Peri-operative 
Reference the institutional protocols for peri-operative management of patients undergoing 
treatment for BTAI.   
 
6.7 
Post-operative Treatment of Endoleaks 
Type I and type III endoleaks warrant immediate treatment.  Type II endoleaks should be 
treated at the physician’s discretion, depending on endoleak source and time from 
implantation. Type III endoleaks should be treated with additional ballooning or prostheses. 
 
6.8 
Secondary Interventions 
Some patients may need secondary intervention(s) for treatment of endoleaks, device 
migration, etc.  The timing and method of such interventions are based on the judgment of 
the treating physician.  If ancillary devices (balloons, stents, etc.) are used during these 
interventions, it is recommended that Instructions for Use (IFU) of that device be reviewed, 
and the risks of using that device be considered. 
 
6.9 
Follow-up  
The results of the endovascular repair will be assessed by clinical and/or imaging evaluation 
intra-operatively and post-operatively, including within 7 days post-procedure, at 30 days 
(± 10 days) post-procedure, and at 6 months (180 ± 30 days), 12 months (365 ± 45 days), 
2 years (730 ± 60 days), 3 years (1095 ± 60 days), 4 years (1460 ± 90 days), and 5 years 
(1825 ± 90 days) post-procedure as summarized in Table 2.  Follow-up windows are 
intended as guidelines only.  They are not absolute and are not intended to limit data 
collection due to scheduling conflicts. 
Table 2.  Study follow-up schedule 
 
Pre-op 
Intra-op 
Post-
procedure 
30-day 
6-month 
12-month3 
 Clinical exam 
X 
 
X 
X 
X 
X 
 Blood tests 
X 
 
X 
 
 
 
 CTA 
 X1  
 
 
X2 
X2 
X2 
 Angiography 
 
X 
 
 
 
 
1The CTA must be obtained as close as possible to the study procedure. 
2MR or non-contrast CT imaging may be used for those patients experiencing renal failure or who are 
otherwise unable to undergo contrast-enhanced CT scan, with TEE being an additional option in the 
event of suboptimal MR imaging. 
3Performed yearly for 5 years. 

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COMPANY CONFIDENTIAL 
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typically have extensive concomitant injuries that would confound the interpretation of 
statistical comparisons to alternative treatments. 
 
7.3  
Site-level Poolability 
Poolability of data from multiple sites will be verified by examining the primary and 
secondary safety and effectiveness measures among sites as well as important patient 
baseline characteristics.  Site-level poolability will be considered appropriate provided that 
these measures are similar among sites. 
It is expected that many sites will have too few patients to provide reasonable site-level 
estimates of primary, secondary, and baseline measures.  Each investigative site will be 
allowed to enroll no more than 10 patients (20% of the total enrollment) to ensure the overall 
result is not biased by the results from a single site. Pooling of this information will be 
explored based on hospital size (large versus small), site enrollment (large versus small), type 
of hospital (community versus teaching), and other group-wise strategies. 
It is recognized that patient baseline characteristics may differ among sites, with some sites 
routinely treating patients with more severe aortic injuries.  It is anticipated that the primary 
and secondary endpoint measures may be related to covariates that reflect this severity, 
which are in turn related to outcome.  Thus, any observed site-specific differences among the 
primary or secondary endpoints will be checked for confounding with other measured 
covariates.  This can be accomplished using regression models (linear and logistic where 
appropriate) that include site and other measured covariates as independent variables. 
 
Should one or more sites significantly differ from the rest, then all subsequent analyses will 
include the discriminating covariate or a covariate to distinguish between the unusual site(s) 
and those sites that are considered poolable. 
 
7.4 
Missing Data 
Missing data will be addressed using three primary strategies: 1) estimating missing data 
with the best available data, 2) case deletion, and 3) multiple imputation. 
The first strategy may be used for missing imaging data.  Previous clinical trial experience 
suggests that some portion of the imaging data may not meet the criteria for accurate 
measurements by the core laboratory.  However, it is recognized that the investigator uses 

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COMPANY CONFIDENTIAL 
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this information to provide the best possible care for the patient.  Therefore, it is reasonable 
to substitute any missing core laboratory measurements with the corresponding 
measurements made by the investigator (or his/her staff).  In addition, the absence or 
presence of clinical sequelae may provide the required missing core laboratory assessment of 
device performance.  Furthermore, imaging at subsequent time points may be available, 
making it possible to infer patient status at the time point of interest.  This strategy is a best 
approximation of the missing data value. 
The second strategy is case deletion.  If the amount of missing data does not result in a 
reduction of analyzable patients to a number that is below that required for sufficient 
statistical power of the primary endpoints, then case deletion will be the method of choice for 
that analysis. 
The third strategy is multiple imputation.  This method will be used to predict missing 
endpoint data.  For missing primary endpoint data, the multiple imputation technique will be 
used to generate random Bernoulli observations with probabilities equivalent to the 
proportion of (non-missing) “Yes”/ “No” entries. It is anticipated that no covariates will be 
used for this model.   This model-based imputation exercise may provide estimates of the 
missing data that can be utilized in estimating event rates and confidence bounds.  Strategies 
originating from Schafer15 will be used, supplemented with notes provided by Schafer.16  The 
computations will be performed using PROC MI and PROC MIANALYZE in SAS version 
9.1 or later.  Unless evidence suggests otherwise, missing at random data will be assumed.  
Additional analyses of missing data may be performed as appropriate, including a tipping 
point analysis. 
 
7.5 
Future Use of Study Data 
The data collected in this study may be used to justify additional studies of variations on the 
Zenith® TX2® Low Profile Endovascular Graft including, but not limited to, design 
variations.  It is anticipated that the safety and effectiveness data obtained may serve as prior 
information in the analysis of the safety and effectiveness of future variations of the Zenith® 
TX2® Low Profile Endovascular Graft. 
 
 

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COMPANY CONFIDENTIAL 
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8.0 
Risk Analysis and Risk Assessment 
Please reference the Clinical Investigator Brochure for a summary of the complete risk 
analysis. 
 
8.1 
Risks and Foreseeable Adverse Device Effects 
Risks of adverse events are likely to be similar to those reported in recent studies of other 
endovascular thoracic aortic grafts.  Adverse events associated either with the Zenith® TX2® 
Low Profile Endovascular Graft or the implantation procedure that may occur and require 
intervention include, but are not limited to: 
 Amputation 
 Anesthetic complications and subsequent related problems (e.g., aspiration) 
 Aortic damage, including perforation, dissection, bleeding, rupture, and death 
 Aortic valve damage 
 Aortobronchial fistula 
 Aortoesophageal fistula 
 Arterial or venous thrombosis and/or pseudoaneurysm 
 Arteriovenous fistula 
 Bleeding, hematoma, or coagulopathy 
 Bowel complications (e.g., ileus, transient ischemia, infarction, necrosis) 
 Cardiac complications and subsequent related problems (e.g., arrhythmia, 
tamponade, myocardial infarction, congestive heart failure, hypotension, 
hypertension) 
 Claudication (e.g., buttock, lower limb) 
 Death 
 Edema 
 Embolization (micro and macro) with transient or permanent ischemia or 
infarction 
 Endoleak 
 Endoprosthesis: improper component placement, incomplete component 
deployment, component migration, suture break, occlusion, infection, stent 
fracture, graft material wear, dilatation, erosion, puncture, perigraft flow, barb 
separation, and corrosion 
 Femoral neuropathy 
 Fever and localized inflammation 

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COMPANY CONFIDENTIAL 
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 Genitourinary complications and subsequent related problems (e.g., ischemia, 
erosion, fistula, incontinence, hematuria, infection) 
 Hepatic failure 
 Impotence 
 Infection of device or access site, including abscess formation, transient fever, 
and pain 
 Lymphatic complications and subsequent related problems (e.g., lymph 
fistula, lymphocele) 
 Neurologic local or systemic complications and subsequent related problems 
(e.g., stroke, transient ischemic attack, paraplegia, paraparesis/spinal cord 
shock, paralysis) 
 Occlusion of coronary arteries 
 Pulmonary embolism 
 Pulmonary/respiratory complications and subsequent attendant problems (e.g., 
pneumonia, respiratory failure, prolonged intubation) 
 Renal complications and subsequent related problems (e.g., artery occlusion, 
contrast toxicity, insufficiency, failure) 
 Surgical conversion to open repair 
 Vascular access site complications, including infection, pain, hematoma, 
pseudoaneurysm, arteriovenous fistula 
 Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, 
bleeding, rupture, death) 
 Vessel damage 
 Wound complications and subsequent related problems (e.g., dehiscence, 
infection) 

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COMPANY CONFIDENTIAL 
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8.2 
Methods to Minimize Risks 
This device will be used only by trained physicians who are experienced in the study 
procedure.  Patients will be selected according to the inclusion/exclusion criteria outlined in 
this document. 
The device design, non-clinical testing, clinical study design, and the Instructions for Use are 
intended to minimize the risks associated with the endovascular procedures. 
 
9.0 
Safety Monitoring and Event Reporting 
9.1 
Data Safety Monitoring Board 
A Data Safety Monitoring Board (DSMB) consisting of independent physicians, who are not 
investigators in the investigation and who do not have a perceived conflict of interest with 
the conduct and administration of the investigation, will be convened on a regular basis to 
evaluate investigation progress and review adverse events.  
 
9.2 
Clinical Events Committee 
An independent Clinical Events Committee (CEC) consisting of physicians, who are not 
investigators in the investigation and who do not have a perceived conflict of interest with 
the conduct and administration of the investigation, will be established to adjudicate clinical 
events reported during the investigation.  This adjudication will be performed according to 
standard operating procedures to assess whether the events were due to a pre-existing or 
unrelated condition, or were procedure-related, technique-related, and/or device-related. 
Regularly scheduled review/monitoring of all patient data will be conducted at the Data 
Coordinating Center, in part, for identification of adverse events and assurance that they are 
correctly reported to the DSMB and CEC. 
 
9.3 
Adverse Event Reporting 
Adverse events are to be reported to the Data Coordinating Center using the appropriate case 
report form.  In cases of adverse device effects or serious adverse events, completed forms 
should be submitted to the Data Coordinating Center as soon as possible upon knowledge of 
the event. 

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COMPANY CONFIDENTIAL 
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The Data Coordinating Center will review the information submitted for possible reporting to 
the Sponsor.  The Sponsor shall, if required according to applicable regulations, report the 
event to the appropriate Regulatory Authority.  The Principal Investigator or designee will 
notify his/her Ethics Committee (EC)/Institutional Review Board (IRB) of applicable events 
according to institutional guidelines.  If indicated, all investigators/sites will be notified by 
the Sponsor. 
 
10.0 
Administrative 
10.1 
Data Collection 
Patient data will be collected and entered by the investigative site into an electronic case 
report form (eCRF) system.  This is a secure, web-based system, allowing those with 
permission to access data from any location at any time.  Site personnel are required to have 
unique login names and passwords in order to enter patient data, and, in accordance with 
21 CFR Part 11, the eCRF system creates a secure, computer-generated, time stamped audit 
trail to record the date and time of operator entries and actions that create, modify, or delete 
electronic records.   
 
10.2 
Data Management and Quality Assurance 
Each principal investigator or appropriately trained designee shall enter clinical data into the 
electronic data capture system.  Investigators will provide all applicable clinical data and 
documentation to the Sponsor.  Patient data and documents pertaining to the investigation 
will be kept and archived by the Sponsor.  Data will be reviewed for missing data, data 
consistency, and reasonableness of responses.  Discrepancies will be resolved through a 
formal query process involving direct contact with investigators or research coordinators.  
Standard operating procedures will be followed for database management, data verification, 
and data archiving and retention. 
As needed to assist the Sponsor in its research (e.g., during evaluation of an adverse event), 
data will be accessible to the Sponsor, the participating investigators, the manufacturer, and 
companies or individuals the Sponsor authorizes. 
Pertinent imaging (pre-procedure, procedural, and follow-up) will be sent to MED Institute, 
Inc., which will coordinate shipment of imaging for independent analysis by the core 
laboratory. 

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COMPANY CONFIDENTIAL 
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10.3 
Data Reporting 
Progress reports and a final report at the conclusion of the clinical investigation will be 
submitted by the investigators and Sponsor to the regulatory bodies and IRBs/ECs as 
required by local regulations. 
 
10.4 
Emergency Situations and Vulnerable Subjects  
Patients will not be treated with the Zenith® TX2® Low Profile Endovascular Graft in 
emergency situations where prior consent of the patient or the patient’s legally-authorized 
representative in accordance with 21 CFR Part 50 is not possible. 
 
10.5 
Criteria and Procedures for Withdrawal 
Subjects may withdraw from the study at any time without penalty or loss of benefits.  The 
investigator may also decide to withdraw a subject from the study at any time on the basis of 
medical judgment.  The investigator must make a reasonable effort to ascertain and record 
the reason for withdrawal or discontinuation for each patient while fully respecting the 
patient’s rights.  The reasons for withdrawal and discontinuation of any patient from the 
investigation shall be recorded.  If such discontinuation is because of problems with safety or 
lack of effectiveness, that patient shall still be followed up in the investigation, if possible. 
 
10.6 
Deviations from Clinical Investigation Plan 
Investigators are not allowed to deviate from this clinical investigation plan (CIP) without 
prior authorization by the Sponsor except under emergency situations when necessary to 
preserve the rights, safety, and well-being of human subjects.  Deviations and non-
compliances will be recorded together with an explanation.  Deviations or non-compliances 
that impact the rights, welfare, or safety of patients shall be reported to the Sponsor, 
regulatory authorities, and IRB/EC as required.   
 
10.7 
Early Termination or Suspension of the Investigation 
The Sponsor reserves the right to terminate/suspend the study at any point should they 
believe that important harmful events might result from its continuation.   
 

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COMPANY CONFIDENTIAL 
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10.8 
Limitations of the Investigation 
This study is inherently limited by the number of patients who will be excluded due to 
general, medical, and anatomical exclusion criteria.  Additional challenges to the study 
include the anticipated comorbidities, which may confound data analysis 
 
10.9 
Publication Policy 
Publication policy, rights, and obligations for this investigation have been negotiated, 
detailed, and defined in the Investigation Contractual Documents and Agreements with the 
Investigation Site and Investigators. 
 
10.10 Approvals and Agreements 
The Sponsor, coordinating investigator (if applicable), and the principal clinical investigators 
for each site shall agree to this document and any modifications.  A justification for any 
modification will be documented.  Approval and agreement will be indicated by signing and 
dating the signature page provided with this document. 
 
10.11 General Information 
10.11.1 
Sponsor 
The Sponsor for this investigation is Cook Incorporated. See Appendix A for contact 
information. 
 
10.11.2 
Manufacturer 
The Manufacturer for this investigation is William Cook Europe, ApS.  See Appendix A for 
contact information. 
 
10.11.3 
Data Coordinating Center/Monitor 
The Data Coordinating Center for this study is MED Institute, Inc.  See Appendix A for 
contact information. 
 
 

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COMPANY CONFIDENTIAL 
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10.11.4 
Investigation Compliance 
This investigation shall be performed according to the Declaration of Helsinki and 21 CFR 
812. 
The investigator is responsible for obtaining approval of this clinical investigation by the 
relevant EC/IRB.  The Sponsor must be provided with a copy of this approval before delivery 
of any study device.  Furthermore, the investigator will ensure that local regulations 
concerning data protection are followed.  Additional requirements imposed by an IRB, EC, 
and/or regulatory authority shall be followed, if appropriate. 
 
10.11.5 
Investigators 
A complete list of the coordinating clinical investigator, principal clinical investigators, and 
clinical investigators, along with their contact information, will be updated and maintained 
by the Data Coordinating Center.   
 
10.11.6 
Monitoring Arrangements 
The monitor for this investigation is MED Institute, Inc.  See Appendix A for contact 
information.  Written procedures for monitoring the investigation are maintained by the 
monitor and can be found in Appendix B. 
 
10.11.7 
Exposition of the Clinical Investigation Plan 
In case of translation of the Clinical Investigation Plan into the language of the participating 
countries, the English version is to be considered as the original, i.e., when expounding the 
contents of the Clinical Investigation Plan in these languages, the English version is 
definitive in cases of doubt. 
 
11.0 
Bibliography 
1. Mohan IV, Hitos K, White GH, et al.  Improved outcomes with endovascular stent 
grafts for thoracic aorta transections.  Eur J Vasc Endovasc Surg 2008;36:152-7. 
2. Murad HM, Rizvi AZ, Malgor R, et al.  Comparative effectiveness of the treatments 
for thoracic aortic transection.  J Vasc Surg 2011;53:193-9. 
3. Lee WA, Matsumura JS, Mitchell RS, et al.  Endovascular repair of traumatic 
thoracic aortic injury: Clinical practice guidelines of the Society for Vascular 
Surgery.  J Vasc Surg 2011;53:187-92. 

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COMPANY CONFIDENTIAL 
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4. Starnes BW, Aldea G.  Endovascular repair of blunt aortic injury – Do we have the 
right devices yet?  Endovascular Today Oct 2009. 
5. Kasirajan K, Dake MD, Lumsden A, et al.  Incidence and outcomes after infolding or 
collapse of thoracic stent grafts.  J Vasc Surg 2012;55:652-8. 
6. Dake MD, White RA, Diethrich EB, et al.  Report on endograft management of 
traumatic thoracic aortic transections at 30 days and 1 year from a multidisciplinary 
subcommittee of the Society for Vascular Surgery Outcomes Committee.  J Vasc 
Surg 2011;53:1091-6. 
7. Matsumura JS, Cambria RP, Dake MD, et al.  International controlled clinical trial of 
thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-
year results.  J Vasc Surg 2008;47:247-25. 
8. Azizzadeh A, Keyhani K, Miller CC 3rd, et al.  Blunt traumatic aortic injury: Initial 
experience with endovascular repair.  J Vasc Surg 2009;49:1403-8. 
9. Xenos ES, Abedi NN, Davenport DL, et al.  Meta-analysis of endovascular vs open 
repair for traumatic descending thoracic aortic rupture.  J Vasc Surg 2008;48:1343-
51. 
10. Walsh SR, Tang TY, Sadat U, et al.  Endovascular stenting versus open surgery for 
thoracic aortic disease: Systematic review and meta-analysis of perioperative results.  
J Vasc Surg 2008;47:1094-8. 
11. Takagi H, Manabe H, Kawai N, et al.  Endovascular versus open repair for blunt 
thoracic aortic injury.  Ann Thorac Surg 2009;87:349-50. 
12. Tang GL, Tehrani HY, Usman A, et al.  Reduced mortality, paraplegia, and stroke 
with stent graft repair of blunt aortic transections: A modern meta-analysis.  J Vasc 
Surg 2008;47:671-5. 
13. Takagi H, Kawai N, Umemoto T.  A meta-analysis of comparative studies of 
endovascular versus open repair for blunt thoracic aortic injury.  J Thorac Cardiovasc 
Surg 2008;135:1392-4. 
14. Hoffer EK, Forauer AR, Silas AM, et al.  Endovacular stent-graft or open surgical 
repair for blunt thoracic aortic trauma: Systematic review.  J Vasc Interv Radiol 
2008;19:1153-64. 
15. Schafer, JL. Analysis of Incomplete Multivariate Data. London: Chapman & Hall; 
1997. 
16. Schafer, JL. Missing Data: A Review. A seminar sponsored by the Cleveland Chapter 
of the American Statistical Association; October 14, 2002; Cleveland, OH. 
17.  Starnes BW, Lundgren RS, Gunn M, et al.  A new classification scheme for treating 
blunt aortic injury.  J Vasc Surg 2012;55:47-54. 
 
 
 

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APPENDIX A 
Contact Information 
 
 
 
 
 

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COMPANY CONFIDENTIAL 
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Contact Information 
 
Manufacturer 
William Cook Europe, ApS 
Sandet 6 
DK 4632  
Bjaeverskov, Denmark  
 
Contact: 
Anna Bjerg Jessen / Director of Quality Assurance and Regulatory Affairs 
Telephone:  
+45 5686 8593 
Fax:   
+45 5686 8568 
E-mail:  
Anna.Jessen@CookMedical.com 
 
 
Sponsor  
Cook Incorporated 
750 Daniels Way 
Bloomington, IN 47404 
USA 
 
Contact:  
Scott Williams / Director of Regulatory Affairs  
Telephone:       (765) 464-0817, 1117 
Fax: 
             (765) 497-0641 
E-mail: 
swilliams@medinst.com 
 
 
 
Data Coordinating Center / Monitor  
MED Institute, Inc. 
1 Geddes Way 
West Lafayette, IN  47906 
 
Contact: 
Alison Conovaloff  / Clinical Project Manager 
Telephone:  
(765) 464-0817, 1190 
Fax: 
 
(765) 497-0641 
E-mail: 
aconovaloff@medinst.com 
 
 
 
 

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APPENDIX B 
Written Procedures for Monitoring Investigations 
 
 
 
 
 

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Written Procedures for Monitoring Clinical Investigations 
 
A. 
Selection of the monitor. 
Designated by the sponsor to oversee the investigation, the monitor may be an 
employee of Cook, an employee of a monitoring organization (CRO), or an 
independent contractor or consultant.  The monitor shall be qualified by training and 
experience to monitor the investigation in accordance with all applicable regulations 
and standards for conducting clinical investigations. 
 
B. 
General duties of the monitor. 
The monitor must ensure that the investigation is conducted in accordance with: 
1. 
The signed investigator agreement. 
2. 
The clinical investigation plan (CIP)/protocol. 
3. 
Any conditions imposed by the IRB/EC or regulatory authority. 
4. 
The requirements of the applicable regulations and standards. 
 
C. 
Reports by the monitor to the sponsor. 
1. 
Any noncompliance with the items listed above.  In the event that the 
investigator is not complying with the requirements outlined above, it is the 
sponsor’s responsibility to secure compliance. 
2. 
Any adverse events or effects that are potentially reportable to a regulatory 
authority. 
 
D. 
Initiating the investigation. 
Prior to initiating any clinical use of the device, the monitor or sponsor representative 
will participate in a pre-investigation or initiation visit with each investigative site.   
At a minimum, the following items shall be addressed during the site initiation visit: 
 
Provide training to investigator on his/her responsibilities per the investigator 
agreement, applicable laws, regulations, and standards; and 
 
Provide training to investigator that the IRB/EC approval letter and informed 
consent/patient information is on file before initiation of the clinical 
investigation. 
Additionally, training may be provided to the investigator on: 
 
The regulatory status of the device/product(s) and the requirements for the 
accountability of same;  

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 
The nature of the clinical investigation plan (CIP); 
 
The requirements for an adequate and well-controlled clinical investigation; 
 
His or her obligation to obtain informed consent in accordance with applicable 
regulations; 
 
His or her obligation to ensure continuing review of the clinical investigation by 
the IRB/EC in accordance with conditions of approval and applicable regulations 
and to keep the sponsor informed of such IRB/EC approval and subsequent 
IRB/EC actions concerning the investigation; 
 
The importance of access to an adequate number of suitable subjects to conduct 
the investigation; 
 
The importance of adequate facilities for conducting the clinical investigation; 
and 
 
The importance of sufficient time from other obligations to carry out the 
responsibilities to which the investigator is committed by applicable regulations. 
 
E. 
During the course of the investigation, at the direction of the Project Manager, the 
monitor should visit the site frequently enough to ensure that: 
 
The facilities and research staff used by the investigator continue to be 
acceptable for purposes of the clinical investigation; 
 
The applicable version of the CIP and agreements are being followed; 
 
Changes to the CIP, informed consent/patient information have been approved 
by the IRB/EC and/or reported to the sponsor and the IRB/EC; 
 
Accurate, complete, and current records are being maintained; 
 
Accurate, complete, and timely reports are being made to the sponsor and 
IRB/EC; and 
 
The investigator is carrying out the agreed-upon activities and has not delegated 
them to other previously unspecified staff. 
As appropriate, the following tasks could be performed during periodic visits:  
 
Device/product accountability review; 
 
Adverse event review to ensure that events are appropriately reported within the 
time periods required by the sponsor, CIP, IRB/EC, and applicable regulatory 
requirements; and 
 
Source data verification per the monitoring plan to determine that: 
o 
Informed consent/patient information has been documented in accordance 
with applicable regulations and expectations of the local IRB/EC; 

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COMPANY CONFIDENTIAL 
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o 
The information recorded in the case report forms (CRFs; paper or 
electronic) is complete, accurate, and legible; 
o 
There are no omissions in the CRFs of specific data elements, such as the 
administration to any patient of concomitant test articles or the 
development of an intercurrent illness; 
o 
Missing visits or examinations are noted; and 
o 
Subjects failing to complete the clinical investigation and the reason for 
each failure are noted. 
 
F. 
Records of the monitor. 
The monitor shall prepare and maintain records of each initiation visit and each 
periodic visit, general site contact, or discussion.  These will include: 
1. 
Date, name, and address of the investigator, and names of other staff members 
present at each meeting. 
2. 
A summary of the findings of the visit. 
3. 
A statement of any action taken by the monitor or investigator to correct any 
deficiencies noted. 
4. 
The monitor shall immediately notify the sponsor of any conditions of non-
compliance with the protocol, clinical investigation plan, conditions of 
IRB/EC or regulatory authority approval, or the applicable regulations. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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COMPANY CONFIDENTIAL 
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APPENDIX C 
Definitions 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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COMPANY CONFIDENTIAL 
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Definitions 
 
Aortic-injury-related  
Mortality: 
Any death determined by the independent clinical events 
committee to be causally related to the initial implant 
procedure, secondary intervention, or rupture of the transected 
aorta. 
 
Barb Separation: 
Radiographic evidence of detachment of barbs from the stent 
strut. 
 
Calcification:  
Fixation zone and iliac artery calcification will be graded based 
upon the following: 
 
 
 
 
None: Lack of calcification;  
 
 
 
 
Mild: Less than 40% circumferential calcification; 
 
 
 
 
Moderate: 40-70% circumferential calcification; 
 
 
 
 
 
  
Severe: Greater than 70% circumferential calcification; or 
Prohibitive:  Severe and cannot be resolved in the opinion of 
the investigator. 
 
Clinical Utility Measures:   
Number of ventilator days; days to resumption of oral fluids; 
days to resumption of normal diet; days to resumption of 
normal bowel function; duration of ICU stay; days to 
discharge. 
 
Device Infolding: 
Infolding upon deployment due to anatomic constraint (i.e., 
device oversizing).5 
 
Device Compression/ 
Collapse:  
Failure of the device to maintain its intended expanded 
diameter after implantation as a result of the dynamic 
application of external forces (i.e., blood flow).5 
 
   
Type I Endoleak:  
 
 
A peri-prosthetic leak occurring at the proximal and/or distal 
fixation zones. 
 

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COMPANY CONFIDENTIAL 
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Type II Endoleak:   
 
 
A leak caused by retrograde flow from patent vessels.  Type IIa 
includes significant subclavian, celiac, or anomalous vertebral 
arteries.  Type IIb includes bronchial and intercostal artery 
involvement or minor leaks. 
 
Type III Endoleak:    
 
A leak caused by a defect in the graft fabric, or inadequate seal 
between modular components. 
 
Type IV Endoleak:    
 
A leak caused by graft fabric porosity, often resulting in a 
generalized blush of contrast into the injury. 
 
Unknown Endoleak:    
 
Continuing blood flow into the injury with undefined origin. 
 
Injury Severity Score:    
The Injury Severity Score (ISS) is an anatomical scoring 
system that provides an overall score for patients with multiple 
injuries.  Each injury is assigned an Abbreviated Injury Scale 
(AIS) score and is allocated to one of six body regions (head, 
face, chest, abdomen, extremities (including pelvis), external).  
Only the highest AIS score in each body region is used.  The 
3 most severely injured body regions have their scores squared 
and added together to produce the ISS score.  
 
Major Adverse Events:   
All-cause death; stroke; paraplegia; Q-wave MI; cardiac event 
involving arrest or resuscitation; renal failure requiring 
permanent dialysis, hemofiltration, or kidney transplant in a 
patient with a normal pre-procedure serum creatinine level; 
conversion to open repair; pulmonary embolism involving 
hemodynamic instability or surgery; graft infection; or wound 
complication requiring return to the operating room. 
 
 
 

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COMPANY CONFIDENTIAL 
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MI (Non-Q-Wave):    
 
Clinical evidence of a myocardial infarction with elevated peak 
CK values greater than or equal to three times the upper limit 
of normal with elevated CK-MB (above the institution’s upper 
limit of normal) in the absence of new pathological Q-waves or 
clinical evidence of a myocardial infarction with troponin 
greater than three times the upper limit of normal, as 
determined by the investigator. 
 
MI (Q-Wave):     
 
 
Requires one of the following criteria: 
 Post-procedure chest pain or other acute symptoms 
consistent with myocardial ischemia and the presence 
of new pathological Q-waves in two or more 
contiguous ECG leads in the absence of timely cardiac 
enzyme data. 
 New, post-procedure pathological Q-waves in two or 
more contiguous ECG leads and elevation of cardiac 
enzymes. 
 
Occlusive Disease:    
Fixation zone and iliac artery occlusive disease will be graded 
based upon the following: 
 
 
 
 
None: Lack of occlusive disease; 
 
 
 
 
 
Mild: Some disease, focal with less than 30% narrowing; 
             
 
 
Moderate: 30-50% narrowing not requiring interventional 
techniques to meet inclusion criteria;  
 
 
 
 
Severe: Greater than 50% or any patient requiring angioplasty 
prior to endograft delivery; or 
Prohibitive:  Severe and cannot be resolved in the opinion of 
the investigator. 
 
Migration (radiographic):   
Core laboratory determination of antegrade or retrograde 
movement of the proximal component of the endoprosthesis 
> 10 mm relative to anatomical landmarks identified on the 
first post-operative CT scan.   
 
 

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COMPANY CONFIDENTIAL 
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Migration (clinical):  
Antegrade or retrograde movement of the proximal component 
of the endoprosthesis resulting in the need for a secondary 
intervention. 
 
Renal Failure:   
 
 
 
Acute or progressive renal insufficiency leading to the need for 
dialysis or hemofiltration.   
 
Stent/Attachment System                                                                                  
Fracture/Break:    
 
 
Fracture or breakage of any portion of the stent or  
attachment system including metallic fracture or breakage of 
any suture material used to construct the stent or secure the 
stent or attachment system to the graft material. 
 
Stroke:  
 
 
 
 
 
Permanent clinically significant central nervous system deficit. 
 
Success, Device 
(30-day):           
Technical success, with none of the following at 30 days: 
 Device collapse;  
 Type I or type III endoleak requiring reintervention; or 
 Conversion to open surgical repair.  
 
Success, Technical: 
Successful access of the injury site and deployment of the 
Zenith® TX2® Low Profile Endovascular Graft in the intended 
location.  The endovascular graft must be patent at the time of 
deployment completion as evidenced by angiographic imaging. 
 
 
 

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COMPANY CONFIDENTIAL 
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Tortuosity:   
 
 
Fixation zone and iliac artery tortuosity will be graded based 
upon the following: 
None: Lack of tortuosity; 
 
 
 
 
Mild: Fairly straight arteries; 
 
 
 
 
Moderate: Angulation manageable with stiff wires, 
< 70 degrees; 
 
 
 
 
Severe: Angulation difficult, may require surgical exposure for  
 
 
 
 
 
  
straightening, not straightened entirely with wires; or 
Prohibitive:  Severe and cannot be resolved in the opinion of 
the investigator. 
 
Traumatic Aortic Injury:  
Injury will be graded based upon the following8,17: 
 
Grade 1: Intimal tear;  
 
Grade 2: Intramural hematoma/large intimal flap (LIF); 
 
Grade 3: Pseudoaneurysm; or 
 
 
 
 
Grade 4: Rupture. 
 
 

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COMPANY CONFIDENTIAL 
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APPENDIX D 
Short-Form and Telephone Consent Templates 
 

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COMPANY CONFIDENTIAL 
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Medical Research Study to Evaluate The Zenith® TX2® Low Profile Endovascular Graft for 
Treatment of Blunt Thoracic Aortic Injury 
Written Summary to Accompany Short Form Consent 
 
Title: Research study to evaluate the Zenith® TX2® Low Profile Endovascular Graft for 
treatment of blunt thoracic aortic injury 
Sponsor: Cook Incorporated 
 
 
Investigator:  
Name of Hospital: 
Study-Related 
Phone Number(s):  
 
 
 
 You are asked to be part of this research study because you have been diagnosed 
with a blunt thoracic aortic injury in your thoracic (chest) aorta, the vessel that 
supplies blood to most of your body.  A blunt thoracic aortic injury is an injury to 
the thoracic aorta that commonly happens as a result of being in a car accident or 
a fall from height.  These injuries can be treated with medical management, open 
surgery, or endovascular treatment (inserting a graft, or tube reinforced by 
flexible metal rings, through arteries in the groin).  
 
 In this study, you will have a procedure called endovascular treatment (inserting a 
graft through arteries in the groin).  The purpose of this study is to evaluate the 
safety and effectiveness of endovascular treatment using the Zenith® TX2® Low 
Profile Endovascular Graft.  This study has been reviewed by the US Food and 
Drug Administration (FDA) and by an  <Institutional Review Board (IRB) or 
Ethics Committee (EC)>, a group that reviews studies at your hospital or medical 
center to make sure your rights as a clinical study participant are protected. 
 
 The Zenith® TX2® Low Profile Endovascular Graft is an investigational device, 
which means it has not been approved by the FDA for treatment of blunt thoracic 
aortic injury.  If you are eligible to be in the study, and depending on the 
measurements of your aorta, you will receive endovascular treatment.   
  
 Your decision to be in this study is voluntary.  You do not have to agree to be part 
of this study in order to be treated for your medical condition.  If you are not part 
of the study, the Zenith® TX2® Low Profile Endovascular Graft will not be used 
in your care.  Other treatments may also be available that could help you.  Your 
treatment choices may include other endovascular grafts, open surgical treatment, 
or medical management.  Ask your doctor about it.  
 
 Study follow-up visits are scheduled for within 7 days of treatment, at 
approximately 30 days, 6 months, and 12 months after the endovascular graft has 
been placed, and yearly thereafter for 5 years.  During the follow-up visit within 

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COMPANY CONFIDENTIAL 
CIP 11-004-01 
7 days of treatment, you will have a physical examination including blood work.  
During the other follow-up visits with your doctor, you will have a CT scan (a 
special x-ray) of your chest and a physical examination.   
 
 If you decide to be in this study and then later change your mind, you can leave 
the study at any time by contacting the study doctor <Add Contact Information>.  
If you choose to withdraw from the study, the study product will not be removed 
from your body unless there are complications (problems).  The doctor or the 
Sponsor can remove you from the study without your approval.  Possible reasons 
could be if participation appears to be medically harmful to you, if it is discovered 
that you do not meet eligibility requirements, or if the study is cancelled.  Should 
you be removed from the study or if you decide to stop before completing the 
study, you may be asked (for your own safety) to undergo final study 
assessments, examinations, and laboratory tests.  You will not lose any benefits if 
you withdraw from the study. 
 
 It is expected that this study will enroll up to 50 participants.  
 
 The common risks of the endovascular procedure include discomfort after the 
procedure and pain or tenderness from your incisions.  You will have to limit your 
activities for a certain period of time while recovering.  Other risks include the 
following: 
Anesthesia risks – The procedure will be done under anesthesia.  Anesthesia 
complications may include breathing problems, slowed or irregular heartbeat, 
blood pressure problems, and death. 
Aortic injury repair risks – You may experience bleeding, accidental damage to 
internal organs, blood clots, lodging of blood clots in lungs (pulmonary embolus, 
which sometimes results in death), aneurysm formation or dissection due to aortic 
damage, infection or fever, heart problems, kidney problems, bowel problems, 
lung problems, reactions to the graft (inflammation or allergic reaction), 
impotence (not able to have an erection), loss of blood flow to the spine (resulting 
in paralysis), legs, or other organs, amputation of toes or legs due to loss of blood 
flow to the legs, and stroke. 
Catheterization risks – During the procedure, x-rays will be used to guide the 
graft to the aorta.  For more accuracy, you will receive injections of a fluid (called 
contrast medium) that allows the doctor to better see your blood vessels.  This 
procedure of placing catheters (long slender tubes) through blood vessels is 
recognized as safe, but has known risks, including less than a 1 in 1,000 chance of 
serious complications such as serious allergic reaction, heart attack, stroke, or 
death.  The potential for damage to the kidneys from contrast medium also exists. 
Endovascular treatment risks – You may experience misplacement or shifting 
in position of the graft, graft wear, folding/collapse of the graft, allergic reaction 
to graft material that may require surgery to remove the graft, continuing blood 
flow into the aortic injury that may require repair, dislodgement of existing 
plaques or clots from your blood vessel, and the need to finish your aortic repair 

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COMPANY CONFIDENTIAL 
CIP 11-004-01 
through open surgery for a number of reasons including bleeding or difficult 
anatomy. 
Anticoagulant (blood thinner) risks – You may be treated with aspirin, heparin 
(a blood thinner), and other medications as determined by the study doctor.  These 
medications may result in bleeding complications. 
Radiation risks – This study involves exposure to radiation from the x-rays used 
during the procedure and also from follow-up testing.  The endovascular 
procedure involves a radiation dose from the x-rays used to guide and place the 
graft.  Generally, the exposure time is expected to be less than 28 minutes.  The 
follow-up after the endovascular procedure involves a radiation dose due to the 
CTs scheduled at 30 days, 6 months, 12 months, and yearly for 5 years.  If you 
have complications from the procedure, you may have more than the scheduled x-
rays, leading to a higher radiation dose.  Contrast medium (“x-ray dye”) is often 
used to increase the quality of CTs.  The risks due to exposure to contrast medium 
include hives or itching, shortness of breath, or seizures, which may be life-
threatening.  The potential for damage to the kidneys also exists.  
Reproductive risks – You should not participate in this study if you are pregnant, 
breastfeeding, or planning to become pregnant in the next 5 years.  If you become 
or suspect you are pregnant during the study, you must notify the study doctor 
immediately.  A child conceived (created) during the study may develop birth 
defects.  This risk is largely due to the need for x-ray follow-up.  Men who 
undergo endovascular or open surgical repair may experience impotence.     
 
There may be potential risks to you (or an embryo or fetus if you are or should 
become pregnant) that the investigators are not currently aware of and that they 
are not able to predict.   
 
 If significant new information becomes available that might affect your 
willingness to participate in the study, the investigator will discuss this with you.  
If you decide to continue in the study, you may be asked to sign an updated 
consent form.  
 
 We cannot promise that you will receive any benefits from this study.  Future 
patients may benefit from the knowledge gained from this study.  You will not be 
paid to be in the study. 
 
 The Sponsor, Cook Incorporated, may be paying the study doctors, hospital, and 
clinical study staff for their work related to this study.   
 
 There are no additional charges to participate in this study.  The charges for 
services that would be performed even if you were not participating in this study 
will be billed to you or your insurance provider; these will not be paid by the 
Sponsor.  Any co-payment or deductible required by your insurance provider will 
be your responsibility.  
 

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COMPANY CONFIDENTIAL 
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 All records related to your participation in this clinical study will be kept 
confidential.  If you choose to be in this study, the study investigator(s) will get 
personal information about your health from talking with you and from looking at 
your past and current medical records.  It will also come from the test results, 
imaging (CT scans), and examinations that are part of the study.  Parts of your 
medical records and the data collected for the study will be sent to and/or looked 
at by persons authorized by the Sponsor.  They also may be looked at by 
representatives of domestic and/or global regulatory authorities as well as Ethics 
Committees or Institutional Review Boards to check that the study is being 
carried out correctly.  Your study information may be used to help obtain market 
approval for the device.  If the study data are published, your identity will remain 
confidential.  You may change your mind about letting us collect your 
confidential medical information at any time.  If so, no new information about 
you will be collected.  Any information already collected may still be used. 
 
 A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not 
include information that can identify you.  At most, the Web site will include a 
summary of the results.  You can search this Web site at any time. 
 
 Your agreement to participate in this study does not waive any of your legal 
rights.   
 
 If you have questions about any part of this study, contact <name of contact 
person> at <contact information>. 
 
 If you have questions about your rights as a participant in this study, contact 
<name of contact person> at <contact information>. 
 
 If you believe you have been injured as a result of being in the study, contact 
<name of contact person> at <contact information>.   
 
 No commitment is made by <insert Name of Institution> to provide free medical 
care or compensation for participation in this study.  Medical services will be 
offered at the usual charge.  If taking part in this research study harms you, there 
are no special compensation arrangements.  If you are harmed due to someone’s 
negligence, then you may have grounds for a legal action. 
 
More detailed information about this study will be provided in a separate consent form.  You 
will be asked to read and then sign that consent form after your condition is stabilized if you 
agree to participate in the research.   

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COMPANY CONFIDENTIAL 
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SIGNATURE 
 
I have explained to the subject the nature and purpose, the potential benefits, and possible 
risks associated with participation in this research study.  I have answered all questions that 
have been raised. 
 
 
 
 
 
Signature of Person Conducting Informed Consent Discussion 
 
Date 
 
 
 
Printed Name of Person Conducting Informed Consent Discussion 
 
 
IMPARTIAL WITNESS STATEMENT 
 
I confirm that the information in the consent summary was accurately explained to, and 
apparently understood by, the subject.   
 
 
 
 
 
Impartial Witness’s Signature 
 
Date 
 
 
 
Impartial Witness’s Printed Name 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Site Number: 
Patient Enrollment Number: 
 
 

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COMPANY CONFIDENTIAL 
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SHORT FORM CONSENT  
To participate in a medical research study to evaluate the Zenith® TX2® Low Profile 
Endovascular Graft for Treatment of Blunt Thoracic Aortic Injury 
 
 
I confirm that the purpose of the research, the study procedures that I can expect, the possible 
risks and discomforts, the potential benefits that I may have, and alternatives to my 
participation in the study have been explained to me. 
 
I agree: 
 To give my consent to voluntarily participate as a patient in this research study.  I 
understand that I am free to withdraw (drop out) at any time, without giving any reason, 
and without my medical care or legal rights being affected.  
 That personal health information about me may be used for ongoing research purposes 
as described above and that my medical records may be looked at by persons 
authorized by the Sponsor, regulatory authorities, and/or IRBs or ECs where it applies 
to my taking part in research.  I give permission for these individuals to have access to 
my medical records. 
 To give my consent to inform my personal doctor about my participation in the study. 
 That I have had the opportunity to ask questions and my questions have been answered. 
 
 
 
 X 
  
 
Patient Name (Printed) 
Patient’s Signature or Signature of Legal 
 Date 
Representative.  If signed by other 
than the patient, state 
relationship/authority to sign 
 
 
 
 
I confirm that the information in the consent form was accurately explained to, and 
apparently understood by, the subject.  The subject freely consented to participate in the 
research study. 
 
 
 
 
 X 
  
 
Name of Impartial Witness 
Signature of Witness 
 Date 
(Printed) 
 
 
Site Number: 
Patient Enrollment Number: 
 
 
 
 
 

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COMPANY CONFIDENTIAL 
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Medical Research Study to Evaluate The Zenith® TX2® Low Profile Endovascular Graft for 
Treatment of Blunt Thoracic Aortic Injury 
Written Summary for Telephone Consent 
 
Title: Research study to evaluate the Zenith® TX2® Low Profile Endovascular Graft for 
treatment of blunt thoracic aortic injury 
Sponsor: Cook Incorporated 
 
 
Investigator:  
Name of Hospital: 
Study-Related 
Phone Number(s):  
 
 
 
 The patient is asked to be part of this research study because the patient has been 
diagnosed with a blunt thoracic aortic injury in his/her thoracic (chest) aorta, the 
vessel that supplies blood to most of the body.  A blunt thoracic aortic injury is an 
injury to the thoracic aorta that commonly happens as a result of being in a car 
accident or a fall from height.  These injuries can be treated with medical 
management, open surgery, or endovascular treatment (inserting a graft, or tube 
reinforced by flexible metal rings, through arteries in the groin).  
 
 In this study, the patient will have a procedure called endovascular treatment 
(inserting a graft through arteries in the groin).  The purpose of this study is to 
evaluate the safety and effectiveness of endovascular treatment using the Zenith® 
TX2® Low Profile Endovascular Graft.  This study has been reviewed by the US 
Food and Drug Administration (FDA) and by an  <Institutional Review Board 
(IRB) or Ethics Committee (EC)>, a group that reviews studies at the patient’s 
hospital or medical center to make sure his/her rights as a clinical study 
participant are protected. 
 
 The Zenith® TX2® Low Profile Endovascular Graft is an investigational device, 
which means it has not been approved by the FDA for treatment of blunt thoracic 
aortic injury.  If the patient is eligible to be in the study, and depending on the 
measurements of his/her aorta, the patient will receive endovascular treatment.   
  
 The decision to be in this study is voluntary.  The patient does not have to be part 
of this study in order to be treated for his/her medical condition.  If the patient is 
not part of the study, the Zenith® TX2® Low Profile Endovascular Graft will not 
be used in his/her care.  Other treatments may also be available that could help the 
patient.  Treatment choices may include other endovascular grafts, open surgical 
treatment, or medical management.  You can ask the patient’s doctor about these 
other treatment options.  
 

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 Study follow-up visits are scheduled for within 7 days of treatment, at 
approximately 30 days, 6 months, and 12 months after the endovascular graft has 
been placed, and yearly thereafter for 5 years.  During the follow-up visit within 
7 days of treatment, the patient will have a physical examination including blood 
work.  During the other follow-up visits with his/her doctor, the patient will have 
a CT scan (a special x-ray) of his/her chest and a physical examination.   
 
 If the patient is in this study and then later changes his/her mind, the patient can 
leave the study at any time by contacting the study doctor <Add Contact 
Information>.  If the patient chooses to withdraw from the study, the study 
product will not be removed from his/her body unless there are complications 
(problems).  The doctor or the Sponsor can remove the patient from the study 
without his/her approval.  Possible reasons could be if participation appears to be 
medically harmful to the patient, if it is discovered that the patient does not meet 
eligibility requirements, or if the study is cancelled.  Should the patient be 
removed from the study or if he/she decides to stop before completing the study, 
the patient may be asked (for his/her own safety) to undergo final study 
assessments, examinations, and laboratory tests.  The patient will not lose any 
benefits if he/she withdraws from the study. 
 
 It is expected that this study will enroll up to 50 participants.  
 
 The common risks of the endovascular procedure include discomfort after the 
procedure and pain or tenderness from the incisions.  The patient will have to 
limit his/her activities for a certain period of time while recovering.  Other risks 
include the following: 
Anesthesia risks – The procedure will be done under anesthesia.  Anesthesia 
complications may include breathing problems, slowed or irregular heartbeat, 
blood pressure problems, and death. 
Aortic injury repair risks – The patient may experience bleeding, accidental 
damage to internal organs, blood clots, lodging of blood clots in lungs (pulmonary 
embolus, which sometimes results in death), aneurysm formation or dissection 
due to aortic damage, infection or fever, heart problems, kidney problems, bowel 
problems, lung problems, reactions to the graft (inflammation or allergic 
reaction), impotence (not able to have an erection), loss of blood flow to the spine 
(resulting in paralysis), legs, or other organs, amputation of toes or legs due to 
loss of blood flow to the legs, and stroke. 
Catheterization risks – During the procedure, x-rays will be used to guide the 
graft to the aorta.  For more accuracy, the patient will receive injections of a fluid 
(called contrast medium) that allows the doctor to better see the blood vessels.  
This procedure of placing catheters (long slender tubes) through blood vessels is 
recognized as safe, but has known risks, including less than a 1 in 1,000 chance of 
serious complications such as serious allergic reaction, heart attack, stroke, or 
death.  The potential for damage to the kidneys from contrast medium also exists. 
Endovascular treatment risks – The patient may experience misplacement or 
shifting in position of the graft, graft wear, folding/collapse of the graft, allergic 

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COMPANY CONFIDENTIAL 
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reaction to graft material that may require surgery to remove the graft, continuing 
blood flow into the aortic injury that may require repair, dislodgement of existing 
plaques or clots from blood vessels, and the need to finish the aortic repair 
through open surgery for a number of reasons including bleeding or difficult 
anatomy. 
Anticoagulant (blood thinner) risks – The patient may be treated with aspirin, 
heparin (a blood thinner), and other medications as determined by the study 
doctor.  These medications may result in bleeding complications. 
Radiation risks – This study involves exposure to radiation from the x-rays used 
during the procedure and also from follow-up testing.  The endovascular 
procedure involves a radiation dose from the x-rays used to guide and place the 
graft.  Generally, the exposure time is expected to be less than 28 minutes.  The 
follow-up after the endovascular procedure involves a radiation dose due to the 
CTs scheduled at 30 days, 6 months, 12 months, and yearly for 5 years.  If the 
patient has complications from the procedure, he/she may have more than the 
scheduled x-rays, leading to a higher radiation dose.  Contrast medium (“x-ray 
dye”) is often used to increase the quality of CTs.  The risks due to exposure to 
contrast medium include hives or itching, shortness of breath, or seizures, which 
may be life-threatening.  The potential for damage to the kidneys also exists.  
Reproductive risks – The patient should not participate in this study if pregnant, 
breastfeeding, or planning to become pregnant in the next 5 years.  If the patient 
becomes or suspects she is pregnant during the study, she must notify the study 
doctor immediately.  A child conceived (created) during the study may develop 
birth defects.  This risk is largely due to the need for x-ray follow-up.  Men who 
undergo endovascular or open surgical repair may experience impotence.     
 
There may be potential risks to the patient (or an embryo or fetus if she is or 
should become pregnant) that the investigators are not currently aware of and that 
they are not able to predict.   
 
 If significant new information becomes available that might affect the patient’s 
willingness to participate in the study, the investigator will discuss this with the 
patient.  If the patient decides to continue in the study, he/she may be asked to 
sign an updated consent form.  
 
 We cannot promise that the patient will receive any benefits from this study.  
Future patients may benefit from the knowledge gained from this study.  The 
patient will not be paid to be in the study. 
 
 The Sponsor, Cook Incorporated, may be paying the study doctors, hospital, and 
clinical study staff for their work related to this study.   
 
 There are no additional charges to participate in this study.  The charges for 
services that would be performed even if the patient was not participating in this 
study will be billed to the patient or the patient’s insurance provider; these will 

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COMPANY CONFIDENTIAL 
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not be paid by the Sponsor.  Any co-payment or deductible required by the 
patient’s insurance provider will be the patient’s responsibility.  
 
 All records related to the patient’s participation in this clinical study will be kept 
confidential.  If the patient chooses to be in this study, the study investigator(s) 
will get personal information about his/her health from talking with the patient 
and from looking at his/her past and current medical records.  It will also come 
from the test results, imaging (CT scans), and examinations that are part of the 
study.  Parts of the patient’s medical records and the data collected for the study 
will be sent to and/or looked at by persons authorized by the Sponsor.  They also 
may be looked at by representatives of domestic and/or global regulatory 
authorities as well as Ethics Committees or Institutional Review Boards to check 
that the study is being carried out correctly.  The patient’s study information may 
be used to help obtain market approval for the device.  If the study data are 
published, the patient’s identity will remain confidential.  The patient may change 
his/her mind about letting us collect his/her confidential medical information at 
any time.  If so, no new information about the patient will be collected.  Any 
information already collected may still be used. 
 
 A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not 
include information that can identify the patient.  At most, the Web site will 
include a summary of the results.  You can search this Web site at any time. 
 
 Agreement to participate in this study does not waive any of the patient’s legal 
rights.   
 
 If the patient has questions about any part of this study, contact <name of contact 
person> at <contact information>. 
 
 If the patient has questions about his/her rights as a participant in this study, 
contact <name of contact person> at <contact information>. 
 
 If the patient believes he/she has been injured as a result of being in the study, 
contact <name of contact person> at <contact information>.   
 
 No commitment is made by <insert Name of Institution> to provide free medical 
care or compensation for participation in this study.  Medical services will be 
offered at the usual charge.  If taking part in this research study harms you, there 
are no special compensation arrangements.  If you are harmed due to someone’s 
negligence, then you may have grounds for a legal action. 
 
This study consent form will be sent to you.  You will be asked to sign and return the consent 
form in order for the patient to participate in the research.  More detailed information about 
this study will be provided in a separate consent form.  You or the patient will be asked to 
read and then sign that consent form after the patient’s condition is stabilized if you agree to 

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COMPANY CONFIDENTIAL 
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allow the patient to participate in the research.  <Please provide instructions on how the form 
must be sent to the institution and also whether any supporting documentation (such as a 
photo identification) must be sent along with the signature page.> 
 
SIGNATURE 
 
I have explained to the subject the nature and purpose, the potential benefits, and possible 
risks associated with participation in this research study.  I have answered all questions that 
have been raised. 
 
 
 
 
 
Signature of Person Conducting Informed Consent Discussion 
 
Date 
 
 
 
Printed Name of Person Conducting Informed Consent Discussion 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Site Number: 
Patient Enrollment Number:

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COMPANY CONFIDENTIAL 
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TELEPHONE CONSENT FORM 
 
I confirm that the purpose of the research, the study procedures that I can expect the patient 
to have, the possible risks and discomforts, the potential benefits that the patient may have, 
and alternatives to the patient’s participation in the study have been explained to me. 
 
I agree: 
 To give my consent to voluntarily allow the patient to participate in this research study.  
I understand that the patient is free to withdraw (drop out) at any time, without giving 
any reason, and without his/her medical care or legal rights being affected.  
 That personal health information about the patient may be used for ongoing research 
purposes as described above and that the patient’s medical records may be looked at by 
persons authorized by the Sponsor, regulatory authorities, and/or IRBs or ECs where it 
applies to the patient taking part in research.  I give permission for these individuals to 
have access to the patient’s medical records. 
 To give my consent to inform the patient’s personal doctor about his/her participation 
in the study. 
 That I have had the opportunity to ask questions and my questions have been answered. 
 
 
                         
 
Patient Name (Printed) 
 
 
 
 
 
 X 
  
 
Legal Representative Name 
Signature 
 Date 
(Printed) 
(State relationship/authority to sign) 
 
 
 
 
 
 
 
I have explained to  
 
 
Legal Representative Name 
the purpose of the research, the 
procedures required, and the possible 
risks and benefits. 
 
 
 X 
  
 
Name of Person who Obtained 
Signature of Person who Obtained 
Date 
Consent (Printed) 
Consent 
 
 
 
 
Site Number: 
Patient Enrollment Number: 
 
 
 

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APPENDIX E 
Mortality Rate Literature Review 
 
 
 

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Studies of Patients with Blunt Aortic Injury since 2008 
 
 
Thoracic Endovascular Aortic Repair (TEVAR) 
Abbreviated citation 
Total number patients 
Number of patients who died within 
30 days 
From Xenos (2008):† 
1  Amabile (2004) 
9 
0 
2  Andrassy (2006) 
15 
2 
3  Broux (2006) 
13 
2 
4  Buz (2007) 
39 
3 
5  Chung (2008) 
26 
2 
6  Doss (2003) 
4 
0 
7  Kasirajan (2003) 
5 
1 
8  Kokotsakis (2007) 
22 
1 
9  Kuhne (2005) 
5 
0 
10  Lebl (2006) 
7 
1 
11  McPhee (2007) 
8 
2 
12  Ott (2004) 
6 
0 
13  Pacini (2005)  
15 
0 
14  Riesenman (2007) 
14 
2 
15  Rousseau (2005) 
29 
0 
16  Stampfl (2006) 
5 
0 
From Walsh (2008): 
17  Reed (2006) 
13 
3 
From Takagi (2009): 
18  Demetriades (2008)‡ 
125 
9 
19  Moainie (2008) 
26 
4 
20  Mohan (2008) 
14 
1 
From Tang (2008): 
21  Agostinelli (2006) 
15 
2 
22  Bortone (2004) 
14 
0 
23  Daenen (2003) 
7 
1 
24  Dunham (2004) 
16 
1 
25  Fattori (2002) 
11 
0 
26  Fujikawa (2001) 
6 
1 
27  Hoornweg (2006) 
28 
4 
28  Lawlor (2005) 
7 
0 
29  Marcheix (2006) 
33 
0 
30  Marty-Ane (2003) 
9 
0 
31  Melnitchouk (2004) 
15 
1 
32  Orend (2002) 
11 
1 
33  Orford (2003) 
9 
1 
34  Pratesi (2006) 
11 
1 
35  Scheinert (2004) 
10 
0 
36  Steingruber (2007) 
22 
1 
37  Tehrani (2006) 
30 
2 
38  Thompson (2002) 
5 
0 
39  Wellons (2004) 
9 
1 
From Murad (2011): 
40  Alsac (2008) 
28 
5 
41  Arthurs (2009) 
95 
17 
42  Botta (2008) 
28 
1 
43  Brown (2008) 
20 
1 

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Thoracic Endovascular Aortic Repair (TEVAR) 
Abbreviated citation 
Total number patients 
Number of patients who died within 
30 days 
44  Canaud (2008) 
27 
1 
45  Day (2008) 
27 
2 
46  Dessl (2004) 
15 
1 
47  Feezor (2009) 
23 
1 
48  Juszkat (2007) 
13 
1 
49  Karmy-Jones (2003) 
11 
3 
50  Kaya (2009) 
42 
1 
51  Khoynezhad (2008)* 
12 
1 
52  Kurimoto (2009) 
13 
2 
53  Lachat (2002) 
12 
1 
54  Methodius-Ngwodo (2008) 
29 
1 
55  Michelet (2005) 
10 
0 
56  Neuhauser (2004) 
13 
0 
57  Peterson (2005) 
11 
0 
58  Rosenthal (2008) 
31 
2 
59  Scharrer-Pamler (2002) 
15 
2 
60  Yamane (2008) 
14 
0 
From Takagi (2008): 
61  Akowuah (2007) 
7 
0 
62  Midgley (2007) 
12 
0 
From Hoffer (2008): 
63  Attia (2007)§ 
11 
2 
64  Bent (2007) 
13 
0 
65  Caronno (2006) 
7 
0 
66  Ferrari (2006) 
18 
1 
67  Go (2007) 
10 
0 
68  Kato (2004) 
6 
0 
69  Kwok (2006)§ 
8 
0 
70  Leurs (2004) 
50 
3 
71  Livi (2007)§ 
13 
0 
72  Neschis (2007) 
20 
4 
73  Pratesi (2006) 
11 
1 
74  Raupach (2007) 
10 
1 
75  Rodriguez (2007) 
11 
0 
76  Saratzis (2007) 
9 
0 
77  Tespili (2007)§ 
16 
1 
78  Thompson (2007) 
21 
0 
79  Veeraswamy (2006)§ 
7 
1 
From Dake (2011) ¥ 
80.  Dake (2011) 
60 
5 
†  Several errors appear in the Xenos study table (page 1349) and in other listed sources with patient numbers 
and publication dates.  The correct data are represented in this table, verified by a review of the initial 
publication abstracts and with comparison to citations in other meta-analyses.  In some cases, full-text was also 
reviewed if discrepancies remained. 
‡  This publication was a prospective, nonrandomized, multicenter trial.  Unless otherwise noted, other reports 
listed were nonrandomized, retrospective, cohort studies. 
*  This publication was a prospective study. 
§  Unable to verify mortality data in abstract. 
¥  This publication included data from five single-center physician-sponsored IDE clinical trials.

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Reports cited: 
 
Xenos ES, Abedi NN, Davenport DL, Minion DJ, Hamdallah O, Sorial EE, et al.  Meta-analysis of 
endovascular vs open repair for traumatic descending thoracic aortic rupture.  J Vasc Surg.  
2008;48:1343-51. 
 
Walsh SR, Tang TY, Sadat U, Naik J, Gaunt ME, Boyle JR, et al.  Endovascular stenting versus open 
surgery for thoracic aortic disease: systematic review and meta-analysis of perioperative results.  J 
Vasc Surg.  2008;47:1094-8. 
 
Takagi H, Manabe H, Kawai N, Goto SN, Umemoto T.  Endovascular versus open repair for blunt 
thoracic aortic injury.  Ann Thorac Surg.  2009;87:349-50. 
 
Tang GL, Tehrani HY, Usman A, Katariya K, Otero C, Perez E, et al.  Reduced mortality, paraplegia, 
and stroke with stent graft repair of blunt aortic transections: a modern meta-analysis.  J Vasc Surg.  
2008;47:671-5.   
 
Murad MH, Rizvi AZ, Malgor R, Carey J, Alkatib AA, Erwin PJ, et al.  Comparative effectiveness of 
the treatments for thoracic aortic transection.  J Vasc Surg.  2011;53:193-99.21-21.  
 
Takagi H, Sawai N, Umemoto T.  A meta-analysis of comparative studies of endovascular versus open 
repair for blunt thoracic aortic injury.  J Thorac Cardiovasc Surg.  2008;135:1392-4. 
 
Hoffer EK, Forauer AR, Silas AM, Gemery JM.  Endovacular stent-graft or open surgical repair for 
blunt thoracic aortic trauma: systematic review.  J Vasc Interv Radiol.  2008;19:1153-64. 
 
Dake MD, White, RA, Diethrich EB, Greenberg RK, Criado FJ, Bavaria JE, et al.  Report on endograft 
management of traumatic thoracic aortic transection at 30 days and 1 year from a multidisciplinary 
subcommittee of the Society for Vascular Surgery Outcomes Committee.  J Vasc Surg.  2011:53:1091-
6.