Study Assessing Safety and Effectiveness of Perivisceral Aortic Aneurysm Treatment With the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® and the Effects on Organ and Extremity Perfusion
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Sponsor: Cook Research Incorporated

Cook Research Incorporated  
Version: 07-003-08
 
 
 
Zenith® Fenestrated and Zenith® p-Branch® Clinical Study 
Version Date: 26-Mar-2018 
 
 
COMPANY CONFIDENTIAL 
 
Page 1 of 61 
  
CLINICAL INVESTIGATION PLAN 
 
 
Study Assessing Safety and Effectiveness of Perivisceral Aortic 
Aneurysm Treatment with the Zenith® Fenestrated AAA Endovascular 
Graft or the Zenith® p-Branch® and the Effects on Organ and Extremity 
Perfusion   
 
 
Global Clinical Number 07-003 
 
 
Sponsor:  
 
 
 
 
Cook Research Incorporated 
 
  
 
 
 
 
 
1 Geddes Way  
 
  
 
 
 
 
 
West Lafayette, IN 47906 
 
  
 
 
 
 
 
 
 
 
  
 
Summary of Changes: 
Version 
Description 
Date 
07-003-01  
Orignal version 
26 February 2007 
07-003-02 
Clarified that the DSMB 
will be independent and 
that each Fenestrated graft 
will be specifically 
designed for each patient 
13 April 2007 
07-003-03 
Added the Zenith® 
Alignment Stent, increased 
the maximum number of 
fenestrations (3 to 4), 
allowed large fenestrations 
on the proximal component 
14 May 2010 
07-003-04 
Added the Zenith® 
p-Branch® device 
28 February 2012 
07-003-05 
 
07-003-06 
Combined the pre-
discharge and 30-day 
follow-up visits 
Figures 1.5.2-1, 1.5.2.1-1, 
1.5.2.1-2, and 1.5.2.2-1 
were updated to reflect 
device and delivery system 
changes.  Proximal neck 
3 October 2014 
 
10 December 2014 

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Page 2 of 61 
diameter exclusion 
criterion was updated to 
align with the current  IFU 
07-003-07 
Removed Duplex 
Ultrasound after 12 months 
and ABIs/Pulse assesments 
after 30 days.  Removed X-
ray and Renal Scintigraphy 
imaging requirements.  
Removed PT, APTT, INR, 
pH, ESR, CBC, and urine 
eosinophil tests.  Removed 
core temperature 
assessments.  Modified 
pre-procedure though 
follow-up data collection 
requirements.  Added 
written monitoring 
procedures. 
 
19-Nov-2015 
 
 
07-003-08  
 
 
 
   Changed Sponsor from                26-Mar-2018 
                                             Cook Incorporated  to Cook  
                                             Research Incorporated. Removed 
 
 
 
 
 
 
         designee and added the title, email, 
                                             address and fax number to the Name 
                                             and Address of the 
Monitor.                                                                                                                                                 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Version Date: 26-Mar-2018 
 
 
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CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
 
 
Sponsor Contact: 
 
This clinical study will be conducted in accordance with the Clinical Investigation Plan 
(CIP), 21 CFR 812, and other applicable requirements as appropriate. The CIP will be 
revised, as appropriate, based on new information. 
 
 
 
 
X 
 
 
 
     Signature 
 
  Date (DD Mon YYYY) 
 
 
 
 
 
     Printed Name 
 
                  Title 
 
 

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Version Date: 26-Mar-2018 
 
 
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Page 4 of 61 
 
CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
Continued 
 
 
Principal 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. 
 
 
X 
 
 
 
     Signature 
 
  Date (DD Mon YYYY) 
 
 
 
 
 
     Printed Name 
 
                  Title 
 
 
 

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Version: 07-003-08
 
 
 
Zenith® Fenestrated and Zenith® p-Branch® Clinical Study 
Version Date: 26-Mar-2018 
 
 
COMPANY CONFIDENTIAL 
 
Page 5 of 61 
CONFIDENTIALITY STATEMENT 
 
 
 
This document shall be treated as a confidential document  
for the sole information and use of the  
clinical study team and the  
 Institutional Review Board (IRB). 
 
 
 

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Page 6 of 61 
Table of Contents 
 
1.  INVESTIGATIONAL PLAN ........................................................................................ 8 
1.1.  Purpose .................................................................................................................... 8 
1.1.1.  Name and Intended Use of the Device ............................................................ 8 
1.1.2.  Specific Aims ................................................................................................... 8 
1.1.3.  Duration of the Investigation ........................................................................... 9 
1.2.  Study Design ........................................................................................................... 9 
1.2.1.  Limitations of the Study................................................................................... 9 
1.2.2.  Safety Monitoring ............................................................................................ 9 
1.3.  Specific Protocol ................................................................................................... 10 
1.3.1.  Definitions...................................................................................................... 10 
1.3.2.  Entry Criteria ................................................................................................. 16 
1.3.3.  Methods.......................................................................................................... 18 
1.3.3.1.  Endovascular Graft Sizing ...................................................................... 18 
1.3.3.2.  Endovascular Graft Deployment ............................................................. 19 
1.3.3.3.  Completion .............................................................................................. 19 
1.3.3.4.  Peri-operative Care ................................................................................. 19 
1.3.3.5.  Post-operative Treatment of Endoleaks .................................................. 19 
1.3.4.  Measurements and Data Collection ............................................................... 19 
1.3.4.1.  Pre-operative Assessment Data Collection ............................................. 22 
1.3.4.2.  Intra-operative Data Collection ............................................................... 23 
1.3.4.3.  Post-operative Data Collection ............................................................... 24 
1.3.4.4.  Follow-up ................................................................................................ 24 
1.3.4.5.  Deaths ..................................................................................................... 25 
1.3.4.6.  Explants................................................................................................... 25 
1.3.4.7.  Lost to Follow-up .................................................................................... 26 
1.3.5.  Assessing Outcome ........................................................................................ 27 
1.4.  Risk Analysis ........................................................................................................ 27 
1.4.1.  Procedure-related Risks ................................................................................. 27 
1.4.1.1.  Failure to Traverse the Iliac Arteries ...................................................... 28 
1.4.1.2.  Inaccurate Deployment of the Fenestrated Aortic Component ............... 28 
1.4.1.3.  Inaccurate Deployment of the Non-Fenestrated Aortic Component ...... 29 
1.4.1.4.  Inaccurate Deployment of the Fenestration Stent ................................... 29 
1.4.1.5.  Failure to Deploy the Endovascular Graft .............................................. 30 
1.4.1.6.  Failure to Deploy the Fenestration Stent ................................................ 30 
1.4.1.7.  Inadvertent Internal Iliac Artery Occlusion and Ischemic Colitis .......... 31 
1.4.1.8.  Stent-graft Displacement ........................................................................ 31 
1.4.1.9.  Dislodgement of the Fenestration Stent .................................................. 31 
1.4.1.10.  Displacement of the Fenestration Stent ................................................ 32 
1.4.1.11.  Injury to Anatomy ................................................................................. 32 
1.4.1.12.  Embolism .............................................................................................. 33 
1.4.1.13.  Stroke .................................................................................................... 33 
1.4.1.14.  Paraplegia .............................................................................................. 33 
1.4.1.15.  Systemic Effects .................................................................................... 33 
1.4.1.16.  Local Effects ......................................................................................... 34 

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1.4.2.  Performance-Related Risks ............................................................................ 34 
1.4.2.1.  Migration of the Endovascular Graft ...................................................... 34 
1.4.2.2.  Component Separation ............................................................................ 35 
1.4.2.3.  Migration of the Fenestration Stent ........................................................ 35 
1.4.2.4.  Graft Limb Occlusion ............................................................................. 36 
1.4.2.5.  Occlusion of Visceral Vessels ................................................................ 36 
1.4.2.6.  Endoleak and Endotension ...................................................................... 36 
1.4.2.7.  Graft Infection ......................................................................................... 37 
1.4.3.  Technical or Material-related Risks ............................................................... 37 
1.4.3.1.  Stent Breakage ........................................................................................ 37 
1.4.3.2.  Fenestration Stent Crush ......................................................................... 38 
1.4.3.3.  Barb Separation ....................................................................................... 39 
1.4.3.4.  Bare Stent Separation .............................................................................. 39 
1.4.3.5.  Fabric Erosion ......................................................................................... 39 
1.4.3.6.  Biocompatibility ..................................................................................... 40 
1.4.4.  Protection Against Risks ................................................................................ 40 
1.4.5.  Potential Benefits to the Subjects and Alternative Treatments ...................... 41 
1.4.5.1.  Observation ............................................................................................. 41 
1.4.5.2.  Conventional Surgery ............................................................................. 42 
1.4.5.3.  Endovascular Repair ............................................................................... 42 
1.5.  Device Description ................................................................................................ 43 
1.5.1.  Zenith® Fenestrated AAA Endovascular Graft .............................................. 43 
1.5.1.1.  Proximal Body Graft ............................................................................... 43 
1.5.1.2.  Proximal Body Graft Introduction System ............................................. 44 
1.5.1.3.  Distal Body Graft .................................................................................... 45 
1.5.1.4.  Distal Body Graft Introduction System .................................................. 46 
1.5.1.5.  Iliac Leg Graft ......................................................................................... 46 
1.5.1.6.  Iliac Leg Graft Introduction System ....................................................... 46 
1.5.1.7.  Fenestration Stent.................................................................................... 46 
1.5.1.8.  Zenith® Alignment Stent Introduction System ....................................... 47 
1.5.1.9.  Ancillary Components ............................................................................ 47 
1.5.2.  Zenith® p-Branch® ......................................................................................... 47 
1.5.2.1.  Proximal Body Graft ............................................................................... 48 
1.5.2.2.  Proximal Body Graft Introduction System ............................................. 51 
1.5.2.3.  Distal Body Graft .................................................................................... 52 
1.5.2.4.  Distal Body Graft Introduction System .................................................. 53 
1.5.2.5.  Ancillary Components ............................................................................ 53 
1.5.3.  Fenestration Stents ......................................................................................... 54 
1.5.4.  Description of Each Important Component, Ingredient, and Property .......... 54 
1.5.5.  The Principle of Operation of the Device ...................................................... 54 
1.5.6.  Description of Anticipated Changes in the Device During the Investigation 54 
1.6.  Monitoring Procedures.......................................................................................... 55 
 
 
 
Appendix A.  Written Procedures for Monitoring ............................................................ 57 

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1.  INVESTIGATIONAL PLAN 
1.1.  Purpose 
The purpose of this study is to assess safety and effectiveness and examine in detail the 
effect of fenestrated stent-graft technology on organ and extremity perfusion, using the 
Zenith® Fenestrated AAA Endovascular Graft or the Zenith® p-Branch®. 
 
1.1.1.  Name and Intended Use of the Device 
The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ 
Introduction System is indicated for the endovascular treatment of patients with 
abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular 
repair.  In some instances, the physician may also choose to use a Zenith® Alignment 
Stent, which is indicated for use as an adjunct to the Zenith® Fenestrated AAA 
Endovascular Graft to assist alignment and patency at the orifice of aortic branch vessels 
with diameters ranging from 3 mm to 8 mm. 
The Zenith® p-Branch® with the Zenith® preloaded delivery system is indicated for the 
endovascular treatment of patients with abdominal aortic aneurysms having morphology 
suitable for endovascular repair.  The Zenith® p-Branch® may require adjunctive 
placement of a balloon-expandable covered stent to assist with alignment and patency at 
the renal and visceral vessels incorporated by the Zenith® p-Branch® endovascular graft 
fenestrations.   
 
1.1.2.  Specific Aims 
This study is intended to: 
1. Assess safety and effectiveness of the Zenith® Fenestrated AAA Endovascular 
Graft to exclude AAA;  
2. Assess safety and effectiveness of the Zenith® p-Branch® to exclude AAA; 
3. Monitor highly sensitive indicators of end organ and extremity perfusion;  
4. Provide additional refinement of the patient population that can potentially benefit 
from fenestrated stent-grafts. 
 

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1.1.3.  Duration of the Investigation 
It is anticipated that patient recruitment could be completed within 84 months of 
initiating the study.  Follow-up data will continue to be collected for five years after graft 
deployment for each patient in the study, making the study duration approximately 
12 years. 
 
1.2.  Study Design 
The design will be a prospective non-randomized study enrolling up to 40 patients to 
receive either the Zenith® Fenestrated AAA Endovascular Graft or the Zenith® p-Branch® 
at two clinical sites.  No comparison groups will be included within this study, although 
study results may be compared with those from other similar patient groups.   
 
1.2.1.  Limitations of the Study 
Due to the overall diminished life-expectancy of the predominantly high risk patient 
population to be enrolled, it is anticipated that there will be a number of unrelated deaths 
that will reduce the number of patients surviving to the end of study follow-up.  This 
study is designed to assess short, medium, and long-term outcomes related specifically to 
organ and extremity perfusion. 
 
1.2.2.  Safety Monitoring 
Data Safety Monitoring Board 
A data safety monitoring board (DSMB) consisting of independent physicians, who are 
not investigators in the investigation, nor 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. 
 
Clinical Events Committee 
An independent clinical events committee (CEC) consisting of physicians, who are not 
investigators in the investigation, nor have a perceived conflict of interest with the 
conduct and administration of the investigation, will be established to adjudicate clinical 

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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, procedure-related, technique-related, and/or device-related. 
 
1.3.  Specific Protocol 
1.3.1.  Definitions 
Proximal neck for treatment with the Zenith® Fenestrated AAA Endovascular Graft: 
Infrarenal aortic segment from the lowest level of the distal-most renal artery intended to 
remain patent to the proximal end of the aneurysmal aorta. 
 
Proximal sealing zone for treatment with the Zenith® p-Branch®:  
Aortic segment from the distal-most aspect of the celiac artery to the proximal end of the 
aneurysmal aorta. 
 
 
 
 
Calcification will be graded based upon the following:  
• None:  Lack of calcification; 
• Mild:  Less than 40% circumferential calcification;  
• Moderate: 40-70% circumferential calcification; or 
• Severe:  Greater than 70% circumferential.  
 
Tortuosity of iliac arteries will be graded based upon the following: 
• None:   Lack of tortuosity; 
• Mild:  Fairly straight arteries; 
• Moderate:  Angulation manageable with stiff wires, <70°;  
• Severe:  Angulation difficult, may require surgical exposure for straightening, not 
straightened entirely with wires. 
 

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Occlusive disease of iliacs: Occlusive disease will be graded based upon the following: 
• None:  Lack of occlusive disease  
• Mild:  Some disease, focal with less than 30% narrowing 
• Moderate:  Between 30-50% narrowing not requiring interventional techniques to 
meet entry criteria 
• Severe:  Greater than 50% or any patient requiring angioplasty prior to endograft 
delivery.  
 
New York Heart Association Classification:  
 
 
 
1 Patient with cardiac disease but without resulting limitations of physical activity.  
Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.  
2 Patients with cardiac disease resulting in slight limitation of physical activity.  
They are comfortable at rest, ordinary physical activity results in fatigue, 
palpitation or dyspnea.  
3    Patients with cardiac disease resulting in marked limitation of physical activity.  
They are comfortable at rest, less than ordinary physical activity causes fatigue, 
palpitation or dyspnea.  
4    Patients with cardiac disease resulting in inability to carry out any physical 
activity without discomfort.  Symptoms of cardiac insufficiency may be present 
even at rest.  If any physical activity is undertaken, discomfort is increased. 
 
Disabling chronic obstructive pulmonary Disease (COPD): 
 
 
Having a forced expiratory volume (FEV1) <1.0 liter or receiving home oxygen therapy. 
 
Medically intractable Hypertension:  
 
 
 
Having a systolic arterial pressure >160 mmHg despite receiving medication. 
 

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MI (Non-Q-Wave): 
 
 
Investigator identified patients having 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 institutions 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): 
 
 
 
 
Post-procedure presence of new Q-waves greater than 0.04 seconds in at least two EKG 
leads. 
 
Renal failure:   
 
 
 
Acute or progressive renal insufficiency leading to the need for dialysis or hemofiltration.   
 
Renal insufficiency:   
 
 
A rise in serum creatinine of more than 30% above the pre-procedure level, resulting in a 
serum creatinine level >2.0 mg/dl that does not spontaneously resolve (does not include 
those patients with a pre-procedure serum creatinine >2.0 mg/dl).  
 
Embolization: 
 
 
 
 
Clinical evidence of ischemic tissue remote from the operative field, presumably caused 
by thrombus dislodged from the aneurysmal sac, aortic neck, or adjacent vessels, 
including ischemia of the kidneys, pelvis (IIA) or lower limbs.  This is, of course, distinct 
from intentional pre-operative, operative, or post-operative embolization procedures.   
 
Limb occlusion:  
 
 
 
The presence of thrombus within one, or both, of the graft limbs (including any legs and 
extensions) creating occlusion. 
 

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Type I endoleak: 
 
 
 
A peri-prosthetic leak occurring at the proximal and/or distal fixation zones, including 
leakage around fenestrations in the case of bare stents in visceral vessels incorporated by 
fenestrations. 
Type II endoleak: 
 
 
 
A leak caused by retrograde flow from patent lumbar or inferior mesenteric arteries. 
 
Type III endoleak: 
 
 
 
A leak caused by a defect in the graft fabric, or inadequate seal of modular graft 
components including leakage around fenestrations in the case of covered stents in 
visceral vessels incorporated by the fenestrations.  
 
Type IV endoleak: 
 
 
 
A leak caused by graft fabric porosity, often resulting in a generalized blush of contrast 
within the aneurysm sac. 
 
Endoleak (early): 
Any endoleak observed within 30 days of device deployment. 
 
Endoleak (late): 
 
 
 
Any endoleak observed later than 30 days after device deployment that was not 
documented during the first 30 days post-deployment. 
 
Radiographic migration (stent-graft):  
 
 
 
 
Antegrade or retrograde movement of the stent-graft >10 mm relative to anatomical 
landmarks identified on the first post-operative CT scan. 
 
Radiographic migration (stent):   
 
 
 
 

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Antegrade or retrograde movement of a fenestration stent >10 mm within the stented 
artery as compared to the position on the first post-operative CT scan. 
Clinically significant migration (stent-graft): 
 
 
 
 
Antegrade or retrograde movement of the stent-graft requiring surgical or endovascular 
intervention.   
 
Clinically significant migration (stent):  
 
 
 
 
 
Antegrade or retrograde movement of any fenestration stent requiring surgical or 
endovascular intervention.  
 
Barb separation:  
 
 
 
Radiographic evidence of detachment of barbs from the stent strut.  
 
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.  
 
Technical Success: 
 
 
Successful access of the aneurysm site and deployment of the Zenith® Fenestrated AAA 
Endovascular Graft or the Zenith® p-Branch™ in the intended location.  The 
endovascular graft and all vessels targeted with fenestrations must be patent at the time of 
deployment completion as evidenced by intraoperative angiography.  
 
Procedural Success: 
 
 
Technical Success, with all of the following at post-procedure (within 30 days): 
• No type I or type III endoleaks; 
• No procedure related serious adverse events or major complications; 

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• Patency of the endovascular graft and all vessels targeted with fenestrations as 
evidenced by CT scan, angiography or by duplex ultrasound in those patients 
experiencing renal failure or otherwise unable to undergo contrast enhanced CT 
scan. 
Treatment Success: 
 
 
Procedural Success, with all of the following at 12 months: 
• No type I or type III endoleaks; 
• No serious adverse events or major complications; 
• No aneurysm enlargement greater than 0.5 cm; 
• Patency of the endovascular graft and all vessels targeted with fenestrations as 
evidenced by CT scan, angiography or by duplex ultrasound in those patients 
experiencing renal failure or otherwise unable to undergo contrast enhanced CT 
scan. 
 
Serious adverse event: 
 
Occurrence of any of the following: 
• Death; 
• Aneurysm rupture; 
• Conversion to open surgical repair. 
 
Major complication: 
 
 
Occurrence of a serious adverse event, or any of the following: 
• Q-wave myocardial infarction; 
• Congestive heart failure; 
• Cardiac ischemia requiring intervention; 
• Renal failure requiring dialysis; 
• Bowel obstruction, ischemia, or fistula; 
• Stroke; 

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• Paralysis. 
 
 
1.3.2.  Entry Criteria 
Patients must meet at least one of the inclusion criteria to be enrolled in the study.  
General and medical exclusion criteria will be assessed during the initial patient 
evaluation by conducting a history and physical examination.  Anatomical exclusion 
criteria will be assessed using a variety of imaging techniques that are routinely 
performed during the evaluation of abdominal aortic aneurysms.  Sectional imaging will 
be performed by CT scan.  Angiography and intravascular ultrasound will be performed 
as needed to further assess inclusion/exclusion criteria.    
Assessment of entry criteria will be based upon data available pre-operatively.  Data 
obtained peri-operatively and post-operatively may contradict pre-operative assessment, 
and such is anticipated in several cases.  However, such contradiction 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.  Therefore, some criteria relate to subjective 
assessment while other criteria are considered absolute and able to be determined 
definitively.   
 
General inclusion criteria 
A patient may be suitable for inclusion in the study if the patient has at least one of the 
following: 
1. Abdominal aortic aneurysm >5.0 cm or 2 times the normal aortic diameter; 
2. Abdominal aortic aneurysm with history of growth >0.5 cm in 6 months; 
3. Penetrating juxtarenal aortic ulcer >10 mm in depth and 20 mm in diameter. 
 
General exclusion criteria (all must be no): 
A patient must be excluded from the study if any of the following conditions are true: 
1. Age <18 years; 

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2. Life expectancy <2 years; 
3. Pregnant or breast feeding; 
4. Inability or refusal to give informed consent; 
5. Unwilling or unable to comply with the follow-up schedule. 
Medical exclusion criteria (all must be no): 
A patient must be excluded from the study if any of the following conditions are true: 
1. Allergy to stainless steel, polyester, solder, gold, or nitinol; 
2. Anaphylactic reaction to contrast that cannot be adequately pre-medicated; 
3. Leaking/ruptured or symptomatic aneurysm; 
4. Uncorrectable coagulopathy; 
5. Previous orificial stent in any vessel to be accommodated with a small 
fenestration that protrudes into the aorta (for the Zenith® Fenestrated AAA 
Endovascular Graft); 
6. Previous orificial stent in any vessel to be accommodated with the SMA 
fenestration or pivot fenestrations that protrudes into the aorta (for the Zenith® p-
Branch®). 
 
Anatomical exclusion criteria (all must be no): 
A patient must be excluded from the study if any of the following conditions are true: 
1. Prohibitive occlusive disease, tortuosity, calcification, or thrombus; 
2. Unsuitable proximal neck/sealing zone length: 
a. For Zenith® Fenestrated AAA Endovascular Graft, proximal neck length 
<4 mm or >15 mm (unless otherwise unsuitable for standard endograft) 
between start of aneurysm and lowest renal artery;  
b. For Zenith® p-Branch®, proximal sealing zone length <15 mm (unless 
otherwise unsuitable for standard endograft) between start of aneurysm 
and the distal-most aspect of the celiac artery;   
3. Unsuitable proximal neck diameter: 

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a. For Zenith® Fenestrated AAA Endovascular Graft, aortic neck diameter 
>31 mm or <19 mm (measurements based on outer diameter unless 
evidence of vessel thickening); 
b. For Zenith® p-Branch®, aortic neck diameter >32 mm or <21 mm 
(measurements based on outer diameter unless evidence of vessel 
thickening); 
4. Unsuitable aortic neck morphology precluding fixation or seal; 
5. Aortic neck angulation precluding ability to cannulate fenestrations; 
6. Tortuosity, calcification, or arterial diameter not conducive to placement of the 
introducer with use of a conduit;  
7. Unsuitable ipsilateral iliac artery fixation site diameter for the abdominal device: 
a. For Zenith® Fenestrated AAA Endovascular Graft, ipsilateral iliac artery 
fixation site diameter <9.0 mm (measured outer wall to outer wall on a 
sectional image prior to deployment); 
b. For Zenith® p-Branch®, ipsilateral iliac artery fixation site diameter <8.0 
mm (measured outer wall to outer wall on a sectional image prior to 
deployment); 
8. For Zenith® Fenestrated AAA Endovascular Graft, iliac artery diameter >21 mm 
(measured outer wall to outer wall on a sectional image); 
9. For Zenith® Fenestrated AAA Endovascular Graft, iliac artery distal fixation site 
<15 mm in length; 
10. Inability to maintain at least one patent hypogastric artery with abdominal device; 
11. Non-bifurcated segment of any artery to be stented <10 mm in length if use of 
covered stent is planned; 
12. For Zenith® p-Branch®, renal and visceral vessel anatomy incompatible with the 
graft (see Section 1.5.2.1. for more details on the renal and visceral vessel 
criteria). 
 
1.3.3.  Methods 
1.3.3.1.  Endovascular Graft Sizing 

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Refer to the IFU for endovascular graft sizing.   
 
1.3.3.2.  Endovascular Graft Deployment 
Refer to the IFU for endovascular graft deployment. 
 
 
1.3.3.3.  Completion 
Following graft deployment, the delivery system is removed leaving the sheath in place.  
Aortography is then performed to confirm perfusion of the celiac artery, SMA, and renal 
arteries, and to visualize exclusion of the aneurysm sac.  The presence of contrast 
material in the aneurysm sac is indicative of an endoleak.  Type I or III endoleaks should 
be treated at the time of implantation by modifications of the proximal or distal fixation 
points.  Definite Type II endoleaks can be treated at the physician’s discretion. 
 
1.3.3.4.  Peri-operative Care 
Treatment with the Zenith® Fenestrated AAA Endovascular Graft or the Zenith® p-
Branch® calls for no departure from the usual peri-operative management of patients 
undergoing endovascular repair with the standard infrarenal Zenith® AAA Endovascular 
Graft.  
 
1.3.3.5.  Post-operative Treatment of Endoleaks 
Type I and III endoleaks warrant immediate treatment.  Type II endoleaks should be 
treated at the physician’s discretion, depending on aneurysm behavior and size, endoleak 
source, and time from implantation.  If the aneurysm is enlarging, treatment by 
embolization or ligation should be considered.  Type III endoleaks should be treated with 
additional ballooning or prostheses.  
 
1.3.4.  Measurements and Data Collection 

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Clinical data and imaging measurements will be collected on standardized forms.  The 
results of the endovascular repair will be assessed by radiologic and/or clinical criteria at 
the time of graft insertion and according to the schedule listed in Table 1.3.4-1. 
 
Table 1.3.4-1.  Study schedule 
 
Pre-op Intra-op 
Post-
procedure1 
6 Month 
12 Month11 
CT 
X  
 
X2 
X2 
X2 
Device x-ray 
 
 
X3 
X3 
X3 
Angiography 
X4 
X 
 
 
 
Duplex Ultrasound5 
X 
 
X 
X 
 X6 
Clinical Exam 
X 
 
X 
X 
 X 
Pulses/ABI 
X 
 
X 
 
  
Blood Test7 
X 
 
X 
X 
X 
CSF Analysis8 
 
 
 
 
 
Endoscopy 
 
 
X9 
X9 
X9 
Colonoscopy 
 
 
X10 
X10 
X10 
1.    Post-procedure follow-up should be completed within 30 days of the index procedure. 
2.    Duplex ultrasound along with a non-contrast CT may be used to assess the aneurysm for 
those patients experiencing renal failure or who are otherwise unable to undergo contrast 
enhanced CT scan.   
3.    Device x-ray performed as needed.      
4.  Pre-procedure angiography performed as needed. 
5.  Duplex ultrasound will be specific to vessels targeted by a fenestration. 
6.    Duplex ultrasound not required after 12-month follow up. 
7.  The following will be tested to establish baseline: AST, ALT, AP, LDH,  Cr, BUN, LA, and 
CPK with follow-up testing only of those that are specific to vessels targeted by a 
fenestration. 
8.  Cerebrospinal fluid will be evaluated for markers of spinal cord ischemia (i.e., neuronal-
specific enolase, glial fibrillary acidic protein, lactate, and S100B) in any patients who 
require placement of an intrathecal catheter. 
9.  Endoscopy and gastric tonometry will be used at follow-up to determine gastric and 
duodenal mucosal pH only if there is an indication of gastric perfusion alteration. 
10. Colonoscopy using narrow band imaging to visualize submucosal vessels for an assessment 
of perfusion will be performed on follow-up only if there is an indication of colon perfusion 
abnormalities. 
11. Patients will be followed up at yearly intervals through five years. 
 
If there is evidence of compromise in organ or extremity perfusion as a result of the 
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may be performed to assess highly sensitive indicators of end organ and extremity 
perfusion, as applicable to the vessels targeted by a fenestration.   
 
 
 
Mesenteric Perfusion 
Perfusion to the liver, spleen, stomach, duodenum and colon will be monitored as 
follows:   
1. Patency of the celiac, superior mesenteric and inferior mesenteric arteries will be 
assessed with duplex ultrasound through 12 months and CTA through 5 years; 
2. Perfusion to the liver and spleen will be evaluated using CT scanning; 
3. Liver function test battery to determine hepatic perfusion (AST, ALT, Alkaline 
Phosphatase, LDH [1,2,3].  
If either of these tests are significantly abnormal, then more invasive testing, if clinically 
indicated, will be performed to include the following tests: 
1. Endoscopy with gastric tonometry will be used to determine gastric and duodenal 
mucosal pH if there is an indication of gastric perfusion alteration;  
2. Colonic perfusion will be assessed via flexible colonoscopy using narrow band 
imaging to visualize submucosal vessels allowing an assessment of perfusion if 
there are indications of colon perfusion abnormalities [4]. 
 
Renal Perfusion 
A wide range of renal function can fall within the boundaries of a “normal” creatinine, 
thus assessment of renal perfusion using serum creatinine is notoriously inaccurate.  As 
indicated, renal perfusion will be assessed by more precise measurements of renal 
function, including: 
1. Renal artery patency will be assessed with duplex ultrasound and CTA; 
2. Creatinine clearance will be determined by calculating glomerular filtration rate 
using the Cockcroft-Gault equation [5];  

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3. Renal perfusion and embolization will be assessed by CT scanning to evaluate for 
wedge infarcts and evidence of microembolization. 
 
Systemic Perfusion 
Systemic indicators of organ and/or extremity perfusion to be evaluated include:  
1. Serum lactate levels; 
2. Creatinine phosphokinase (CPK); 
3. Cerebrospinal fluid will be evaluated for markers of spinal cord ischemia, 
including neuronal-specific enolase, glial fibrillary acidic protein, lactate, and 
S100B [6] in any patients who require placement of an intrathecal catheter. 
 
1.3.4.1.  Pre-operative Assessment Data Collection 
Patients meeting the selection criteria who have provided informed consent will undergo 
a detailed pre-procedural examination.  Data will be collected and stored in a database.  
Data points include: 
1. Date of examination; 
2. Age, gender, weight, and height; 
3. Past medical history; 
4. Lower extremity pulse and ABI evaluation; 
5. Radiographic results listed on case report forms including: 
a. Aortic diameters; 
b. Aortic lengths; 
c. Common iliac artery measurements; 
d. Extent of iliac artery occlusive disease, calcification, tortuosity; 
e. Renal and visceral artery measurements; 
6. Baseline laboratory data including: 
a. BUN; 
b. Creatinine; 

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c. Alkaline phosphatase; 
d. AST; 
e. ALT; 
f. Lactate; 
g. LDH. 
h. CPK 
 
1.3.4.2.  Intra-operative Data Collection 
The endovascular aneurysm procedure will be documented in such a way to permit 
analysis of any untoward occurrences in terms of cause and effect.  Data will be collected 
and stored in a database.  Data points include: 
1. Date of procedure; 
2. Procedure time (skin to skin); 
3. Endoprosthesis time (from insertion of initial catheter to removal of final 
angiographic catheter); 
4. Contrast volume: 
5. Total fluoroscopy time; 
6. Estimated blood loss; 
7. Exogenous blood transfused and cell saver blood transfused; 
8. Diameter, length and configuration of the prosthesis (derived from product label); 
9. Assessment of system performance including:  ease of insertion, visualization, 
and ease of removal; 
10. Assessment of ability to successfully place peripheral stents; 
11. Make, model, diameter, and length of each renal or visceral vessel stent; 
12. Ancillary equipment needed; 
13. Adjunctive maneuvers including:  balloon dilation of iliac arteries, additional 
stents required, additional surgical procedures, maneuvers to move or re-align 
stents, the need for thrombectomy; 

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14. Nature of completion assessment (angiogram or IVUS); 
15. Findings of completion assessment:  patency, endoleak, kinks. 
 
1.3.4.3.  Post-operative Data Collection 
The interval between deployment of the endoprosthesis and within 30 days post-
procedure will be documented.  Data points include: 
1. Date of discharge; 
2. Survival or death; if the patient has died, a study exit form should be filled out; 
3. Complications (if any); 
4. Patient withdrawal; 
5. Post-operative imaging information including: 
a)  Device integrity (kink, separation, stent fracture, barb separation); 
b)  Aortic diameters; 
c)  Iliac diameters; 
d)  Endoleak; 
e)  Graft patency; 
f)  Branch vessel status; 
6. Duration of ICU stay; 
7. Time to resumption of fluid intake; 
8. Condition of incision; 
9. Lower extremity  pulse and ABI evaluation; 
10. Laboratory data at time of discharge (to include the assessments listed under #65 
in Section 1.3.4.1); 
 
1.3.4.4.  Follow-up 
The results of the endovascular repair will be assessed by radiologic and/or clinical 
criteria at the time of graft insertion and according to the schedule given in Table 1.3.4-1.   

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Data points to be obtained during follow-up include: 
1. Date of examination; 
2. Survival or death; 
3. Complications (if any); 
4. Patient withdrawal; 
5. Follow-up imaging information (to include the assessments listed under #5 in 
Section 1.3.4.3 and migration assessment); 
6. Clinical exam; 
7. Laboratory data at follow-up (to include the assessments listed under #10 in 
Section 1.3.4.1); 
8. Evaluation of patency of visceral vessels targeted by a fenestration by duplex 
ultrasound (post-procedure to 12-months). 
 
1.3.4.5.  Deaths 
Details of any deaths occurring during the evaluation will be stored in a database.  Data 
points include: 
1. Date of death; 
2. Whether an autopsy was performed; 
3. Underlying cause of the fatal condition: 
a. Related to the prosthesis; 
b. Related to the procedure; 
c. Related to a previous condition. 
 
1.3.4.6.  Explants 
An autopsy may be requested for patients who die with a prosthesis in place.  At the 
autopsy, the entire abdominal aorta (over the extent of the endograft) will be excised 
down to and including both common iliac arteries.  Both the excised aorta and the 
endovascular graft will undergo examination.  If the family does not wish for a full 

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autopsy to be performed, a limited autopsy to remove the involved vasculature and graft 
will be requested. 
If the prosthesis is excised in the course of conversion to open repair, the position, and 
attachment of the prosthesis within the arterial tree will be recorded.  In addition, every 
precaution will be taken to ensure that the prosthesis is removed intact.  For example, 
vascular clamps will be applied at remote sites from stent attachments.  The prosthesis 
will then be washed with saline to remove surface thrombus.  The graft components 
should be fixed in 4% formaldehyde for subsequent examination.  
Explanted devices will be examined radiographically while still within the aorta before 
destructive studies are initiated.  Explanted devices will undergo gross and microscopic 
examination to assess structural integrity of the graft material and stent components.  
Gross photography and/or scanning electron microscopy will both be used to examine the 
structural integrity of the z-stent components, the attachment barbs, and any renal or 
visceral vessel stents.  Any device-related gross pathology will also be documented. 
Histopathologic studies will be conducted on the aorta and iliac artery tissues in the near 
vicinity of the endovascular graft as well as in the regions of the attachment sites, the 
mid-graft region and the main body/leg extension docking sites. 
Data will be collected and stored in a database. 
Data points include: 
1. Date of explant; 
2. Patient’s status at explant; 
3. Reason for explant; 
4. Degree of attachment/ingrowth. 
 
1.3.4.7.  Lost to Follow-up 
Efforts will be taken to avoid patients becoming lost to follow-up.  Prior to enrollment in 
the trial, the requirement for timely and complete follow-up will be discussed with the 
patient and their primary physician.  .  
If a patient is lost to follow-up, the following information will be recorded: 
1. Date of last contact with patient; 

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2. Reasons for patient’s unavailability:  withdrawal, moved away, unreachable, etc.; 
3. Summary of attempts to contact patient; 
 
1.3.5.  Assessing Outcome 
In addition to assessing the indicators of perfusion described in Section 1.3.4, the study 
will provide an assessment of serious adverse events, major complications, endoleak, 
migration, change in aneurysm size, clinical utility measures (ICU stay, days to 
resumption of oral fluid intake, days to hospital discharge, and blood replacement 
requirements), device integrity, technical success, procedural success, treatment success, 
and secondary interventions. 
 
1.4.  Risk Analysis 
The Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® are 
implantable endoprosthetic devices intended to prevent aneurysm rupture.  The hazards 
associated can be categorized as procedure-related, performance-related, or technical or 
material-related.  The consequent risks to the patient depend on the incidence and effects 
of each hazard, which have been explored in a large number of experimental and clinical 
insertions.  These risks of endovascular aneurysm repair must be weighed against the 
risks associated with the current alternative forms of management. 
 
1.4.1.  Procedure-related Risks 
The complications considered to be deployment-related hazards are those that occur 
during the insertion procedure.  Previous clinical experience has provided extensive 
information on the incidence, avoidance, treatment, and consequences of many of these 
risks.  These include possible failure to traverse the iliac arteries, inaccurate deployment 
of the proximal or distal aortic component or fenestration stent, failure to deploy the 
endovascular graft or fenestration stent, inadvertent internal iliac artery occlusion and 
ischemic colitis, stent-graft or fenestration stent displacement, injury to access arteries, 
aortic injury, damage to the visceral vessels or visceral organs, embolism, systemic 
effects, and local effects. 
 

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1.4.1.1.  Failure to Traverse the Iliac Arteries 
Failure to traverse the iliac arteries is unlikely because the delivery systems have a long, 
tapered tip for trackability, and a central cannula for uniform stiffness.  The gradient 
stiffness of the nose of the device greatly facilitates insertion through tortuous iliacs.  The 
soft, flexible end of the tip follows a wire guide around almost any bend, and in so doing, 
exerts force on the next segment of the tip to pass into the bend in the artery.  This 
segment is less flexible, but with the help of the preceding segment, it too can bend.  This 
effect is repeated as the rest of the tip passes through the bend, with the segments 
becoming progressively stiffer.  Eventually, the iliac artery is sufficiently straight to 
allow the remainder of the central carrier and sheath to pass.  The stiffer central carrier of 
the Zenith® delivery system actually facilitates insertion through the tortuous iliac artery 
by preventing kinking of the sheath.  Tortuosity is rarely a serious impediment to device 
insertion, in the absence of severe calcification, which limits iliac artery straightening, or 
severe atherosclerosis, which diffusely narrows the iliac artery lumen.  
1.4.1.2.  Inaccurate Deployment of the Fenestrated Aortic Component 
The Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® aortic 
components have a staged deployment with multiple points of control.  Independent 
mechanisms for partial deployment, markers around the fenestrations, and the use of 
catheter alignment between fenestrations and the visceral arteries afford additional 
control of position and orientation.  
Both ends of the stent-graft are attached to the delivery system by trigger wires.  The bare 
stent with barbs remains contained within the topcap of the delivery system following 
sheath withdrawal to allow for fine adjustments in position and orientation.  For the 
Zenith® Fenestrated AAA Endovascular Graft, the insertion of a bridging catheter 
between each fenestration and the corresponding visceral artery is sometimes facilitated 
by further adjustments in stent-graft position or orientation.  These catheters then guide 
the last stages of stent-graft expansion.  The result is a precise alignment of fenestrations 
and visceral vessel orifices.  Only then is the bare stent with barbs deployed, fixing the 
Zenith® Fenestrated AAA Endovascular Graft in position.  This position can be further 
secured by replacing the bridging catheters with stents (Zenith® Alignment Stent, 
JOSTENT, iCAST™).  

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The Zenith® p-Branch® uses a preloaded delivery system which features preloaded wires 
that are placed through both renal fenestrations to eliminate the need to cannulate the 
fenestrations and to facilitate cannulation of the target vessels (see Section 1.4.1.5).  
At each step stent-graft position is assessed by reference to serial visceral vessel 
angiograms.  Experience with the standard Zenith® system showed that the aorta can 
move as caudally directed force is applied to the iliac arteries during sheath withdrawal.  
Precise control over stent-graft position is of no value unless angiographic visceral vessel 
localization is equally precise.  All participants in this study are experienced users of the 
standard Zenith® device, and all are familiar with these lessons of the Zenith® study. 
Exact placement of fenestrations is more a function of stent-graft design than 
implantation technique.  The risk of inadvertent visceral vessel artery occlusion is 
minimized by: the large combined experience of the imaging team and product specialists 
who will review all pre-operative imaging and order forms; a strict protocol for pre-
operative imaging; conservative selection criteria to eliminate sources of variability in 
stent-graft orientation, such as neck angulation, and sources of difficult visceral vessel 
catheterization, such as orificial stenosis; and a high level of skill and experience in both 
Zenith® implantation and visceral vessel intervention, which will be required of all 
participants in this study. 
1.4.1.3.  Inaccurate Deployment of the Non-Fenestrated Aortic Component  
The modularity of the Zenith® Fenestrated AAA Endovascular Graft and Zenith® p-
Branch® allows the operator to focus independently on precise deployment of the two 
ends of the stent-grafts.  The goals in placing the non-fenestrated aortic component are to 
ensure an adequate seal to the aneurysm is achieved, any vessel intended to remain patent 
is not covered, and an adequate overlap with the fenestrated aortic component is 
achieved.  These goals should be readily achieved in each case by referring to 
angiographic and stent-graft landmarks before deployment.   
 
1.4.1.4.  Inaccurate Deployment of the Fenestration Stent  
The risk of inaccurate deployment of the Zenith® Alignment Stent is minimized by the 
presence of radiopaque markers on both the balloon catheter and on the stent itself.  The 
platinum marker bands on the balloon catheter are located proximal and distal to the 
undeployed stent.  The gold markers on the stent indicate the distal end of the flarable 
segment of the device and should be aligned with the gold markers around the 

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fenestration or scallop of the Zenith® Fenestrated AAA Endovascular Graft prior to stent 
deployment.  If unable to accurately deploy the Zenith® Alignment Stent, the stent and 
delivery system can be removed as one unit, leaving the wire guide in place.  Available 
balloon-expandable covered stents (JOSTENT and/or iCAST™) may also be used. 
If a Zenith® Alignment Stent is inadvertently deployed too proximal or too distal to the 
intended location, an additional stent can be deployed.  Given the presence of the 
radiopaque markers and the lack of significant stent foreshortening, inaccurate 
deployment of the Zenith® Alignment Stent is expected to be a rare occurrence. 
The primary risk of the Zenith® p-Branch® over other fenestrated/branched devices is the 
ability to cannulate the vessels if a misalignment between the pivot fenestrations and the 
target vessels occurs.  This risk is mitigated by the ability of the implant positioning to be 
manipulated, double diameter reducing ties, and the preloaded system (where the renal 
fenestrations are preloaded with wires).  Adjusting tension of the preloaded wire guide 
may facilitate cannulation of the renal arteries by changing the angle of the preloaded 
sheath relative to the fenestration.  Pushing on the preloaded wire just distal to the valve 
of the sheath will increase the angle of the sheath relative to the fenestration.  Additional 
tension may be placed on both ends of the preloaded wire guide to apply additional 
compression to the graft at the level of the pivot fenestrations.  This may provide extra 
space to allow cannulation of the renal arteries.   
1.4.1.5.  Failure to Deploy the Endovascular Graft 
The most difficult aspect of modular endovascular graft deployment is often 
catheterization of the short limb of the non-fenestrated AAA component.  The Zenith® 
Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® incorporate features 
designed to minimize this problem.  First, the independent deployment of the distal body 
permits one to access the short limb while maintaining the capability to reorient the graft 
body.  Second, the long trunk of the endovascular graft brings the orifice of the short limb 
close to the contralateral common iliac artery.  Finally, if one is still unable to obtain 
access to the main endovascular graft body through the short limb using the brachial or 
contralateral femoral arteries, the device can be converted into an aortouni-iliac device 
quite easily. 
 
1.4.1.6.  Failure to Deploy the Fenestration Stent 

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The most difficult aspect of stenting visceral vessels is gaining and maintaining wire 
guide access.  If extensive manipulations are required, time may be added to the 
procedure, radiation exposure may be increased, and the risk of embolization to the 
kidney may be increased.  These risks are reduced by a high level of operator skill and 
exclusion of patients with high risk pathology such as severe renal artery stenosis. 
If unable to deploy the fenestration stent accurately, the stent and delivery system can be 
removed as one unit while leaving the wire guide in place.  Another fenestration stent can 
then be implanted.   
When balloon-expandable stents are used as the fenestration stent, flaring of the stent is 
expected to minimize the length of stent protruding into the lumen of the endovascular 
graft.  This is expected to reduce the risk of stent displacement during reinstrumentation 
during the implant procedure or during a secondary intervention, if required.    
 
1.4.1.7.  Inadvertent Internal Iliac Artery Occlusion and Ischemic Colitis 
The short leg/long leg configuration of the non-fenestrated AAA component is the same 
as the distal half of early versions of the Zenith® AAA Endovascular Graft, which was 
used extensively in Europe and Australia with a low rate of inadvertent internal iliac 
artery occlusion.  The sole case of ischemic colitis in the Zenith® AAA Endovascular 
Graft clinical study followed inadvertent internal iliac artery occlusion.  We expect the 
rate to be as low, or lower, in the current study.  Strict adherence to the guidelines 
regarding the preservation of hypogastric patency should minimize this risk. 
 
1.4.1.8.  Stent-graft Displacement  
Displacement through re-instrumentation during deployment is very rare with the Zenith® 
family of endovascular grafts.  The Zenith® Fenestrated AAA Endovascular Graft and the 
Zenith® p-Branch® are expected to behave in the same way. 
 
1.4.1.9.  Dislodgement of the Fenestration Stent 
An insertion tool is provided with the Zenith® Alignment Stent to minimize the risk of 
stent dislodgement during insertion through a hemostatic valve.   
If dislodgement of the stent from the balloon catheter occurs prior to deployment of the 

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stent, the stent and guiding catheter/sheath should be removed as one unit, leaving the 
wire guide in place.  Another fenestration stent can then be implanted. 
 
1.4.1.10.  Displacement of the Fenestration Stent  
The Instructions for Use for the Zenith® Alignment Stent recommend flaring of the 
proximal segment of the stent.   
Flaring of the stent is expected to minimize the length of stent protruding into the lumen 
of the endovascular graft, thereby reducing the risk of stent displacement during re-
instrumentation and/or during secondary interventions. 
 
1.4.1.11.  Injury to Anatomy 
Injury to access arteries 
The risks of femoral or external iliac artery injury have been very low with the Zenith® 
family of endovascular grafts.  Any likelihood for injury to access arteries will be 
minimized through the use of access conduits when necessary. 
 
 
 
Aortic injury 
The presence of stiff wire guides in the descending thoracic aorta, and even the arch, 
raises the possibility of perforation or dissection.  Very few such injuries have been 
observed in studying the Zenith® family of endovascular grafts, and we expect an even 
lower incidence in this study.  All the investigators in this study are experienced enough 
to pay careful attention to wire guide position, and to use interventional techniques which 
minimize unobserved, uncontrolled movements of wire guides, catheters, and sheaths. 
 
Damage to the visceral vessels 
Perforation and dissection are possible risks from any visceral vessel instrumentation and 
stenting.  The risks are reduced by:  a high level of operator skill; selection criteria that 

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eliminate cases of high risk anatomy, such as early bifurcation, and high risk pathology, 
such as severe renal artery stenosis.  
 
1.4.1.12.  Embolism 
Deployment of non-fenestrated Zenith® components produces a very low rate of 
embolism, despite femoral artery flow throughout the procedure.  Fenestrated stent-graft 
deployment increases risk somewhat, due to the additional perigraft instrumentation 
involved in visceral vessel catheterization and stenting, particularly if there is extensive 
(circumferential) thrombus in this area.  These factors will be considered during patient 
selection, and only those investigators experienced in visceral interventions will 
participate. 
 
1.4.1.13.  Stroke 
The risk of stroke increases as the aneurysm approaches the origins of the cerebral 
vessels.  The lack of aortic cross-clamp placement with endovascular repair may diminish 
the risk of stroke.  The necessity of wire placement within the ascending aorta demands 
instrumentation on the arch, which is believed to be associated with a risk of embolic 
stroke.  These factors will be considered during patient selection. 
 
 
 
1.4.1.14.  Paraplegia 
While the absence of aortic cross-clamping may reduce the risk for paraplegia, this may 
be counterbalanced by the inability to re-implant intercostal arteries.  Consequently, as 
the length of aneurysm increases, so does the risk for paraplegia with repair.  Patients 
requiring extensive aneurysm repair (e.g., concurrent thoracic and abdominal aneurysm 
repair) are believed to be at greater risk than those with less extensive repairs.  These 
factors will be considered during patient selection. 
 
1.4.1.15.  Systemic Effects 

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The incidence of cardiopulmonary complications following any surgical procedure likely 
reflects the severity of the pre-existing disease and the physiologic stress induced by 
surgery.  The main advantage of an endovascular approach to aneurysm exclusion is the 
avoidance of many of the pathologic stresses associated with abdominal operation, aortic 
cross-clamping, and prolonged lower extremity ischemia.  Lower rates of complications 
such as myocardial infarction, pneumonia, venous thrombosis, and prolonged mechanical 
ventilation are expected for the endovascular approach to aneurysm treatment as 
compared to open surgical procedures due to the limited femoral dissection, lower blood 
loss, and diminished amount of fluid sequestration resulting from this approach. 
 
1.4.1.16.  Local Effects 
Local effects, such as wound infection and hematoma at the insertion site, are expected to 
be low due to the limited access required for the procedure.  In addition, the absence of 
graft material in the femoral region decreases the anticipated severity of these 
complications markedly.   
 
1.4.2.  Performance-Related Risks 
The properly functioning endovascular graft and fenestration stent (if applicable) carries 
blood freely to the visceral vessels, the pelvis and the legs, and prevents blood from 
entering the aneurysm cavity.  To accomplish this, the endovascular graft must have a 
patent lumen, targeted visceral vessel arteries must remain patent, and the ends of the 
device must remain affixed in the vessel to the arteries proximal and distal to the 
aneurysm.  Performance-related risks include the potential for migration, component 
separation, graft limb occlusion, occlusion of stented visceral vessels, endoleak and 
endotension, and graft infection. 
 
1.4.2.1.  Migration of the Endovascular Graft 
The fenestrated components are very sensitive to migration, as small disturbances in 
position of a fenestration relative to its corresponding visceral vessel would cause 
stenosis, thrombus deposition, and complete occlusion.  However, the likelihood for 
migration is expected to be low, as the Zenith® Fenestrated AAA Endovascular Graft and 
the Zenith® p-Branch® incorporate several design features intended to prevent migration.  

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Both fenestrated aortic components utilize an uncovered stent with anchoring barbs for 
fixation.  Additionally, the system features a two-piece main body, which reduces the 
forces applied to the fenestrated portion of the graft, enhancing placement and reducing 
risk of disturbing position of the fenestrations.  Although the barbed suprarenal fixation 
stent is the primary source for resistance to migration, the radial force exerted by the 
proximal sealing stent is also a contributor to graft fixation. 
 
1.4.2.2.  Component Separation 
As the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® are part 
of modular systems, there exists the potential for component separation.  In designing the 
endovascular grafts, it was determined that the benefits of a modular system outweighed 
the risks of component separation, which can be readily managed through regular follow-
up and early intervention with use of ancillary stent-graft components to increase the 
length of overlap between separating modular components.  To mitigate the risk of 
component separation, the endovascular grafts were designed to include z-stents of 
sufficient radial force for ensuring apposition and friction between the components within 
the overlap region.  Additionally, the z-stents within the overlap region have been 
positioned so as to maximize graft-to-graft contact between the proximal and distal 
components in the main body overlap; this not only augments the frictional forces 
between components within the overlap, but also promotes sealing within the overlap in 
order to minimize the likelihood for Type III endoleak.  Furthermore, proctor overview of 
planning and sizing may be provided to review the length of overlap between 
components.  The connection between the contralateral iliac extension and its docking 
site on the distal aortic component of the endovascular grafts is not as stable as the 
connection between aortic components.  The overlap is not as long, the surface area is not 
as high, and the iliac extension is more flexible than the aortic components.  
Nevertheless, the rate of component separation at this site was very low in the standard 
Zenith® AAA Endovascular Graft clinical study, and we would expect it to be even less 
in the current study, because the recommended overlap is longer.  
 
1.4.2.3.  Migration of the Fenestration Stent 
Stent migration occurs primarily because of undersizing with respect to the target vessel 
or underexpansion of the stent.   

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The risk of undersizing is mitigated for the Zenith® Alignment Stent through the sizing 
recommendations (1.0 to 1.1 times the reference vessel diameter) and physician 
experience with renal and visceral vessel stenting.  Labeling also includes the stent 
diameter at balloon nominal inflation pressure, reducing the risk of underexpansion 
during stent deployment. 
The Zenith® p-Branch® may be used with the JOSTENT and/or iCAST™ balloon-
expandable covered stents, where manufacturer instructions for vessel sizing should be 
followed. 
 
1.4.2.4.  Graft Limb Occlusion 
The iliac limbs of the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-
Branch® are essentially the same as those of the standard Zenith® AAA Endovascular 
Graft and have the same risk of thrombosis.  In the U.S. pivotal study, the cumulative rate 
of limb thrombosis was 0.3% at 1 year.  There appear to be three circumstances that 
predispose to limb thrombosis:  narrowing of the distal aorta, acute angulation of the 
common iliac artery, and external iliac implantation combined with oversizing, orificial 
stenosis or angulation.  These factors will be considered during patient selection.  
 
1.4.2.5.  Occlusion of Visceral Vessels 
The presence of fenestrations in the graft targeting visceral vessels may lead to 
thrombosis or neointimal hyperplasia in the stented segment.  Placement of a stent 
(Zenith® Alignment Stent, JOSTENT, and iCASTTM) with a history of clinical use for 
similar applications is expected to minimize this risk. 
 
1.4.2.6.  Endoleak and Endotension 
Endoleak represents incomplete aneurysm isolation from arterial flow, and endotension 
represents incomplete aneurysm isolation from arterial pressure.  Both are associated with 
aneurysm dilatation and persistent risk of rupture.  However, prevailing opinion is that 
the indirect forms of endoleak (Type II), generally through patent lumbar vessels or the 
inferior mesenteric artery, are more benign than direct endoleak around the ends of the 
stent-graft (Type I), from modular joints or through defects in the stent-graft (Type III).  
Therefore, the study protocol mandates intervention for direct endoleak, while 

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intervention for Type II endoleak is performed at the physician’s discretion, depending 
on factors such as aneurysm diameter, aneurysm diameter change, and endoleak duration. 
Although a fenestrated stent graft does allow the proximal sealing stent to be deployed in 
a healthier, more cylindrical segment of the aorta, it does nothing to lengthen the critical 
interface between the stent-graft and non-dilated infrarenal neck.  Poor apposition in this 
area will likely cause endoleak through the fenestration into the aneurysm.  We anticipate 
a higher rate of adjunctive maneuvers, such as balloon dilatation, or additional stent 
implantation to enhance apposition, optimize the seal, and eliminate endoleak.  All the 
investigators in this study have experience with these types of maneuvers.  The risk of 
endoleak is somewhat reduced by excluding patients with a very tortuous aorta. 
 
1.4.2.7.  Graft Infection 
All endovascular grafts and the Zenith® Alignment Stent will be sterilized with ethylene 
oxide.  The effectiveness of this sterilization procedure is validated prior to initiating this 
study.  These devices will be opened in the operating room under the same conditions as 
traditional open resection vascular graft material. 
 
1.4.3.  Technical or Material-related Risks 
Technical or material-related risks include the potential for stent breakage, barb 
separation, proximal stent separation, fabric erosion, and biocompatibility for the 
endovascular grafts and the potential for stent breakage, stent crush, and biocompatibility 
for the fenestration stent. 
 
 
 
1.4.3.1.  Stent Breakage 
The Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® utilize the 
same time-proven z-stent technology as is used by all other products in the Zenith® 
family of endovascular grafts.  These self-expanding stainless steel and nitinol z-stents 
have a long history of use and proven structural integrity.  Use of the z-stent design is 
expected to minimize the likelihood of stent fracture.   

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The Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® may use 
additional fenestration stents within the renal and visceral vessels.  A variety of balloon-
expanded and self-expanding stents have been used in these locations.  None are known 
to have led to clinical problems due to stent breakage.  In vitro testing appropriate to 
fenestration stents has shown comparable results between the Zenith® Alignment Stent 
and representative balloon-expandable stents. 
 
1.4.3.2.  Fenestration Stent Crush 
A fenestration stent may become crushed due to:  longitudinal movement of the 
endovascular graft, rotational movement of the endovascular graft, inaccurate 
deployment of the endovascular graft, and incorrect planning and sizing of the 
endovascular graft.    
Although the rate of graft migration is low (see Section 1.4.2.1.), some initial longitudinal 
movement (<5 mm) of the proximal endovascular component is possible before the bare, 
barbed stent becomes seated in the aorta.  In most instances, the radial force of the 
proximal sealing stent is able to withstand physiologic forces (i.e., downward blood flow) 
contributing to longitudinal movement during barb seating; however, longitudinal 
movement with subsequent stent crush is possible.  In addition, stent crush due to 
longitudinal movement is mitigated by planning the location of the vessel/stent at the 
distal end of a small fenestration when possible.     
The risk of rotational movement is mitigated by several factors.  During deployment of 
the Zenith® Fenestrated AAA Endovascular Graft  and the Zenith® p-Branch®, diameter 
reducing ties are used on one side of the device to keep the grafts from fully expanding, 
allowing for rotational control of the device during alignment with and cannulation of the 
visceral vessels.  Once access has been gained to the targeted vessels, a trigger-wire 
connected to these diameter reducing ties is removed, allowing expansion of the graft to 
aortic diameter.  The bare, barbed stent is then deployed by releasing the top cap.  
Excessive oversizing of the graft may lead to uneven expansion and rotational forces on 
the fenestration stent.   
Should stent crush occur, kidney/bowel function should be assessed by the physician and 
a secondary surgical or endovascular intervention may be necessary. 
The Zenith® Alignment Stent is available for use as a fenestration stent.  To mitigate the 
effects of uneven expansion and rotational forces due to excessive oversizing, the Zenith® 

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Alignment Stent features additional crush resistance in the location of the fenestration.  
The risk of incorrect planning and sizing and inaccurate deployment (see Section 1.4.1.2.) 
is minimized by: the large combined experience of the imaging team and product 
specialists who may review pre-operative imaging and graft order forms and may be 
present at cases with new investigators; a strict protocol for pre-operative imaging; 
conservative selection criteria to eliminate sources of variability in stent-graft orientation, 
such as neck angulation, and sources of difficult renal catheterization, such as orificial 
stenosis; and a high level of skill and experience in both Zenith® implantation and renal 
intervention, which will be required of all investigators in this study.  
The risk of fenestration stent crush in the Zenith® p-Branch® is mitigated by the pivot 
nature of the fenestrations.  The pivot fenestrations may be manipulated during 
deployment to accommodate a range of renal anatomies.  As the pivot fenestrations are 
designed to be manipulated, they may allow limited longitudinal movement of the 
proximal endovascular graft to occur without crushing the fenestration stent. 
Additionally, use of the JOSTENT and/or iCAST™ balloon-expandable covered stents, 
which have a history of clinical use for similar applications, should mitigate the risk. 
 
1.4.3.3.  Barb Separation 
The Zenith® Fenestrated AAA Endovascular Graft and the  Zenith® p-Branch® utilize the 
same barb design (including barb wire diameter and barb number) as with other grafts in 
the Zenith® family, which have a time-proven history of durable performance (i.e., 
Zenith® AAA Endovascular Graft and Zenith® TX2® TAA Endovascular Graft). 
 
1.4.3.4.  Bare Stent Separation 
Early experience using predicate designs of the standard Zenith® AAA Endovascular 
Graft showed a few rare cases of proximal stent separation and catastrophic caudal 
migration of the covered portion of the stent-graft.  These observations resulted in a 
doubling of the sutures between the proximal stent and the proximal margin of the graft.  
The result was a significant increase in the durability of the attachment, based on the 
findings of accelerated durability testing.  The Zenith® Fenestrated AAA Endovascular 
Graft and the Zenith® p-Branch® incorporate the double suture attachment technique. 
 

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1.4.3.5.  Fabric Erosion 
All current stent-grafts combine a soft, flexible fabric with relatively stiff, unyielding 
stents.  These widely differing mechanical properties are a potential source of late failure, 
particularly if there exists any potential for movement of one element relative to the 
other.  The Zenith® design addresses these issues in two ways.  First, the stent and fabric 
are securely attached to one another by many continuous sutures.  Second, the fabric of 
the Zenith® endovascular grafts is relatively thick and tightly woven.  Very similar 
fabrics are available for conventional surgical use; a role in which they have 
demonstrated long-term durability.  In this regard, the Zenith® Fenestrated AAA 
Endovascular Graft, Zenith® p-Branch®, and standard Zenith® stent-grafts are identical.  
Fenestrations in the fabric are heat sealed to prevent fraying.  The interface between the 
fenestration and the visceral vessel stent is a potential source of injury to the graft, if 
repetitive movement were to occur at this site.  However, when properly deployed the 
stent acts as a sort of rivet, preventing movement and protecting the graft from injury. 
 
1.4.3.6.  Biocompatibility 
Biocompatibility risks include a lack of sterility, toxicity, or biodegradation of the device. 
The devices will be packaged and sterilized by exposure to ethylene oxide using 
sterilization cycles validated to industry standards.  The endovascular grafts and stents 
will be opened in the operating room under the same conditions of sterility used for 
routine surgical procedures.  Component materials of construction for the Zenith® 
Fenestrated AAA Endovascular Graft and Zenith® p-Branch® include stents made of 304 
stainless steel or nitinol, graft material woven from polyester yarn, mono-filament sutures 
composed of polypropylene, braided sutures composed of polyester, gold radiopaque 
markers, and small fenestration support rings composed of nitinol.  The Zenith® 
Alignment Stent materials of construction include stents made of 316L stainless steel 
with radiopaque gold markers.  All of these materials have known biocompatibility and 
implant histories.  The specified balloon-expandable covered stents (JOSTENT and 
iCAST™) also have an established history with respect to biocompatibility. 
1.4.4.  Protection Against Risks 
As described above, the design of the devices and the Instructions for Use, along with a 
physicians’ training program, are intended to minimize the risks associated with 
endovascular procedures. 

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Previous clinical and animal experience has been used to: 
1. Improve the delivery system; 
2. Improve endovascular graft fixation; 
3. Develop an adequate insertion and deployment technique; 
4. Determine methods to treat complications; 
5. Improve patient selection. 
 
1.4.5.  Potential Benefits to the Subjects and Alternative Treatments 
Although this procedure is being performed worldwide for both high and standard risk 
patients, the benefits offered to high risk patients are straightforward.  The best method to 
evaluate these benefits is to compare the potential alternative treatment modalities to that 
of endovascular repair. 
International clinical experience with the Zenith® Fenestrated AAA Endovascular Graft 
has shown this to be an effective method of treatment of AAA in those patients who meet 
the anatomic criteria.  Implantation of the Zenith® Fenestrated AAA Endovascular Graft 
is a much less invasive surgical procedure than open surgical repair, therefore the 
procedure provides a treatment option for those high medical risk patients who are not 
candidates for open surgery.  Standard risk patients who are enrolled are likely to have 
suitable AAA repair with less risk and fewer complications than patients treated by 
traditional open resection. 
The Zenith® Fenestrated AAA Endovascular Graft is custom-designed for each patient 
with an abdominal aortic aneurysm.  The sizing and manufacturing process for 
customization requires 4-8 weeks; consequently, this device cannot be implanted in 
patients requiring urgent repair.  In contrast, the Zenith® p-Branch® is intended to be an 
“off-the-shelf” device, with 2 configurations that may be used in immediate treatment of 
up to 70-80% of patients with juxtarenal or pararenal aneurysms.  The ability to have 
immediate access to this device has the potential to benefit many patients, especially 
those with very large aneurysms and those with symptoms attributable to aneurysms that 
currently cannot be treated using endovascular means.  
 
1.4.5.1.  Observation 

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A patient who is not treated is at risk for aneurysm rupture at an overall rate that depends 
on the aneurysm's size and the patient’s longevity.  All patients eligible for inclusion in 
this study have a risk of rupture, the degree of risk being based primarily on aneurysm 
size.  
 
1.4.5.2.  Conventional Surgery 
Conventional repair of peri-visceral aneurysms is highly effective at preventing aneurysm 
rupture.  However, it is associated with a significant risk of cardiopulmonary 
complications as a result of a prolonged abdominal operation, significant blood loss and 
aortic cross-clamping.  As such, conventional surgery is not an option for many of the 
patients who will be eligible for this study.  For those patients who survive open surgical 
repair the long-term risks are small, despite the potential for the development of bowel 
obstructions, graft infections, occlusions and para-anastomotic aneurysms. 
 
1.4.5.3.  Endovascular Repair 
Endovascular repair minimizes the pathologic stress of surgery by avoiding aortic cross-
clamping and celiotomy or thoracotomy.  The reported lower incidence of 
cardiopulmonary complications noted with endovascular repairs has the potential to 
significantly benefit patient care.  There is an accumulating body of evidence to support 
the assumption that aneurysm exclusion documented by CT, angiographic or ultrasound 
criteria indicates freedom from the risk of rupture.  Aneurysm rupture following 
endovascular repair occurs in the presence of endoleak.  Therefore, a patient without 
evidence of endoleak can be considered effectively treated.  However, endoleaks are 
present in approximately 10-20 percent of patients following endovascular aneurysm 
repair.  Based on worldwide experience, it appears that most of these can be treated by a 
secondary endovascular procedure.   
The long-term benefits and risks of endovascular aneurysm repair are less clear.  
Conventional surgery has few problems, while the long-term results of endovascular 
repairs give cause for concern on many counts.  The most serious problem is stent-graft 
migration leading to late endoleak formation followed by aneurysm rupture.  The Zenith® 
Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® design features are 
intended to reduce the risk of these problems.  The implantation of a barbed stent and 
balloon-assisted seating of sealing zones is an approach calculated to maximize secure 

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stent-graft attachment.  Coupled with proper stent-graft sizing and reliable materials, the 
incidence of this problem is expected to be reduced.  
 
1.5.  Device Description 
1.5.1.  Zenith® Fenestrated AAA Endovascular Graft 
The Zenith® Fenestrated AAA Endovascular Graft shares many attributes of the Zenith® 
AAA Endovascular Graft, being a modular system constructed of full-thickness woven 
polyester fabric sewn to self-expanding stainless steel z-stents with braided polyester and 
monofilament polypropylene sutures (Figure 1.5.1-1).  As with the approved standard 
AAA device, the modules are fully stented to provide stability and expansile force during 
deployment, and attachment and seal of the graft to the vessel wall after deployment.  
Identical to the standard AAA device, the bare suprarenal stent at the proximal end of the 
graft contains barbs that are placed at 3 mm increments for additional fixation of the 
device.  Refer to the IFU for planning and sizing information. 
 
 
 
 
 
 
 
1.5.1.1.  Proximal Body Graft 
The bare suprarenal stent at the proximal end of the proximal body graft (Figure 1.5.1.1-
1) is identical to that of the Zenith® AAA Endovascular Graft, containing barbs that are 
placed at 3 mm increments for additional fixation of the device.  This graft component 
includes up to four precisely located holes (fenestrations) at or near the proximal margin 
of the graft material.  The fenestrations may be a combination of small fenestrations, 
large fenestrations, and scallop fenestrations, and allow the proximal margin of the device 
to sit higher in the abdominal aorta than the standard AAA device.  This design permits 
uninterrupted blood flow to branch vessels of the aorta such as the renal and superior 
mesenteric arteries after device deployment.   
Figure 1.5.1-1. The Zenith® Fenestrated AAA Endovascular 
Graft is a modular system that includes a proximal fenestrated 
body, a distal bifurcated body, and iliac leg component(s). 

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In order to facilitate cannulation of small fenestrations, the perimeter of each small 
fenestration is supported by an open loop nitinol wire ring.  The nitinol rings are secured 
to the graft material surrounding the fenestration with braided polyester sutures. 
To facilitate fluoroscopic visualization of the stent graft, four gold radiopaque markers 
are positioned in a circumferential orientation within 1 mm of the most superior aspect of 
the graft material and one gold marker on the lateral aspect of the most distal stent.  To 
facilitate orientation and alignment of fenestrations, gold markers are also positioned as 
follows:  three vertically-aligned gold markers on the anterior aspect of the graft and 
three horizontally-aligned gold markers on the posterior aspect of the graft for 
anterior/posterior orientation, four gold markers around the perimeter of each large and 
small fenestration, and three gold markers around each scalloped fenestration. 
 
1.5.1.2.  Proximal Body Graft Introduction System 
The Zenith® Fenestrated AAA Endovascular Graft proximal graft is shipped preloaded 
onto the H&L-B One-Shot™ Introduction System (Figure 1.5.1.2-1).  It has a sequential 
deployment method with built-in features to provide continuous control of the 
endovascular graft throughout the deployment procedure.  During manufacture the graft 
is reduced in diameter by an independent wire tied to removable diameter reducing ties.  
This feature allows the partially constrained graft to be manipulated within the aorta to 
allow accurate positioning of the graft so that the fenestrations can line up with the 
desired arteries before complete device deployment.  The bare suprarenal stent is 
constrained within a top cap and held there by a trigger-wire.  The distal end of the graft 
Figure 1.5.1.1-1.  Zenith® Fenestrated 
AAA Endovascular Graft proximal body 
graft. 

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is also attached to the delivery system and held by an independent wire.  The H&L-B 
One-Shot™ Introduction System enables precise positioning and allows readjustment of 
the final graft position before deployment of the bare barbed suprarenal stent.  The 
delivery system uses a 20 French H&L-B One-Shot™ Introduction System.  All systems 
are compatible with a 0.035 inch wire guide. 
 
 
 
 
 
 
 
 
 
1.5.1.3.  Distal Body Graft 
The Zenith® Fenestrated AAA Endovascular Graft distal body graft is bifurcated with one 
long limb with iliac cuff and one short limb on the contralateral side (Figure 1.5.1.3-1).  
To facilitate fluoroscopic visualization of the stent graft, there is a radiopaque marker at 
the graft bifurcation and a radiopaque checkmark at the distal end of the contralateral 
limb. 
 
 
 
 
 
 
 
 
 
Figure 1.5.1.2-1.  H&L-B One-Shot™ Introduction System used to deliver the 
proximal components of the Zenith® Fenestrated AAA Endovascular Graft. 
Figure 1.5.1.3-1.  Zenith® Fenestrated AAA 
Endovascular Graft distal body graft. 
 

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1.5.1.4.  Distal Body Graft Introduction System 
The Zenith® Fenestrated AAA Endovascular Graft distal body graft is shipped preloaded 
onto the H&L-B One-Shot™ Introduction System.  It has a sequential deployment 
method with built-in features to provide continuous control of the endovascular graft 
throughout the deployment procedure.  Both the proximal and distal ends of the graft are 
attached to the delivery system and held by independent wires.  The H&L-B One-Shot™ 
Introduction System enables precise positioning and allows readjustment of the final graft 
position before deployment of the stent-graft.  The delivery system uses a 20 French 
H&L-B One-Shot™ Introduction System.  All systems are compatible with a 0.035 inch 
wire guide. 
 
1.5.1.5.  Iliac Leg Graft 
The Zenith® Fenestrated AAA Endovascular Graft uses the same iliac legs as the 
standard Zenith® graft.  The iliac legs are tubular grafts which are used to extend the 
fenestrated graft into the iliac arteries.  An iliac leg must be placed into the short limb 
from the contralateral side. 
 
1.5.1.6.  Iliac Leg Graft Introduction System 
The Zenith® AAA Endovascular Graft iliac legs are shipped preloaded onto the H&L-B 
One-Shot™ Introduction System.  The delivery system is designed for ease of use with 
minimal preparation.  The iliac leg delivery system uses a 14 French or 16 French H&L-
B One-Shot™ Introduction System.  All systems are compatible with a 0.035 inch wire 
guide.  
 
1.5.1.7.  Fenestration Stent 
Stenting of all small fenestrations is recommended.  At the physician’s discretion, the 
Zenith® Alignment Stent may be chosen as the fenestration stent and can be deployed 
through scallops or fenestrations in a Zenith® Fenestrated AAA Endovascular Graft into 
branch vessels of the aorta.  The stent is constructed of 316L stainless steel.  The distal 
segment of the stent (non-flared segment) is designed to be expanded across the target 

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lesion.  The proximal segment of the stent (flared segment) is designed to extend into the 
lumen of a Zenith® Fenestrated AAA Endovascular Graft already deployed in the aorta.  
This proximal segment of the stent is denoted by circumferentially arranged gold eyelets 
to facilitate alignment with the fenestration and can be flared (allowing for easier access 
of the branch vessel if a secondary intervention is required) using a standard non-
compliant balloon.  The remainder of the stent is not intended to be flared.  The region of 
the stent that is intended to be aligned with the fenestrations of a Zenith® Fenestrated 
AAA Endovascular Graft has been reinforced with wider struts.  The Zenith® Alignment 
Stent is available in lengths of 18 and 26 mm, and nominal expanded diameters of 3, 4, 5, 
6, 7, and 8 mm. 
 
1.5.1.8.  Zenith® Alignment Stent Introduction System 
The Zenith® Alignment Stent is pre-mounted between two radiopaque (platinum) marker 
bands on a balloon catheter, which serves as the delivery system.  The Zenith® Alignment 
Stent balloon catheter is offered in an 80 cm length and has a low outside diameter 
profile, which permits vascular access via 6.0 or 7.0 Fr introducer sheaths.  The balloon 
catheter design is consistent with other commercially available non-compliant balloon 
catheters. 
 
1.5.1.9.  Ancillary Components 
The Zenith® Fenestrated AAA Endovascular Graft is compatible with the same ancillary 
components as the standard Zenith® graft.  The following ancillary endovascular 
components are available: 
1. Main body extensions; 
2. Leg extensions; 
3. Converters; 
4. Iliac occluders/plugs. 
 
1.5.2.  Zenith® p-Branch® 
The Zenith® p-Branch® is a modular system constructed of full-thickness woven 
polyester fabric sewn to self-expanding stainless steel and nitinol z-stents with braided 

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polyester and monofilament polypropylene sutures (Figure 1.5.2-1).  
 
 
 
 
The Zenith® p-Branch® endovascular graft features three holes (fenestrations) and a cut-
out from the proximal margin (scallop) of the graft material through which a balloon-
expandable covered stent (JOSTENT and/or iCAST™) may be placed to preserve blood 
flow to the visceral vessels.  Two of the fenestrations are conical shaped pivot 
fenestrations, aimed to accommodate a range of renal anatomies with a single design.  
The graft is available in 2 fenestration/scallop configurations to provide an optimal fit for 
individual patient anatomies (see Section 1.5.2.1).  Refer to the IFU for planning and 
sizing information. 
 
 
 
 
 
 
1.5.2.1.  Proximal Body Graft 
 
  The device includes three holes (fenestrations) and a 
cut-out from the proximal margin (scallop) of the graft material to preserve blood flow to 
renal and visceral vessels.  Two of the fenestrations are pivot fenestrations used to 
cannulate the renal arteries, and the third fenestration is used to cannulate the SMA.  
 
 
 
 
   
Figure 1.5.2-1.  The Zenith® p-Branch® is part of a modular system that 
may include bifurcated devices (e.g., Zenith® Universal Bifurcated 
Body Endovascular Graft) and commercially avalible iliac leg devices.  
 
  p-Branch                            Distal Body Graft 
 
 
 
 
Iliac Leg Grafts 

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Two device configurations (A and B) accommodate a range of patient anatomies with a 
single design (see Figures 1.5.2.1-1 and 1.5.2.1-2).  All radial measurements are 
calculated assuming the SMA position is 12:00 o’clock (0°). 
 
 
Configuration A: 
• Celiac scallop:  20 mm wide, centered at 12:30 (15°), 11 mm proximal to SMA; 
• SMA fenestration:  8 mm in diameter, centered at 12:00 (0°); 
• Right pivot (renal) fenestration:  6 mm inner diameter and 15 mm outer diameter, 
5 mm deep, centered at 9:30 (285°), 12 mm distal to SMA (center-to-center); 
• Left pivot (renal) fenestration:  6 mm inner diameter and 15 mm outer diameter, 
5 mm deep, centered at 2:30 (75°), 12 mm distal to SMA (center-to-center). 
 
 
 
 
 
 
 
 
 
 
 
Figure 1.5.2.1-1.  Zenith® p-Branch® endovascular graft configuration A. 
 
* For 36 mm diameter grafts only 
 
Celiac 
Scallop 
SMA 
Fenestration 
Left Pivot 
Fenestration 
Right Pivot 
Fenestration 

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Configuration B: 
• Celiac scallop:  30 mm wide, centered at 12:30 (15°), 9 mm proximal to SMA; 
• SMA fenestration:  8 mm diameter, centered at 12:00 (0°); 
• Right pivot (renal) fenestration:  6 mm inner diameter and 15 mm outer diameter, 
5 mm deep, centered at 9:30 (285°), 16 mm distal to SMA (center-to-center); 
• Left pivot (renal) fenestration:  6 mm inner and 15 mm outer diameter, 5 mm 
deep, centered at 2:30 (75°), 20 mm distal to SMA (center-to-center). 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1.5.2.1-2.  Zenith® p-Branch® endovascular graft configuration B. 
 
* For 36 mm diameter grafts only 
 
Celiac 
Scallop 
SMA 
Fenestration 
Left Pivot 
Fenestration 
Right Pivot 
Fenestration 

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Anatomic Criteria for Zenith® p-Branch®  
Standard Zenith® p-Branch® endovascular graft configuration A or B will be chosen in 
accordance with the following criteria.  All radial measurements are calculated assuming 
the SMA position is 12:00 o’clock (0°). 
1. Criteria for configuration A (renal fenestrations at same longitudinal level): 
a. The celiac artery arises from the aorta between 11:30 and 1:30 (345° and 
45°);  
b. The SMA is ≥11 mm distal to the celiac artery (unless the celiac artery is 
occluded or expendable); 
c. Longitudinal positions of renal arteries arise 4.5 mm – 19.5 mm distal to 
the SMA; 
d. The circumferential location of the right renal artery can range between 
8:30 and 10:30 (255° and 315°) and the circumferential location of the left 
renal artery can range between 1:30 and 3:30 (45° and 105°) (assuming 
the endovascular graft diameter is approximately 30 mm); 
2. Criteria for configuration B (left renal fenestration lower longitudinally than right 
renal fenestration): 
a. The celiac artery arises from the aorta between 11:00 and 2:00 (330° and 
60°); 
b. The SMA is ≥9 mm distal to the celiac artery (unless the celiac artery is 
occluded or expendable); 
c. Longitudinal position of the right renal artery arises 8.5 mm – 23.5 mm 
distal to the SMA; 
d. Longitudinal position of the left renal artery arises 12.5 mm – 27.5 mm 
distal to the SMA; 
e. The circumferential location of the right renal artery can range between 
8:30 and 10:30 (255° and 315°) and the circumferential location of the left 
renal artery can range from 1:30 and 3:30 (45° and 105°) (assuming the 
endovascular graft diameter is approximately 30 mm). 
 

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1.5.2.2.  Proximal Body Graft Introduction System 
The Zenith® p-Branch® endovascular graft is shipped loaded onto a 20 Fr or 22 Fr 
(dependent on graft diameter) Zenith® preloaded delivery system.  The delivery system 
uses a sequential deployment method with built-in features to provide continuous control 
of the graft throughout deployment.  During manufacture, the graft is reduced in diameter 
by two independent wires tied to diameter reducing ties.  This feature allows the partially 
constrained graft to be manipulated within the aorta to accurately position the 
fenestrations with the corresponding visceral vessels before complete deployment.  The 
bare, barbed supraceliac stent is constrained within a top cap and held by a trigger-wire.  
A preloaded wire is placed through each renal fenestration to eliminate the need to 
cannulate the fenestrations and to facilitate cannulation of the target vessels.  The distal 
end of the graft is attached to the delivery system and held by an independent wire.  
Trigger-wire release mechanisms lock the endovascular graft onto the delivery system 
until released by the physician (Figure 1.5.2.2-1).  The delivery system enables precise 
positioning of the graft and allows readjustment of the final graft position before 
deployment of the supraceliac stent.  The delivery system is compatible with a 0.035 inch 
wire guide to enable it to track through the aorta into position.  The delivery system 
features a Flexor® introducer sheath with a Captor® Hemostatic Valve.  For added 
hemostasis, the Captor® Hemostatic Valve can be opened or closed for the introduction 
and/or removal of ancillary devices.  The Flexor® introducer sheath resists kinking and is 
hydrophilically coated.  Both features are intended to enhance trackability. 
 
 
 
 
 
 
 
 
 
 

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Figure 1.5.2.2-1.  Top:  Zenith® preloaded delivery system showing preloaded nitinol 
wire.  Bottom:  Detail of the release handles. 
 
1.5.2.3.  Distal Body Graft 
The distal component of the Zenith® p-Branch® endovascular graft is the Zenith® 
Universal Distal Body Endovascular Device.  The distal body graft is constructed of 
woven polyester fabric sewn to self-expanding stainless steel z-stents with braided 
polyester and monofilament polypropylene sutures.  The graft is fully stented to provide 
stability and the expansile force necessary to open the lumen of the graft during 
deployment.  The graft is bifurcated with one long ipsilateral iliac limb and one short 
contralateral limb.  Gold radiopaque markers are sewn into the graft material to aid in 
alignment with the visceral vessels during deployment.  Refer to the IFU for device sizes 
and planning and sizing information. 
 
White: Distal 
Trigger Wire 
Gold: Diameter 
Reducing Ties 
Black: Proximal 
Trigger Wire 
Black: Cannula 
Tie Down Wire 

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1.5.2.4.  Distal Body Graft Introduction System 
The Zenith® Universal Distal Body Endovascular Device is shipped preloaded onto a 
20 French H&L-B One-Shot™ Introduction System.  The delivery system uses a 
sequential deployment method with built-in features to provide continuous control of the 
graft throughout deployment.  Both the proximal and distal ends of the graft are attached 
to the delivery system and held by independent wires.  The delivery system enables 
precise positioning and allows for readjustment of the final graft position before 
deployment.  The delivery system is compatible with a 0.035 inch wire guide.   
 
1.5.2.5.  Ancillary Components 
The following ancillary endovascular components are available for the Zenith® p-
Branch®: 
1. Main body extensions; 
2. Iliac leg grafts and extensions; 
3. Converters; 
4. Iliac occluders/plugs. 
 
1.5.3.  Fenestration Stents 
iCAST™ and/or JOSTENT balloon-expandable covered stents will be used in the renal 
and visceral vessels incorporated by the Zenith® p-Branch® endovascular graft 
fenestrations.  The manufacturers’ instructions for use should be referred to for additional 
information.   
 
1.5.4.  Description of Each Important Component, Ingredient, and Property  
Each component and its associated properties have been described. 
 
1.5.5.  The Principle of Operation of the Device 
The Zenith® Fenestrated AAA Endovascular Graft and Zenith® p-Branch® are 
implantable endoprosthetic devices intended to prevent aneurysm rupture.  The principle 

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of operation of the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-
Branch® is described in the Methods section of this protocol and further description and 
device illustrations are included in the respective Instructions for Use.  If applicable, the 
principle of operation of the Zenith® Alignment Stent is described in the Methods section 
of this protocol and further description and device illustrations are included in the 
Instructions for Use. 
 
1.5.6.  Description of Anticipated Changes in the Device During the Investigation 
The purpose of this study is to examine safety and effectiveness of fenestrated stent-graft 
technology and the effects on perfusion, namely the effects of perivisceral aortic 
fenestrated stent-grafting on organ perfusion.  The need for use of a fenestrated stent-
graft to achieve aneurysm exclusion may arise not only from proximal extension of 
abdominal aortic aneurysmal disease to the perivisceral segment, but also distal extension 
of descending thoracic aortic aneurysmal disease to the perivisceral segment.  Therefore, 
incorporation of a distal fenestrated thoracic stent-graft for treatment of descending 
thoracic aortic aneurysms not treatable with current thoracic stent-grafts is anticipated to 
allow for further evaluation of the effects of perivisceral aortic fenestrated stent-grafting 
on organ perfusion.   
 
1.6.  Monitoring Procedures 
The study will be monitored in accordance with written standard operating procedures 
consistent with 21 CFR 812. 
 
  
 
 
 
 
 
  

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APPENDIX A 
Written Procedures for Monitoring Studies 
 
A. Selection of the monitor. 
 
Designated by the sponsor to oversee the clinical study, 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 
study in accordance with all applicable regulations and standards for conducting clinical 
studies. 
 
B. General duties of the monitor. 
 
The monitor must ensure that the study is conducted in accordance with: 
 
1. The signed investigator agreement. 
2. The Clinical Investigation Plan (CIP). 
3. Any conditions imposed by the IRB 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 which are potentially reportable to a regulatory 
authority. 
 
D. Initiating the study. 
 
Prior to initiating any clinical use of the device, the monitor/sponsor representative will 
participate in a pre-study or initiation visit with each clinical site.  
 

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At a minimum, the following items shall be addressed during the site initiation visit: 
1. Provide training to investigator on his/her responsibilities per the investigator 
agreement, applicable laws, regulations and standards; and 
2. Provide training to investigator that the IRB approval letter and informed 
consent/patient information should be on file before initiation of the clinical 
study. 
 
Additionally, training may be provided to the investigator on: 
1. The regulatory status of the device and the requirements for the accountability of 
same;  
2. The nature of the CIP; 
3. The requirements for an adequate and well-controlled clinical study; 
4. His or her obligation to obtain informed consent in accordance with applicable 
regulations; 
5. His or her obligation to ensure continuing review of the clinical study by the IRB 
in accordance with conditions of approval and applicable regulations and to keep 
the sponsor informed of such IRB approval and subsequent IRB actions 
concerning the study; 
6. The importance of access to an adequate number of suitable patients to conduct 
the study; 
7. The importance of adequate facilities for conducting the clinical study; and 
8. 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 study, at the direction of the Project Manager, the monitor 
should visit the site frequently enough to ensure that: 
 
1. The facilities and research staff used by the investigator continue to be 
acceptable for purposes of the clinical study; 
2. The applicable version of the CIP and agreements are being followed; 
3. Changes to the CIP, informed consent/patient information have been approved 
by the IRB and/or reported to the sponsor and the IRB; 
4. Accurate, complete, and current records are being maintained; 
5. Accurate, complete, and timely reports are being made to the sponsor and IRB; 
and 

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6. 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:  
1. Device accountability review; 
2. Adverse event review to ensure that events are appropriately reported within the 
time periods required by the sponsor, CIP, IRB, and applicable regulatory 
requirements; and 
3. Source data verification per the monitoring plan to determine that : 
a. Informed consent/patient information has been documented in accordance 
with applicable regulations and expectations of local IRB; 
b. The information recorded in the CRFs (paper or electronic) is complete, 
accurate, and legible; 
c. 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; 
d. Missing visits or examinations are noted; and 
e. Patients failing to complete the clinical study 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. 
The monitor shall immediately notify the sponsor of any conditions of non-
compliance with the CIP, conditions of IRB or regulatory authority approval, 
or the applicable regulations. 

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