Zenith® p-Branch® Pivotal Study
Phase: NA
Conditions: Aortic Aneurysm Abdominal
Sponsor: Cook Research Incorporated

Cook Research Incorporated 
Zenith® p-Branch™ Pivotal Study  
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COMPANY CONFIDENTIAL 
CIP 14-09-03 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CLINICAL INVESTIGATION PLAN  
 
 
 
 
Zenith® p-Branch™ Pivotal Study 
 
 
Global Clinical Number 14-09 
Version: 14-09-03                                                       
Version Date: 17 June 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
Sponsor: 
      
 
 
     Cook Research Incorporated 
     1 Geddes Way 
 
 
 
 
 
      West Lafayette, IN 47906 
 
 
 
 
 
      USA

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COMPANY CONFIDENTIAL 
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CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
 
This clinical investigation will be conducted in compliance with the Clinical Investigation Plan (CIP), 
ISO 14155, ICH GCP, 21 CFR 812, and other applicable requirements as appropriate. 
 
 
Signatures: 
 
Sponsor Contact 
 
 
 
 
 
 
Signature 
 
DD/MM/YYYY 
 
 
 
 
 
 
Printed Name 
Title 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CLINICAL INVESTIGATION PLAN SIGNATURE PAGE, CONTINUED 
 
 
National Principal Investigator 
 
I hereby confirm that I approve of this Clinical Investigation Plan (CIP) and agree to comply with its 
terms as laid out in this document. 
 
 
 
 
 
 
Signature 
 
DD/MM/YYYY 
 
 
 
 
 
 
Printed Name 
 
Title 
 
 
 
 
 

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Zenith® p-Branch™ Pivotal Study  
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CLINICAL INVESTIGATION PLAN SIGNATURE PAGE, CONTINUED 
 
Principal Clinical Investigator 
 
I hereby confirm that I approve of this Clinical Investigation Plan (CIP) and agree to comply with its 
terms as laid out in this document. 
 
 
 
 
 
 
Signature 
 
DD/MM/YYYY 
 
 
 
 
 
 
Printed Name 
 
Title 
 
 
 

Cook Research Incorporated 
Zenith® p-Branch™ Pivotal Study  
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COMPANY CONFIDENTIAL 
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CONFIDENTIALITY STATEMENT 
 
 
 
 
 
 
 
 
 
This document shall be treated as a confidential document for the sole 
information and use of the clinical investigation team and Institutional 
Review Board (IRB). 
 
 

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TABLE OF CONTENTS 
1.0  
Clinical Investigation Plan Overview .........................................................................8 
2.0 
Objectives of the Clinical Investigation .....................................................................9 
2.1 
Primary Objective ...............................................................................................9 
2.2 
Secondary Objectives .......................................................................................10 
3.0 
Device Description and Intended Use ......................................................................10 
3.1 
General Device Description ..............................................................................10 
3.2 
Indication for Use .............................................................................................16 
3.3 
Product Identification and Tracking .................................................................16 
3.4 
Instructions for Use ..........................................................................................17 
3.5 
Summary of Necessary Training and Experience ............................................17 
3.6 
Description of the Necessary Medical or Surgical Procedures ........................17 
4.0 
Summary of Preliminary Investigations ..................................................................17 
5.0 
Risk Analysis and Risk Assessment .........................................................................17 
5.1 
Risks and Foreseeable Adverse Device Effects ...............................................17 
5.2 
Methods to Minimize Risks ..............................................................................19 
6.0 
Design of the Clinical Investigation ..........................................................................19 
6.1 
Type of Investigation ........................................................................................19 
6.2 
Inclusion and Exclusion Criteria ......................................................................19 
6.2.1 Inclusion Criteria ..................................................................................20 
6.2.2 Exclusion Criteria .................................................................................20 
6.3 
Endpoints ..........................................................................................................22 
6.3.1 Primary Endpoints ................................................................................22 
6.3.2 Secondary Endpoints ............................................................................22 
6.3.3 Rationale for Endpoints ........................................................................23 
6.4 
Variables to be Measured to Demonstrate Achievement of Endpoints ............23 
6.5 
Measures to be Taken to Avoid or Minimize Bias ...........................................24 
7.0 
Methods .......................................................................................................................24 
7.1 
Patient Assessment, Screening, and Consent ...................................................24 
7.2 
Point of Enrollment ..........................................................................................25 
7.3 
Medications ......................................................................................................25 
7.4 
Pre-procedure ....................................................................................................25 
7.5 
Procedure ..........................................................................................................25 
7.6  
Post-procedure/Follow-up ................................................................................26 
7.8 
Duration of Study and Patient Participation .....................................................27 
7.9      Criteria and Procedures for Withdrawal ...........................................................27 
7.10 
Imaging .............................................................................................................27 
7.11 
Participation Endpoints of the Study ................................................................27 
8.0  
Statistical Considerations ..........................................................................................28 
8.1 
Hypothesis to be Tested ....................................................................................28 
8.2 
Statistical Analysis ...........................................................................................28 
8.3 
Sample Size Calculation ...................................................................................29 

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8.4 
Missing Data .....................................................................................................29 
8.5 
Site-level Poolability ........................................................................................30 
8.6 
Limitations of the Study ...................................................................................30 
9.0 
Deviations from Clinical Investigation Plan ............................................................30 
10.0 
Data Collection and Reporting .................................................................................31 
10.1 
Electronic Case Report Forms ..........................................................................31 
10.2 
Data Reporting ..................................................................................................31 
11.0 
Data Management and Quality Assurance ..............................................................31 
11.1 
Data Entry and Quality Assurance ...................................................................31 
11.2 
Data Monitoring Arrangements ........................................................................32 
12.0 
Safety Monitoring and Procedures for Reporting Adverse Events .......................32 
12.1 
Safety Monitoring .............................................................................................32 
12.2 
Adverse Event Reporting..................................................................................33 
13.0 
Early Termination or Suspension of the Investigation ...........................................33 
14.0 
Ethical Considerations...............................................................................................33 
15.0 
Publication Policy.......................................................................................................33 
16.0 
Trial Administration and Investigators ...................................................................34 
16.1 
Approvals and Agreements ..............................................................................34 
16.2 
Investigators......................................................................................................34 
16.3 
Insurance ...........................................................................................................34 
 
 
 
APPENDIX B – Written Procedures for Monitoring Investigations ................................37 
APPENDIX C – Definitions ..................................................................................................41 

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1.0  
Clinical Investigation Plan Overview 
This clinical investigation is intended to evaluate the safety and effectiveness of the Zenith® p-Branch™  
in combination with Atrium iCAST™ covered stents for the treatment of pararenal or juxtarenal aortic 
aneurysms.  The primary safety and effectiveness endpoint is treatment success at 12 months.  This 
prospective, non-randomized, multicenter clinical investigation will enroll 80 patients to receive the 
Zenith® p-Branch™ at up to 30 clinical sites (maximum of 20 patients per site).  Patient enrollment is 
expected to be completed within 2.5 years of study initiation.  Follow-up data will be collected for 5 
years post-procedure. 
 
Patients with a pararenal or juxtarenal abdominal aortic aneurysm (AAA) ≥5.0 cm in diameter (or 
2 times normal aortic diameter), history of growth ≥0.5 cm/year, or saccular aneurysm with aortic 
diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based 
upon physician interpretation, with anatomy suitable for treatment with the Zenith® p-Branch™ may be 
eligible for enrollment.  The study flow diagram is presented in Figure 1.1.

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Figure 1.1.  Study flow diagram. 
 
2.0 
Objectives of the Clinical Investigation 
2.1 
Primary Objective  
The primary objective of this study is to evaluate the safety and effectiveness of the Zenith® p-Branch™ 
used for treatment of pararenal or juxtarenal AAAs.  Safety and effectiveness will be measured by the 
rate of treatment success at 12 months.  
 
 
 
 
Patient presents with 1) a pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic 
diameter or 2) a pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year or 3) saccular aneurysm 
with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture 
based upon physician interpretation 
 
 
 
 
 
 
Physician reviews available medical history and imaging and considers patient a candidate for enrollment 
 
 
 
 
 
 
Patient meets at least one inclusion criterion and no general or medical exclusion criteria 
 
 
 
 
 
 
Informed consent is obtained 
 
 
 
 
 
 
 
 
Pre-procedural CTA, duplex ultrasound, clinical exam, blood tests 
 
 
 
 
 
 
 
 
Patient meets at least one inclusion criterion and no exclusion criteria 
 
 
 
 
 
 
Endovascular repair of pararenal or juxtarenal AAA with procedural angiography 
 
 
 
 
Post-procedural (within 30 days) CTA, duplex ultrasound, clinical exam, blood tests 
 
 
 
 
6 month:  CTA, duplex ultrasound, clinical exam, blood tests 
 
 
 
 
 
 
12 month:  CTA, duplex ultrasound, clinical exam, blood tests 
 
 
 
 
 
 
2 year and yearly thereafter to 5 years:  CTA, clinical exam, blood tests 
 

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Treatment success is defined as technical success and freedom from all of the following at 12 months: 
• Type I or Type III endoleaks that require intervention post-discharge (including Type I and 
Type III endoleaks identified for treatment on the 12 month follow-up CT); 
• Aneurysm growth > 0.5 cm; 
• AAA related serious adverse event (i.e. death, rupture,  or conversion to open surgical 
repair); 
• AAA-related major complication (i.e. renal failure requiring permanent dialysis, bowel 
obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis). 
 
2.2 
Secondary Objectives 
In addition to the primary objective stated above, the following secondary objectives, evaluated for 
descriptive purposes (not for the purpose of statistical inference), include an assessment of the 
following:  
• Myocardial infarction (MI) 
• Congestive heart failure (CHF) 
• Cardiac ischemia requiring intervention 
• Visceral vessel events  
• Changes in aneurysm size 
• Secondary interventions 
• Endoleak 
• Device migration 
• Device patency 
• Device integrity 
 
3.0 
Device Description and Intended Use 
3.1 
General Device Description 
The Zenith® p-Branch™ is part of a modular system which may include a distal bifurcated device 
(Zenith® Universal Distal Body Endovascular Graft) and iliac leg devices (Zenith® Spiral-Z® AAA Iliac 
Leg Graft), as shown in Figure 3.1. 
 
 
 
 

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Figure 3.1.  Zenith® p-Branch™ is part of a modular system that may include a bifurcated device 
(Zenith® Universal Distal Body Endovascular Graft) and commercially available Zenith® Spiral-Z® 
AAA Iliac Leg Grafts.   
 
3.1.1 Zenith® p-Branch™ 
 
The Zenith® p-Branch™ is a modular system (Figure 3.1) constructed of full-thickness woven polyester 
fabric sewn to self-expanding stainless steel and nitinol Z-stents, and is introduced using the Zenith® 
preloaded delivery system (Figures 3.2 and 3.3).  Three fenestrations and a scallop in the graft material 
preserve blood flow to the renal and visceral vessels.  The two renal artery fenestrations are conical-
shaped and may be manipulated to accommodate a range of renal anatomies with a single design.  The 
endovascular graft is available in two fenestration/scallop configurations (A and B) to provide an 
optimal fit for individual patient anatomies (Figures 3.4 and 3.5).  Refer to the Manufacturer’s 
Instructions for Use (IFU) for the device sizes available and planning and sizing information for the 
clinical investigation.  
 
 
 
 
 
 
 
 
 
Figure 3.2.  Zenith® preloaded delivery system showing preloaded nitinol wire. 
 
 
     p-Branch™                             Universal Body 
 
   Iliac Legs 

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Figure 3.3.  Detail of the release handles of the Zenith® preloaded delivery system. 
 
Configuration A: 
• Celiac scallop:  20 mm wide, centered at 12:30 o’clock (15°) 11 mm above SMA; 
• SMA fenestration:  8 mm diameter, located at 12:00 o’clock (0°); 
• Right pivot (renal) fenestration:  6 mm inner and 15 mm outer diameter, 5 mm deep, oriented at 
9:30 o’clock (285°), 12 mm below SMA (center-to-center); 
• Left pivot (renal) fenestration:  6 mm inner and 15 mm outer diameter, 5 mm deep, oriented at 
2:30 o’clock (75°), 12 mm below SMA (center-to-center). 
 
Configuration B: 
• Celiac scallop:  30 mm wide, centered at 12:30 o’clock (15°), 9 mm above SMA; 
• SMA fenestration:  8 mm diameter, located at 12:00 o’clock (0°); 
• Right pivot (renal) fenestration:  6 mm inner and 15 mm outer diameter, 5 mm deep, oriented at 
9:30 o’clock (285°), 16 mm below SMA (center-to-center); 
• Left pivot (renal) fenestration:  6 mm inner and 15 mm outer diameter, 5 mm deep, oriented at 
2:30 o’clock (75°), 20 mm below SMA (center-to-center). 
 
 
 
 
 
White: Distal 
Trigger Wire 
Gold: Diameter 
Reducing Ties 
Black: Proximal 
Trigger Wire 
Black: Cannula 
Tie Down Wire 

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Figure 3.4.  Configuration A fenestration locations.  
*For 36 mm diameter grafts only 
 
 
 
 
 
 
 
 
 
 
Figure 3.5.  Configuration B fenestration locations.  
                    *For 36 mm diameter grafts only 
 
 
Celiac 
Scallop 
SMA 
Fenestration 
Left Pivot 
Fenestration 
Right Pivot 
Fenestration 
Celiac 
Scallop 
SMA 
Fenestration 
Left Pivot 
Fenestration 
Right Pivot 
Fenestration 

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Anatomical Criteria 
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°).  Refer to the Investigator’s Brochure for more details about the anatomical criteria. 
1. Criteria for configuration A (renal fenestrations at same longitudinal level): 
a. The celiac artery arises from the aorta between 11:30 o’clock and 1:30 o’clock (345° and 
45°) or arises above the top of the graft;  
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 o’clock and 
10:30 o’clock (255° and 315°) and the circumferential location of the left renal artery can 
range between 1:30 o’clock and 3:30 o’clock (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 o’clock and 2:00 o’clock (330° and 
60°) or arises above the top of the graft; 
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 o’clock and 
10:30 o’clock (255° and 315°) and the circumferential location of the left renal artery can 
range between 1:30 o’clock and 3:30 o’clock (45° and 105°) (assuming the endovascular 
graft diameter is approximately 30 mm). 
 
3.1.2  Zenith® Universal Distal Body Endovascular Graft  
The Zenith® p-Branch™ is designed to be used with the Zenith® Universal Distal Body Endovascular 
Graft (Figure 3.6).  The Zenith® Universal Distal Body Endovascular Graft is delivered with the H&L-B 

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One-Shot™ Introduction System (Figure 3.7).  Refer to the Manufacturer’s Instructions for Use (IFU) 
for the device sizes available and  sizing information. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.1.3. Atrium iCAST™ Stent 
Commercially available Atrium iCAST™ stents will be used in conjunction with the Zenith® p-
Branch™ to preserve blood flow to the visceral vessels. The Atrium iCAST™ covered stent is a 
balloon-expandable endoluminal device consisting of a laser cut 316L stainless steel stent with an 
encapsulated cover made of expanded polytetrafluoroethylene (PTFE).  The sizes listed in Table 3.1 
reflect the subset of commercially available sizes that are recommended for use in combination with the 
Zenith® p-Branch™ as part of the study. 
 
 
 
Figure 3.6.  Zenith® Universal Distal Body Endovascular Graft. 
Figure 3.7.  H&L-B One-Shot™ Introduction System. 

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Table 3.1. Atrium iCAST™ covered stent availability. 
Diameter (mm) 
Length (mm) 
Catheter Length* (cm) 
Introducer (Fr) 
5 
16 
80 or 120 
6 
5 
22 
80 or 120 
6 
6 
16 
80 or 120 
6 
6 
22 
80 or 120 
6 
7 
22 
80 or 120 
7 
7 
38 
80 or 120 
7 
8 
38 
80 or 120 
7 
9 
38 
80 or 120 
7 
10 
38 
80 or 120 
7 
*Stents intended for placement in renal arteries must use 120 cm catheters and be of a compatible French size to extend 
through the 90 cm sheaths used with Zenith® p-Branch™. 
 
3.1.4  Other Devices 
Other commercially available Zenith® endovascular devices such as main body extensions, iliac leg 
extensions, converters, and iliac plugs may also be required during an aortic endovascular procedure.  
Each individual device has its own Instructions for Use.  
 
3.2 
Indication for Use 
The Zenith® p-Branch™ is indicated for the endovascular treatment of patients with pararenal or 
juxtarenal AAA having morphology suitable for endovascular repair.  Refer to the Manufacturer’s 
Instructions for Use for details regarding indications for  use. 
 
3.3 
Product Identification and Tracking 
The identification and labeling of the products under investigation are outlined in the Investigator’s 
Brochure and Manufacturer’s Instructions for Use. 
Products under investigation will be tracked throughout the course of the clinical investigation through 
use of a Product Log, upon which lot numbers, quantity, and disposition of product will be recorded.  
Product Logs will be maintained in the site’s Investigator File.  Additionally, the quantity(s), size(s), and 
lot number(s) of products used in patients will be recorded on case report forms (CRFs). 
 
 

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3.4 
Instructions for Use  
Refer to the Manufacturer’s Instructions for Use for complete instructions including device sizes, 
installation, storage and handling requirements, preparation for use, and any intended re-use, pre-use 
checks for safety and performance, and precautions to be taken after use. 
 
3.5 
Summary of Necessary Training and Experience 
Please reference the Manufacturer’s Instructions for Use for a complete summary of the necessary 
training and experience required for use of this product. 
 
3.6 
Description of the Necessary Medical or Surgical Procedures 
Refer to the Manufacturer’s Instructions for Use for a complete description of the procedures involved 
in the use of this product. 
 
4.0 
Summary of Preliminary Investigations 
Refer to the Investigator’s Brochure for a summary of non-clinical testing and a summary of previous 
clinical experiences with the device or other similar devices. 
 
5.0 
Risk Analysis and Risk Assessment 
Refer to the Investigator’s Brochure for a summary of benefits and a complete risk analysis. 
 
5.1 
Risks and Foreseeable Adverse Device Effects 
Adverse events that may occur and/or require intervention include, but are not limited to:  
• Amputation; 
• Anesthetic complications and subsequent attendant problems (e.g., aspiration); 
• Aneurysm enlargement; 
• Aneurysm rupture and death; 
• Aortic damage, including perforation, dissection, bleeding, rupture, and death; 
• Arterial or venous thrombosis and/or pseudoaneurysm;  
• Arteriovenous fistula; 
• Bleeding, hematoma, or coagulopathy; 

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• Bowel complications (e.g., ileus, transient ischemia, infarction, necrosis); 
• Cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial 
infarction, congestive heart failure, hypotension, hypertension); 
• Claudication (e.g., buttock, lower limb); 
• Death; 
• Edema;  
• Embolization (micro and macro) with transient or permanent ischemia or infarction; 
• Endoleak; 
• Endoprosthesis:  improper component placement, incomplete component deployment, 
component migration, suture break, occlusion, infection, stent fracture, graft material wear, 
dilatation, erosion, puncture, perigraft flow, barb separation, and corrosion; 
• Fever and localized inflammation; 
• Genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, 
fistula, incontinence, hematuria, infection); 
• Graft or native vessel occlusion; 
• Hepatic failure; 
• Impotence; 
• Infection of the aneurysm, device, or access site, including abscess formation, transient fever, 
and pain; 
• Lymphatic complications and subsequent attendant problems (e.g., lymph fistula); 
• Neurologic local or systemic complications and subsequent attendant problems (e.g., stroke, 
transient ischemic attack, paraplegia, paraparesis, paralysis); 
• Open surgical conversion; 
• Pulmonary/respiratory complications and subsequent attendant problems (e.g., pneumonia, 
respiratory failure, prolonged intubation); 
• Renal complications and subsequent attendant problems (e.g., infarction, artery occlusion, 
contrast toxicity, insufficiency, failure); 
• Splenic injury (e.g., infarction, ischemia); 
• Vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, 
arteriovenous fistula; 
• Vessel damage; 

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• Wound complications and subsequent attendant problems (e.g., dehiscence, infection); 
• Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, 
death). 
 
5.2 
Methods to Minimize Risks 
This device will be used only by trained healthcare professionals who are experienced in the study 
procedure.  Patients will be selected according to the labeled indication and in accordance with 
inclusion/exclusion criteria outlined in this document.  
 
The device design, non-clinical testing, clinical study design, and the Manufacturer’s Instructions for 
Use are intended to minimize the risks associated with the use of this device.  The risks of the study 
have been minimized and the potential benefits and the importance of the knowledge to be gained about 
the safety and effectiveness of the device outweigh the risks. 
 
6.0 
Design of the Clinical Investigation 
 
6.1 
Type of Investigation 
This prospective, non-randomized, multicenter clinical investigation will evaluate the safety and 
effectiveness of the the Zenith® p-Branch™ in combination with Atrium iCAST™ covered stents for the 
treatment of pararenal or juxtarenal aortic aneurysms.  This study will enroll 80 patients at up to 30 
clinical sites.  Patient enrollment is expected to be completed within 2.5 years of study initiation.  
Follow-up data will be collected for 5 years post-procedure.  The total study duration should be 
approximately 7.5 years. 
 
6.2 
Inclusion and Exclusion Criteria 
Assessment of selection criteria will be based upon data available pre-operatively.  Data obtained peri-
operatively and post-operatively (including the results from core laboratory analysis of pre-procedure 
imaging) may contradict pre-operative assessment.  However, such contradiction is not considered a 
violation of the Clinical Investigation Plan and should not be construed as evidence of inadequate or 
inaccurate pre-operative assessment with respect to the enrollment criteria or evidence of inappropriate 
enrollment.  Enrollment is to be based upon best available pre-operative data.  Some criteria relate to 
subjective assessment while other criteria are considered absolute and are able to be determined 

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definitively.  Variability in assessment between centers, investigators, and observers is expected with 
several criteria. 
 
6.2.1 Inclusion Criteria 
A patient is deemed suitable for inclusion in the study if the patient meets at least one the following 
criteria: 
1. Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter; 
2. Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year; 
3. Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is 
deemed to be at risk for rupture based upon physician interpretation. 
 
6.2.2 Exclusion Criteria 
General Exclusion Criteria 
A patient must be excluded from the clinical investigation if any of the following are true: 
1. Age <18 years; 
2. Life expectancy <2 years; 
3. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months; 
4. Inability or refusal to give informed consent by the patient or a legally authorized representative; 
5. Unwilling or unable to comply with the follow-up schedule; 
6. Simultaneously participating in another investigative device or drug study.  (The patient must 
have completed the primary endpoint of any previous study at least 30 days prior to enrollment 
in this study.) 
 
Medical Exclusion Criteria 
A patient must be excluded from the clinical investigation if any of the following are true: 
1. Leaking, ruptured, or mycotic aneurysm; 
2. Active systemic infection (e.g., sepsis); 
3. Serum creatinine level >2.0 mg/dl; 
4. Patient does not have two viable renal arteries intended to be accommodated by the pivot 
fenestrations; 

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5. Significant surgical procedures (including endovascular repair) within 30 days before or after 
aneurysm repair; 
6. Presence of a stent in any vessel to be accommodated with a fenestration that will interfere with 
deployment of the Zenith® p-Branch™ or stenting of renal and visceral vessels accommodated 
by a fenestration; 
7. Previous endograft in the abdominal aorta; 
8. Bleeding, diathesis, or uncorrectable coagulopathy; 
9. Refuses blood transfusion;  
10. Allergy to materials of the graft(s) or their delivery systems (stainless steel, nitinol, polyester, 
solder [tin, silver], polypropylene, urethane, or gold) or the Atrium iCAST™ stent (stainless steel 
or polytetrafluoroethylene); 
11. Anaphylactic reaction to contrast that cannot be adequately pre-medicated. 
 
Anatomical Exclusion Criteria 
A patient must be excluded from the clinical investigation if any of the following are true: 
1. Suitable proximal neck for treatment with a standard Zenith® AAA Endovascular Graft; 
2. Infra-SMA sealing zone length < 4 mm; 
3. Greater than 10% increase in diameter over the length of the proximal sealing zone; 
4. Proximal sealing zone angulated > 60 degrees relative to the centerline of the aneurysm or 
proximal sealing zone angulated > 45 degrees relative to the supraceliac aorta; 
5. Proximal sealing zone diameter > 32 mm or < 21 mm (measurements based on outer diameter 
unless evidence of vessel thickening); 
6. Renal and visceral vessel anatomy incompatible with graft or fenestration stents (see Section 3.1, 
subsection Anatomical Criteria, for more details on the renal and visceral vessel criteria and 
Section 3.1 for more details on fenestration stents); 
7. Non-bifurcated segment of any artery to be stented < 15 mm in length if use of covered stent is 
planned; 
8. Renal artery or SMA stenosis > 50%; 
9. Renal artery diameter < 5 mm; 
10.  SMA diameter < 6 mm or  ≥ 12 mm; 
11. Sacrifice of IMA, accessory renal arteries, or internal iliac arteries that would significantly 
compromise physiological function in the opinion of the investigator; 

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12. Distance from the distal-most aspect of the lowest renal artery to the aortic bifurcation that is 
incompatible with the available lengths of the Zenith® Universal Distal Body Endovascular Graft 
(if used);   
13. Distance from the center of the SMA to the aortic bifurcation that is incompatible with the 
available lengths of the Zenith® p-Branch™; 
14. Prohibitive occlusive disease, calcification, or thrombus of the proximal sealing zone; 
15. Tortuosity, calcification, or arterial diameter not conducive to placement of the introducer with 
use of a conduit; 
16. Unsuitable arterial anatomy. 
 
6.3 
Endpoints 
6.3.1 Primary Endpoints 
The primary safety and effectiveness endpoint is treatment success at 12 months.  Treatment success is 
defined as technical success and freedom from all of the following at 12 months: 
• Type I or Type III endoleaks that require intervention post-discharge (including Type I and 
Type III endoleaks identified for treatment on the 12 month follow-up CT); 
• Aneurysm growth > 0.5 cm; 
• AAA related serious adverse events (i.e., death, rupture, or conversion to open surgical 
repair) as adjudicated by an independent CEC; 
• AAA-related major complications (i.e., renal failure requiring permanent dialysis; bowel 
obstruction, ischemia, or fistula; stroke with permanent deficit; or paralysis) as adjudicated 
by an independent CEC. 
 
6.3.2 Secondary Endpoints 
The following secondary endpoints will be evaluated for descriptive purposes (not for the purpose of 
statistical inference):  
• Myocardial infarction 
• Congestive heart failure 
• Cardiac ischemia requiring intervention 
• Visceral vessel events  
• Changes in aneurysm size 
• Secondary interventions 

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• Endoleak 
• Device migration 
• Device patency 
• Device integrity 
 
6.3.3 Rationale for Endpoints 
The primary endpoint incorporates the measures relevant to fully evaluate the safety and effectiveness of 
the Zenith® p-Branch™.  Specifically, success first requires graft deployment in the intended location 
with patency of all vessels targeted by a fenestration (i.e., technical success).  A patient must be free 
from Type I endoleak requiring intervention, which is relevant given that the device is intended to 
provide aneurysm exclusion.  Likewise, a patient must be free from Type III endoleak requiring 
intervention, which is relevant given the use of covered stents in contributing to sealing of the aneurysm 
at the junction with a fenestration.  Not only must patients be free from AAA-related serious adverse 
events (death rupture, or conversion to open surgical repair), but they must also be free from major 
complications (stroke with permanent deficit and paralysis) and related events specific to the target 
vessels (e.g., renal failure requiring dialysis, bowel obstruction, ischemia, or fistula). 
 
6.4 
Variables to be Measured to Demonstrate Achievement of Endpoints 
The safety and effectiveness endpoint measured by treatment success at 12 months will be assessed by 
collecting and analyzing the following data: 
• Technical success will be determined by collecting deployment information and procedural 
angiography; 
• Type I and III endoleaks will be assessed by CT at each follow-up visit; 
• Aneurysm growth >0.5 cm will be assessed by comparing the maximum aneurysm diameter 
measurement on each follow-up CT (post-procedure CT measurement should be considered 
baseline); 
• 
SAEs and major complications will be assessed by clinical exams at each follow up. 
 
Independent core laboratories (to be designated) will be used to provide detailed analysis for data 
collected (e.g., angiographic, ultrasound, CT, X–ray, and MRI). 
 
The clinical data and imaging measurements will be collected on standardized CRFs, which may serve 
as source documents.  The schedule for assessments is summarized in Table 6.1. 
 

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Table 6.1. Data collection schedule 
 
Pre-
procedure 
Procedure 
Post-
procedure1 
6 month 
12 month 
2 year2 
CTA3 
X4  
 
X5 
X5 
X5 
X5 
Angiography 
 
X 
 
 
 
 
Duplex ultrasound6 
X 
 
X 
X 
X 
 
Clinical exam 
X 
 
X 
X 
X 
X 
Blood test7 
X 
 
X 
X 
X 
X 
1 Post-procedure follow-up within 30 days of procedure. 
2 Patients will be followed up at yearly intervals through five years. 
3 Device X-rays may be requested to provide more focused imaging if potential device integrity issues are identified, 
but are unable to be confirmed, using CT. 
4Imaging should be performed within 6 months of the procedure, with imaging within 3 months of the procedure 
considered to be optimum. 
5 Duplex ultrasound and non-contrast CT may be used for those patients experiencing documented renal failure or 
who are otherwise unable to undergo a contrast-enhanced CTA scan.   
6 In cases of reinterventions for stenosis/occlusion of a branch vessel targeted by a fenestration, duplex ultrasound 
should be performed prior to the reintervention procedure. 
7 Required blood tests include creatinine, BUN, AST, and ALT. 
 
 
6.5 
Measures to be Taken to Avoid or Minimize Bias 
This clinical investigation is not randomized or blinded.  It is intended to collect information regarding 
physician use of the Zenith® p-Branch™.  The study will utilize uniform definitions for study endpoints, 
event adjudication by an independent clinical events committee, and imaging data analysis by a 
centralized core laboratory.  Study results will be analyzed in accordance with a prospectively defined 
analysis plan. 
 
7.0 
Methods 
 
7.1 
Patient Assessment, Screening, and Consent 
Patients will be screened to ensure they meet the inclusion criteria and do not meet any of the exclusion 
criteria.  Patients who meet the inclusion criteria and do not meet any of the exclusion criteria will be 
invited to participate in this investigation.  All patients eligible for entry into the investigation will have 
the Clinical Investigation Plan explained to them, as well as the potential risks and benefits of their 
participation in the investigation.  Each patient who agrees to participate, or a legally authorized 
representative, will be required to sign an informed consent document prior to the procedure.  If new 

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information is obtained after a patient receives treatment with the device, patients who have not exited 
the study will be informed about the new information, and will be re-consented at the discretion of the 
investigator and/or the site’s IRB. 
 
7.2 
Point of Enrollment 
Point of enrollment will be based on the intent-to-treat population and is defined to include any patient 
for whom the treatment procedure is initiated.  More specifically, the patient would be included in the 
intent-to-treat population upon procedure initiation (i.e., cutdown or initiation of percutaneous access).  
Informed consent will be obtained and assessment of the patient’s conformance to the 
inclusion/exclusion criteria will occur prior to the procedure.  
 
7.3 
Medications 
The hospital’s standard protocol should be followed with respect to medication.  Dual anti-platelet 
therapy is recommended for three months following the index endovascular procedure or after a 
secondary intervention involving the visceral vessels.  Aspirin therapy is recommended indefinitely.  
 
7.4 
Pre-procedure 
Planning and sizing of the Zenith® p-Branch™ endovascular graft is completed pre-operatively based on 
radiologic assessments, including CTA.   
 
7.5 
Procedure 
Each patient will receive one Zenith® p-Branch™ endovascular graft in combination with Atrium 
iCAST™ stents for the SMA and renal fenestrations.  Use of the Zenith® Universal Distal Body 
Endovascular Graft is dependent on patient anatomy and physician discretion.  For example, in instances 
where a surgically implanted graft has been previously placed in the aorta, the Zenith® Universal Distal 
Body Endovascular Graft may not be required if an adequate distal seal within the prior graft is obtained 
with the Zenith® p-Branch™.  Commercially available Zenith® Spiral-Z® AAA Iliac Leg Grafts will be 
used.  The Manufacturers’ Instructions for Use should be referred to for additional information.  
Standard techniques for placement of arterial access sheaths, guiding catheters, angiographic catheters, 
and wire guides should be employed during use of the Zenith® p-Branch™.  The device and delivery 
system are compatible with 0.035 inch diameter wire guides.   
Refer to institutional protocols relating to anesthesia, anticoagulation, access technique, and monitoring 
of vital signs during the procedure.    

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The completion imaging should be carefully interrogated for potential endoleaks as well as residual 
kinking/stenosis/dissection of vessels accommodated by fenestrations.  Use of imaging modalities 
beyond conventional angiography (e.g., rotational angiography [i.e., flat-panel volume CT or cone beam 
CT] or IVUS) is recommended to fully assess the completeness of repair and confirm the absence of 
Type I and Type III endoleaks as well as stent compression or kinking/stenosis/dissection of vessels 
accommodated by a fenestration, especially at the distal end of a fenestration stent.    
Type I and Type III endoleaks not expected to resolve with the reversal of procedural heparin warrant 
treatment prior to completion of the endovascular procedure.  Likewise, any evidence of kinking, 
stenosis, or dissection of vessels accommodated by fenestrations should be resolved prior to completion 
of the procedure.  In such cases of either Type I or Type III endoleak or residual 
kinking/stenosis/dissection of vessels accommodated by a fenestration, additional stenting or balloon 
angioplasty should be considered.  
Refer to the Manufacturer’s Instructions for Use for complete details regarding use of the Zenith® p-
Branch™.  Fluoroscopic guidance and angiography should be used throughout the procedure to verify 
positioning of the device with respect to patient anatomy. 
 
7.6  
Post-procedure/Follow-up 
The results of the endovascular repair will be assessed by clinical and imaging evaluation intra-
operatively and post-operatively, including within 30-days post-procedure, and at 6 months (180 ± 30 
days), 12 months (365 ± 45 days), 2 years (730 ± 60 days), 3 years (1095 ± 60 days), 4 years (1460 ± 90 
days), and 5 years (1825 ± 90 days) post-procedure according to the study schedule (Table 6.1).  Follow-
up windows are intended as guidelines only.  They are not absolute and are not intended to limit data 
collection due to scheduling conflicts.   
Type I and Type III endoleaks detected during follow-up warrant treatment, particularly in the setting of 
aneurysm growth.  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 I and Type III endoleaks should be 
treated with additional ballooning or prostheses. 
The patency of vessels accommodated by fenestrations should be assessed at each follow-up.  
Additional ballooning and/or stenting may be warranted in the setting of stenosis (e.g., > 60%) or 
occlusion.  In cases of reinterventions for stenosis/occlusion of a branch vessel targeted by a 
fenestration, duplex ultrasound should be performed prior to the reintervention procedure, and is 
suggested to be performed after the reintervention procedure, as per the standard of care for the site.  
 
7.7 
Reintervintion 
Reintervention should be performed according to the institution’s standard of care. 

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7.8 
Duration of Study and Patient Participation 
The total duration of patient participation is 5 years.  After graft deployment, follow-up data will 
continue to be collected for 5 years for each patient in the clinical investigation. 
 
7.9    Criteria and Procedures for Withdrawal 
A patient may decide to withdraw from the investigation at any time either before or after undergoing 
the procedure without prejudice or loss of care.  The patient should notify the investigator of their desire 
to withdraw.  The investigator will notify the Sponsor.  The investigator may also decide to withdraw a 
patient from the investigation at any time based on medical judgment.  In these instances of withdrawal, 
data collected up to the time of patient withdrawal, including the Study Exit form shall be submitted to 
the Data Coordinating Center, and will include the reason why the patient has been withdrawn from the 
study.  Any data collected on the patient up to the point of withdrawal may be used in the study. 
In the event a patient is lost to follow-up or cannot be contacted for post-treatment assessments, at least 
three attempts will be made to locate the patient, and these efforts will be documented.  If the patient 
cannot be located, a lost to follow-up entry will be submitted. 
An autopsy, including explant of the study device, may be requested for patients who die with a study 
device in place.  Both the excised aorta and the study device should be sent to the Data Coordinating 
Center for subsequent examination.  Any study device excised in the course of conversion to open 
surgical repair should also be sent to the Data Coordinating Center.  Further instructions will be 
provided as needed.  Data will be collected and stored in a database. 
 
7.10 
Imaging 
An imaging manual will be provided by the sponsor.  The imaging criteria specified in the manual shall 
be followed for all imaging required per the CIP. 
 
7.11 
Participation Endpoints of the Study 
A patient’s follow-up in the study will end after any of the following: 
1. Failure to deploy the device +30 days; 
2. Conversion to open surgical repair +30 days; 
3. Patient withdrawal or lost to follow-up; 
4. Patient death; 
5. Closure of the investigation; or 
6. Completion of all scheduled clinical and imaging visits through 5 years. 

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8.0  Statistical Considerations 
 
8.1 
Hypothesis to be Tested 
The primary hypothesis will assess the treatment success rate evaluated at 12 months for the Zenith® p-
Branch™.  
 
 
 
 
 
  
 a 
 performance goal of 80% has been established.  The performance goal 
will be said to have been met provided that the null hypothesis is rejected in favor of the alternative with 
a one-sided exact binomial test at the 0.05 level.  The null (H0) and alternative (HA) hypotheses are 
expressed as follows, where π is the proportion of patients treated with the Zenith® p-Branch™ with 
treatment success at 12 months: 
Null Hypothesis:  The 12-month treatment success rate for patients treated with the Zenith® p-Branch™ 
does not meet the performance goal (80%). 
 
  H0: π ≤ 80% 
 
Alternative Hypothesis: The 12-month treatment success rate for patients treated with the Zenith® p-
Branch™ meets the performance goal (80%). 
 
  HA: π > 80% 
The safety and effectiveness of the Zenith® p-Branch™ will be established if the null hypothesis is 
rejected in favor of the alternative at a type I error rate of 0.05 (one-sided).  This analysis will be 
performed on the intent-to-treat population. 
 
8.2 
Statistical Analysis 
Statistical analyses will be performed using SAS® for Windows® (release 9.3 or higher) or other widely 
accepted statistical software.  Descriptive summaries will be provided where appropriate for each of the 
primary and secondary endpoints.  In general, summaries will be completed over the total population.  
Continuous variable summaries will include the number of subjects (N), mean, standard deviation, 
minimum, and maximum.  Categorical variable summaries will include the frequency and percentage of 
subjects who are in the particular category.  Survival analysis techniques such as Kaplan-Meier or Cox 

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Proportional Hazards will be incorporated if censoring of data occurs.  
 
8.3 
Sample Size Calculation 
 
 
 
 
 
  With a clinically relevant margin of 10%, 
 
 
Thirty-four (34) patients are necessary to assess the primary hypothesis, under an 
expected 12-month treatment success rate of 97.4% 
 
 
, with a one-sided exact binomial 
test, at a Type I error rate of 0.05 and a power of 0.8.  A sample size of 80 patients will be enrolled to 
account for possible loss to follow-up while also ensuring sufficient use of both p-Branch graft 
configurations.  
No more than 20 patients (i.e., 25% of total enrollment) will be enrolled at any one site
 
 
 
 
  
 
8.4 
Missing Data 
Missing data will be addressed using three primary strategies: 1) estimating missing data with the best 
available data, 2) case deletion, and 3) multiple imputation. The first strategy may be used for missing 
imaging data. Previous clinical study experience suggests that some portion of the imaging data may not 
meet the criteria for accurate review by the core laboratory; however, it is recognized that the 
investigator uses this information to provide the best possible care for the patient. Therefore, it is 
reasonable to substitute any missing core laboratory measurements with the corresponding 
measurements made by the investigator or institutional staff. In addition, the absence or presence of 
clinical sequelae may supplement the required missing core laboratory assessment of device 
performance. This strategy is a best approximation of the missing data value. 
 
The second strategy is case deletion. If the amount of missing data does not result in a reduction of 
analyzable patients to a number that is below that which is required for sufficient statistical power of the 

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primary endpoints, then case deletion will be the method of choice for that analysis. 
 
The third method is multiple imputation.  This method will be used to predict missing endpoint or 
covariate data for any reason, including patient lost to follow-up.  It may be that the primary study 
endpoints depend upon certain covariates; therefore, it may be possible to model study endpoints, given 
a series of related covariates.  This model-based imputation exercise may provide approximations of the 
missing data that can be utilized in estimating event rates and confidence bounds. 
 
8.5 
Site-level Poolability 
Poolability of data from multiple sites will be verified by examining the primary endpoint among sites.  
Site-level poolability will be considered appropriate provided that this measure is similar among sites.  It 
is expected that some sites may have too few patients to provide reasonable site-level estimates of the 
primary endpoint.  Pooling of this information will be explored based on hospital size (annual discharge 
and number of beds), type of hospital (community versus teaching), and other group-wise strategies.  
Should one or more sites differ from the rest, then subsequent analyses will include the discriminating 
covariate or a covariate to distinguish between the unusual site(s) and those sites that are considered 
poolable. 
 
8.6 
Limitations of the Study 
This study is designed as a single-arm study without a concurrent control group.  The hypothesis of the 
study involves meeting a performance goal derived from previous clinical study results and literature.  In 
the unlikely event that major changes in medical practice have occurred since those studies were 
performed, the determination of whether or not the device met the performance goal may be questioned.   
 
Study results may be generalizable only to the types of patients enrolled in the study, which is expected 
to represent the Medicare patient population based on age.  For a previous study, with similar inclusion 
and exclusion criteria, the mean was 75 years (IDE # G040063).3 
 
9.0 
Deviations from Clinical Investigation Plan 
Investigators are not allowed to deviate from this clinical investigation plan (CIP) without prior 
authorization by the Sponsor except under emergency situations when necessary to preserve the rights, 
safety, and well-being of human subjects.   
 

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Deviations and non-compliances will be recorded together with an explanation.  Deviations or non-
compliances that impact the rights, welfare, or safety of patients shall be reported to the Sponsor and 
IRB as soon as possible.   
 
If appropriate, corrective and preventive actions will be discussed by the sponsor, investigator, and/or 
the IRB to determine a suitable course of action.  
 
10.0 
Data Collection and Reporting 
 
10.1 
Electronic Case Report Forms  
Patient data will be collected and entered by trained personnel at the investigative site into an electronic 
Case Report Forms (eCRFs) through an electronic data capturing (EDC) system..  This is a secure, web-
based system that allows those with permission to access data from any location at any time.  Source 
data are to be retained for data entered into the EDC system.  Data obtained and simultaneously entered 
into the EDC system may also serve as source documentation (e.g. telephone follow-up).  Site personnel 
are required to have unique login names and passwords in order to enter patient data.  In accordance 
with 21 CFR Part 11, the EDC system creates a secure, computer-generated, time-stamped audit trail to 
record the date and time of operator entries and actions that create, modify, or delete electronic records.   
 
10.2 
Data Reporting 
Annual progress reports and a final report at the conclusion of the clinical investigation (or if the study is 
terminated early) will be submitted by the investigators and the Sponsor to the regulatory bodies and 
IRBs as required by local regulations. 
This clinical study shall be registered with the National Institutes of Health (NIH) National Library of 
Medicine’s (NLM) ClinicalTrials.gov website.  Registration and reporting of results shall be submitted 
in accordance with Section 801 of the Food and Drug Administration Amendments Act. 
 
11.0 
Data Management and Quality Assurance 
 
11.1 
Data Entry and Quality Assurance 
Each principal investigator or appropriately trained designee shall enter the clinical data into the EDC on 
standardized eCRFs.  Investigators will provide all applicable clinical data and documentation to the 

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sponsor. Patient data and documents pertaining to the study will be kept and archived by the sponsor.  
Data will be reviewed for missing data, data consistency, and reasonableness of responses.  
Discrepancies will be resolved through a formal query process involving direct contact with 
investigators or research coordinators.  The data coordinating center is responsible for database 
management, data verification, data archiving and data retention. 
Pertinent imaging (pre-procedure, procedure, and follow-up) will be sent to MED Institute, which will 
coordinate shipment of imaging for independent analysis. 
 
11.2 
Data Monitoring Arrangements 
The conduct of the clinical study will be supervised through a process of centralized and on-site 
monitoring. The Data Coordinating Center will remotely monitor the study for data completeness and 
for adverse events. On-site monitoring will be implemented as necessary throughout the course of the 
study. The investigator/institution will provide direct access to source data/documents for study-related 
monitoring, audits, IRB review and regulatory inspection. Written procedures for monitoring the 
investigation are maintained by the monitors and can be found in Appendix B. 
 
12.0 
Safety Monitoring and Procedures for Reporting Adverse Events 
 
12.1 
Safety Monitoring 
A Data Safety Monitoring Board (DSMB) consisting of independent physicians and a least one 
independent statistician, who are not investigators in the investigation, and who do not have a perceived 
conflict of interest with the conduct and administration of the investigation, will be convened on a 
regular basis to evaluate investigation progress and review adverse events. 
An independent Clinical Events Committee (CEC) consisting of physicians, who are not investigators in 
the investigation, and who do not have a perceived conflict of interest with the conduct and 
administration of the investigation, will be established to adjudicate clinical events reported during the 
investigation.  This adjudication will be performed to assess whether the events were due to a pre-
existing or unrelated condition, or were procedure-related, technique-related, and/or device-related. 
Regularly scheduled review/monitoring of all patient data will be conducted at the Data Coordinating 
Center, in part, for identification of adverse events and assurance that they are correctly reported to the 
DSMB and CEC. 
 
 

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12.2 
Adverse Event Reporting 
Adverse events are to be reported to the Data Coordinating Center using the appropriate eCRF.  In cases 
of adverse device effects or serious adverse events, completed forms should be submitted to the Data 
Coordinating Center as soon as possible upon knowledge of the event. 
The Data Coordinating Center will review the information submitted for possible reporting to the 
Sponsor.  The Sponsor shall, if required according to applicable regulations, report the event to the 
appropriate Regulatory Authority.  The Principal Investigator or designee will notify their IRB of 
applicable events according to institutional guidelines.  If indicated, all investigators and sites will be 
notified of applicable by the Sponsor. 
 
13.0 
Early Termination or Suspension of the Investigation 
Any decision to suspend enrollment or terminate the clinical study, either completely or at one or more 
clinical sites, will be made by the Sponsor and, if appropriate, the local IRB.  If a decision is made to 
terminate the study, all patients already treated will be followed for 60 months following the procedure.  
Regulatory authority(ies) and/or IRB(s) will be notified as required by local regulations. 
 
14.0 
Ethical Considerations 
The investigation will be conducted in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki and in compliance with ISO 14155, ICH GCP, 21 CFR 812, and any regional or 
national regulations, as appropriate. 
The investigator is responsible for obtaining approval of this clinical investigation by the relevant IRB at 
their associated institution and the clinical investigation will not begin until a favorable opinion of the 
IRB .The Sponsor must be provided with a copy of this approval prior to delivery of the study device.  
The investigator is responsible for complying with requirements imposed by an IRB and/or regulatory 
authority.  Furthermore, the Sponsor and the investigator will ensure that local regulations concerning 
data protection are followed. 
Written informed consent must be obtained from all patients, or the patients’ legally-authorized 
representative, in accordance with applicable regulatory requirements prior to enrollment in the study. 
 
15.0 
Publication Policy 
Publication policy, rights, and obligations for this investigation have been negotiated, detailed, and 
defined in the Investigation Contractual Documents with the investigation sites and investigators. 

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16.0 
Trial Administration and Investigators 
 
16.1 
Approvals and Agreements 
The Sponsor, national principal investigator, and the principal clinical investigators for each site shall 
agree to this document and any modifications.  A justification for any modifications will be documented.  
Approval and agreement will be indicated by signing and dating the appropriate document. 
 
16.2 
Investigators 
To see a complete list of the Sponsor, Manufacturer, Data Coordinating Center, and Monitor, along with 
their contact information, please refer to Appendix A.  A complete list of the national principal 
investigator, principal investigators and coordinating investigators, and core laboratory, along with their 
qualifications and contact information, will be updated and maintained by the Data Coordinating Center.   
 
16.3 
Insurance 
The devices are covered by the Sponsor’s product liability insurance, and a clinical investigation 
insurance policy will be taken out according to local requirements.  Insurance for the study will be 
obtained by the sponsor prior to patient enrollment.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX B – Written Procedures for Monitoring Investigations 
 
 
 
 
 

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

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

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o 
Informed consent/patient information has been documented in accordance with 
applicable regulations and expectations of local IRB; 
o 
The information recorded in the CRFs (paper or electronic) is complete, accurate, and 
legible; 
o 
There are no omissions in the CRFs of specific data elements, such as the 
administration to any patient of concomitant test articles or the development of an 
intercurrent illness; 
o 
Missing visits or examinations are noted; and 
o 
Patients failing to complete the clinical investigation and the reason for each failure 
are noted. 
 
F. 
Records of the monitor. 
The monitor shall prepare and maintain records of each initiation visit and each periodic visit, 
general site contact, or discussion.  These will include: 
1. 
Date, name and address of the investigator, and names of other staff members present at 
each meeting. 
2. 
A summary of the findings of the visit. 
3. 
A statement of any action taken by the monitor or investigator to correct any deficiencies 
noted. 
4. 
The monitor shall immediately notify the Sponsor of any conditions of non-compliance 
with the Clinical Investigation Plan, conditions of IRB or Regulatory Authority approval, 
or the applicable regulations. 
 
 
 
 
 
 
 
 
 

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APPENDIX C – Definitions 
 
 
 
 
 

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Adverse device event: 
Adverse event related to the use of an investigational medical device. 
Adverse event: 
 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device. 
 
Barb separation:  
 
 
 
Radiographic evidence of detachment of barbs from the stent strut.  
 
Calcification:  
Calcification will be graded based upon the following:  
• None:  Lack of calcification; 
• Mild:  Less than 40% circumferential calcification;  
• Moderate:  40-70% circumferential calcification; 
• Severe:  Greater than 70% circumferential.  
 
Clinical utility measures:   
Amount of contrast used during index procedure, radiation dose, procedure time, days to resumption of 
oral fluids, duration of ICU stay, days to discharge. 
 
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.  
 
 
 

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Device deficiency: 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or 
performance. Device deficiencies include malfunctions, use errors, and inadequate labeling. 
Disabling chronic obstructive pulmonary disease (COPD):  
 
 
Having a forced expiratory volume (FEV1) <1.0 liter or receiving home oxygen therapy. 
 
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.   
 
Estimated glomerular filtration rate (eGFR): 
A measure of kidney function based on serum creatinine, age, race, and gender that is used to determine 
stage of chronic kidney disease. 
 
Limb occlusion:  
 
 
 
The presence of thrombus within one or both graft limbs (including any legs and extensions) creating 
occlusion. 
 
Major complications: 
 
 
Occurrence of any of the following:  death, aneurysm rupture, or conversion to open surgical repair; 
renal failure requiring dialysis; bowel obstruction, bowel ischemia, or aorto-enteric fistula; stroke; 
paralysis. 
 
Medically intractable hypertension:  
 
 
 
Having a systolic arterial pressure >160 mmHg despite receiving medication. 
 
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 

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the institution’s upper limit of normal) in the absence of new pathological Q-waves or clinical evidence 
of a myocardial infarction with troponin greater than three times the upper limit of normal, as 
determined by the investigator. 
 
MI (Q-Wave): 
 
 
 
 
Post-procedure presence of new Q-waves greater than 0.04 seconds in at least two EKG leads. 
 
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. 
 
Occlusive disease of iliac arteries:  
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.  
 
Procedural duration: 
Incision time to closure time. 
 
Proximal sealing zone: 
Non-aneurysmal aortic segment from the distal margin of the SMA to the proximal extent of the graft.   

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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):  
 
 
 
 
 
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. 
 
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 (176.8 µmol/L) that does not spontaneously resolve (does not include those 
patients with a pre-procedure serum creatinine >2.0 mg/dl [176.8 µmol/L]).   
 
Severe adverse device event: 
 
An adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
 
Serious adverse event (SAE): 
An adverse event that: 
(a) led to death, 
(b) led to serious deterioration in the health of the subject, that either resulted in: 
(1) a life-threatening illness or injury, or 
(2) a permanent impairment of a body structure or a body function, or 
(3) in-patient or prolonged hospitalization, or 
(4) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function. 
(c) led to fetal distress, fetal death or a congenital abnormality or birth defect. 
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.  

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Technical success: 
 
 
Successful access of the aneurysm site and deployment of the Zenith® p-Branch™ endovascular graft 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.  
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. 
 
Treatment success: 
Technical success and freedom from all of the following at 12 months: 
• Type I or Type III endoleaks that require intervention post-discharge (including Type I and 
Type III endoleaks identified for treatment on the 12-month follow-up CT); 
• Aneurysm growth > 0.5 cm; 
• AAA related serious adverse events (i.e. death, rupture, or conversion to open surgical repair) 
as adjudicated by an independent CEC; 
• AAA-related major complications (i.e., renal failure requiring permanent dialysis; bowel 
obstruction, ischemia, or fistula; stroke with permanent deficit; or paralysis) as adjudicated 
by an independent CEC. 
 
Type Ia endoleak: 
 
 
 
A leak occurring at the proximal fixation zone of the stent-graft. 
 
 
Type Ib endoleak: 
 
 
 
A leak occurring at the distal fixation zone of the stent-graft. 
 
 
 

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Type Ic endoleak: 
 
 
 
A leak occurring at the distal fixation zone of the covered stents in the visceral vessels incorporated by 
the fenestrations.   
 
Type II endoleak: 
 
 
 
A leak caused by retrograde flow from patent lumbar arteries, inferior mesenteric artery, or other 
collateral vessels. 
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. 
 
Unanticipated serious adverse device event: 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified 
in the current version of the risk analysis report.