Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts
Phase: NA
Conditions: Thoracoabdominal Aneurysm, Abdominal Aortic Aneurysm
Sponsor: The Cleveland Clinic

  
  
Investigational Device Exemption 
G 010002 
 
Endovascular Exclusion of Thoracoabdominal 
Aortic Aneurysms or Abdominal Aortic 
Aneurysms Utilizing Fenestrated/Branched 
Stent-grafts 
 
 
 
 
 
Massachusetts General Hospital 
55 Fruit Street, WACC 440 
Boston, MA   02114 
Version:  1 JAN 2018 

  
  
1) REPORT OF PRIOR INVESTIGATIONS/BACKGROUND 
3 
2) INVESTIGATIONAL PLAN 
4 
a) 
Purpose 
4 
i) 
Intended Use 
4 
ii) 
Objectives 
4 
iii) 
Duration 
4 
b) 
Protocol 
5 
i) 
Study Design 
5 
ii) 
Inclusion Criteria 
5 
iii) 
Data Points 
8 
iv) 
Stent-graft sizing 
14 
v) 
Statistical Analysis 
13 
vi) 
Implant Procedure Description 
13 
c) 
Risk Analysis 
16 
i) 
Device Complications 
16 
ii) 
Anticipated Adverse Events 
18 
iii) 
Endoleaks 
20 
iv) 
Protection Against Risks 
20 
v) 
Deaths 
22 
vi) 
Explants 
24 
vii) 
Loss to Follow-up 
23 
viii) 
Study Population 
23 
d) 
Device Description 
25 
e) 
Monitoring 
28 
3) MANUFACTURING INFORMATION 
30 
4) INVESTIGATOR INFORMATION 
30 
5) IRB INFORMATION 
31 
6) SALES INFORMATION 
31 
7) LABELING 
31 
8) SUBJECT RECRUITMENT & INFORMED CONSENT 
32 
9) ENVIRONMENTAL IMPACT 
32 
10)  PROTOCOL AMENDMENTS 
32 

 
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APPENDIX A:  INFORMED CONSENT 
APPENDIX B:  CASE REPORT FORMS 
APPENDIX C:  RELEVANT PUBLICATIONS 
APPENDIX D:  DEVICE DESCRIPTIONS 
 

 
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1) 
Report of Prior Investigations/Background 
 
Endovascular repair of abdominal aortic aneurysms has become the dominant form of 
treatment for anatomically suitable patients.  Yet limitations to the technique are multiple 
and primarily relate to the complex morphologies of some aneurysms.  Although 
improvements of stabilizing features have been made, such as suprarenal stenting and 
the use of barbs, a segment of proximal and distal artery must adequately appose to the 
graft material and create a seal (defined as the neck).  In the absence of an adequate 
amount of infrarenal neck, we are unable to create an adequate proximal seal between 
the prosthesis fabric and the aortic wall to exclude the aneurysm from systemic pressures 
if conventional devices are employed.  Most endovascular devices require a minimum of 
15 mm of proximal neck below the renal arteries to ensure aneurysm exclusion.    
Although recent devices have been advocated for use in shorter necks (< 15mm), none 
have reported successful long-term outcomes.  Furthermore, data from the EVAR trails at 
10 years indicates that the stability of repairs in the setting of complex anatomy is 
questionable at best.  Prior devices that had been marketed for short proximal necks had 
significant complications, and post hoc analyses of studies as well as post market data 
have resulted in a revision of the guidelines to utilize the graft only in patients with necks 
lengths greater than 15mm (AneurRx).  Other strategies rely upon columnar support to 
mitigate the need for fixation and sealing in the aorta around the renal arteries.  The later 
grafts are stiff graft and contain longitudinal support structures in an effort to prevent 
migration.  Such devices are intended to “stand up” within the iliac arteries.  However, the 
applicability of rigid columnar support in the setting of aortic or iliac tortuosity is not valid.  
Consequently, it seems only logical for clinicians to strive to define a region of healthy 
vessel above and below the diseased (aneurysmal) artery to provide durable fixation and 
sealing.  Following the identification of such regions, the area intended to be excluded 
should then be inspected for arterial branches that supply critical organs with arterial 
blood, and those arteries must be incorporated into the repair.  This is the basis for 
fenestrated and branched aortic grafts.   
Open surgery has been employed for such aneurysms using techniques including 
supravisceral segment clamping, reimplantation of visceral arteries, and cardiopulmonary 
bypass.  However, in healthy surgical candidates at centers of excellence carry mortality 
rates of 10% or greater.  Statewide medicare audits estimated mortality for such 
procedures to be 19% at 30 days and 31% at 12 months.  Other complications, including 
respiratory, cardiac, renal and neurologic are frequent.  Many patients, particularly those 
over 70-75 years of age are never offered surgical repair and do not undergo aneurysm 
treatment.  Thus, the advent of endovascular technologies that result in a lower incidence 
of the aforementioned complications will allow the treatment of patients that historically 
have no surgical option, or in healthier patients diminish the exceptionally high surgical 
risks.   
 
 

 
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2) 
Investigational Plan 
a) Purpose 
i) 
Intended Use 
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the 
exclusion of abdominal aortic aneurysms involving critical branches, thoracoabdominal 
aortic aneurysms, iliac aneurysms, renal artery aneurysms S45 and SMA aneurysms S207.  
The evaluation shall be conducted with subjects considered to be “high-risk”, thus would 
be at risk for developing complications following open surgical repair.  Patients will be 
grouped in accordance with the anatomic extent of the aneurysm intended to be treated 
as follows: 
1) Patients with infrarenal or iliac disease in the presence of an infrarenal neck ≥ 3 
mm distal to the lowest renal artery are considered to have a juxtarenal 
aneurysm.   
2) Patients with aneurysms involving the origin or actual branch vessel including of 
the renals, superior mesenteric, or celiac arteries are considered to have a 
thoracoabdominal aneurysm.   
3) Patients with aneurysms involving the iliac artery or arteries in addition to an 
aneurysmal aortic segment are considered to have aortoiliac aneurysms 
potentially in addition to one of the two previous categories.   
The sealing zones of the device will exist proximal to the most cranial extent of the 
aneurysm and distal to the most distal extent of the aneurysm intended for treatment.  
Given that each of the three anatomic categories of patients will have markedly different 
expected outcomes when surgical procedures are utilized, they will be separately 
analyzed from the endovascular standpoint.  The methods by which the critical branches 
will be incorporated will include  fenestrations and side-arm branches. Please see section 
2d and Appendix D for more detailed information 
ii) Objectives 
The primary objective of the study is to assess the safety of the fenestrated/branched 
endovascular prosthesis in the prevention of aneurysm rupture in patients considered 
high-risk for open surgical repair.  Secondary analyses include an assessment of the risks 
associated with fenestrated/branch repairs with respect to cardiac, pulmonary, renal, 
neurologic and other complications.   
iii) Duration 
The duration of the investigation shall include a two year follow-up period for subjects that 
were treated with a fenestrated/branched endograft in a staged fashion or whose graft 
construction included a low-profile system including both nitinol stents and low-profile graft 
material.   Subjects shall be evaluated at pre-operative, operative, prior to hospital 
discharge, one, six (if considered medically necessary), twelve and twenty-four months.  
Subjects will be encouraged to continue follow-up thereafter given that the presence of 
extensive aneurysmal disease emphasizes the benefit of follow-up for the repaired 
segment as well as other regions of the arterial system that may be at risk for late 

 
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degeneration.  Remaining patients will be offered clinical follow up for the completion of 
the study with no data collection.    
 
b) Protocol 
i) 
Study Design 
This study will be a prospective, non-randomized evaluation of endovascular aneurysm 
repair with fenestrated/branched devices in high-risk patients. 
 
ii) Inclusion Criteria 
Patients will be considered suitable if they fulfill all of the Inclusion Criteria, which includes 
both general and anatomic criteria.  General inclusion criteria will be assessed during the 
initial patient evaluation.  Anatomic criteria will be assessed using a variety of imaging 
techniques that are routinely performed during the evaluation of abdominal aortic 
aneurysms. 
General: 
1) At least 18 years of age 
2) Not pregnant 
3) Willing and able to comply with two-year follow-up period 
4) Willing and able to give informed consent prior to enrollment 
 In case of urgent repair with a standard p-Branch device only, patient (if 
capable) or family member are acceptable to provide  informed consent prior 
to treatmentS229 
5) No known allergy to stainless steel, nitinol, or polyester. For patients getting a Low-
Profile device they may have an allergy to stainless steel as this is not a component of 
those grafts constructionss306.  
6) No history of anaphylactic reaction to contrast material with an inability to properly 
prophylax the patient appropriately. 
7) Life expectancy greater than two years (except for p-Branch protocol for ruptured 
aneurysms) 
8) High risk candidate for open surgical repair 
9) Presence of at least one of the following aneurysms is necessary to drive the need for a 
repair with a fenestrated/branched device: 
 i) An abdominal or thoracoabdominal or aortic aneurysm ≥ 4 cm or suggestive 
of a high risk of rupture as a result of morphology, growth history or 
symptoms 

 
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 ii) An Iliac aneurysm > 35 mm or suggestive of a high risk of rupture as a result 
of morphology, growth history or symptoms 
 iii) A renal artery aneurysm > 20 mm (or twice the diameter of native renal 
artery) S45 
iv)  An SMA aneurysm >30 mm S207 
Subsequent anatomic inclusion criteria refer to the anatomic extent of disease for the 
given patient. 
 
 
I.  Juxtarenal Aneurysms treated with Fenestrated devices  
(Subjects must meet ALL of the Anatomic Inclusion Criteria) 
1) Proximal neck length below distal most visceral artery to remain patent ≥ 3 mm and ≤ 
15 mm in lengthS# 322 
 
2) Proximal neck diameter ≤ 32 mm 
 
3) Proximal neck angulation ≤ 80° 
 
4) Iliac artery diameter ≥ 7 mm (anticipated diameter following balloon angioplasty, 
stenting, dottoring, or conduit) or ≥ 6 mm for patients receiving a Low-Profile devices306.  
 
5) Iliac angulation that will not preclude device delivery or surgical modification of the iliac 
system 
 
6) For a bifurcated or aorto-monoiliac prosthesis, the iliac implantation site(s) are ≤ 20 mm 
in diameter and ≥ 20mm in length 
 
7) For a straight aorto-aortic prosthesis, distal neck (normal aorta between the aneurysm 
and iliac bifurcation) ≥ 15 mm in length and ≤ 32 mm in diameter  
 
8)  If a hypogastric branch will be used to treat the common iliac aneurysm S34, S145, 
S232:  
a) the intended common iliac artery is > 20mm in diameter or the aneurysm has 
morphology concerning for rupture; and  
b) the intended distal fixation site within the internal iliac is ≤ 10mm in diameter.  
 
9) Renal arteries or other visceral vessels arising from the aorta in an orientation that is 
evident and measurable from cross-sectional imaging (CT or MR) 
 
 
II. Thoracoabdominal aneurysms treated with Fenestrated/Branched devices: 
(Subjects must meet ALL of the following) 
 
1) An absence of adequate aortic neck (≥ 3mm) below one or more critical aortic branches 
requiring a seal to be created above the lowest critical branch with a mating stent-graft 
designed in accordance with the use of reinforced fenestrations or side arm branches.   
 
2) Proximal neck diameter ≤ 40 mm and proximal neck length ≥ 10mm 
 

 
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VERSION:  4 JAN 2018 
 
 
3) Iliac artery diameter ≥ 7 mm (anticipated diameter following balloon angioplasty, 
stenting, dottoring, or conduit) or ≥ 6 mm for patients receiving a Low-Profile devices306. 
 
4) Iliac angulation that will not preclude device delivery or surgical modification of the iliac 
system 
 
5) For a bifurcated or aorto-monoiliac prosthesis, iliac implantation sites require ≤ 20 mm 
in diameter and ≥ 20 mm in length 
 
6) For a straight aorto-aortic prosthesis, distal neck (normal aorta between the aneurysm 
and iliac bifurcation) ≥ 10 mmS238 in length and ≤ 40 mm in diameter 
7) If a hypogastric branch will be used to treat the common iliac aneurysm S34, S145, S232 
a) the intended common iliac artery is > 20mm in diameter or the aneurysm has 
morphology concerning for rupture; and  
b) the intended distal fixation site within the internal iliac is ≤ 10mm in diameter.  
 
8) Renal arteries or other visceral vessels arising from the aorta in an orientation  that 
is 
evident and measurable from cross-sectional imaging (CT or MR) 
 
9) Visceral branch diameters (for incorporated vessels) between 4 mm - 11 mm at the 
intended distal sealing site (thus distal to a visceral artery aneurysm in such 
circumstances).  
  
10) > 5 mm of proximal visceral branch length to allow for a seal with the mated device, or 
the ability to exclude an early branch. 
 
A standardized branched device (p-Branch) may be used in place of custom Fen/Branch 
device if the patient meets criteria p-branch designs options A or B as defined below. 
III.  Specific Anatomic Inclusion Criteria for Standard p-Branch: 
(Subjects must meet ALL of the anatomic criteria in Option A or ALL of the 
anatomic criteria in Option BS207; for ruptured or symptomatic aneurysm, see 
Option CS235). 
 
A. Pivot Fenestration Option A (renal fenestrations come off at same longitudinal level)  
1) The celiac artery arises from the aorta between 11:30 – 1:30 with respect to the SMA 
position (20mm wide scallop that is 20mm deep). 
 
2) The SMA is ≥ 11 mm distal to the celiac artery (unless the celiac artery is occluded or 
expendable). 
 
3) Longitudinal positions of renal arteries arise 4.5 mm – 19.5 mm distal to the SMA. 
 
4) Radial measurements are calculated based on a clock position of the SMA at 12:00. 
The circumferential location of the right renal can range from 8:30 – 10:30 and the 
circumferential location of the left renal artery can range from 1:30 – 3:30 based on an 
assumed aortic stent graft diameter of approximately 30 mm. 
 
B. Pivot Fenestration Option B (left renal fenestration lower longitudinally than right)  
1) The celiac artery arises from the aorta between 11:00 – 2:00 with respect to the 
SMA position (30 mm wide scallop that is 16mm deep). 

 
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VERSION:  4 JAN 2018 
 
2) The SMA is ≥ 9 mm distal to the celiac artery (unless the celiac artery is occluded 
or expendable). 
3) Longitudinal position of the right renal artery arises 8.5 mm – 23.5 mm distal to 
the SMA. 
4) Longitudinal position of the left renal artery arises 12.5 mm – 27.5 mm distal to 
the SMA. 
5) Radial measurements are calculated based on a clock position of the SMA of 
12:00. The circumferential location of the right renal can range from 8:30 – 10:30 
and the circumferential location of the left renal artery can range from 1:30 – 3:30 
based on an assumed aortic stent graft diameter of approximately 30 mm. 
 
Rotational Option for Options A and B: The clock position of the right pivot 
fenestration is equivalent to the SMA fenestration's clock position minus 1 1/2 to 3 
1/2 hours. Thus if the SMA is at 1:00 vs. 12:00, the location of the right renal artery 
can arise at 9:30 - 11:30 vs. 8:30 - 10:30 and still be accommodated with this option, 
providing the longitudinal measurements' criteria are met. 
The circumferential location of the left pivot fenestration is equivalent to the SMA 
fenestration's clock position plus 1 1/2 to 3 1/2 hours. Thus if the SMA at 1:00 vs. 
12:00, the location of the left renal artery can arise 2:30 - 4:30 vs. 1:30 - 3:30 and still 
be accommodated with this option, providing the longitudinal measurements' criteria 
are met. 
 
C.  In the setting of a need for an urgent repair for ruptured or symptomatic aneurysm 
using a standardized p-branch device, the following criteria will be used for inclusion*: 
If the proximal neck has angulation <60 degrees (allowing for longitudinal 
repositioning of the device as the renals are cannulated), the range on the renal 
arteries is increased by one radius (7.5 mm) of the pivot fenestration.  In this light 
the renals will be as follows: 
Option A: Longitudinal positions of renal arteries arise: 3 mm proximal to the 
SMA to 27 mm distal to the SMA. 
Option B: Right renal: arises 1 mm to 31 mm distal to the SMA.  Left renal: 5 mm 
to 35 mm distal to the SMA. 
 
* Note: In certain situations, one may elect to occlude one of both renal arteries to 
allow for repair to be accomplished. 
 
The documentation of the inclusion criteria is located in subject’s study binder. 
 
 
iii) Data Points  
Data will be collected prospectively and recorded.  Case report forms (CRFs) will be kept 
electronically in a database (OmniComm Clinical software R042).  The case report forms 
allow for an extensive collection of data, some of which is pertinent to the study (white 
regions) and other portions are not relevant to the study (grey regions) but which may be 
useful for analysis of other outcomes.  The CRFs include regions that are shaded grey 
(data that is not required for all enrolled patients) and unshaded segments (white) which 
includes data pertinent to the study analysis.   

 
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Preoperative Imaging:  The choice of axial imaging technique will be left up to the ordering 
physician.  However, a cross-sectional imaging study is mandatory, while angiography 
and intravascular ultrasound will be performed selectively as is currently done prior to 
infrarenal abdominal aneurysm repair. 
Follow-up Imaging:  The results of the endovascular repair will be assessed by radiologic 
and/or clinical criteria at the time of graft placement, prior to hospital discharge, and at 
follow-up approximately 1, 6 (optional S128), 12 and 24 months post implantation, according 
the imaging schedule listed below.  Follow-up studies of devices that are primarily 
constructed of stainless steel will include CT imaging.  Nitinol devices that provide 
acceptable signal-voids with MRI studies can be imaged with that modality. 
Imaging Schedule for IDE G# 010002: 
 
A) Angiography will be performed selectively.  MR may be substituted depending on 
physician preference 
B) These studies may be obtained prior to hospital discharge or within the 1 month follow-
up window S187 
C) 6 month studies are optional and generally indicated in the presence of a concerning 
endoleak, or other factor that may warrant further evaluation S128 
D) Long term follow up (beyond 24 months) is not part of the study protocol.  Studies, 
following the initial 24 months, may be obtained  
 
Preoperative Data: 
Data will be collected and stored in a database.  The case report forms (CRFs) contain the 
information which we will be collecting.  In summary the focus of the data collection 
includes but is not exclusive to: 
  
1) 
Physical Exam  
2) 
Past Medical and Surgical History 
3) 
Family History 
 
Pre-op 
Intra-op 
Prior to 
d/c 
1 month 
6 month 
12 months 
24 month 
Yearly 
Surveillance 
CT Scan 
XA 
 
XB 
XB 
XC 
X 
X 
XD 
Angiography 
XA 
X 
 
 
 
 
 
 
KUB 
 
 
XB 
XB 
XC 
X 
X 
XD 
Ultrasound 
 
 
XB 
XB 
XC 
X 
X 
XD 
 

 
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4) 
Lab values 
5) 
Pulse Evaluation or ABI S6 
6) 
Current Medications 
7) 
Imaging studies 
 
Intraoperative Data: 
Data will be collected and stored in a database.  The case report forms (CRFs) contain the 
information which we will be collecting.  In summary the focus of the data collection 
includes but is not exclusive to: 
 
1) Date of Procedure 
2) Significant Times during procedure 
3) General Anesthesia Records 
4) Device information 
5) Details on Additional Procedures 
6) System Evaluations   
 
 
Pre-discharge Data: 
The interval between deployment of the endoprosthesis and discharge from the hospital 
will be documented.  The case report forms (CRFs) contain the information which we will 
be collecting.  In summary the focus of the data collection includes but is not exclusive to: 
 
1) Date of Discharge 
2) Physical Exam 
3) Lab values 
4) Incisional Status 
5) Pulse Evaluation or ABI S6 
6) Assessment of Adverse Events 
7) Relevant Imaging Studies  

 
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Follow-up Data: 
The case report forms (CRFs) contain the information which we will be collecting.  In 
summary the focus of the data collection includes but is not exclusive to: 
 
1)        Date of Examination   
2)  
Physical Exam 
3) 
Lab values 
5)  
Pulse Evaluation or ABI S6 
6) 
Assessment of Adverse Events 
7)  
Imaging Studies 
 
Deaths: 
 
Details of any deaths occurring during the evaluation will be stored in a database.  The 
case report forms (CRFs) contain the information which we will be collecting.  In summary 
the focus of the data collection includes but is not exclusive to: 
  
1) 
Date of Death 
2) 
Cause of Death (if available) 
3) 
Whether or not the Death was Device or Procedure Related 
4) 
Whether or not the Death was Related to a Previous Condition  
5) 
Whether or not an autopsy was performed 
 
Explants: 
 
Attempts will be made to obtain an autopsy in all patients who die at the treating center 
with prosthesis in place.  If possible, at the autopsy, the entire abdominal aorta will be 
excised – from the celiac axis down to and including both common iliac arteries.  The 
specimen will undergo histologic examination and be sent to the manufacturer to for 
further evaluation.   
 

 
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Data will be collected and stored in a database.  The case report forms (CRFs) contain the 
information which we will be collecting.  In summary the focus of the data collection 
includes but is not exclusive to: 
 
1) 
Date of explant 
 
2) 
Patient’s status at explant 
 
3) 
Reason for explant 
 
 
Loss to Follow-up or Patient Withdrawal:  
 
If a patient is lost to follow-up or decides to withdraw, data collected is stored in a 
database.  The case report forms (CRFs) contain the information which we will be 
collecting.  In summary the focus of the data collection includes but is not exclusive to: 
 
1) 
Date of last contact with patient 
 
2) 
Reasons for patient’s unavailability:  withdrawal, moved away, unreachable, and 
so forth 
 
3) 
Summary of attempts to contact patient 
 
 
iv) Stentgraft sizing 
Grafts may be custom made for each patient or utilize a standard design (p-branch) is 
chosen based on the findings from preoperative radiologic studies, including computerized 
tomography, magnetic resonance imaging, and possibly conventional angiography. Rarely 
will one patient have anatomy amenable to the use of a customized graft of another 
patient, but should measurements coincide, then the devices may be used accordingly. 
Stent-graft Diameter 
The diameter of the graft is generally 10 to 20 percent larger than the intended 
proximal implantation site.  The attachment site for distal implantation is oversized by 
5 to 15 percent.  The assumption being that a small amount of graft redundancy 
would be inconsequential, whereas, as small deficiency in the diameter of the graft 
would result in either endoleakage or graft migration. 
Determination of proximal graft diameter depends primarily on a measurement of the 
aneurysm neck from reconstructions based upon CT data.  Centerline of flow 
analyses are the current preferred method for sizing and planning, but in some 
circumstance and historically (when such techniques were not readily available) axial 
images were assessed.  In the setting of an elliptical appearance of the aorta axial 
images, the true profile may be assumed to be circular, and the true diameter is more 
closely approximated by the diameter of the narrowest part (short axis) of the ellipse.   

 
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Stent-graft Length 
Given the tension of the graft on the delivery system at the time of distal stent 
implantation, it is assumed that the graft will take the shortest path available from 
proximal to distal.  The primary imaging modality used to determine the length of the 
graft will vary depending on the tortuosity of the aorta and the availability of multiplanar 
reconstructions, surfaced shaded displays, centerline of flow analyses and other 
representations of spiral CT, MR data, or angiographic images.   
Sizing for fenestrations and branches 
Visceral vessel anatomy and relative orientation adds a level of complexity to 
endovascular repair of aortic aneurysms.  The majority of this will be accomplished 
from data obtained from spiral CT scans.  Important characteristics include the 
relationship of the renal arteries, the distance between them and the superior 
mesenteric artery, as well as the relationship between the celiac and superior 
mesenteric artery.  The radial orientations of the aortic branches are expressed as 
clock positions assuming noon to be the most anterior location on the aorta.  These 
will be assessed using cross-sectional images or centerline of flow reconstructions 
when available.  In general, fenestrations will be placed as closely as possible to the 
target vessel, while sidearm branches will terminate 1-2 cm above or below the target 
branch (downward and upward going branches respectively).  Pivot fenestrations are 
intended to have the larger circumference overlap with the target branch.   
v) Statistical Analysis 
The subject data will be collected and descriptive statistics shall be preformed to assess 
safety.  Mortality will include all-cause mortality and aneurysm related mortality analysis.  
The latter is defined by any death within 30 days of the index procedure, secondary 
intervention, or death related to the target aneurysm repair.  Given the absence of a 
comparison group (control group), there is no definitive cutoff point describing safety or 
efficacy for the study.  Instead, the data with respect to mortality, and other complications, 
will be tabulated throughout the 2 years of the study, and over longer follow-up durations 
when data is available.  Data will be tabulated and submitted to the FDA as part of the 
annual progress report.   
 
vi) Implant Procedure Description  
The procedure will be performed in the operating room under local, epidural, or general 
anesthesia depending on patient factors.  The patient will be positioned on a radiolucent 
operating table to permit fluoroscopic examination of the entire abdomen and groins.  A 
high-resolution digital imaging system is required to guide placement.  Several 
publications have described the various implantation techniques in detail.  The 
fundamentals of the procedures are highlighted here with respect to the method by which 
the branch artery will be incorporated: 
1) Conventional fenestration device:  the visceral segment of the graft is 
deployed and aligned with the target arteries.  Access into the aortic graft 
from an alternative site (contralateral femoral, iliac, or brachial) is achieved, 
and the target fenestration is selectively cannulated.  The target visceral 
vessel is then cannulated through the fenestration, and a reasonably stiff wire 
is placed into the fenestration.  A sheath is advanced into the target artery, 

 
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and the mating stentgraft is positioned within the sheath to join the target 
artery with the aortic stentgraft such that 3-4mm of the mating stentgraft 
protrudes into the aorta.  The sheath is withdrawn, and the mating stentgraft 
is deployed on a balloon sized to the target artery.  A larger balloon is then 
used to flare the proximal (aortic) component creating a rivet like seal.  This is 
repeated for each fenestration, and then the required mating components are 
inserted to mate with the visceral component to complete the repair.   
2) Preloaded fenestrated device:  In this situation, one or more fenestrations are 
preloaded with a wire that transcends the delivery system.  Preloaded 
fenestrations can be accessed in a conventional manner (as above) or with 
the use of the preloaded wire (ipsilateral to the main device).  In the later 
situation, a sheath is advanced over the preloaded wire and positioned near 
the target fenestration after the aortic component is oriented and partially 
deployed.  A second catheter and wire within the sheath is then used to 
access the target vessel.  Once all of the target vessels have been 
cannulated, the preloaded wire is removed and the sheath is advanced over 
a wire into the target artery.  The mating stentgraft is deployed as described 
above. This is repeated for each fenestration, and then the required mating 
components are inserted to mate with the visceral component to complete 
the repair. 
3) Side-arm branches:  Generally one or more of the side-arm branches have 
preloaded wires. This is retrieved from an alternative access site, and a 
sheath is advanced from that location over the preloaded wire into the target 
branch.  A second catheter and wire is then used to cannulate the target 
vessel from within the branch, and a stiff wire is introduced.  The sheath is 
advanced into the branch if necessary (requiring removal of the preloaded 
wire) or a mating self-expanding or balloon-expandable stentgraft delivery 
system can be advanced into the target artery.  The mating stentgraft is 
deployed and ballooned if necessary. This is repeated for each branch, and 
then the required mating components are inserted to mate with the visceral 
component to complete the repair. 
4) Fenestrations and side-arm branches: In some instances in which the graft 
design incorporates both fenestrations and side-arm branches, pre-loaded 
wires simultaneously incorporate both a fenestration and side-arm branch 
S306. These designs are utilized as outlined above with the fenestration  being 
accessed as a preloaded fenestration and the side-arm branch being 
accessed from a remote vessel as a preloaded branch.  
Grafts may be inserted from either femoral artery with consideration given to the degree of 
tortuosity and occlusive disease noted from preoperative imaging techniques, and 
adjunctive iliac procedures include, but are not limited to, angioplasty, stenting, 
stentgrafting or conduit placement.  Patients are anticoagulated during the procedure, and 
when available activated clotting times are used to monitor the anticoagulation 
intermittently throughout the procedure.  Angiography, selective arterial catheter 
placement or fusion imaging techniques may be used to help locate the visceral arteries.  
Correct positioning of the prosthesis depends on the relationship of the imaging system to 
the patient.  The aortic visceral component is advanced to bring the metallic stents to the 
desired location.  The position of the graft, as indicated by the position of the proximal and 
distal stents, can be modified during deployment by manipulation of the delivery system. 
Once the proximal aspect of the graft is in the appropriate location, markers on the 
fenestration of the graft would be aligned with the orifice of the visceral vessel to be 
treated.  The graft is then partially deployed.  Because of the proximal and distal fixation of 

 
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the endograft to the delivery device, the whole system can be rotated, or realigned with the 
visceral vessel, after partial deployment.  The fenestrations or branches are then mated 
with the target artery as described above.  Following access into each of the target 
arteries, the aortic component is allowed to expand fully by removal of the constraining 
wires.  Several different possible designs exist, thus some flexibility in the deployment 
sequence is allowed and may be customized for each patient.  The proximal (when 
necessary) and distal portion (potentially using additional components) is then completed.  
These include thoracic grafts, aortic cuffs, distal bifurcated components, hypogastric 
branch components, or customized one-piece designs with the bifurcation portion of the 
device incorporated into the fenestrated/branched portion.  Additional stents or stentgrafts 
may be required to ensure adequate end-organ perfusion and the elimination of sac 
pressurization and endoleaks.   
In certain situations, there may be a need to block off a fenestration in the prosthesis 
following implantation.  This can occur in one of two circumstances:1) planned - in 
the setting of a ruptured or symptomatic aneurysm where an off-the-  shelf device 
is utilized and the patient has only one kidney that can be incorporated into the 
repair, the non-relevant fenestration may be required to be occluded. 
2) unplanned - in the setting of an inability to cannulate the target artery after the  
fenestration is cannulated, the fenestration may be required to be occluded. (note:  
this is considered to be a technical failure in such a case). 
  
Occlusion of a fenestration is accomplished using different methods.  When the 
fenestrations are longitudinally disparate, a conventional aortic extension may be used to 
cover a fenestration.  If that is not possible a modification to a covered branched stentgraft 
(Atrium or Jomed) may be used.  In this manner the balloon expandable stent is placed 
over a wire that is through the fenestration, but not in the target artery (that cannot be 
cannulated).  A long stent is utilized (usually 38mm).  A balloon is then placed over the 
wire and the stent is mounted on the balloon such that the proximal portion of the stent 
extends beyond the tip of the balloon on the wire.  One or more sutures are used to tie the 
proximal end of the stent (proximal to the balloon) which will prevent it from expanding 
(forming a blind-end over the wire, the wire hole will likely occlude).  The balloon stent 
combination is advanced through a sheath into the fenestration such that the tied tip of the 
stentgraft is distal to the fenestration, and the portion mounted to the balloon is within the 
fenestration.  The balloon is then inflated locking the stentgraft within the fenestration, 
leaving the blind end distal to the fenestration.  The in-fenestration portion of the occluding 
stentgraft may then be flared as needed.   
 
In certain situations, such as extensive aortic aneurysms, it is necessary to stage 
procedures with placement of a portion of the stent graft system in one surgical setting and 
placement of another component in a planned second stage. Many of these first stage 
procedures are performed with commercially available devices. It is intended that the 
patient will be considered “enrolled” in this current evaluation when the first non-
commercially available device is attempted to be inserted S263.  In order to better capture 
the outcomes of overall complex aneurysm repair, the subjects who are treated only with 
commercially available devices in their first stage of repair will be a part of a parallel 
registry until the investigational device is implanted at the second stage of repair.  
 
For this registryS315: 
• 
Subjects will be consented prior to the first stage of their procedure 
• 
The data for the first stage will be captured in a separate database and will be 
collected from the subjects medical records 
• 
Subjects will be followed after the first stage as per routine standard of care prior to 
the fenestrated/branched endograft placement 
• 
Subsequent follow-up intervals will be based on the date of the procedure when the 
investigational device is implanted 

 
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VERSION:  4 JAN 2018 
 
• 
Reports will include information on all patients enrolled in the study, regardless of 
whether they have had the investigational device implanted; however, reports for 
patients that have not had the investigational device implanted will be relatively limited 
until they receive the investigational device as compliance with the IDE follow-up 
protocol is not required until after the investigational device is implanted. 
 
Perioperative Care 
The endovascular method calls for no departure from the usual perioperative 
management of patients undergoing aneurysm repair.  The preoperative evaluation and 
intraoperative monitoring will be performed as though the patient was undergoing 
conventional repair or commercial endovascular repair appropriate to the status of the 
patient and their co-morbidities.  Post-operative management will be dictated by clinical 
circumstances, and is likely to differ somewhat from the usual management of patients 
following aneurysm repair, because the patients tend to experience fewer physiologic 
derangements. 
 
c) Risk Analysis 
There are several areas of risk which may be categorized as follows; device 
complications, adverse events and endoleaks. 
i) 
Device Complications 
 1) Delivery Issues 
 
Failure to traverse the iliac arteries 
 
Improper alignment of stentgraft 
 
Failure to deploy the stentgraft 
 
Difficulty with delivery system removal 
 
Failure to access target vessel (this may or may not be related to device) 
                    
  2) 
Graft Integrity Issues 
 
Migration 
 
Stent fracture Suture breakage identified as a type III endoleak 
 
Graft material degradation 
 
Early Graft infection (occurring within 1 year from the procedure) 
 
Component separation  

 
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VERSION:  4 JAN 2018 
 
ii) Anticipated Adverse Events 
There are several categories of anticipated adverse events; cardiovascular, pulmonary, 
renal, bowel, wound, neurologic and vascular. 
The involvement of visceral vessels within the confines of the endograft places these 
vessels in jeopardy should there be any migration or other stentgraft complications.  One 
considerable risk includes early or late occlusion of the involved visceral vessel.  
Dissection of the distal aspect of the vessel is possible during the initial implantation of the 
stent, and may predispose to occlusion.    Other causes of visceral vessel occlusion may 
include mal-alignment of the aortic component, severe angulation within the visceral 
segment, a size mismatch between visceral vessel and the mating device used, 
progression of atherosclerotic disease or the development of neointimal hyperplasia. 
 
Pre-existing conditions at admission are not considered adverse events for the purpose of 
the study analysis (e.g. home oxygen therapy prior to admission).  Additionally, common 
standard of care practices are excluded as adverse events.    
Anticipated Adverse Events: 
Cardiovascular: 
 
Myocardial Infarction 
 
Congestive Heart Failure 
 
Arrhythmias which require new medication or treatment  
 
Cardiac ischemia requiring intervention 
 
Medically intractable hypertension (excludes patients with these conditions 
pre-procedure) 
Pulmonary: 
 
Respiratory insufficiency/failure (excludes patients with these conditions pre-
procedure) 
 
Pneumonia requiring antibiotics 
 
COPD (excludes patients with these conditions pre-procedure) exacerbation 
 
Anaphylactic reaction 
 
Sepsis 
 
Post implant syndrome – including fever, leukocytosis, back pain, anorexia 
and fatigue 
Renal: 
 
Creatinine rise > 30% from baseline on two or more follow-up tests. 

 
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This includes creatinine rise caused by renal infarct, renal ischemia or renal occlusion.  
Creatinine levels will be assessed at 2448 hours post-procedure or at discharge 
whichever occurs first.  If the first assessment is elevated, confirmatory test will be 
administered.  Both tests must show an elevated (outside the normal range) 
creatinine level in order to be considered an adverse event.  Transient creatinine 
elevations due to contrast loading or other factors without clinical consequence 
(normal renal function) are not expected to result in sustained creatinine elevations 
and therefore, are not considered adverse clinical events for the purpose of this study.  
Clinically significant renal injury, whether due to contrast, renal artery occlusion, renal 
perfusion defects, device manipulation or other procedure related causes are 
intended to be included.   
 
New renal artery stenosis 
 
New renal artery occlusions (unintended) 
 
Renal artery dissections 
Bowel: 
 
Perioperative bowel obstruction  
 
Bowel Ischemia resulting from the device or procedure 
 
Aorto-enteric fistula  
 
Paralytic ileus > 4days (excludes patients with these conditions pre-
procedure) 
Wound: 
 
Infection requiring antibiotic treatment 
 
Hernia 
 
Lymph fistula 
 
Dehiscence    
 
Necrosis requiring debridement (excludes patients with these conditions pre-
procedure)   
 
Hematoma 
Neurologic: 
 
Stroke (thrombotic or hemorrhagic).   
 
TIA 
 
Spinal cord ischemia/paralysis (excludes patients with these conditions pre-
procedure) 
 
Paraparesis   

 
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VERSION:  4 JAN 2018 
 
Vascular: 
 
Limb thrombosis   
 
Venous thrombosis 
 
Distal embolization resulting in tissue loss or requiring intervention.   
 
Claudication (excludes patients with these conditions pre-procedure) 
 
Pseudo-aneurysm 
 
Acute visceral vessel occlusion 
Misplacement of the visceral segment of the endovascular graft will result in malalignment 
of some or all of the visceral vessels.  If this precludes adequate end organ perfusion, then 
attempts should be made to re-establish flow through the target artery.  Considerations will 
include additional endovascular techniques, extra-anatomic bypass procedures or open 
surgical conversion.  These must be tailored to the patient specific comorbidities. 
 
Chronic visceral vessel occlusion 
Should graft migration occur, stenting of the fenestrated vessel prove impossible, or late 
vessel thrombosis occur as a result of distal disease, progressive atherosclerosis, 
restenosis, or simply an acute thromboembolic event, it is possible that a visceral vessel 
will become occluded remote from the acute endograft implantation time.  Although the 
event may happen and present acutely, it will be consider a chronic visceral vessel 
occlusion if it occurs > 30 days from the index endograft implantation.   
 
Visceral vessel dissection 
Dissections detected either acutely or chronically will be treated in the presence of flow 
limiting lesions primarily using distal stenting techniques.  If these prove impossible, the 
involved visceral vessels will be either observed or treated operatively with a distal bypass 
approach. 
 
Other vascular injury ( other procedure related causes) 
 
Aneurysm leak or rupture 
 
Increase in aneurysm size by more than 0.5 cm relative to smallest of any 
prior measurement   
 
Coagulopathy 
 
Impotence 
Pain: 
 
Groin 
 
Abdominal 
 
Back 

 
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VERSION:  4 JAN 2018 
 
 
Extremity (not defined as claudication) 
 
Hemtologic: 
 
Hemorrhage 
 
Hypercoagulation 
 
Anemia 
 
Sepsis 
 
DIC 
 
Need for transfusions 
Genitourinary (GU): 
 
Infection (UTI, bladder, kidney) 
 
Urethral trauma (unable to void, hematuria, etc.) 
 
iii) Endoleaks 
 
Type I 
 
Type II 
 
Type III 
 
Type IV 
 
Type Unknown 
 
iv) Protection Against Risks 
Previous clinical and animal experience (in compliance with the Good Laboratory Practice 
regulations) has been used to achieve the following goals: 
 
Improve the delivery system 
 
Develop an adequate insertion and deployment technique 
 
Determine methods to treat complications 
 
Improve patient selection 

 
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VERSION:  4 JAN 2018 
 
It is hoped that, guided by experience, the above directions will make the endovascular 
treatment of aortic aneurysms safer and more effective than open surgical repair.  Steadily 
improving results suggest this to be the case. 
 
Potential benefits to the subjects and alternative treatments 
The benefits offered to high risk patients are straight forward, as they have few 
reasonable alternatives available to them, if any at all. The best method to evaluate 
these benefits is to compare the potential alternative treatment modalities to that of 
endovascular repair. 
 
Observation 
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 patients’ longevity.  All patients eligible for 
inclusion in this study have a high risk of rupture, based primarily on aneurysm size or 
specific morphology.  Once the aneurysm has ruptured, it is usually too late to 
consider treatment in this patient sub-group as most will die, however some of the 
newly developed techniques can be employed in the setting of emergent/urgent 
situations and will be tracked in accordance with their presentations. 
 
Conventional surgery 
Conventional repair of abdominal aortic aneurysms is highly effective at preventing 
aneurysm rupture.  However, it is associated with a significant degree of 
cardiopulmonary complications as a result of a prolonged abdominal operation, 
significant blood loss and aortic cross clamping.  High risk patients are defined as 
such because they do not have enough cardiopulmonary reserve to withstand 
traditional therapy.  Despite the potential for the development of bowel obstructions, 
graft infections, occlusions and paraanastomotic aneurysms, the long-term risks of 
open surgical repair are small.  The initial physiologic insults are significant and 
difficult to quantify.  A prospective multi-center review involving 666 aneurysm patients 
calculated a 15 percent risk of cardiac complications, 8.4 percent risk of pulmonary 
issues, and 6 percent risk of postoperative renal dysfunction.  However, these risks 
were noted to be both surgeon and institution dependent.  We presume the 
complications to be more significant for aneurysms involving or in close proximity to 
the visceral vessels. 
 
Endovascular repair 
In theory, endovascular repair minimizes the physiologic stress of surgery by avoiding 
aortic cross clamping and celiotomy.  There is now an increasing body of data to 
support that assumption.  The reported lower incidence of cardiopulmonary 
complications noted with endovascular repairs has the potential to significantly benefit 
patient care.  There is significant evidence to support the assumption that aneurysms 
considered to be excluded based upon CT, angiographic, or ultrasound criteria, have 
a low risk of rupture.  However, aneurysm rupture following endovascular repair can 

 
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VERSION:  4 JAN 2018 
 
occur, but generally this is only in the setting of sac reperfusion as a result of device 
migration, the development of an endoleak, or a device integrity problem resulting in 
sac repressurization.  Therefore, a patient without evidence of endoleak can be 
considered effectively treated, but must be followed for evidence of any of the above 
factors that may predispose to rupture.    The risk of these problems developing is 
likely more than that of a conventional repair with an infrarenal device, simply due to 
the greater number of components.  However, the ability to treat to healthy aorta and 
incorporate branches should provide greater proximal and distal stability of the device.   
 
v) Deaths 
Details of any deaths occurring during the evaluation will be collected.  Data points 
include but not limited to: 
 
Immediate cause of death 
 
Underlying cause of the fatal condition 
 
Related to the prosthesis 
 
Related to the procedure 
 
Related to a previous condition 
 
Status of the prosthesis at the time of death 
 
 
vi) Explants 
An autopsy will be requested in all patients who die with an IDE device in place.  At 
the autopsy, the entire abdominal aorta will be excised – from the celiac axis down to 
and including both common iliac arteries.  The specimen will undergo histologic 
examination. 
When 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 care 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 will be fixed in 4% formaldehyde for subsequent histologic examination.  
Data will be collected and stored in a database.  Data points include but not limited to: 
 Date of explant 
 
 Subject’s status at explant 
 
 Reason for explant 
 
 Degree of attachment / ingrowth 
 

 
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VERSION:  4 JAN 2018 
 
vii) Loss to Follow-up 
If a patient is lost to follow-up, the following information will be recorded: 
 
Date of last contact with patient 
 
Reasons for patient’s unavailability:  withdrawal, moved away, unreachable, 
and so forth 
 
Summary of attempts to contact patient 
 
Name and address of any physician who is following the patient 
 
viii)  Study Population 
Characteristics 
The study population shall consist of female and male subjects, of at least 18 years of 
age, with aneurysmal disease of the aorta. There is no maximum age; however, 
patients must have an approximated life expectancy greater than 2 years (except in 
the setting of emergent or urgent repairs). Racial and ethnic origin is not an issue in 
this study. In addition, subjects enrolled shall be high risk candidates for open surgical 
repair and have anatomies unsuitable for currently marketed endovascular stent-
grafts.   
Prior to enrollment, all subjects shall undergo a general medical evaluation to assess 
co-morbidities and risk factors associated with aneurysmal disease.  All subjects shall 
undergo preoperative imaging evaluation. 
 
Number of Subjects 
Up to  1440 S323subjects shall participate in the study.  Subject enrollment shall occur on a 
rolling basis. 
 
d) Device Description 
Complete device descriptions are available in Appendix D. In general, devices included in 
this study include: 
1. Custom designed implants constructed with fenestrations and/or side-branches. 
2. p-Branch device S207 
3. Low-Profile custom designed implants constructed with fenestrations and/or side-
branches S306 
4. Hypogastric branch components which include standard helical hypogastric 
branched device abnd the Bifurcated-Bifurcated hypogastric branched device S145 

 
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VERSION:  4 JAN 2018 
 
The devices utilized in the study are considered custom implants with the exception of 
standard p-Branch devices S207 and hypogastric components S34, S145. The stents are made 
with T-304 stainless steel and nitinol and there are no likely biocompatibility issues related 
to the stent.  The directional branch device S37, hypogastric branch device and p-Branch 
devices are made with combination of both stainless steel and nitinol with no likely 
biocompatibility issues. The graft material is twill woven from Micrel polyester yarn or 
Polyethylene terephthalate [PET] fabric. The Low-Profile (LP) devices are constructed with 
nitinol stents and the same polyester yarn as the standard configuration, but it is more 
densely and tightly woven S306. Biocompatibility issues are unlikely. 
Vessels that will be incorporated into the repair will be addressed with the use of a variety 
of methods including fenestrations and side-arm branches.Descriptions of the device 
attributes are as follows: 
1) Fenestrations: These are circular, elliptical, or hemi-oval openings in the graft 
fabric.  These are intended to be aligned with the target vessel.  The fenestration 
and the target artery are mated with a balloon expandable stent or stentgraft to 
maintain patency of the vessel and to prevent an endoleak (when mating 
stentgrafts are utilized).  In some cases large fenestrations or hemi-ovals are 
aligned with the target arteries, but do not require additional stenting to maintain 
vessel patency. 
a. Initially fenestrations were simply cut into the fabric and mated with the 
desired stent to adjoin the aortic component with the target vessel. 
b. The addition of a support ring around the fenestrations was employed to 
improve the sealing between the mating stentgraft and aortic device, as 
well as to control the intentional fabric defect over time.  These are 
termed reinforced fenestrations S37. Fenestrations are termed “small 
fenestrations” or “large fenestrations.” Small fenestrations are 6-8 mm in 
height and 6 mm in width, while large fenestrations by be up to 12 mm in 
height and 12 mm in width S239. Fenestrations may be constructed to be 
strut free. Mulitple fenestrations are permissible on a supporting aortic 
stent graft to accommodate any number of visceral vessels S306. 
Radiopaque markers are used to outline the edges of the fenestrations.  
c. Modifications of the fenestrations were made over time to provide a 
means to cannulate the target vessels when exact alignment is not 
possible or in an effort to avoid customization delays.  These 
fenestrations involve the use of a cone-shaped section of fabric around 
the fenestration providing a range for the target vessel equal to or in 
excess of the cone.  These fenestrations are termed pivot fenestrations 
(p-Branch fenestrations or p-Branch devices) S207. As with standard 
fenestrations, radiopaque markers are used to outline the edges of the 
fenestrations. 
2) Side-arm branches:  These are extensions of the graft from the main body of the 
device that are mated with a balloon-expandable or self-expanding stentgraft 
joining the aortic component and target artery.  The overlap segments of such 
branches may be external, internal or both with respect to the aortic component 
and will be from 6-8 mm in diameter S37, S306. Side-arm branches may be of helical 
shape or straight S306. Side-arm branches may be unsupported or supported with 
additional nitinol rings. 

 
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VERSION:  4 JAN 2018 
 
3) Devices may involve only fenestrations, only side-arm branches or a hybrid 
construct involving both methods of target branch incorporation. Approved 
configurations include multiple fenestrations; one directional branch and multiple 
fenestrations; two directional branches and multiple fenestrations; three 
directional branches and multiple fenestrations; or four directional branches with 
no fenestrations S306. 
4) Bridging Stents: Fenestrations and directional branches are mated with their 
target vessels using a variety of balloon expandable covered stents and/or self-
expanding covered stents. The approved bridging stents for specific device 
constructions are as follows: 
a. Reinforced Fenestrations S37, S55, S272, S284, S295: 
Jomed (Jomed International, Helsingborg, Sweden) stent-grafts 
Stent Diameter 
Stent Lengths 
4-9 mm 
17, 28, 38 mm 
6-12 mm 
17, 28, 38 mm 
 
iCast Stent Grafts (Atrium Medical Corporation, Hudson, NH) 
Stent Diameter 
Stent Lengths 
5 mm 
16, 22, 38 mm 
6 mm 
16, 22, 38 mm 
7 mm 
16, 22, 38 mm 
8 mm 
38 mm 
9 mm 
38 mm 
 
 
CCF Balloon Expandable COVERED STENT (Atrium Medical Corporation, Hudson, NH) 
Stent Diameter 
Stent Lengths 
5 mm 
32 mm 
6 mm 
32 mm 
7 mm 
32 mm 
8 mm 
32 mm 

 
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VERSION:  4 JAN 2018 
 
9 mm 
32 mm 
 
b. Side-arm 
branches 
(Hypogastric 
and 
Visceral/Renal): 
Side-arm 
branches designed to incorporate the hypogastric, visceral or renal  
arteries will utilize the following bridging stents:  
i. For 6 mm diameter directional branches: 
1. 7 or 8 mm Viabahn (Gore Medical, Flagstaff, AZ) stent 
graft S34 
2. 8 mm Fluencey stent graft (Bard Medical, Covington, 
GA) S39 
3. 7 mm Jomed stent graft S34 (must have ringed branch) 
4. 8 mm iCast stent graft S34, S55 (must have ringed branch) 
ii. For 8 mm diameter directional branches 
1. 9 or 10 mm Viabahn (Gore Medical) stent graft S34 
2. 10 mm Fluencey stent graft (Bard Medical) S39 
3. 9 mm Jomed stent graft S34 (must have ringed branch) 
4. 10 mm iCast stent graft S34, S55 (must have ringed 
branch) 
Often a number of commercially available devices are used in conjunction with the 
investigational devices to ensure the optimal result.  Examples include (but not limited to) 
the following S148: 
1) Surgical grafts used as conduits or to replace damaged femoral or axillary vessels 
2) Self-expanding or balloon expandable stents (examples include SMART stents, 
Zilver stents, Palmaz stents, Genesis stents, iCast stents, Viabahns, Fluency and 
others). 
3) Occluding devices such as coils or plugs 
4) Ancillary devices (examples include Cook TX2P/TX2D, Proform, Renu, 
Alphas316)and so forth 
In addition, when the use of the Low-Profile system is utilized for construction of the 
fenestrated/branched aortic device, the additional use of the Zenith TX2 Low Profile endovascular 
components may be utilized in order to provide a proximal or distal extension of the Low Profile 
fenestrated/branched component S306.   
 
 

 
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VERSION:  4 JAN 2018 
 
e) Monitoring 
Clinical Research Personnel to perform internal QA.  IMARC Inc., in conjunction with Cook 
Research, Inc, will assist with the monitoring of study records for adherence to the study 
protocol, adequacy of reporting, continued adequacy of facility and staff, and compliance 
with FDA requirements. 
 
HVI (Heart and Vascular Institute) Research  
 
Cleveland Clinic Foundation  
 
9500 Euclid Ave. 
 
Cleveland, OH  44195 
 
IMARC, Inc. 
 
22560 Lunn Road 
Strongsville, OH 44149 
 
Cook Research Inc. 
 
 
1 Geddes Way 
West Lafayette, IN 47906 

 
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VERSION:  4 JAN 2018 
 
 
3) Manufacturing Information 
The graft material for the device is manufactured and assembled by Cook, Inc. The device 
will be constructed, sterilized and loaded into the delivery system by Cook Medical, Inc, 
Cook Australia, or Cook Europe. The devices will be supplied to the investigators in the 
same manner (with respect to sterilization and packaging) as the remainder of the 
investigational devices in the IDE.  
 
Device Manufacturer: 
 
Cook Incorporated 
P O Box 489 
Bloomington, IN 47402-0489 
1-800-346-2686 
Cook Australia 
95 Brandl Street 
Eight Mile Plains 
Queensland  4113  Australia 
617 384 111 88 
William Cook Europe 
Sandet 6 
DK 4632 Bjaeverskov 
Denmark 
45 56 868686 
 
 
4) Investigator Information 
The study shall be conducted at the Cleveland Clinic Foundation by the following 
investigators: 
 
Matthew Eagleton, MD – SponsorS300, S326/Principal InvestigatorS276 R109 
Federico Parodi, MD S297 –  Principal Investigator R109 
Behzad Farivar, MD R109 
 
Roy K. Greenberg, MD – Sponsor/Principal Investigator (Historical) S300 
Tara Mastracci, MD – Co-Investigator (Historical) R038 
Daniel Clair, MD – Co-Investigator (Historical) R076 
Sean Lyden, MD – Co-Investigator (Historical) S324 
Eric Roselli, MD – Co-Investigator (Historical) S324 
Sunita Srivastava, MD – Co-Investigator (Historical) S324 
 
 
 
All investigators shall agree to conduct the investigation in accordance with the 
investigational plan, FDA regulations, and IRB guidelines and shall supervise all use of the 
investigational device involving human subjects and ensure that the requirements for 
obtaining informed consent is met. 
 

 
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VERSION:  4 JAN 2018 
 
 
5) IRB Information 
The protocol shall be evaluated and approved by the Institutional Review Board at the 
Cleveland Clinic Foundation prior to proceeding with the study. 
 
 
Institutional Review Board 
Alan Lichtin, MD – IRB Chairman 
Cleveland Clinic Foundation 
9500 Euclid Avenue, OS 1 
Cleveland, OH 44195 
 
(216) 444-5848 
 
 
6) Sales Information 
The device cost will approximately cover materials and labor for manufacturing.   The 
endovascular stent graft devices used as part of their medical care is billed to the subject 
and or his medical insurance S163.  
 
7) Labeling 
Sample Label: 
 

 
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VERSION:  4 JAN 2018 
 
8) Subject Recruitment & Informed Consent 
Patients referred for abdominal aortic aneurysm, thoracoabdominal aortic aneurysm, iliac 
aneurysm, renal artery aneurysm or SMA aneurysm repair will be assessed for 
acceptability into the study.  If they meet the clinical and anatomic criteria, the possibility of 
an endovascular repair will be discussed in the setting of a scheduled office visit.   
The investigator will review the patient’s history, physical examination, and radiographic 
studies prior to obtaining informed consent.  A written informed consent form will be 
obtained from the subject after the purposes of the study, the risks, expected discomforts, 
and potential benefits have been explained.  In case of urgent repair utilizing the standard 
p-Branch devices, the informed consent form may be signed by the subject (if able) or by 
a family memberS207.  Patients who speak English poorly will have the opportunity to 
discuss the procedure with the investigator through a translator.  The lack of an 
appropriate translator will be regarded as a barrier to informed consent, thus resulting in 
exclusion from the study.  Copies of the informed consent will be included in the study 
records.  Another copy will be given to the patient. 
 
9) Environmental Impact 
Devices shipped under the Investigational Device Exemption are intended to be used for 
clinical studies in which waste will be controlled or the amount of waste expected to enter 
the environment may reasonably be expected to be nontoxic. 
 
 
10) 
Protocol Amendments 
(1) Zip Plug addition, 4/9/2001: S1 
(2) Optional ABI or Peripheral Pulses at Follow-up, 2/6/2002: S6 
(3) Flexor Delivery System, 8/20/2002: S# unknown 
(4) Study Expansion- 50 additional patients, 2/20/2003: S13 
(5) Optional Purse String Tie, 5/29/2003: S# unknown 
(6) New CRFs and Introduction of Oracle Database, 12/2/2003: S# unknown 
(7) Hypogastric Branch Device Addendum, 4/19/2004: S34 
(8) Branch Technology, new CRFs, new devices, 7/6/2004: S37 
(9) Additional  Fluency Device, 8/31/2004: S39 

 
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VERSION:  4 JAN 2018 
 
(10)  New Co-Investigator, new CRFs, 9/21/2004: S40 
(11)  Modification of inclusion criteria to treat renal artery aneurysm, 3/9/2005: S45 
(12)  Addition of iCast Device, 9/29/2005: S63 
(13)  New Co-Investigators (Matthew Eagleton, Eric Roselli), 3/13/2006:S# unknown 
(14)  Study Expansion- 50 additional patients, 3/21/2006: S74 
(15)  New Co-Investigator (Sunita Srivastava) 4/3/2006: S# unknown 
(16)  Superflex delivery system to be used on TAA devices, 8/1/2006: S# unknown 
(17)  Addition of Polyurethane Vessel Dilators, 8/28/2006: S# unknown 
(18)  Optional Discharge Datapoints, 8/29/2006: S# unknown 
(19)  Study Expansion- 50 additional patients, 11/21/2006: S98 
(20)  Study Expansion- 50 additional patients, 7/17/2007: S114 
(21)  Study Expansion- 100 additional patients, 4/8/2008: S127 
(22)  Optional 6 month visit, 5/1/2008: S128 
(23)  New Co-Investigator (Tara Mastracci), 7/9/2008: S129 
(24)  Change of address for one manufacturing plant (Cook Australia), 9/22/2008: S133 
(25)  Study Expansion – 100 additional patients, 2/26/2009: S141 
(26)  Update in monitoring plan, 2/26/2009: S140 
(27)  Bifurcated-bifurcated (Bif-bif) Device Addendum, 3/20/2009: S145 
(28)  Cleveland Clinic Vascular Surgery Change of Address, 5/4/2009: S147 
(29)  Clarification of Use of Off-the-shelf Devices, 5/8/2009: S148 
(30)  Addition of Modified Iliac (Flexor) Component, 9/30/2009: S162 
(31)  Addition of ZHIS Curved Catheter, 11/16/2009: S164 
(32)  Study Expansion – 100 additional patients, 2/10/2010: S175 
(33)  Addition of Proform, 3/22/2010: S178 
(34)  Clarification of Trigger Wires, 3/29/2010: S179 
(35)  Change in Ultrasound Schedule, 8/12/2010: S187 
(36)  Addition of Preloaded Device, 9/13/2010: S189, S201 
(37)  Study Expansion – 20 additional patients, 11/3/2010: S195 

 
SPONSOR: MATTHEW J. EAGLETON M.D. 
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VERSION:  4 JAN 2018 
 
(38)  Addition of Spiral Trigger Wire, 11/5/2010: S194 
(39)  Change in IDE Title, 12/3/2010: S203 
(40)  Addition of p-Branch Device, 2/15/2011: S207 
(41)  Study Expansion – 100 additional subjects, 4/12/2011: S216 
(42)  Modified Hypogastric Branch Device, 5/18/2011: S219 
(43)  Addition of Spiral-Z Device, 7/22/2011: S226 
(44)  Revised General Inclusion Criteria, 9/1/2011: S229 
(45)  Modified Anatomic Inclusion Criteria for Hypogastric Branch Device,  9/29/2011: 
S232 
(46)  Modified Inclusion Criteria for Urgent p-Branch cases, 11/2/2011: S235 
(47) Clarification of Anatomic Inclusion Criteria re: landing zones, 1/12/2012: S238 
(48)  Clarification of large fenestration, 1/11/2012: S239 
(49)  Clarification of optional datapoint re: date of resumption of ambulation, 1/11/2012: 
S240 
(50)  Study Expansion – 130 additional subjects. 3/29/2012: S245 
(51)  Dr. Eagleton as Study P. I., 2/25/2013: S276 
(52)  Study Expansion – 100 additional subjects, 5/30/2013: S286 
(53)  Addition of Dr. Parodi as a Co-Investigator, 11/26/2013: S297 
(54)  Transfer of Sponsorship to Dr. Eagleton, 1/24/2014: S300   
(55)  Removing Dr. Mastracci, 7/29/2014: R038 
(56)  Database Transfer from Oracle Clinical to OmniComm, 9/29/2014: R042 
(57)  p-Branch distal diameter change to 22 mm: 10/13/2014, S304 
(58)  Updated IOP re: Reportable Events: 11/6/2014, S305 
(59)  Preloaded-Preloaded LP device addendum: 11/11/2014, S306 
(60)  p-Branch construction changes: 1/5/2015, S307 
(61)  Study Expansion: 1/1/2015, S308  
(62)  Study Expansion: 3/9/2015, S309 
(63)  Master Protocol reflecting the change approved in S309: 4/13/2015, S311 
(64)  Clarification of Study Enrollment – Additional Information for S311: 6/5/2015, S312 

 
SPONSOR: MATTHEW J. EAGLETON M.D. 
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VERSION:  4 JAN 2018 
 
(65)  Clarification of Study Enrollment and Staged Procedure Registry: 8/10/2015, S313 
(66)  Clarification of S313, Master Protocol Modification: 11/2/2015, S315 
(67)   Addition of Cook Alpha Device: 1/28/2016, S316 
(68)   Removing Dr. Clair: 2/23/2016, R076 
(69)   Study Expansion (additional 120 subjects, total 1340): 3/7/2016, S318 
(70)   Clarification of Proximal Neck Length for Juxtarenal Aneurysm Repair, S# 322    
(71) Study Expansion (additional 100 Subjects, total 1440): 5/1/2017, S323 
(72)  Removing Drs. Lyden, Roselli and Srivastava from the study: 6/6/2017, S324 
(73)   Dr. Eagleton leaving Cleveland Clinic on 12/15/2017, Dr. Parodi as PI, Dr. Farivar 
added as Co-investigator: 11/6/2017, S326 
(74) Fenestrated Device Group Final Report: 12/12/2017, R109