Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms
Phase: NA
Conditions: Thoracoabdominal Aortic Aneurysms
Sponsor: NYU Langone Health

 
 
Official Title: 
Visceral Manifold Study for the Repair of Thoracoabdominal Aortic 
Aneurysms   
NCT Number: 
NCT03246126 
Study Number: 
16-01441 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
November 17, 2020 
 
 

Clinical Protocol 
 
Visceral Manifold Study for the repair of thoracoabdominal aortic aneurysms 
 
Protocol Number: IP-01-001 Version 8 
 
Device:  Valiant™Thoracoabdominal Stent Graft System 
 
IDE Approval Date: March 21, 2017  
 
IDE Number: G170048 
 
 
 
 
 
 
 
 

 
 
 
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Title: Visceral Manifold Study for the repair of thoracoabdominal aortic aneurysms   
 
Protocol Number: IP-01-001 Version 8 
I confirm that I have read this protocol. I will comply with the protocol and the 
principles of Good Clinical Practice (GCP), as described in the United States Code of 
Federal Regulation (CFR) 21 Parts 11, 50, 54, 56, and 812 and the appropriate 
International Conference on Harmonisation guidance documents. 
 
 
 
Signature 
 
 
 
 
July 29, 2020 
Thomas Maldonado MD 
Principal Investigator 
 
Thomas S. Maldonado, MD 
New York University Langone Medical Center 
530 First Avenue, Suite 6F 
New York, NY 10016 
(212) 263-7311 
(212) 263-7472 (fax) 
Thomas.maldonado@nyumc.org 
 
 
  
 
 

 
 
 
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1. Table of Contents 
1. Table of Contents 
2. Protocol Synopsis 
3. Report of Prior Investigations 
3.1 Anatomy 
3.2 Pathophysiology 
 
 
3.2.1 Emergent/Urgent/Ruptured Aneurysms 
 
 
3.2.2 Type B Dissections 
 
 
3.2.3 Aneurysm with Renal Insufficiency 
 
 
3.2.4 Aneurysm with Small Branch Vessels <5 mm 
3.3 Treatment Options 
3.3.1 Medical Management 
3.3.2 Open Surgical Repair3.3.2.1 Open Surgical Repair of Ruptured, 
Urgent, and Emergent TAAAs 
 
3.3.2.2 Open Surgical Repair of Chronic Type B Dissections 
3.3.3 Endovascular Repair 
3.3.3.1 TAAA Repair with Parallel Grafts 
3.3.3.2 TAAA Repair with Sandwich Techniques 
3.3.3.3 TAAA Repair with Fenestrated Stent Grafts 
3.3.3.4 TAAA Repair with Cook t-Branch Stent Grafts 
3.3.3.5 TAAA Repair with Flow Diverting Devices 
3.3.3.6 Endovascular Repair of Ruptured, Urgent, and Emergent TAAAs 

 
 
 
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3.3.3.7 Endovascular Repair of Chronic Type B Dissections 
3.3.3.8 Staged Endovascular Repair 
 
3.3.3.8.1 Planned Staged Repair 
 
3.3.3.8.2 Bail-out Staged Repair  
3.3.3.9 Summary of Alternative Treatments 
3.3.3.9.1 Summary of Treatments for Staged Procedure or Staged 
Bail-out Procedure 
3.4 Benefits and Risks of Treatment Options 
 
 
3.4.1 Open Surgical Repair 
3.4.2 Endovascular Techniques 
 
 
 
3.4.2.1 Staged Procedures 
3.4.3 Stent graft designs 
3.4.4 Analysis of bridging stent characteristics 
3.5 Justification for Specific Patient Selection Criteria Relevant for this Study  
 
 
3.5.1 Rationale for Exposing Target Population to Potential Risks of Staging 
3.6 Device Descriptions and Drawings 
3.7 Potential Study Device Benefits and Risks Based on Leveraged Clinical Information  
3.8 Institution Experience and Infrastructure 
3.9 Report of Prior Investigations Synopsis  
4. Investigational Plan 
 
4.1 Purpose 
 
4.2 Intended Use 
 
4.3 Device Description  
4.4 Protocol 

 
 
 
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4.4.1 Description of Patient Population 
 
 
4.4.2 Eligibility Criteria 
 
 
4.4.3 Study Endpoints 
 
 
4.4.4 Follow-up Schedule 
 
 
4.4.5 Methods 
4.4.5.1 Case Planning 
4.4.5.2 Pre-operative procedures 
4.4.5.3 Implant Procedures 
4.4.5.4 Completion Procedures 
4.4.5.5 Post-operative Care 
4.4.5.6 Follow-up Visits 
 
 
4.4.6 Sample Size Justification 
 
 
4.4.7 Data Presentation and Analysis Plan 
 
 
 
4.4.7.1 Statistical Methods 
 
 
4.4.8 Limitations of the Study 
 
4.5 Risk Analysis 
4.5.1.1 Procedural-related risks  
 
4.5.1.2 Material-related risks 
 
4.5.1.3 Performance related risks 
 
 
4.5.2 Mitigation of Risks 
 
4.6 Data Management and Entry 
 
4.7 Reporting 
 
4.8 Oversight 

 
 
 
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4.9 Definitions 
5. Manufacturing Information 
6. Investigator Agreement and Certification 
7. IRB Information 
8. Amount to be charged 
9. Labeling 
10. Medicare Generalizability  
11. References 
 
 
 
 
 
 
 
 
 
 
 
2. Protocol Synopsis 

 
 
 
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Investigational Plan Synopsis 
Study Title 
 Visceral Manifold Study for the repair of thoracoabdominal 
aortic aneurysms.  
Investigational Devices 
  Valiant™ Thoracoabdominal Stent Graft System 
Sponsor/Principal 
Investigator  
Dr. Thomas Maldonado, MD 
Investigational Sites 
New York University Langone Medical Center  
Purpose   
The primary objective of the clinical investigation is to assess 
the use of the thoracic bifurcation and the visceral manifold 
to repair thoracoabdominal aortic aneurysms in patients 
having appropriate anatomy. The primary intent of the study 
is to assess safety (i.e. freedom from major adverse events 
(MAE) at 30 days) and preliminary effectiveness (i.e., 
treatment success and technical success) of the device (i.e., 
the proportion of treatment group subjects that achieve and 
maintain treatment success at one year).   

 
 
 
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Additionally, the study will assess technical success and 
treatment success at each follow-up interval. 
Number of Subjects 
15  (6 patients to be enrolled in primary arm, 9 to be enrolled 
in expanded arm) 
Study Type and 
Duration 
Prospective, single center, nonrandomized, multi-arm study.  
The duration of the Investigation is anticipated as follows: 
• Time to Complete Enrollment: 24 months 
• Subject Follow-up Time: 5 years from last subject 
enrollment 
• Total Duration Time: 7 years 
Intended  Use 
 The Valiant™ Thoracoabdominal Stent Graft System is 
indicated for the endovascular treatment of thoracoabdominal 
aortic aneurysm (Crawford Type 1,2,3, and 5) in patients 
with the following characteristics: 
• 
An aneurysm with a maximum diameter of > 5.5 
cm or 2 times the normal diameter just proximal 
to the aneurysm using orthogonal (i.e., 
perpendicular to the centerline) measurements 

 
 
 
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• 
Aneurysm with a history of growth > 0.5 cm in 6 
months  
• 
Saccular aneurysm deemed at significant risk for 
rupture 
• 
Symptomatic aneurysm greater than or equal to 
4.5 cm 
• 
Axillary or brachial and iliac or femoral access 
vessel morphology that is compatible with 
vascular access techniques, devices or 
accessories, with or without use of a surgical 
conduit 
• 
Proximal landing zone for the thoracic bifurcation 
stent graft that has: 
o ≥ 2.5 cm of  nonaneurysmal aortic 
segment including previously 
placed graft material (neck) distal 
to the left subclavian artery (LSA)  
o Diameter in the range of 26-42 mm 
o Adequate distance from the celiac 
artery, in order to accommodate 
cannulation from the antegrade 
access point when considering the 

 
 
 
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total deployed length of the 
thoracic bifurcation and visceral 
manifold 
• Iliac artery or aortic distal fixation site, including 
both native tissue and previously placed graft, 
greater than or equal to 15 mm in length and 
diameter in the range of 8 – 25 mm 
• Age: ≥ 18 years old 
• Life expectancy: > 1 year 
Primary Arm Inclusion 
Criteria 
A patient may be entered into the study if the patient has at 
least one of the following: 
• An aneurysm with a maximum diameter of > 5.5 
cm or 2 times the normal diameter just proximal 
to the aneurysm using orthogonal (i.e., 
perpendicular to the centerline) measurements 
• Aneurysm with a history of growth > 0.5 cm in 6 
months  
• Saccular aneurysm deemed at significant risk for 
rupture 
• Symptomatic aneurysm greater than or equal to 
4.5 cm 

 
 
 
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Other inclusion criteria 
• Axillary or brachial and iliac or femoral access 
vessel morphology that is compatible with 
vascular access techniques, devices or accessories, 
with or without use of a surgical conduit 
• Proximal landing zone for the thoracic bifurcation 
stent graft that has: 
≥ 2.5 cm of  nonaneurysmal aortic 
segment including previously 
placed graft material (neck)  distal 
to the left subclavian artery (LSA)  
o Diameter in the range of 26-42 mm 
o Adequate distance from the celiac artery, 
in order to accommodate cannulation 
from the antegrade access point when 
considering the total deployed length of 
the thoracic bifurcation and visceral 
manifold 
• Iliac artery or aortic distal fixation site, including 
both native tissue and previously placed graft, 

 
 
 
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greater than or equal to 15 mm in length and 
diameter in the range of 8 – 25 mm 
• Age: ≥ 18 years old 
• Life expectancy: > 1 year 
Primary Arm Exclusion 
Criteria 
General exclusion 
• Patient is a good candidate for and elects for open 
surgical repair 
• Can be treated in accordance with the instructions 
for use with a legally marketed endovascular 
prosthesis 
• Is eligible for enrollment in a manufacturer-
sponsored IDE at the investigational site 
• Unwilling to comply with the follow-up schedule 
• Inability or refusal to give informed consent by 
patient or legal representative 
• Urgent or emergent presentation 
• Patient is pregnant or breastfeeding 
• Patient has a contained rupture 
• Patient has a ruptured aneurysm 
• Patient has a dissection in the portion of the aorta 
intended to be treated 

 
 
 
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• Obstructive stenting of any or all of the visceral 
vessels 
• Poor performance status including two major 
system failures (cardiovascular, pulmonary, renal, 
hepatobiliary, and neuromuscular) 
• Prior aneurysm repair that would involve relining 
of the previously placed graft material requiring 
placement of the investigational system in a 
landing zone that expands beyond any limits of the 
previously placed graft material 
 
Medical exclusion criteria 
• Known sensitivities or allergies to the materials of 
construction of the devices, including nitinol 
(Nickel: Titanium), polyester, platinum-iridium, 
polytetrafluoroethylene (PTFE), platinum, gold, 
polyethylene, or stainless steel.   
• Known hypersensitivity or contraindication to 
anticoagulation or contrast media that cannot be 
adequately medically managed  
• Uncorrectable coagulopathy 

 
 
 
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• Body habitus that would inhibit x-ray visualization 
of the aorta or exceeds the safe capacity of the 
equipment 
• Patient has had a major surgical or interventional 
procedure unrelated to the treatment of the 
aneurysm planned < 30 days of the endovascular 
repair 
• Unstable angina (defined as angina with a 
progressive increase in symptoms, new onset at 
rest or nocturnal angina) 
• Systemic or local infection that may increase the 
risk of endovascular graft infection 
• Baseline creatinine greater than 2.0 mg/dL  
• History of connective tissue disorders (e.g., 
Marfan Syndrome, Ehler’s Danlos Syndrome) 
 
Anatomical exclusion criteria 
• ranch vessel diameter less than 5 mm 
• Thrombus or excessive calcification within the 
neck of the aneurysm 
• Anatomy that would not allow maintenance of at 
least one patent hypogastric artery 

 
 
 
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• Anatomy that would not allow primary or assisted 
patency of the left subclavian artery  
Expanded Use Arm 
Inclusion Criteria 
 
 
 
An expanded use arm of the study will broaden inclusion 
criteria to include patients with the following : 
• Branch vessel diameter <5mm 
• Urgent or emergent presentation 
• Patient has a contained rupture 
• Patient has a ruptured aneurysm  
• Patient has a type B dissection (subacute or 
chronic) in the portion of the aorta intended to be 
treated 
• Poor performance status including two major 
system failures (cardiovascular, pulmonary, renal, 
hepatobiliary, and neuromuscular)   
• Baseline creatinine greater than 2.0 mg/dL 
• Anatomy that does not allow maintenance of at 
least one hypogastric artery 
• Anatomy that does not allow primary or assisted 
patency of the left subclavian artery 
• Prior aneurysm repair that would involve relining 
of the previously placed graft material requiring 
placement of the investigational system in a 
landing zone that expands beyond any limits of 
the previously placed graft material 
• Obstructive stenting of any or all of the visceral 
vessels 
 

 
 
 
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Treatment of the patient population listed above will be 
considered for this expanded arm of the study if they are 
not a candidate for open surgical repair, cannot be treated 
with approved devices, and do not meet inclusion into the 
primary study arm as per opinion of the Principal 
Investigator, with the concurrence of the IRB.   
Primary Endpoint(s) 
The primary safety endpoint is freedom from major adverse 
events (MAE) at 30 days or during hospitalization if this 
exceeds 30 days. Major adverse events include death, bowel 
ischemia, myocardial infarction, paraplegia, renal failure, 
respiratory failure, and stroke. 
The primary effectiveness endpoint is the proportion of the 
study subjects with treatment success at 1 year.  Treatment 
success is defined as a composite of technical success and 
freedom from the following:  
• 
Aneurysm enlargement i.e., >5mm as 
compared to any previous CT measure using 
orthogonal (i.e., perpendicular to the centerline) 
measurements 
• Aneurysm rupture 
• Aneurysm-related mortality 
• Conversion to open repair  
• Secondary intervention for migration, Type I 
and III endoleaks, device integrity failure (e.g., 
fracture), and patency-related events (i.e., 

 
 
 
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device component stenosis or occlusion and 
embolic events) 
Secondary Endpoints 
Secondary endpoints include: 
• Technical success and the individual components of 
technical success:  
o Successful delivery 
o Deployment at the intended implantation site 
o Patency of all endovascular graft and stent 
components 
o Absence of device deformations requiring 
unplanned placement of an additional device  
o Absence of inadvertent covering of aortic 
branch vessels 
o Successful withdrawal  
• Freedom from the individual components of the 
primary safety endpoint at 30 days: 
o Death 
o Bowel ischemia 
o Myocardial infarction 
o Paraplegia 
o Renal failure 

 
 
 
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o Respiratory failure 
o Stroke 
• Freedom from paraparesis at 30 days 
• The following at each follow-up interval: 
o Treatment success and the individual components 
of treatment success including freedom from the 
following:  
­ Aneurysm enlargement  
­ Aneurysm-related mortality  
­ Aneurysm rupture 
­ Conversion to open repair 
­ Secondary intervention for migration, type 
I and III endoleaks, device integrity failure 
(i.e., fracture), and patency-related events 
(i.e., device stenosis or occlusion and 
embolic events).  
­ Renal failure 
­ All-cause mortality 
­ Endoleaks 
­ Device integrity failure (e.g., fracture) 
­ Patency-related events (i.e., device 
stenosis or occlusion and embolic events) 

 
 
 
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­ Other device-related events 
 
Follow-up Schedule 
Patients included in the study will undergo follow-up at one 
month, six months, twelve months and then annually for five 
years.   
Sample Size Justification 
The sample size for the feasibility study is limited to 15 
patients, as this is adequate to provide preliminary clinical 
safety data and effectiveness of the device.  6 will be 
enrolled in the primary arm of the study and an additional 9 
will be enrolled in the expanded use arm. The device, while 
novel, has been evaluated in a clinical setting and has 
initially demonstrated both safety and effectiveness1,2 The 
limited sample size allows adequate patient data to be 
collected under a controlled protocol without exposing a 
large patient population to the risk associated with a novel 
device design.  The safety and effectiveness data collected in 
this study will be pooled with other physician sponsored 
investigational device exemptions (PS-IDEs) evaluating the  
Valiant™ Thoracoabdominal Stent Graft System  and should 
be sufficient to develop an appropriate pivotal study 
Limitations to the Study 
Limitations of the study are that it is a single center study 
with a small patient population.   
Study Monitor 
Clinical Research Monitoring: Biomedical Research Alliance 
of New York,  

 
 
 
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1981 Marcus Avenue, Suite 210, Lake Success, NY 11042 
Study Oversight 
Data Safety Monitoring Board 

 
 
 
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3. Report of Prior Investigations (§ 812.27) 
3.1 Anatomy 
The aorta is the main artery that originates in the left heart chamber, ascends to the arch, 
and descends through the thoracic cavity and diaphragmatic muscle into the abdomen. The aorta 
gives a number of side branches throughout its trajectory from the mediastinum to the chest and 
abdomen. These branches include the coronary arteries, innominate artery, left common carotid 
artery, left subclavian artery, celiac axis (CA), superior mesenteric artery (SMA), renal arteries 
and inferior mesenteric artery (IMA) and various lumbar arteries. The aorta terminates at the 
aortic bifurcation where it divides into the common iliac arteries. Several smaller parietal side 
branches originate throughout the length of the aorta and include bronchial, intercostal, phrenic 
and lumbar arteries. A number of anatomical variants and accessory branches have been 
described. Approximately 15% to 30% of individuals have one or more accessory renal arteries. 
The hepatic arteries can originate as a separate branch from the aorta, or as replaced branches 
from the left gastric or SMA in 5% to 15% of individuals3. In addition to accessory or replaced 
anatomy, the diameter, location and angle of the visceral arteries have significant variation, 
which may have implications with respect to arterial hemodynamics.  
3.2 Pathophysiology 
Aortic aneurysm is a progressive disease characterized by structural deterioration, 
gradual expansion, and eventual potential for rupture of the aorta if left untreated. The definition 
of aortic aneurysm is a localized or diffuse dilatation encompassing all three layers of the aorta 
with diameter >50% larger than the expected normal aortic diameter.   

 
 
 
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An aneurysm which spans both the thoracic and abdominal cavities defines a 
thoracoabdominal aortic aneurysm.  The expansion rate of thoracoabdominal aneurysms ranges 
from 2-4mm per year and is not influenced by the size of the aneurysm at the time of 
diagnosis4,5.  The expansion rate of thoracoabdominal aneurysms does not appear to increase as 
individual aneurysms enlarge.  The presence of COPD and hypertension are factors associated 
with an increased rate of enlargement6,7.  Thoracoabdominal aortic aneurysms become a risk for 
rupture if they are above 5.5-cm in diameter or if they are less than 5.5-cm in diameter and are 
growing more rapidly than 0.5-mm in 6 months.  The 5-year survival of thoracoabdominal 
aneurysm patients ranges from 7-20% depending on the percentage of aneurysms secondary to 
aortic dissection5,8.  Half of the thoracoabdominal aneurysm deaths are attributed to rupture and 
the other half are due to some sort of comorbidity such as myocardial infarction.  The overall 
survival of thoracoabdominal aortic aneurysm patients is often overestimated, because the 
patients with advanced comorbid medical illness are not included and account for 46-68% of the 
patients reported in past natural history studies5,8-11.  Dissecting aneurysms have a higher rate of 
rupture and have a worse prognosis without intervention. 
Most patients with a descending thoracic or thoracoabdominal aneurysm do not have 
symptoms when first diagnosed9,12.  They are likely diagnosed with a CT scan for another 
disease.  Some patients have vague chest, back, flank, or abdominal pain.  The pain may increase 
in severity as the aneurysm enlarges, or it may be sudden due to rapid expansion and impending 
rupture.  Symptoms can result from compression of or erosion into adjacent intra-thoracic 
structures or bony thorax9,13,14.  Hoarseness from stretching or compression of the left recurrent 
laryngeal nerve, tracheal deviation, persistent cough, or other respiratory symptoms is sometime 

 
 
 
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seen.  Patients with a thoracoabdominal aortic aneurysm may have a palpable pulsatile mass in 
the upper abdomen.   
3.2.1 Emergent/Urgent/Ruptured Aneurysms 
A ruptured aneurysm is either an emergent or urgent situation and many times is fatal 
carrying an overall mortality rate of 90%.  Ruptures present in many different ways.  One study 
states that 80% of ruptures present as a retroperitoneal rupture3.  A retroperitoneal rupture can 
lead to slow progressive bleeding which forms a large hematoma that is contained by the 
periaortic tissues.  Approximately 4% of ruptured aneurysms are contained ruptures.  Surgical 
treatment is recommended within 24 hours of presentation of a contained rupture.  An acute 
ruptured aneurysm requires immediate intervention and it is said that endovascular techniques 
may improve the survival for patients with ruptured aneurysms3.   
In a combination of retrospective and prospective IDE data from Sanford Health (IDE 
Application G140207), there have been 3/33 subjects treated emergently and 3/33 subjects 
treated urgently.  Of the three treated emergently, there were no intraoperative deaths.  All of the 
emergent subjects had prior open repair that failed and were left with at least one major 
complication from prior open surgery.  One died on day 14, one was discharged and presented 
with an acute onset of paraplegia and passed away at 30 days, and one survived to 3 months.  
Recent results have reported the mortality rate of emergent/urgent open repair to be 43% with the 
average visceral ischemic time of 36 minutes with average blood loss of 2875cc4.  Another 
center reported a 36.8% 30-day mortality in patients treated with a hybrid approach5.  When 
compared with these results and the fact that Sanford Health had no ischemic time and an 

 
 
 
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average blood loss of 1250 cc in their emergent cases, the probable risk of the using the 
investigational device is no greater than the probable risk of open repair or from the disease.   
Sanford Health has treated three subjects urgently requiring repair within one week of 
presentation.  One subject treated urgently was doing well at his 30 day visit and succumbed to a 
hemorrhagic stroke at 35 days, one died of leukemia at 14 months, and one is nearing her three 
year visit and is doing well.  Of the subjects treated urgently, none of them died of aneurysm or 
device related deaths and all but one survived past one year.   
Presentation of a subject requiring emergent treatment needs to be treated immediately 
while urgent treatment needs to be completed within a week of presentation.  Due to the many 
comorbidities of these subjects, an open repair is not recommended for the same reasons as an 
elective open procedure.  Therefore, we feel that treatment with our investigational device is 
warranted to minimize the risks associated with open repair.  Our device is an endovascular 
option that can be used off the shelf and delivered quickly to treat an emergent case while 
reducing the procedure time and overall blood loss.  Due to the high overall mortality of open 
repair, the probable risk of the investigational device is no greater than the probable risk from the 
subject’s condition.  While these subjects would benefit from the investigational device, these 
subjects should not be included in the primary study arm as the expanded selection criteria could 
present confounding results making it challenging to separate the safety and effectiveness of the 
device from the underlying disease process.   
3.2.2 Type B Dissections 
A Stanford type B dissection begins distal to the brachiocephalic artery.  We plan on 
treating both type B dissections that are subacute and chronic with aneurysmal changes.  

 
 
 
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Treating dissection subjects involves determining the true and false lumens and which lumen 
feeds the visceral vessels.  The visceral manifold device design does not mimic natural anatomy 
and has the ability to cross between true and false lumen to treat the dissection, feed the visceral 
vessels, and accommodate the device even in a small true lumen by utilizing both the true and 
false lumen as conduits to complete the case.  Our device can cross between naturally occurring 
fenestrations or a laser may be used to create a fenestration between the true and false lumen.  
The risks of using a laser to create fenestrations include perforating the aorta or branch vessels, 
extension of the dissection, vascular trauma, embolism, pseudoaneurysm, and bleeding.  These 
risks will be mitigated by utilizing the smallest possible laser and using fluoroscopic guidance to 
locate and create the area for the fenestration.  The risk of potential dissection extension in 
chronic type B dissections is very low.  The risk of potential dissection extension is higher in 
subacute type B dissections and would be mitigated by controlling blood pressure while 
deploying, conservative oversizing of the stent graft, and having a cardiothoracic surgeon 
available if there is a retrograde dissection.   
A large number of these patients have been excluded from the study for dissection. 
Sanford Health has treated 15% (5/33) of subjects electively for TAAA with a dissection. A laser 
is used to perforate the aortic wall between the lumens to allow for placement of the graft and 
limbs when a natural fenestration is not found.  All of the procedures were successful and there 
were no device related events or disease related mortalities. Type II endoleaks were observed in 
2 of the 5 subjects, but have not required intervention or lead to aneurysm enlargement. 60% 
(3/5) of these subjects are doing well at two years post procedure. Of the two that are deceased, 
one died of a CVA four months while the other death was self-induced due to alcohol abuse post 
procedure (Sanford Health (IDE Application G140207). Literature cites an in-hospital mortality 

 
 
 
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rate of 29% for open surgical repair of type B dissection.  Given the small population treated 
with our branched endograft to date with no mortalities related to the device or the dissection, we 
believe the patient population presenting with type B aortic dissection involving the visceral 
segment could benefit from the use of this device over currently available options.  These 
subjects should be included in the expanded selection arm rather than the primary study arm due 
to presentation with a concomitant disease process that falls outside the study’s intended use.   
3.2.3 Aneurysm with Renal Insufficiency 
Subjects with known renal insufficiency and renal failure are excluded from the primary 
study arm due to underlying renal insufficiency that increases their risk of peri-operative renal 
failure confounding the differences between the efficacy of the device and the underlying disease 
process.  This device would still be beneficial for this subject population because it allows for 
continued perfusion of the renal arteries and may in some instances treat underlying causes for 
renal insufficiency.   
A 2004 report that evaluated the outcomes of aneurysm repair in patients with established 
renal failure reported that subjects presenting with chronic renal impairment have a high 
incidence of concurrent cardiovascular morbidity and are at high risk for aneurysm disease.  
They also reported that aneurysm subjects with renal dysfunction that were non-operative had a 
20% 5-year survival rate, with 39% of subjects dying from rupture of their aneurysm.  One study 
cited a 25% mortality in subjects on hemodialysis and 67% of subjects with renal insufficiency 
(creatinine >4 mg/dl) requiring post-operative dialysis6.  Several precautions are put into place to 
protect renal function during the procedure including hydration, a minimal volume of nonionic 
contrast agent, and continual monitoring of post procedure creatinine levels.  Subjects 

 
 
 
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undergoing dialysis at the time of procedure will be dialyzed before and after the procedure to 
protect any remaining renal function. One research study indicates that elevated creatinine levels 
do not indicate post-op renal failure and that the creatinine level may not be a contraindication 
for EVAR treatment if proper precautions are used7.      
3.2.4 Aneurysms with Small Branch Vessels <5 mm 
Small branch vessels less than 5 mm are excluded from the primary study arm due to an 
increased risk of increased intimal hyperplasia, branch occlusion, and potential end organ failure.  
These same principles are true even in open bypass surgery.  These subjects would still benefit 
from the use of this device due to the gradual sweeping endobypasses that deliver more 
developed flows to reduce the risk of branch vessel occlusion.  Additionally, it is extremely rare 
to see a SMA with a diameter less than 5 mm therefore reducing the risk of fatal branch 
occlusion.  These subjects will still benefit from exclusion of the aneurysm and reduced risk of 
aortic rupture.  Due to the significant mortality associated with rupture or open repair, this 
patient population is willing to assume a higher risk of renal insufficiency or renal failure.    
When treating subjects with impaired renal function, there is an increased probability of 
subjects having renal arteries < 5 mm or underlying significant stenosis.  While this is our 
current requirement, there has been one subject treated with a renal artery less than 5 mm in the 
Sanford Health experience.  This subject has had no adverse events related to the treatment of a 
smaller vessel.  As we open the criteria to increased comorbidities, there will be more subjects 
presenting will smaller vessels.  Current technologies, including T-branch and fenestrated stent 
grafts, treat vessels with diameters ranging from 4-8 mm.    
3.3 Treatment Options 

 
 
 
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3.3.1 Medical Management 
Medical management of both fusiform thoracoabdominal aneurysms and type B aortic 
dissections includes normalizing blood pressure to prevent further dilation or dissection.  Close 
monitoring should be performed.  Operation should be limited to patients whose aneurysms are 
at least 5.5-cm in diameter, whose symptoms persist, whose aneurysms enlarge and are at least 
4.5-cm in diameter, or who develop evidence of bleeding.  But if any of those conditions are 
observed (persistent symptoms, aneurysm enlargement, and evidence of bleeding), the patient 
should be offered repair.  For dissections, operation is suggested for symptomatic patients and 
those with complications including malperfusion syndrome or active hemorrhage.   
 
3.3.2 Open Surgical Repair 
Open repair of thoracoabdominal aneurysms, especially in patients with preexisting 
comorbidities, is fraught with complications. A meta-analysis of 7,833 open repairs of 
thoracoabdominal aneurysm repairs from 2000 to 2010 found a 30 day mortality rate of 7%, in-
hospital mortality of 10%, spinal cord ischemia rates of 7.5%, renal failure rates of 19%, and 
pulmonary dysfunction rates of 36%16.  Predictors of adverse events after elective open repair 
based on pre-existing comorbidities have been established.  Advanced age (>70 years)17-20, 
respiratory disease19, renal insufficiency21, coronary artery disease17,20, symptomatic aneurysms, 
extent 1 and 2 aneurysms22-25, and diabetes26 are reported to be a predictor of 30-day mortality.  
Cardiac function27, extent 1 and 2 aneurysms23,28-30, symptomatic cases30, and diabetes26 are 
reported to be predictors of paraplegia.  The outcomes reported above are in a low- to moderate- 

 
 
 
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risk patient population.  It is a logical extension to assume the outcomes in moderate- to high- 
risk patients would be worse.   
3.3.2.1 Open Surgical Repair of Ruptured, Urgent, and Emergent TAAAs 
Open repair of any thoracoabdominal aneurysms, especially in patients with preexisting 
comorbidities, is fraught with complications. A recent review of emergent patients with a 
ruptured TAAA looked at the overall mortality of 51 emergently treated patients with TAAA 
between 1994 and 2014.  The study evaluated Crawford Type I, II, III, and IV presenting 
hemodynamically unstable (94%) and hemodynamically stable (3%).  In this study 54.9% 
(28/51) had true aneurysms and 45% (23/51) had dissecting aneurysms.  These were further 
broken into 94% (48/51) that presented emergently requiring treatment in 2-6 hours and 6% 
(3/51) that presented urgently and required treatment within 24 hours.  The overall mortality in 
this study was 43% (23/51); 15% (8/51) of these occurring during the procedure and 27% 
(14/51) occurred post-operatively.  Of the 84% (43/51) that survived the initial procedure, 16% 
(6/42) developed paraplegia/paraparesis, 18.6% (8/43) had acute renal failure, 35% (15/43) had 
pulmonary insufficiency, and 18.6% (8/43) with post-operative bleeding.  The average visceral 
ischemic time was 36 minutes and the average blood loss was 2875cc4.   
3.3.2.2 Open Surgical Repair of Chronic Type B Dissections 
Open repair of chronic type B dissections is known to have a higher mortality and 
morbidity rate.  A 2014 review of open and endovascular outcomes for patients with chronic type 
B dissections cited an operative mortality of 6%, stroke rate of 16%, and paraplegia of 9%.  The 
one year major morbidity or mortality in these open repair patients was 25% 8.   Another large 
study evaluating open repair results in 1542 subjects reported a 30-day mortality of 17.8% 9.  

 
 
 
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One advantage of open repair compared to endovascular repair of type B dissections is a lower 
re-intervention rate8.   
3.3.3 Endovascular Repair 
3.3.3.1 TAAA Repair with Parallel Grafts 
Parallel grafts (often referred to as snorkels, chimneys, periscopes, or CHIMPs) are 
combinations of aortic and branch stent grafts deployed simultaneously.  They are typically all 
straight-tube grafts where the open end is either on the proximal or distal extent (and sometimes 
both) of the aortic component.  The combination of straight tube stent grafts allows for the 
physician to treat emergent patients being as the assembly does not need to be custom made.  
There are some criticisms though about the lack of circumferential seal and fixation though with 
parallel grafts.  This lack of circumferential seal and fixation may leave the patient vulnerable to 
endoleak. 
There have been case reports which describe two parallel stent graft techniques used to 
repair thoracoabdominal aneurysms.  The first ‘terrace technique’ has two chimney stents in 
contact with a more proximal thoracic graft and two chimney stents in contact with a more distal 
thoracic graft31.  The second has two chimney stents going to the celiac and superior mesenteric 
arteries.  Then there are two snorkel stents pulling retrograde flow and going to the renal 
arteries32-34.  
Snorkel and chimney grafts can be implanted with good technical success rates if care is 
taken, but long term renal function is in question.  Seal and fixation are also in question, so the 
parallel graft techniques should be avoided in elective settings and reserved for emergent 
settings35.  A recent review found that 10.7% of patients in the literature treated for 

 
 
 
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thoracoabdominal aneurysm with parallel grafts experienced type 1 endoleak.  The investigator 
thought the approach would be useful for a recovery maneuver or for emergent cases where 
fenestrated grafts are not readily available, but long term durability and proximal fixation remain 
in question36.  
3.3.3.2 TAAA Repair with Sandwich Techniques 
Two sandwich techniques have been proposed in order to care for patients with an off-
the-shelf approach.  The first used dual bifurcated infrarenal grafts in the descending thoracic 
aorta37.  The second used 3-4 bridging stents sandwiched with a thoracic graft in the descending 
thoracic aorta38.  While these sandwich techniques can be used off-the-shelf, they do not provide 
for circumferential seal and fixation, and long term durability is in question. 
3.3.3.3 Fenestrated Stent Grafts 
While combinations of branched and fenestrated endografts can be specified and ordered 
from manufacturers to be customized for the patient in Europe, there are few studies of purely 
fenestrated endografts used in the repair of thoracoabdominal aneurysms.  A study showed the 
technique by which endografts can be modified in order to treat urgent cases of 
thoracoabdominal aneurysms39.  These authors recently published a case where this technique 
was used to repair a thoracoabdominal aneurysm in a 74 year old male patient with very 
asymmetric visceral and renal vessels.  The repair was done by sewing Gore Viabahns to the 
fenestrations as ‘mini cuffs’ which helped to increase the amount of seal obtained.  The patient 
had been followed for two months40.  Also a retrospective study in 2011 which reviewed the 
cases done in Paris, France and Cleveland, Ohio for type 4 thoracoabdominal aneurysms with 
custom manufactured fenestrated grafts was reported.  All patients were considered high risk for 

 
 
 
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open repair.  Over a six year period, 231 patients were treated.  Thirty day mortality was 2.6% 
and 2 year survival was 83%.  Freedom from secondary intervention was 93% at 30 days and 
73% at 2 years41.   
 3.3.3.4 TAAA Repair with Cook t-Branch Stent Grafts 
Branched stent grafts have been used for juxtarenal and pararenal aneurysms.  Modified 
branched stent grafts have only been reported to be used with thoracoabdominal aneurysms to 
date40,42.  There are no large scale studies of unibody axially-oriented multi-branched grafts for 
pararenal aneurysms as they are more frequently used for thoracoabdominal aneurysms.   
Branches have been attached to the aortic component to provide for bridging stent 
overlap, increased overlap encouraged seal and fixation.  It also allowed for the use of self-
expanding stent grafts which help accommodate tortuosity.  Several variations of branch 
orientation exist including axial, helical, antegrade, and retrograde.  Axial branches were 
deployed proximal to the target vessels.  The branches were cannulated from an arm approach, 
and mating stents were deployed.  Bard Fluencies were commonly used and the length of overlap 
was typically 10-mm.  These were sometimes lined with balloon-expandable stents to prevent 
component separation.  Alignment between the axial branch stent and target vessel was noted as 
a problem if it caused angulation in the bridging stent, potentially leading to bridge stent kink.  
To increase durability, self-expandable bare metal stents such as Boston Scientific Wallstents 
were occasionally used.  The helical branches exit the aortic component posteriorly and wrap 
around the main body.  The distal end landed 10-mm from the ostium of the target vessel.  The 
longer overlap and gentle sweeping centerline made lining the stents less critical.  The branch 
stent curved to become in-line with the target vessel.  The drawback was that the helical stents 
make for a bulky construct requiring a large diameter delivery system. 

 
 
 
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 3.3.3.5 TAAA Repair with Flow Diverting Devices 
Flow diverting stents are used in limited applications for repairing thoracoabdominal 
aortic aneurysms in Europe. They provide for more simplified implant in that the branch vessels 
do not need to be stented.  Instead the three layer micro-woven nitinol mesh significantly slows 
and alters the flow of blood into the aneurysm sac encouraging thrombus formation.  All the 
while, flow channels are developing to the branch vessels43-45.  The IFU must be followed very 
closely so that the stents do not overlap graft cloth, that 20-25% oversizing is followed, and so 
that larger stents are always deployed within smaller stents.  If these instructions are not 
followed, devastating ruptures may follow46-48.  Data is limited and largely retrospective in 
nature49.  The one registry reported had 380 patients but showed a technical success rate of 0% 
when the IFU was not adhered to (n=38/38)50. 
3.3.3.6 Endovascular Repair of Ruptured, Urgent, and Emergent TAAAs 
There are no reports we found describing branched grafts being used for TAAA repair in 
a ruptured or emergent setting.  This is likely due to either manufacturer control of the use of the 
devices or control of the publication of information.  We did however find several studies of 
parallel grafts being used in this setting.  A meta-analysis published revealed 15 reports of 93 
such patients.  24.7% were operated on in an urgent setting, but the results were not compared to 
results of patients treated in a non-urgent setting.  Because of this we cannot draw any 
conclusions10.    A further study examined parallel grafts used in ruptured thoracoabadominal 
aortic aneurysms and pararenal aneurysms used in 9 patients (6 thoracoabadominal aortic 
aneurysms, 2 pararenal aortic aneurysms, and 1 short neck infrarenal aneurysm).  The study 
mentions stable renal function in all patients and a very low 30-day mortality rate11.    Yet 

 
 
 
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another study examined 29 patients treated with the parallel graft technique of these14 patients 
were ruptures and 15 patients were symptomatic.  Nine lesions were in the aortic arch, ten were 
in the descending aorta, and ten were in the branched visceral segment.  Twenty two were treated 
in the first 24 hours and 7 were treated in the first 3 days.  Median follow-up was 2 years.  There 
were four 30 day deaths (1 cerebral infarct, 1 visceral ischemia, 1 multiple organ failure, and 1 
heart failure).  The authors remarked that this technique is promising with low rates of early 
mortality when considering that the patients were emergent12.  Three additional cases were 
reported but the cases focused mainly on technical feasibility and endoleaks, as a means of 
demonstrating the technique with little focus on the clinical sequelae that may develop during 
urgent repair of thoracoabadominal aortic aneurysms with endovascular techniques13-15.    From 
this limited data set coupled with our current understanding of the outcomes of patients treated 
with open repair in the urgent setting, it appears that the benefit of endovascular repair may 
outweigh the risks.   
3.3.3.7 Endovascular Repair of Chronic Type B Dissections 
Incidence rates of aortic dissection is estimated to be roughly 3 per 100,000 people per 
year16,17.  Until recently acute Stanford type B aortic dissections were managed with blood 
pressure control18,19.  If endovascular intervention is offered in acute dissections the goal is 
typically to cover the proximal entry tear in order to block antegrade flow to the false lumen. 
This starts the process of aortic remodeling by depressurizing the false lumen20.  If only the 
thoracic aorta is to be treated, growth of the true lumen and shrinking of the false lumen are 
generally not associated with distal reperfusion or endoleak – meaning there is a lower rate of 
reintervention21.   As endovascular repair is becoming more prevalent, we are learning that 
chronic dissections tend to have a thicker fixed septum which leaves the aorta less susceptible to 

 
 
 
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remodeling after repair22.  Therefore, treating acute Type B dissections with blood pressure 
management may not be the best approach, because if endovascular repair is needed later the 
process of remodeling may not happen.  If the aneurysm and dissection extend distally beyond 
the diaphragm, the types of fenestrations that are found in extensive Stanford type B dissections 
leave the patient prone to distal reperfusion of the false lumen even after cover of the proximal 
entry tear23,24.  These patients will require some sort of branched or fenestrated repair.  If the 
patient has an aneurysm complicated by type B dissection where visceral branches arise from 
both true and false lumen the treatment options are even further limited, and bridging stents will 
have to cross the septum increasing the technical difficulty of completing the case.  Small true 
lumens and visceral arteries arising from either true- or false- lumen and dissection extending to 
branches have made endovascular repair sometimes near impossible.   
 
3.3.3.8 Staged Endovascular Repair 
3.3.3.8.1 Planned Staged Procedures 
Staged procedures have been used in endovascular repair of thoracoabdominal aortic 
aneurysms in an effort to limit the incident and severity of spinal cord ischemia.  The hypothesis 
behind this is the staging of procedures allows for the development of a collateral network.  The 
collaterals would maintain some perfusion and allow other vessels to compensate reducing the 
overall impact of spinal cord ischemia.  One center studying 87 Type II subjects found that 
staging reduced the overall SCI rates significantly 51.  The SCI rate in single stage procedures 
was 37.5% (12/32) and 11% (3/27) in two-stage procedures.   The rate was slightly higher in 
unintentionally staged procedures at 14% (4/28).  Unintentional staging was defined as prior 
aortic repair, 21% (6/28) had prior thoracic repair and the remainder were abdominal aortic 

 
 
 
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repair.  In the staged procedures, the two-stage repair SCI events were all temporary and 
resolved by discharge and the unintentional staging had 10% (3/28) that resulted in permanent 
SCI.  This study had a median time between stages of 5 months (range 1-60 months), but the 
investigators believe 2-3 weeks to be optimum51.  The investigators also noted that symptomatic 
patients should be monitored and considered for earlier repair.  While there is no specific length 
of aortic coverage to determine the threshold where one should consider staging, this study cites 
that aortic coverage of 200 cm or greater may indicate the threshold where subjects would 
benefit from staging.   
There are several techniques used for staging endovascular TAAA repair.  Techniques 
include coverage of the proximal thoracic aorta up to the celiac artery in a staged procedure with 
visceral stenting performed at the completion procedure.  Other techniques reference placing the 
main aortic stents, but allowing perfusion from an open celiac branch, perfusion branches, or 
unstented contralateral iliac limb52.  The use of perfusion branches may be preferred to allow for 
better hemodynamics and avoid excessive pressurization of the aneurysm sac.   
3.3.3.8.2 Bail-out Staged Procedures 
 
There is limited information available on use of staging as a bail-out procedures.  Several 
sites and investigators discuss alternative techniques such as chimney and snorkels as alternative 
techniques to be used in technically challenging cases complicated by anatomy53, but fail to 
reference the use of staging and outcomes.  Literature also cites several intra-operative 
techniques for bail-out maneuvers in the operating room54, but currently available TAAA 
technologies do not allow for staging of the aortic components and limited data is available on 
the outcomes of these cases.   

 
 
 
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3.3.3.9 Summary of Alternative Treatments 
A few endovascular options are available for treating thoracoabdominal aneurysms.  A limited 
number of centers have access to commercially available branch-fenestrated devices, but they 
typically require customization.  This customization has an associated lead time of several 
weeks.  The endovascular options present a real problem of patients not being able to either 
travel to the select sites or being emergent and not having the time to wait for a custom graft.  In 
these instances it may appropriate for the patients to be treated either with off-label devices 
(sandwich approach) or with physician-modified endografts.   Sandwich configurations tend to 
have excellent patency rates but lack circumferential seal and fixation.  Branch-fenestrated grafts 
have good seal and fixation but tend to have high frequency of reintervention and can be limited 
by patient anatomy.  In all instances careful case planning is in order and all aspects of parallel 
grafts as well as branch-fenestrated grafts should be carefully considered relative to individual 
patient anatomy.3.3.3.9.1 Summary of Treatments for Staged Procedure or Staged Bail-out 
Procedure 
Due to the proximal seal zone of this device, several options are available to stage 
patients with either a planned procedure or as a bail-out procedure.  Literature supports the 
hypothesis that a controlled endoleak or perfusion branch can be protective for SCI events by 
helping create a protective collateral network.  When planned visceral artery bridge endoleak can 
be provided via a low-risk staged procedure that does not put the patient at significant risk from 
the intervention.  The use and experience with staged procedures as a bail-out method is not 
widely understood, but still allows the patient to maintain perfusion to the visceral vessels and 
lower extremities while they recover and prepare for completion of the procedure.  The bail-out 

 
 
 
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staging method is only intended to be used in extreme circumstances when patient status declines 
intraoperatively or unforeseen technical challenges are encountered.   
3.4 Benefits and Risks of Treatment Options 
3.4.1 Open Surgical Repair 
Contemporary series have shown that open repair of thoracoabdominal aneurysms, is 
associated with a significant mortality risk and increase in major complications. One report 
describes 7,833 open TAAA repairs from 2000 to 2010 found a 30 day mortality rate of 7%, in-
hospital mortality of 10%, spinal cord ischemia rates of 7.5%, renal failure rates of 19%, and 
respiratory failure rates of 36%16.  The risks of open repair are significantly higher than any other 
option for repair.  Open repairs are durable but have substantial perioperative mortality and 
postoperative morbidity.  Additionally, due to existing comorbidities and the high risk for 
complications this is not an option for many patients.   
3.4.2 Endovascular Techniques 
There is limited availability of data reporting the results of endovascular repair of 
thoracoabdominal aneurysms.  Many of these techniques require off-label use or modification of 
the grafts, which bring into question the safety and long-term durability. The literature suggests 
that snorkel and chimney grafts can be performed with decent technical success rates, but seal 
and fixation and long term durability are in question and have not been formally evaluated35.  A 
recent review found that 10.7% of patients in the literature treated for thoracoabdominal 
aneurysm with parallel grafts experienced type 1 endoleak.   

 
 
 
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A 2004 to 2006 study of the novel t-branch device (Cook Medical) was studied in high 
risk subjects.  The study showed a technical success of 93%, thirty-day mortality of 5.5%, major 
perioperative complications 14% including paraplegia 2.7%, new onset dialysis 1.4%, respiratory 
failure 6.8%, myocardial infarction 5.5%, and stroke 1.4%.  All-cause mortality at twelve months 
was 6 subjects.  There was no evidence of stent migration or aneurysm growth over the twelve 
month period55.     
In a study of type 4 thoracoabdominal aneurysms with custom manufactured fenestrated 
grafts over a six year period, 231 patients were treated.  Thirty day mortality was 2.6% and 2 
year survival was 83%.  Freedom from secondary intervention was 93% at 30 days and 73% at 2 
years41.   
Experience with the t-branch device evaluating 22 patients between 2010 and 2013 
reported a technical success of 100%.  The re-intervention rate at 6 months was 90%, branch 
occlusion was 14%, paraplegia was 5%, and paraparesis in 5%.  Again, these lack long-term data 
to address the durability of the stent grafts.  In all endovascular options, close surveillance is 
mandatory for early identification of visceral or branched vessel stenosis or pre-occlusion.   
A large number of subjects may benefit from alternative endovascular treatments that 
may be performed with less risk of complications and shorter recovery time.  For these subjects, 
endovascular repair with a manifold system that is not based on patient anatomy may be the only 
treatment option.  This patient population is faced with a serious and life threatening disease and 
have limited clinical options.  The subjects are willing to assume a higher degree of risk with an 
investigational device due to the progressive nature of the disease and the high mortality and 
morbidity rates when left untreated.   

 
 
 
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A retrospective study reported by Sanford Health (IDE Application G140207, Clinical 
Use Summary) reports the only subjects that would not be ideal candidates include subjects with 
prior suprarenal fixation stents, dissection, present emergently.  The retrospective study 
examines 12 patients which meet the clinical study criteria that were treated between 2012 and 
2014.  In this patient population, there was one subject with renal failure and one subject with a 
respiratory event in the first 30 days.  There was one unrelated patient death and one CVA in the 
first year.  Additionally, in this study there was one instance of branch vessel occlusion and 
secondary intervention.   
3.4.2.1 Staged Procedures 
With the Valiant Thoracoabdominal stent graft system, the risks of planned staging via 
the visceral artery bridge endoleak during the procedure are comparable to the single stage 
procedure in the current protocol. We do not believe staging presents any new risks that are not 
currently covered under the risk profile for the VTAAA system, but these risks may happen at a 
higher frequency.  These risks still present no greater risk than the probable risk from the 
progression of the patient’s condition.  The increased risks for a planned stage procedure 
(visceral artery bridge endoleak or delayed distal seal) are risks from an additional procedure 
including anesthetic and contrast exposure, compounded physiologic insult from multiples 
procedures, access site complications, wire injury, device integrity issues from component 
interaction, paraplegia, spinal cord ischemic event, aneurysm enlargement, aneurysm rupture, 
and death.  Increased risks for a bail-out staged procedure include the above risks and increased 
procedure time or failure to treat.    
 

 
 
 
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3.4.3 Stent graft designs 
 
The manifold system has the advantage of being independent of patient anatomy allowing 
for use off-the-shelf.  It can also adapt to numerous anatomical variations including tortuosity 
and vessel location.  The design allows for continuous flow to the visceral and infrarenal 
segments throughout the procedure.  Additionally, the proximal deployment and delayed distal 
seal allows for more flexibility in stenting the visceral vessels, multiple bail outs, or staging of 
the procedure throughout device deployment.  The importance of proximal deployment and 
gradual sweeping branch stents has been reported as a critical element for maintaining vessel 
patency56.   
3.4.4 Analysis of bridging stent characteristics 
 It has become evident that the use of the appropriate bridging stent including placement 
and stent is necessary to minimize risk of target vessel occlusion and kinking56.  The ideal stent 
has not been determined or standardized, but currently a balloon expandable stent covered is 
preferred.  The use of a covered stent has the advantages of optimal seal, minimizing risk of 
endoleak, and improved patency rates57.  The two most widely used stents are the iCAST 
covered stent (Atrium Medical) and the JoMed stent (Abbott).  The iCAST covered stent has 
been widely used and reported in the literature, and was the most frequently used stent in the 
recent GLOBALSTAR registry, with only five of 889 visceral arteries lost during follow up58.  
The JoMed stent has been also widely used and it is the balloon expandable covered stent of 
choice by the Cleveland Clinic group, with recent report of >95% 5-year visceral artery patency 
among 632 subjects treated by fenestrated endografts59.  The long-term risks of stent fracture and 
dislodgment have not been systematically reported but seem to be exceptionally low with 

 
 
 
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adequate selection of proximal landing zone.  The Fluency stent (Bard Peripheral Vascular, 
Tempe, AZ) has been used by one investigator, with excellent patency rates and low risk of 
kinking or stent fracture60. 
3.5 Justification for Specific Patient Selection Criteria Relevant for this Study   
Treatment of TAAA aneurysms in all patients will be considered for this study.  All 
patients diagnosed with a TAAA repair are considered high risk due to the natural history of a 
patient with a TAAA.  Their options are limited for endovascular repair and due to the 
comorbidities in this population they are all high risk open repair.  Additionally, all patients 
undergoing open surgical repair of a thoracoabdominal aneurysm are considered to be at high 
risk for comorbidities and complications.  Based on initial clinical experience, we believe that we 
can treat all patients with outcomes better to those of open surgical repair.  The current approach 
is an endovascular repair with lower surgical morbidity and mortality rate compared to open 
repair.  Endovascular repair may also decrease the recovery time and length of hospital stay.  
From the initial clinical evaluation, certain patients may not be good candidates for this approach 
have been identified.  This patient population includes patients presenting emergently, with 
compromised renal access, or dissections.  The inclusion and exclusion criteria for this study has 
been refined to present a patient population that we feel may significantly benefit from this 
procedure without undue risk.  The inclusion criteria listed in section 4.4.2 including aneurysm 
characteristics, access vessel morphology, minimum neck length, diameter of aneurysm, branch 
vessel size, and size of distal fixation site are required as inclusion criteria to achieve an adequate 
seal zone and optimal placement with the stent graft and branches.   

 
 
 
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The patient population being excluded from this study includes patients with a ruptured 
aneurysm (or contained rupture), obstructive stenting of the visceral vessels, or a dissection in 
the treated portion of the aorta.  Also patients with thrombus or excessive calcification within the 
neck of the aneurysm will be excluded as they put the patient at high risk of aneurysmal rupture 
or embolic event during surgical manipulation.  Anatomy that does not allow for primary or 
assisted patency of the left subclavian artery will be excluded because it is required for access.  
Additionally, anatomy that would not allow for maintenance of at least one patent hypogastric 
artery will be excluded in order to prevent organ and/or pelvic ischemia and paraplegia.     
 3.5.1 Rationale for Exposing Target Population to Potential Risks of Staging 
The planned staged method via the visceral artery bridge endoleak and delayed distal seal 
has been used successfully in 6 cases under PS-IDEs G170048 and G170024; 4 patients had their 
aneurysm successfully excluded (3 via the visceral artery bridge endoleak and 1 via delayed 
distal seal) in a staged fashion with 2 patients awaiting completion (1 via the visceral artery 
bridge endoleak and 1 via delayed distal seal). (Dr. Murray Shames, IDE G170024).  There were 
no intra-operative deaths or SCI events, supporting that the device when used in planned staged 
procedure can be implanted safely and repeatedly.  When compared to literature reported SCI 
rates for single stage TAAA procedures, this is a viable option for patients at higher risk for SCI 
events.  Given the success we have experienced with patients treated to date and the low risk of 
the completion procedure, we feel that it is justified to expose the target patient population to the 
potential risk.   
 
3.6 Device Description and Drawings 

 
 
 
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The Visceral Manifold System is made up of two main body components and makes use 
of several off-the-shelf FDA-approved stent graft components (see Appendix B) for system 
drawing).  The two custom main body grafts are the thoracic bifurcation (Figure 1A) and the 
visceral manifold (Figure 1B).  The thoracic bifurcation is deployed in the thoracic aorta and 
provides the proximal seal for the device.  For a Type I or II thoracoabdominal aneurysm the 
proximal seal is in zone 3, for Type III and V the device seals in zone 4.  The two limbs of the 
thoracic bifurcation allows for continued aortic flow while deploying the visceral segment.  The 
visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the 
stage for the visceral debranching.  The branches of the visceral manifold extend to the visceral 
vessel with the use of covered bridging stents and provide distal seal of the manifold.   The 
smaller 16 mm limb of the thoracic bifurcation extends to the infrarenal segment to either seal in 
zone 9 for a Type I and V and in zone 10 for Type II, and III.  All other connections in the device 
make use of sizes that are modular and independent of patient anatomy. 
Figure 1:  Valiant™ Thoracoabdominal Stent Graft System 
 
A 
B 
Figure 1: Images of the manufactured device A) the thoracic bifurcation main 
body graft and B) visceral manifold main body graft 
Aortic components 

 
 
 
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The thoracic bifurcation stent graft (Medtronic) seals to the native aorta/healthy tissue 
and bifurcates blood flow in the descending thoracic aorta.  The distal end bifurcates into two 
smaller legs (20 mm and 16 mm) suitable for modular connection to the visceral manifold stent 
graft and the visceral bypass stent graft.  The thoracic bifurcation is composed of a self-
expanding, metallic spring scaffold made from nitinol stents sewn to a polyester fabric graft with 
nonresorbable sutures and is manufactured in the following sizes:  
 
 
Table 1.  Thoracic bifurcation dimensions 
 
The proximal end of the visceral manifold stent graft (Medtronic) deploys into the 20 mm 
leg of the thoracic bifurcation and quadfurcates to perfuse the celiac, SMA, right, and left renal 
arteries via bridging stents.  The visceral manifold is composed of a self-expanding, metallic 
spring scaffold made from nitinol stents sewn to a polyester fabric graft with nonresorbable 
sutures and is manufactured in the following sizes: 
 
Table 2.  Visceral manifold dimensions 
Branch components 

 
 
 
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The limbs of the visceral manifold are extended to the target branch vessel with 9-mm 
balloon expandable stents (Atrium, iCast).  The Atrium iCasts are a stainless steel stent covered 
with a PTFE film and these are not modified by the physician.  The balloon expandable stents are 
overlapped to reach the target branch vessel and the distal end is appropriately sized to the 
branch vessel.  The interfaces between the branch components are lined with self-expanding bare 
metal nitinol stents to improve resistance to kinking and stent graft separation.   
Iliac extension components 
The visceral bypass (Medtronic) deploys into the 16 mm limb of the thoracic bifurcation 
to perfuse the iliac segment.  The visceral bypass is composed of a self-expanding, metallic 
spring scaffold made from nitinol stents sewn to a polyester fabric graft with nonresorbable 
sutures and is manufactured in the following sizes: 
 
Table 3.  Visceral bypass dimensions 
 
The infrarenal bifurcation (Medtronic) deploys into the visceral bypass to bifurcate aortic 
flow to the iliac segments.  The infrarenal bifurcation is composed of a self-expanding, metallic 
spring scaffold made from nitinol stents sewn to a polyester fabric graft with nonresorbable 
sutures and is manufactured in the following sizes: 

 
 
 
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Table 4. Infrarenal bifurcation dimensions 
 
The iliac limbs and extenders (Medtronic, Endurant II) will be utilized from a 
commercially available Endurant II limb or appropriately sized iliac limb extension stent graft.  
These will be deployed in the infrarenal bifurcation and will provide distal seal of the stent graft 
system.  The iliac limbs will be available in the commercially manufactured sizes and 
appropriately oversized for implantation in the infrarenal bifurcation.   
Principles of Operation 
 
 
 
The TAAA Debranching Stent Graft works to bifurcate aortic flow upstream of the target 
visceral vessels.  This bifurcation has a two-fold benefit.  First it allows for aortic flow to be 
compartmentalized into a visceral segment and an infrarenal segment providing for uninterrupted 
flow to the visceral vessels as well as the infrarenal segment throughout the procedure.  If any of 
the connections cannot be made or the patient status declines during the procedure, then it can be 
staged and the connections can be made at a later date.  Second, the upstream bifurcation 
encourages more favorable flow conditions in the bridging stents and target vessels which may 
prevent target vessel occlusion.  This is due to the fact that the bifurcations are upstream 
providing a sweeping transition into the renal arteries that is smooth providing for relatively 
laminar flow conditions.  The design demonstrates that more central aortic flow is obtained with 
this design increasing flow rates in the visceral vessels to potentially increase target vessel 
patency (Figure 2). 

 
 
 
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The device can be used as an off-the-shelf system, negating the need for lead times 
associated with custom-built devices.  The critical sizing that will need to be done is with the 
proximal end of the thoracic bifurcation, distal landing zone in the aorta or iliac arteries, and the 
bridging stents.  The proximal end of the thoracic bifurcation can be sized by choosing any of the 
available sizes of the Medtronic TAAA thoracic bifurcation stent grafts, and the sizes of the 
bridging stents can be manipulated by choosing any of the commercially available sizes of the 
Atrium iCast.  The Atrium iCasts are added to the system in-vivo and connected with passive 
fixation which negates the need to size the main body components based on the target vessel 
sizes.  All other connections in the device make use of sizes that are the same, independent of 
patient anatomy. 
The deployment of this device is also independent of device alignment.  Angular 
alignment of the thoracic bifurcation and the visceral manifold has very little impact on the 
outcome of the case.  Longitudinal alignment is more important, but a safety factor has been 
built-in by calling for the distal ends of the visceral manifold to be deployed above their target 
vessels by 1-2 cm.  The longitudinal landing should be optimized so that the graft is not landed 
too low so that the connection with the visceral vessels is challenging to make. 

 
 
 
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Intended Use/Indications for Use 
The Valiant™ Thoracoabdominal Stent Graft System is indicated for the endovascular 
treatment of thoracoabdominal aortic aneurysm (Crawford Type 1,2,3, and 5) in patients with the 
following characteristics: 
• An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just 
proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) 
measurements 
• Aneurysm with a history of growth > 0.5 cm in 6 months 
Figure 2: Assembly drawing showing the thoracic bifurcation, the 
visceral manifold, the branch stents, and the infrarenal grafts, all 
deployed within an idealized aneurysm sketch. 

 
 
 
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• Saccular aneurysm deemed at significant risk for rupture 
• Symptomatic aneurysm greater than or equal to 4.5 cm 
• Axillary or brachial and iliac or femoral access vessel morphology that is compatible 
with vascular access techniques, devices or accessories, with or without use of a surgical 
conduit 
o Proximal landing zone for the thoracic bifurcation stent graft that has: 
• 
≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft 
material (neck) distal to the left subclavian artery (LSA) and a diameter in the 
range of 26-42 mm 
 
• 
Adequate distance from the celiac artery, in order to accommodate 
cannulation from the antegrade access point when considering the total 
deployed length of the thoracic bifurcation and visceral manifold 
• Iliac artery or aortic distal fixation site, including both native tissue and previously placed 
graft, greater than or equal to 15 mm in length and diameter in the range of 8 – 25 mm 
• Age: ≥ 18 years old 
• Life expectancy: > 1 year 
3.7 Potential Study Device Benefits and Risks Based on Leveraged Clinical Information 
 Patients diagnosed with TAAA have a poor natural history and require surgical 
intervention to extend life.  Several repair techniques have been developed, but each carry risk.  
As discussed previously, open repairs are durable but have substantial perioperative mortality 
and postoperative morbidity.  Endovascular techniques are plagued by high procedural 

 
 
 
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complexity and poor branch vessel patency.  Parallel techniques may have poor seal and may be 
prone to endoleak.  In contrast, the manifold approach has circumferential seal at the proximal 
end of the system.  It has relatively simple case planning and it has virtually no ischemic time.  
Due to these advantages, we believe the novel proposed technique may overcome some of the 
current clinical risks with other approaches.   
 
Patients who participate in this study may benefit from having a less invasive procedure 
compared to open repair of their thoracoabdominal aortic aneurysm.  We expect the amount of 
discomfort, total blood loss, recovery time, and overall hospital stay to be less than open repair.  
Many of the patients presenting with a thoracoabdominal aneurysm are not candidates for open 
repair due to existing comorbidities.  With the progressive nature of the disease, these patients 
have limited options for medical intervention and are willing to assume a higher amount of risk.   
 
Patients who have a planned staged procedure may benefit from reduced SCI events, 
contrast exposure, fluids, procedure time, and less overall insult to their pulmonary status. We 
expect the amount of discomfort, total blood loss, recovery time, and overall hospital stay to be 
similar to an unstaged repair.  These subjects would be placed at increased risks related to a 
second procedure including those identified in the risk analysis.  With the progressive nature of 
the disease, these patients have limited options for medical intervention and may be willing to 
assume a higher amount of risk.   
3.8 Institution Experience and Infrastructure 
 
The Division of Vascular Surgery at New York University Langone Medical Center is 
comprised of 11 vascular surgeons and covers three hospitals within the medical center, Tisch 
Hospital, Bellevue Hospital, and the Manhattan Veterans Administration Hospital. We have a 
robust experience in endovascular repair of aortic aneurysms and are a regional referral center 

 
 
 
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for complex aortic pathology including aortic dissection and aneurysmal disease.  We have a 
strong history and collaboration with our cardiothoracic surgery colleagues and function together 
as part of an Aortic Center with regular multidisciplinary conferences where case management is 
discussed.  NYU Langone Medical Center performs roughly 250 aortic surgeries annually. We 
have been leaders in the field of endovascular aortic surgery and participated in most industry 
sponsored clinical trials related to aortic pathology, including the original EVT (ANCURE) trials 
in the 1990’s. 
Table of Clinical Trials: Aortic Endovascular Treatment of Aortic pathology  
• Phase II: A Clinical Trial of the Endovascular Grafting System as Compared to the 
Standard Surgical Procedure in the Treatment of Abdominal Aortic Aneurysms 
(Guidant) 
• Enact T Endovascular Aneurysm Clinical Trial-Tube: A Phase III Clinical Study of the 
Bifurcated Endovascular Grafting System (EGS) Compared to the Standard Surgical 
Procedure in the Treatment of the Abdominal Aortic Aneurysm (Guidant) 
• Enact B Endovascular Aneurysm Clinical Trial - Bifurcated: A phase II  Clinical Study 
of the EGS System as compared to the Standard Surgical Procedure in the Treatment of 
the Abdominal Aortic Aneurysms (Guidant) 
• A Clinical Study Comparing the Use of the Bifurcated Excluder Endoprosthesis to 
Open Surgical Repair in the Primary Treatment of Infrarenal Abdominal Aortic 
Aneurysms-Continued Access (Gore) 
• Clinical Study of the Ancure tube and Bifurcated systems extended indications 
evaluation: A Phase III Clinical Study of the ANCURE System as Compared to the 
Standard Surgical Procedure I the treatment of Abdominal Aortic Aneurysms (Guidant) 
• RENU Registry: AAA Ancillary Graft (Cook) 
• Medtronic Vascular TALENT Thoracic Endovascular Stent Graft System (Medtronic) 
• Valor II:  Evaluation of the clinical performance of the Valiant Thoracic Stent Graft 
System for treatment of Descending Thoracic Aneurysms (Medtronic)Zenith TX2 
Thoracic Endovascular Graft Clinical Investigation (Cook) 
• Zenith Dissection Clinical Study (Cook)  
• STAPLE-2: Pivotal Study of the Aptus Endovascular AAA Repair System (Aptus) 
• ANCHOR: Aneurysm Treatment Using the HeliFX™ Aortic Securement 
System      Global Registry-sponsor Aptus Endosystems 
• Endurant Stent Graft System US Clinical Study (Medtronic) 
• Zenith Fenestrated AAA Endovascular Graft Clinical Study (Cook) 
• Zenith Low Profile AAA Clinical Study-Spiral Z (Cook) 
• Zenith p_Branch Pivotal Study (Cook) 

 
 
 
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We currently have four actively enrolling clinical trials and over a dozen investigator driven 
studies ongoing. We have no competing trials for endovascular treatment of thoracoabdominal 
aortic pathology. We are academically active. We present our research at our national societal 
meeting and publish regularly in peer-reviewed journals. 
 
We have been especially active in industry sponsored clinical trials for fenestrated 
endovascular aortic aneurysm (FEVAR) for treatment of pararenal aortic aneurysms. We were a 
site for the Cook sponsored FEVAR trial (Zenith Fenestrated AAA Endovascular Graft Clinical 
Study) and are currently enrolling in the Cook sponsored pivotal-branch trial (Zenith p_Branch 
Pivotal Study).  We have a robust experience in endovascular treatment of thoracoabdominal 
aortic aneurysms using  CHIMPS (CHIminey, Periscope, Snorkel) techniques, having treated 
over 30 patients in this manner. In addition, we have a significant experience with back table 
modification of devices. Dr. Maldonado, in particular, has implanted over 40 back-table 
modified fenestrated and branched devices for thoracoabdominal aneurysms. This experience in 
particular has provided the greatest education for mastering technique and understanding 
nuances in endovascular treatment of thoracocabdominal aortic aneurysms (extent III,IV,V).  
We have a strong commitment to research and have three research coordinators who assist in 
patient enrollment for clinical trials, data management, follow-up, facilitating external 
monitoring and audits, as well as maintaining intramural research databases.  Our research 
coordinators also support our participation in regional/national databases such as the Vascular 
Quality Initiative (VQI).  We work closely with biostatisticians from our Department of 
Population Health and partner with Biomedical Research Alliance of New York (BRANY) 

 
 
 
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and/or the NYU School of Medicine Office of Science and Research for research support 
including assistance with IRB review, contracting and Medicare coverage analysis. For the 
current proposed PS-IDE we will utilize BRANY as our clinical research monitoring service 
(BRANY, 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042).  Our institutional review 
board (IRB) meets weekly.  
3.9 Report of Prior Investigations Synopsis 
The single center experience with the Visceral Manifold Thoracoabdominal Stent Graft 
System from Sanford Health  (Dr. Patrick Kelly;  PS-IDE (G140207) were recently reported .1 .   
29 patients were successfully treated between March 2012 and January 2016.  Twenty-seven 
patients were followed up to 1 month, 21 were followed up to 6 months, 16 were followed up to 
1 year, and 8 have been followed past 1 year thus far. Using the Crawford classification, there 
were 8 with a type 1/type 2, 6 type 3, 8 with type 4, and 7 with type 5.   97.3% (108 of 111) of 
target vessels were successfully stented and 99% (107 of the108) target vessels remained patent 
throughout follow-up. 15 patients in this experience met inclusion criteria (identical to ours) and 
were enrolled in the primary arm and 14 did not meet inclusion criteria and were treated as 
compassionate use.  The majority of this latter group would have been considered part of the 
expanded arm of our protocol. Specifically, 4 were emergency ruptures, 5 were chronic type B 
dissections, and the remaining 5 had suprarenal fixated stents or an occluded renal (total n=14). 
In the group meeting IDE inclusion criteria, there was an average length of stay of 7.5 days with 
no in-hospital or 30-day death, no cases of paraplegia, and one case of renal failure which 
resolved. There was one death at 11 months from a CVA. In the group not meeting IDE 
inclusion criteria, there was an average length of stay of 9.5 days, with no in hospital or 30-day 
death, two cases of paraplegia, and six cases of temporary or permanent renal failure.  

 
 
 
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When contrasted with open repair’s significant complication rates and branch fenestrated 
device’s significant anatomic and logistic limitations, the potential risk of the proposed novel 
graft does not outweigh the potential benefit of widened anatomic availability and improved 
patency rates.  Given the potential benefits, we feel that it is justified to expose the target patient 
population to the potential risk.  The non-clinical testing performed by Medtronic and the clinical 
results reported by Sanford Health show adequate safety of the device to support a clinical study.   

 
 
 
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4. Investigation Plan 
4.1 Purpose 
The primary objective of the clinical investigation is to assess the use of the thoracic 
bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients 
having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom 
from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment 
success and technical success) of the device (i.e., the proportion of treatment group subjects that 
achieve and maintain treatment success at one year).   
Additionally, the study will assess technical success and treatment success at each 
follow-up interval. 
4.2 Intended Use 
 
The Valiant™ Thoracoabdominal Stent Graft System is indicated for the endovascular 
treatment of thoracoabdominal aortic aneurysm (Crawford Type 1,2,3 and 5) in patients with 
the following characteristics: 
o An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal 
diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the 
centerline) measurements.  
o Aneurysm with a history of growth > 0.5 cm in 6 months.   
o Saccular aneurysm deemed at significant risk for rupture 
o Symptomatic aneurysm greater than or equal to 4.5 cm 

 
 
 
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o Axillary or brachial and iliac or femoral access vessel morphology that is 
compatible with vascular access techniques, devices or accessories, with or 
without use of a surgical conduit 
• Proximal landing zone for the thoracic bifurcation stent graft that has: 
≥ 2.5 cm of nonaneurysmal aortic segment including previously placed 
graft material (neck) distal to the left subclavian artery (LSA) and a 
diameter in the range of 26-42 mm 
• Adequate distance from the celiac artery, in order to accommodate 
cannulation from the antegrade access point when considering the total 
deployed length of the thoracic bifurcation and visceral manifold 
• Iliac artery or aortic distal fixation site, including both native tissue and 
previously placed graft, greater than or equal to 15 mm in length and diameter in 
the range of 8 – 25 mm 
• Age: ≥ 18 years old 
• Life expectancy: > 1 year 
4.3 Device Description 
 
The Valiant™ Thoracoabdominal Stent Graft System is made up of two main body 
components and makes use of several off-the-shelf FDA-approved stent graft components.  The 
two custom main body grafts are the thoracic bifurcation (Figure 3A) and the visceral manifold 
(Figure 3B).  The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal 
seal for the device.  For a Type I or II thoracoabdominal aneurysm the proximal seal is in zone 3 
and for Type III and V the device seals in zone 4..  The two limbs of the thoracic bifurcation 

 
 
 
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allows for continued aortic flow while deploying the visceral segment.  The visceral manifold is 
deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral 
debranching.  The branches of the visceral manifold extend to the visceral vessel with the use of 
covered bridging stents and provide distal seal of the manifold.   The smaller 16 mm limb of the 
thoracic bifurcation extends to the infrarenal segment to either seal in zone 9 for a Type I and V 
and in zone 10 for Type II and III..  All other connections in the device make use of sizes that are 
modular and independent of patient anatomy. 
 
 
A 
B 
Figure 3: Images of the manufactured device A) the thoracic bifurcation main 
body graft and B) visceral manifold main body graft 
 
4.4 Protocol 
 
This study is a prospective, single-center, non-randomized, multi-arm study to evaluate 
the therapeutic benefit of the Valiant™ Thoracoabdominal Stent Graft System.  A total of 15 
patients will be enrolled in this study. 
• 6 subjects total will be treated in the primary study arm  
• 9 subjects total will be treated in the expanded selection arm  

 
 
 
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The duration of the Investigation is anticipated as follows: 
• Time to Complete Enrollment: 24 months 
• Subject Follow-up Time: 5 years from last subject enrollment 
• Total Duration Time: 7 years 
4.4.1 Description of the Patient Population 
 
The study will evaluate 15 patients with type 1,2,3 and 5 thoracoabdominal aneurysms 
meeting protocol inclusion criteria for either the primary study arm or the expanded selection 
arm.  The patient population includes both male and female patients greater than 18 years old 
with a life expectancy of at least one year.   
4.4.2 Eligibility Criteria 
Primary Study Arm 
Inclusion Criteria 
• A patient may be entered into the study if the patient has at least one of the following: 
o An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal 
diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to 
the centerline) measurements 
o Aneurysm with a history of growth > 0.5 cm in 6 months  
o Saccular aneurysm deemed at significant risk for rupture 
o Symptomatic aneurysm greater than or equal to 4.5 cm 
• Axillary or brachial and iliac or femoral access vessel morphology that is compatible 
with vascular access techniques, devices or accessories, with or without use of a 
surgical conduit 

 
 
 
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• Proximal landing zone for the thoracic bifurcation stent graft that has: 
o ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft 
material (neck) distal to the left subclavian artery (LSA) and a diameter in the 
range of 26-42 mm 
 
o Adequate distance from the celiac artery, in order to accommodate cannulation 
from the antegrade access point when considering the total deployed length of the 
thoracic bifurcation and visceral manifold 
• Iliac artery or aortic distal fixation site, including both native tissue and previously 
placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 – 
25 mm 
• Age: ≥ 18 years old 
• Life expectancy: > 1 year 
Exclusion Criteria 
General exclusion 
• Patient is a good candidate for and elects for open surgical repair 
• Can be treated in accordance with the instructions for use with a legally marketed 
endovascular prosthesis 
• Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational 
site 
• Unwilling to comply with the follow-up schedule 
• Inability or refusal to give informed consent  

 
 
 
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• Urgent or emergent presentation 
• Patient is pregnant or breastfeeding 
• Patient has a contained rupture 
• Patient has a ruptured aneurysm 
• Patient has a dissection in the portion of the aorta intended to be treated 
• Obstructive stenting of any or all of the visceral vessels 
• 
Poor performance status including two major system failures (including but not 
limited to cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular) 
• Prior aneurysm repair that would involve relining of the previously placed graft 
material requiring placement of the investigational system in a landing zone that 
expands beyond any limits of the previously placed graft material 
 
Medical exclusion criteria 
• Known sensitivities or allergies to the materials of construction of the devices, 
including nitinol (Nickel: Titanium), polyester, platinum-iridium, 
polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.   
• Known hypersensitivity or contraindication to anticoagulation or contrast media 
that cannot be adequately medically managed  
• Uncorrectable coagulopathy 
• Body habitus that would inhibit x-ray visualization of the aorta or exceeds the 
safe capacity of the equipment 

 
 
 
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• Patient has had a major surgical or interventional procedure unrelated to the 
treatment of the aneurysm planned < 30 days of the endovascular repair 
• Unstable angina (defined as angina with a progressive increase in symptoms, new 
onset at rest or nocturnal angina) 
• Systemic or local infection that may increase the risk of endovascular graft 
infection 
• Baseline creatinine greater than 2.0 mg/dL  
• History of connective tissue disorders (e.g., Marfan Syndrome, Ehler’s Danlos 
Syndrome) 
Anatomical exclusion criteria 
• 
Branch vessel diameter less than 5 mm 
• Thrombus or excessive calcification within the neck of the aneurysm 
• Anatomy that would not allow maintenance of at least one patent hypogastric 
artery  
• Anatomy that would not allow primary or assisted patency of the left subclavian 
artery  
Expanded Selection criteria 
Subjects who meet inclusion criteria for the primary study arm may be enrolled under an 
expanded selection arm if they meet the following criteria. 
Inclusion Criteria 

 
 
 
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• Patient that meets the criteria for inclusion in the primary study arm but has 
one or more of the following criteria which would exclude them from the 
primary study arm: 
o Minimum branch vessel diameter less than 5 mm 
o Urgent or emergent presentation 
o Patient has a contained rupture 
o Patient has a ruptured aneurysm  
o Patient has a type B dissection (subacute or chronic) in the portion of 
the aorta intended to be treated 
o Poor performance status including two major system failures 
(cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular) 
o Baseline creatinine greater than 2.0 mg/dL 
o Anatomy that would not allow for maintenance of at least one 
hypogastric artery 
o Anatomy that would not allow for primary or assisted patency of the 
left subclavian artery 
 
Or 
• Patient that meets the criteria for inclusion in the primary study arm and:  
o Would not be eligible for the primary study arm per a documented 
reason other than those outlined above, and 

 
 
 
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o Per the opinion of the Principal Investigator, with concurrence of the 
IRB, alternative therapies are unsatisfactory and the probable risk of 
using the investigational device is no greater than the probable risk 
from the disease or condition. 
4.4.3 Study Endpoints 
The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or 
during hospitalization if this exceeds 30 days.   
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, 
renal failure, respiratory failure, and stroke. 
The primary effectiveness endpoint is the proportion of the study subjects with treatment 
success at 1 year.  Treatment success is defined as a composite of technical success and freedom 
from the following:  
• Aneurysm enlargement i.e., >5mm as compared to any previous CT measure 
using orthogonal (i.e., perpendicular to the centerline) measurements 
• Aneurysm rupture 
• Aneurysm-related mortality 
• Conversion to open repair  
• Secondary intervention for migration, Type I and III endoleaks, device integrity 
failure (e.g., fracture), and patency-related events (i.e., device component 
stenosis or occlusion and embolic events) 
Secondary endpoints include: 

 
 
 
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• Technical success and the individual components of technical success:  
o Successful delivery 
o Deployment at the intended implantation site 
o Patency of all endovascular graft and stent components 
o Absence of device deformations requiring unplanned placement of an 
additional device  
o Absence of inadvertent covering of aortic branch vessels 
o Successful withdrawal  
• Freedom from the individual components of the primary safety endpoint at 30 
days: 
o Death 
o Bowel ischemia 
o Myocardial infarction 
o Paraplegia 
o Renal failure 
o Respiratory failure 
o Stroke 
• Freedom from paraparesis at 30 days 
• The following at each follow-up interval: 
o Treatment success and the individual components of treatment success 
including freedom from the following:  
­ Aneurysm enlargement  
­ Aneurysm-related mortality  

 
 
 
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­ Aneurysm rupture 
­ Conversion to open repair 
­ Secondary intervention for migration, type I and III endoleaks, 
device integrity failure (i.e., fracture), and patency-related 
events (i.e., device stenosis or occlusion and embolic events).  
­ Renal failure 
­ All-cause mortality 
­ Endoleaks 
­ Device integrity failure (e.g., fracture) 
­ Patency-related events (i.e., device stenosis or occlusion and 
embolic events) 
­ Other device-related events 
4.4.4 Follow-up Schedule 
Patients included in the study will undergo follow-up at one month, six months, twelve 
months and then annually for five years.  In the event of patient death, an autopsy may be 
performed.   
Table 5. Follow-up Table  
Month 
 
Pre- op Intra- op Pre- discharge 
1 
6 
12 
24 
36 
48 
60 
CTA/CT Scan with 
and without 
X 
 
X8 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X-Ray 
X1 
 
 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
Angiography 
X3 
X 
 
 
 
 
 
 
 
 
Blood Tests 
X4 
X5, 6 
X4 
X4 
X4 
X4 
X4 
X4 
X4 
X4 
Clinical Exam 
(including ABI) 
 
X7 
 
 
X 
 
X7 
 
X7 
 
X7 
 
X7 
 
X7 
 
X7 
 
X7 
Branch Patency2 
(duplex ultrasound) 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 

 
 
 
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1 Device X-ray may be requested to provide more focused imaging if potential device integrity issues are identified, 
but are unable to be confirmed, using CT. Per standard of care: A/P, Lateral and Bilateral oblique views. 
2   In patients experiencing renal failure during follow-up, duplex ultrasound may be used in conjunction with non-
contrast CT.   
3   Pre-procedure angiography may be requested at discretion of film reviewer. 
4   Blood tests include hemoglobin and creatinine; PTT and prothrombin collected pre-op and pre- discharge only. 
5   Blood test for ACT. 
6   Other intra-op labs for anesthesia.   
7   Urine pregnancy test (for female patients of childbearing age) 
8   If deemed necessary by the Principal Investigator 
4.4.5 Patient Enrollment and Screening 
The investigator will assess potential study subjects with thoracoabdominal aortic 
aneurysms for their suitability for enrollment into the clinical study.  If the patient appears to 
meet eligibility criteria, either for the primary study arm or the expanded selection arm, then the 
investigator or clinical study coordinator will discuss the study with the patient and provide 
patient education materials to adequately inform the patient of potential risks and benefits, 
required follow-up procedures, and answer any questions.  The clinical study coordinator will 
facilitate the informed consent process.  After the patient has been properly consented, the 
patient will complete additional screening procedures that need to be completed.  If the patient 
does not sign the informed consent, they will not be enrolled in the study.  Information to be 
collected for screening includes: 
o Patient demographics 
o Medical history 
o Current health status 
o Physical examination 
o Ankle Brachial Index (ABI) 
o Pregnancy test (for female patients of childbearing age) 

 
 
 
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o An X-Ray will be performed per local standard of care.  A/P, Lateral and 
Bilateral Oblique Images will be obtained. 
o CTA of the chest, abdomen, and pelvis with 3D reconstruction if renal function 
allows to evaluate: 
• Access vessels for compatibility with vascular access techniques 
• Obstructive stenting of the visceral vessels 
•  Vessel diameters suitable for use with the Valiant™ 
Thoracoabdominal Stent Graft System 
• Aneurysm rupture 
• Branch stenosis   
• Dissection 
• Patency of left subclavian artery, hypogastric arteries, lumbar arteries, 
and all four visceral vessels 
• Thrombus or excessive calcification in the neck of the aneurysm 
•  
o Complete blood count  
o Basic metabolic panel  
o For patients with a history of smoking a pulmonary function test 
o Cardiac clearance 
4.4.5.1 Case Planning 
From the pre-op CT, the surgeon will make the following recommended measurements to 
size the endografts. 

 
 
 
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1. Length of the proximal seal zone, the distance required to land the thoracic 
bifurcation stent graft, this requires ≥ 2.5 cm section of healthy aorta, distal to the left 
subclavian artery.   
2. Diameter of the proximal landing zone to define the required diameter of the thoracic 
bifurcation stent graft.  The diameter of the thoracic bifurcation stent graft should be 
10-15% larger than the diameter of the aorta to proper oversize the stent graft.  
  
3. Distance from the top of the celiac to the top of the most cephalic renal.   
4. Distance from the top of the proximal seal zone to the takeoff of the celiac.   
5. Distance from the top of the celiac to the SMA.   
6. Angulation at the mid-thoracic aorta. 
7. Angulation at the diaphragm. 
8. Angulation at the renal arteries. 
9. Distance from the right renal to the ispilateral internal iliac artery. 
10. Distance from lower renals to aortic bifurcation.    
11. Diameter of the branch vessels (celiac, SMA, left renal, and right renal) to determine 
the diameter bridging stents needed and percent patency.   
12. Diameter of the right and left common iliac to secure the distal seal of the infrarenal 
bifurcation.   
13. Minimum diameter of the access sites (right and left femoral and brachial access site).   
14. Length from the access sites to the target treatment zone (right and left femoral and 
brachial access site).   

 
 
 
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Note: If treating a dissection under the expanded selection arm the true and false 
lumen as well as any naturally occurring fenestrations will be evaluated to determine 
placement of the device and which lumen feeds the branch vessels.   
.  
 
4.4.5.2 Pre-operative procedures 
The patient will be removed from anti-coagulants prior to surgery.  The day of surgery 
the following labs will be taken: 
o Complete blood count  
o Basic metabolic panel  
o Prothrombin time (at physician discretion) 
o Partial thromboplastin time (at physician discretion) 
o Pregnancy test (for female patients of childbearing age) 
The patient will be treated with general anesthesia under standard medical practices along 
with placement of a lumbar drain when possible.   
i. 
Spinal Drain 
o The use of a spinal drain is required for all non-staged procedures on subjects 
being treated for a Crawford Type I, II, III, or V thoracoabdominal aneurysm 
o In the case of prior spinal surgery or any reason that would put the 
patient at higher risk for complications, the use is at the physician’s 
discretion 
o The use of a spinal drain on staged procedures is at the physician’s discretion 

 
 
 
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The management of anesthesia and the lumbar drain will be performed by the staffed 
anesthesia team.  Standard heparinization practices will be followed and active clotting time will 
be monitored throughout the procedure.  The patient will be prepped in normal sterile fashion 
from the clavicle to mid-thigh.  Additionally contrast will be diluted 50/50 in saline to reduce 
contrast exposure.  Radiation reduction procedures will be followed as allowed.   
 
4.4.5.3 Implant Procedures 
Note I: For proximal extension of the thoracic bifurcation, two Valiant Captivia or 
Valiant Navion thoracic grafts can be used.  One to extend the landing zone more 
proximally and one to layer to prevent wear. Deploy the Valiant Captivia or Valiant 
Navion thoracic grafts according to their respective manufacturer’s IFU and continue 
according to the implant procedures the Medtronic Valiant Thoracoabdominal Stent 
Graft System IFU.  
Note II: For subjects with advanced iliac atherosclerosis and calcification, we will 
selectively perform use of open conduits to deliver devices, rather than percutaneous 
approach.  We will selectively perform on table Dyna CT – angiograms at the completion 
of the case. This will give us a better 3-Dimensional image of the stent and help 
determine if there is any degree of compression, which can be treated at that time with 
further stenting.    
 
 
 
 

 
 
 
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A. The use of thoracic grafts as a method of staging as a pre-operative adjunct procedure. 
a. Thoracic Graft Placement 
i. This refers to implanting stent-grafts into the thoracic aorta prior to enrollment 
into the IDE clinical study.  
ii. Device Visualization and Preparation 
Refer to the Instructions for use provided for the thoracic components to be used.   
iii. Device Placement 
Ensure that the distal edge of the thoracic graft is 5-7 cm proximal to the celiac artery. 
iv. Thoracic Aorta Component Deployment 
Follow the study protocol or IFU for deploying the thoracic graft components. 
v. Completion  
The date of the index procedure will be targeted for within 6 weeks of the thoracic 
graft placement, but will be based on physician discretion, clinical presentation, 
and patient compliance.   
B. The implantation of the Valiant™ Thoracoabdominal Stent Graft System is conducted 
under fluoroscopic/angiographic guidance.  Refer to the Valiant™ Thoracoabdominal 
Stent Graft System (IFU) for techniques and methods for device deployment and 
implantation.   
C. The Valiant Thoracoabdominal Stent Graft System may be implanted in a staged procedure per 
physician discretion (in either a planned or bail-out fashion).  The physician may choose to 
perform the procedure in two or more stages due to the following conditions/scenarios including 
but not limited to: hypogastric patency, LSA patency, visceral vessel patency, decreased 
MEP/SEP potentials, at risk dominant segmental arteries, pulmonary status, or any patient whose 

 
 
 
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physiologic limitations places them at risk  because of the expected length of surgery. The 
preferred method for planned staging is to create a controlled endoleak which provides limited 
and temporary perfusion to the aneurysm sac.  These methods include but are not limited to 
placing a bare metal stent in the celiac artery bridge, placing a bare metal stent in the bridge to an 
alternate visceral artery (ie:SMA or renal), or not completing distal seal in the aorta or iliac 
arteries.      
a. Planned Staged Procedure: Visceral artery bridge endoleak 
i. This refers to leaving open a portion of the covered stent bridge between 
the visceral manifold and target vessel. This is achieved by combining 
bare metal stents with covered stents to leave ~1-2cm of uncovered 
conduit along the pathway. This intentional endoleak is resolved in a 
subsequent intervention where the open portion is covered over by an 
additional covered stent. It is preferable to achieve this configuration with 
the bridge to the celiac artery but it can be done in analogous fashion with 
either the SMA or renal arteries.  
ii. Device Visualization and Preparation 
Refer to the Instructions for use provided for the bare metal stent for 
visualization and preparation instruction.  
iii. Bridging Stent Deployment 
Follow directions in the IFU when deploying bridging stents. Always 
deploy a covered stent in the leg of the visceral manifold per the VTAAA 
IFU (9mm iCast at 8atm inflation pressure). When possible, covered stents 
should be used in the target vessel. The chain of covered stents should be 
non-continuous in nature with at least one bare metal balloon expandable 

 
 
 
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stent connecting them. The segment of completely bare stent should be 
short (~1-2cm) with 2-3cm overlapping with covered stent on either side. 
Creation of the uncovered segment in as straight a configuration as the 
anatomy allows will facilitate wire passage during the completion 
procedure below.   
Note: The controlled endoleak should never be created by leaving a 
visceral manifold limb unconnected to a visceral vessel or with an 
uncovered segment >2cm due to the pressurization of the aneurysm sac.  
If a visceral vessel is occluded, the corresponding visceral manifold limb 
should be plugged with a vascular plug and an alternative (patent) vessel 
utilized for the staging procedure.  The placement of the non-continuous 
chain of covered bringing stents and a bare metal stent helps direct flow 
while creating a controlled endoleak.   
iv. Completion  
Completion of the staged procedure is targeted for 4-6 weeks following 
the index procedure, but will be based on physician discretion, clinical 
presentation, and patient compliance.   
Note: The physician may choose to complete the procedure earlier if the 
patient is symptomatic or has other concerns for aneurysm sac growth or 
rupture.   
Completion procedure may be performed under local or general 
anesthesia.  Vascular access will be established in the brachial or axillary 

 
 
 
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artery. The staged limb of the visceral manifold will be cannulated and the 
bare segment will be covered over by at least one iCast.  
 
b. Planned Stage Procedure: Delayed distal seal 
i. This refers to completing the visceral debranching (manifold to target 
arteries) with covered stents and subsequently leaving out one or more of 
the distal aortic/iliac components.  
ii. Device Visualization and Preparation 
Refer to the Instructions for use provided for the distal aortic/iliac 
components to be used.   
iii. Distal Aortic/Iliac Component Deployment 
Follow the study protocol or IFU for deploying the distal aortic/iliac 
components.   
iv. Completion  
Completion of the staged procedure is targeted for 4-6 weeks following 
the index procedure, but will be based on physician discretion, clinical 
presentation, and patient compliance.   
Note: The physician may choose to complete the procedure earlier if the 
patient is symptomatic or has other concerns for aneurysm sac growth or 
rupture.   
Completion procedure may be performed under local or general 
anesthesia.   
c. Bail-out Stage Procedure 

 
 
 
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i. A bail-out method may be used for staging in the event patient status 
declines during the case or inability to technically complete the case.   
ii. Device Visualization and Preparation 
Refer to the Instructions for use provided for the components to be used.   
iii. Device Deployment 
Refer to the Valiant™ Thoracoabdominal Stent Graft System (IFU) for 
device deployment and implantation of the remaining components.   
iv. Completion due to patient status decline 
Completion of a bail-out staged procedure due to patient status should be 
completed as soon as clinically feasible following the index procedure, but 
will be based on physician discretion, clinical presentation, and patient 
compliance.   
Note: The physician may choose to delay staging if the patient has 
complications or there are concerns with completing the secondary 
procedure.   
v. Completion due to inability to technically complete the case 
Completion of a bail-out procedure due to technical challenges have the 
following options that present no more risk than the alternative of no 
treatment.   
a. Complete case at another date 
b. Medical management 
c. Convert to open surgical repair 

 
 
 
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d. Referral to another facility/investigator that can complete 
the procedure 
 
Note:  Caution should be taken when relining previously placed graft material to prevent 
complications from graft on graft friction including decreased graft maneuverability and 
challenges repositioning. 
Note: For proximal extension of the thoracic bifurcation, two Valiant Captivia or Valiant 
Navion thoracic grafts can be used.  One to extend the landing zone more proximally and 
one to layer to prevent wear. Deploy the Valiant Captivia or Valiant Navion thoracic 
grafts according to their respective manufacturer’s IFU and continue according to the 
implant procedures the Medtronic Valiant Thoracoabdominal Stent Graft System IFU. 
Note: For type 1 and 5 aneurysms the distal end of visceral bypass (VB) should be sized 
to provide the distal seal with the aorta and then proceed to Step 4.4.5.5, Completion 
Procedures.  For type 2 and3 proceed to deployment of the infrarenal bifurcation and 
Endurant II limb stent graft instructions in the Medtronic TAAA Debranching Stent Graft 
System IFU.   
Note: If the VB is too short or too small to provide distal seal, a Valiant Captivia stent 
graft or Endurant Limb may be used in place or in conjunction with the Visceral Bypass 
to provide adequate distal seal.  For type 2and 3 proceed to deployment of the infrarenal 
bifurcation and Endurant II limb stent graft instructions in the Medtronic TAAA 
Debranching Stent Graft System IFU. If a commercially available Endurant limb or 
Valiant stent graft is used as the Visceral Bypass a commercially available Endurant 

 
 
 
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mainbody stent graft with suprarenal fixation and a Gore cuff is required for adequate 
fixation.  See Step 1.4.5.5.3.C and Step 1.4.5.5.4.D. below for deployment procedures. 
Note: If treating a subject with an occluded visceral vessel, a vascular plug may be used 
to occlude the extra limb of the TAAA Visceral Manifold stent graft. 
B. Surgical Decision Pathway and Bailouts 
 
Figure 4: Surgical decision path and possible bailouts  
C. Visceral Bypass (VB) Instructions (Endurant Long Limb) 
1. Insert a guidewire from the groin through the 16-mm limb of the thoracic bifurcation. 
2. Refer to the manufacturer’s IFU (Endurant) for visualization and preparation instructions.   

 
 
 
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3. The proximal radiopaque marker of the VB stent graft should be aligned with the 
bifurcation of the thoracic bifurcation.   
4. Verify there is a 5 cm overlap with the 16 mm leg of the thoracic bifurcation.  
5. Deploy the VB according to the manufacturer’s IFU (Endurant).   
6. Leave the guidewire in place and remove the delivery system according the to 
manufacturer’s IFU (Endurant).   
D. Infrarenal Bifurcation (IB) Instructions (Endurant Mainbody)  
1. Refer to the manufacturer’s IFU (Endurant) for visualization and preparation instructions.   
2. Identify the guidewire that passes through the VB stent graft.  
3. From the ipsilateral groin access point, insert the delivery system over the guidewire.   
4. Slowly advance the bifurcated graft into the VB stent graft. 
5. Verify there is a 4-5cm overlap with the VB stent graft.  
6. Confirm the distal portion of the contralateral leg is above the aortic bifurcation.   
7. Confirm the radiopaque ring marker on the distal end of the contralateral leg is in a 
position to allow for cannulation from the contralateral iliac artery.   
8. Confirm the distal target landing zone relative to anatomical landmarks (i.e. internal iliac 
artery).   
9. Deploy the bifurcated graft according to the manufacturer’s IFU (Endurant).   
10. Release the tip capture mechanism according to the manufacturer’s IFU (Endurant).   
11. Remove the delivery system according the to manufacturer’s IFU (Endurant).   
12. Complete distal seal of the bifurcated graft into the common iliacs according the 
manufacturer’s IFU (Endurant).   

 
 
 
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13. If the Endurant mainbody with suprarenal fixation is used deploy a Gore Aortic Extender 
Endoprosthesis according to the manufacturer’s IFU (Gore Excluder) over the suprarenal 
fixation stent of the bifurcated graft (Endurant mainbody) to seal and prevent endoleaks in 
the event the suprarenal fixation stent were to puncture the graft material.   
 
4.4.5.4 Completion Procedures 
1. At the physician’s discretion line the bridging stent grafts with self-expanding bare 
metal stent(s) to provide additional radial support.  Note: In the event a bridging stent 
or self-expanding stent needs reinforcement a Viabahn stent graft of appropriate 
sizing may be used.   
2. Begin to optimize spinal perfusion.   
3. After deployment of all stent grafts, all contact points will be balloon angioplasties.   
4. Perform an angiogram to verify stent graft apposition, seals, patency, device defects 
and any endoleaks.  Perform additional procedures, such as ballooning, cuff 
placement, or use of covered stent grafts as necessary to treat endoleaks or device 
failures.  Perform any adjunct procedures including but not limited to ballooning, 
atherectomy, or placement of stents to repair or treat any arterial issues or 
concomitant disease process in the iliac system to maintain flow to the lower 
extremities or the upper access arm extremity.    
5. Remove all sheaths, wires, and remaining accessories and repair of arterial access sites 
using standard surgical closure techniques. 
6. Dopplerable signals will be confirmed in bilateral lower extremities and the access 
upper extremities.  

 
 
 
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7. Once adequate perfusion is confirmed, heparinization will be reversed. 
8.  In the event of patient death an autopsy may be performed.     
4.4.5.5 Post-operative Care 
Patients may remain intubated and be transferred to the ICU standard post-operative care.  
Patients with a spinal drain will remain in bed with optimization of spinal perfusion pressure for 
48-72 hours whenever possible.  Post-operative care will be tailored to the patient taking into 
account events of surgery as well as pre-operative comorbidities to optimize the patient’s 
recovery.  On post-operative day two, attempts will be made to normalize the MAP and clamp 
the spinal drain if used.  Prior to spinal drain removal all coagulopathies and low platelet counts 
are corrected.  The patient’s neurological status is closely watched for the next 4-6 hours.  If it 
remains stable, the drain is removed and the patient is monitored for hypoxia, anemia, and 
hypotension.  In the event of patient death an autopsy may be performed.  Prior to discharge 
from the hospital, the following tests will be performed:  
o 
Physical examination 
o 
Complete blood count to evaluate white blood cells, hemoglobin, and platelets 
o 
Basic metabolic panel to evaluate creatinine 
o 
Prothrombin time (at physician’s discretion)  
o 
Partial thromboplastin time (at physician’s discretion) 
o 
CTA of the chest, abdomen, and pelvis if clinically necessary and renal function 
allows 
4.4.5.6 Follow-up Visits 

 
 
 
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All patients will undergo follow-up at one month, six months, twelve months and then 
annually for five years (as described in Section 1.4.4).  At each of the follow-up visits the 
following tests will be performed:  
o 
Physical examination  
o 
Complete blood count to evaluate white blood cells, hemoglobin, and platelets 
o 
Basic metabolic panel to evaluate creatinine 
o 
Pregnancy test (for female patients of child bearing age) 
o 
CTA of the chest, abdomen, and pelvis if renal function allows 
o 
If deemed necessary by the investigator, an X-Ray may be performed if 
potential device integrity issues are identified but unable to be confirmed by 
CT.  This will be done per local standard of care with  A/P, Lateral and Bilateral 
Oblique Images obtained. 
4.4.6 Sample Size Justification 
The sample size for the feasibility study is limited to 15 patients, as this is adequate to 
provide preliminary clinical safety data and effectiveness of the device We plan for  6 subjects to 
enroll in the primary arm, and 9 subjects to be enrolled under extended criteria. The device, 
while novel, has been evaluated in a clinical setting and has initially demonstrated both safety 
and effectiveness.  The limited sample size allows adequate patient data to be collected under a 
controlled protocol without exposing a large patient population to the risk associated with a 
novel device design.  The safety and effectiveness data collected in this study will be pooled with 
other physician sponsored investigational device exemptions (PS-IDEs) evaluating the Visceral 
Manifold System and should be sufficient to develop an appropriate pivotal study.   

 
 
 
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4.4.7 Data Presentation and Analysis Plan 
The primary purpose of this study is to evaluate the safety of this device as there are no or 
very limited devices and clinical options available for this patient population.  The primary 
safety endpoint of this study is freedom from major adverse events (MAE) at 30 days or during 
hospitalization if this exceeds 30 days.  Major adverse events include death, bowel ischemia, 
myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.  The primary 
safety endpoint will be analyzed to determine statistical significance when compared to a target 
performance goal.  A literature review of outcomes of open surgical repair was used to create the 
performance goal as there is not a comparable endovascular option to use for analysis.  The 
performance goal was selected based on the range of subjects experiencing a major adverse event 
at 30 days.  The range was calculated based on assumptions of the minimum and maximum 
number of subjects experiencing at least one MAE in the historical open surgical repair group 
(Table 6).  Based on the literature reviewed and the above assumptions the range of subjects 
experiencing at least one MAE in the open surgical repair group is 30.5% to 77.4%.   
The primary effectiveness endpoint is the proportion of the study subjects with treatment 
success at 1 year.  The data will be presented as quality outcomes, with the number of study 
subjects who experience treatment success compared to the overall patient population.    
Additionally, data outcomes from this study will be entered into a common vascular 
database so that data can be pooled with other PS-IDEs.  This would provide consistent reporting 
across the PS-IDEs.  Additionally, the PS-IDEs will be evaluating the same device and endpoints 
to allow for a pool-ability of data across the sites.   

 
 
 
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The data will be separated into two separate study arms: primary study arm and expanded 
selection arm.   
4.4.7.1 Statistical Methods 
The primary hypothesis of the Visceral Manifold Study is the number of subjects 
experiencing a major adverse event through 30 days will be less than a target performance goal 
(PG) of 50%. The PG was determined by using a conservative target that is approximately the 
average of the open surgical repair MAE rate calculated above (30.5%-77.4%, Table 6).  The 
anticipated test device 30 day MAE rate was based on the current rate of MAE’s (26%, Table 7) 
observed in 20 subjects meeting inclusion criteria into the primary study as of June 2016.   
The sample size for the Visceral Manifold Study was determined using an exact method 
based on a one-sided 2.5% significance level and an anticipated 26% investigational device 30 
day major adverse event rate.  Based on these assumptions, a sample size from the pooled PS-
IDE data of 46 subjects provides at least 80% power to test the primary hypothesis.   
Table 6. Historical Comparison for Primary Safety Endpoint (MAE Rate at 30 days for 
Open Repair) 
Reference 
# of 
Patients 
Mortality 
Bowel 
Ischemia 
Myocardial 
Infarction 
Paraplegia 
Renal Failure 
Respiratory 
Failure 
Stroke 
Rigberg et 
al 
1010 
191 (19%) 
 
 
 
 
 
 
Becquemin 
et al 
1678 
90 (5.4%) 
51 (3%) 
20 (1.2%) 
16 (1%) 
289 (17.2%) 
124 (7.4%) 
12 (0.7%) 
Murana et 
al 
542 
46 (8.5%) 
 
 
22 (4.2%) 
 
 
 
Ferrer et al 
257 
16 (6.2%) 
 
 
53 (20.8%) 
31 (12.3%) 
31 (12.3%) 
 
Bensley et 
al 
450 
45 (10%) 
 
10 (2.4%) 
 
48 (10.7%) 
202 
(45.1%) 
9 (2.2%) 
Nathan et al 
83 
6 (5.6%) 
 
 
 
 
 
 
Dayama et 
al 
682 
68 (10%) 
 
87 (12.9%) 
 
117 (17.2%) 
286 (42%) 
 

 
 
 
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Ferrante et 
al 
200 
5 (2.5%) 
 
25 (12.8%) 
 
22 (11%) 
27 (13.8%) 
 
Tsilimparis 
et al 
1091 
58 (5.4%) 
 
87 (8%) 
 
109 (10%) 
229 (21%) 
 
Piazza et al 
7833 
1331 
(17%) 
 
 
587 (7.5%) 
1488 (19%) 
2819 (36%) 
 
Total 
13826 
1855/1382
6  
51/1678  
229/4101  
678/10310  
2104/12191  
3718/12191  21/2128  
Rate of 
MAE at 30 
Days for 
Open 
Surgical 
Repair 
 
13.4% 
3.0% 
5.6% 
6.6% 
17.3% 
30.5% 
1.0% 
Table 7. Historical Comparison for Expected Investigational Device 30 Day MAE Rate 
(Outcomes of subjects treated with the Visceral Manifold System and meeting 
inclusion into the primary study as of June 2016) 
Dataset 
Mortality 
Bowel 
Ischemia 
Myocardial 
Infarction 
Paraplegia 
Renal Failure 
Respiratory 
Failure 
Stroke 
Subjects meeting 
VMS  
PS-IDE I/E 
criteria 
0/20 (0%) 
0/20 (0%) 
0/20 (0%) 
2/20 (9.5%) 
1/20 (5%) 
3/20 (14%) 
0/20 (0%) 
 
4.4.8 Limitations of the Study 
Limitations of the study are that it is a single center study with a small patient population.   
4.5 Risk Analysis  
The risk analysis includes a description and analysis of all increased risks to the research 
subjects and how these risks will be minimized. The risks can be separated into three categories: 
procedural-related risks, device performance-related risks, and device material-related risks.    
4.5.1 Potential Risks 
4.5.1.1 Procedural-related risks  
Procedural related risks including general and device specific procedural risks can result 
in several serious harms to the patient including contrast damage, allergic response, paraplegia, 
peripheral nerve damage, injury to access vessel, dislodging of thrombus, dissection of vessel, 

 
 
 
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embolism, branch artery or parenchyma damage of ischemia, inadvertent internal iliac occlusion 
or ischemic colitis, system effects including increased risk of morbidity and mortality, local 
effects at the access site including wound infection, hematomas, seromas, arterial or venous 
damage, failure to access the aorta, inaccurate deployment of devices, failure to deploy devices, 
and displacement of devices.  These risks can be mitigated in a number of ways including strict 
adherence to the investigational protocol, patient eligibility criteria, procedures performed by 
trained and qualified physicians, use of standard surgical and endovascular techniques, and 
regular follow-ups.  Although the risk is lowered by following these mitigation strategies, the risk 
cannot be completely eliminated.  However, the potential benefit of the manifold system as 
compared to other surgical techniques outweighs the potential procedural related risks to the 
patient.    
4.5.1.2 Material-related risks 
Material related risks are risks that are associated with physical components of the stent 
graft including risks related to stent breakage, branch vessel stent crush, barb fracture, fabric 
wear, biocompatibility, and sterility.  Risks of these components include vessel occlusion, 
embolism, component separation, migration, and infection.  These risks can be mitigated several 
ways including careful case planning for patient selection, device placement, proper sizing, use 
of compatible components, and regular follow-ups to identify early evidence of migration or 
separation.    
4.5.1.3 Performance related risks 
There are performance risks of the modular components succumbing to material fatigue 
resulting in component separation, endoleak or endotension, graft occlusion, kinking, or 
migration.  These risks can be mitigated several ways including adhering to industry standard 

 
 
 
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seal zone lengths, proper oversizing, lining branch stents with self-expanding stents, regular 
follow-ups to identify early evidence of migration or separation and allow for appropriate 
treatment, by the use of completion angiography coupled with cuffs, ballooning, or additional 
stent grafts if evidence of endoleak.    
4.5.2 Mitigation of Risks 
Significant care and thought has gone into designing The Valiant™  Thoracoabdominal 
Stent Graft System and investigational procedure for proper delivery and deployment of devices 
to minimize risks to patients to the greatest degree possible.  The design of the stent graft is 
bifurcated to provide flow to uninterrupted blood flow to the visceral and infrarenal segments 
during the repair process, negating the need for aortic clamping utilized in open repair.  
Additionally, the design of the stent graft system is modular to allow for bailouts and staging of 
the procedure throughout device deployment.  At any point in the procedure, the patient still has 
the opportunity for alternative treatments such as open surgical repair or other endovascular 
techniques.   
All efforts will be made to minimize the identified risks including:  
• 
Adherence to eligibility criteria and screening procedures to ensure that 
appropriate patients are selected and enrolled. 
• 
Adherence to the investigation protocol and clinical methods for case 
planning, device modification, and implantation will be followed.   
• 
Patients will be carefully monitored throughout the study period.  
• 
The investigator will evaluate the adverse events during the course of the 
study.   

 
 
 
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4.6 Monitoring Procedures 
Study monitoring and auditing will be performed by experienced and appropriately 
trained personnel appointed by the sponsor/investigator to ensure that the investigation is 
conducted in accordance with FDA IDE regulations.  Monitoring functions will be conducted by 
dedicated Clinical Research Monitors at Biomedical Research Alliance of New York (BRANY) 
(1981 Marcus Avenue, Suite 210, Lake Success, NY 11042).  Monitoring will be performed 
according to procedure. 
Informed Consent 
• Review 100% of all informed consents to ensure: 
• That the subject signed and dated the informed consent form for 
him/herself. 
• A valid (current IRB-approved version) copy of consent form was 
used. 
• Review documentation of informed consent process. 
Protocol 
• Confirm that the study staff is conducting the study in compliance 
with the protocol approved by the IRB. 
Source Document Verification 
• Review first five subject charts for: 

 
 
 
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• Trial eligibility.  If there are any subjects that did not meet trial 
eligibility, then five additional charts will be monitored.  These 
additional charts will be chosen randomly.   
• Primary and secondary safety and efficacy data- If there are 
discrepancies/errors discovered with reporting this data, then five 
additional charts will be monitored.  These additional charts will 
be chosen randomly.   
• Any correction made to the source documents is dated, initialed, 
and explained.  The original entry should not be obscured. 
• The protocol specific source documents are on file. 
• Source documents are completed in ink. 
• Note to files are made for missing or incomplete data and to 
explain any discrepancies or additional comments. 
Electronic Case Report Forms in Redcap or equivalent eCRF system 
• Ensure the data reported on the eCRF is consistent with the source 
documents. 
• Discrepancies between the source documents and eCRF are 
explained in a note to file or captured in a comment in the eCRF. 
Adverse Events & Serious Adverse Events 
• Monitor will review all subject research chart and medical records 
to ensure the following: 

 
 
 
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• All AEs and SAEs have been reported including any abnormal 
physical exam findings determined to be clinically significant. 
• They have been reported in a timely manner defined as within ten 
(10) business days between the time the site staff became aware of 
the event to the time it has been recorded and entered in eCRF. 
• AEs have been reviewed; attribution has been assigned and signed 
by investigator in a timely manner. 
• Ensure any AEs and SAEs have been submitted to the IRB and 
FDA that meets IRB/FDA reporting criteria.  
• All subject deaths have been reported appropriately. 
Protocol Deviations 
• Ensure all protocol deviations that meet reporting requirements 
have been reported to     the IRB as well as reported in eCRF. 
Investigational Product 
• Ensure investigational product has been properly handled and 
stored.   
Monitoring Intervals: 
Monitoring will occur at regular intervals throughout the duration of the trial.  Monitoring 
can be performed on-site or remotely 
4.7 Reporting  

 
 
 
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All reports to FDA will be identified as SI-IDE Reports: 
Deviations from the investigational plan:  The sponsor-investigator will notify the 
reviewing IRB and FDA of any deviation from the investigational plan to protect the life 
or physical well-being of a subject in an emergency. The notice will be provided as soon 
as possible but no later than 5 working days after the emergency occurred. If the change 
or deviation may affect the scientific soundness of the investigational plan or the rights, 
safety or welfare of the subject, the sponsor will obtain prior IRB approval and also FDA 
approval for the deviation by submitting an IDE supplement. 
Unanticipated adverse device effects:  The sponsor-investigator will report the results 
of an evaluation of an unanticipated adverse device effect to FDA and all reviewing IRBs 
within 10 working days after the sponsor-investigator first receives notice of the adverse 
effect. 
Withdrawal of IRB approval: The sponsor-investigator will notify FDA of the 
withdrawal of IRB approval of an investigation (or any part of an investigation) within 5 
working days of receipt of the withdrawal of approval. 
Progress report or annual reports: The sponsor will provide progress reports to the 
reviewing IRB and to the FDA using the suggested format provided at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYo
urDevice/InvestigationalDeviceExemptionIDE/ucm046717.htm#sugforforidefin 
To describe the follow-up compliance for the study, the sponsor will include a table 
in the annual progress report:  

 
 
 
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Table 8. Annual progress report 
 
 
# (%) 
Adequate imaging to assess the parameter*** 
# (%) 
Events occurring before next interval 
# (%) 
Visit 
Eligible 
for 
follow-
up* 
Subjects 
with data 
for that 
visit 
 
CT 
 
X-
ray 
Subjects 
with follow-
up 
pending** 
Size 
Increase 
 
Endoleak 
 
Migration 
Fracture 
Death 
Conversion 
LTF 
Not 
due 
for 
next 
visit 
Operative 
 
 
  
N/A 
 
N/A 
 
 
 
 
 
 
 
30 day 
 
 
 
 
 
 
 
 
 
 
 
 
 
6 month 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 year 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional 
years 
 
 
 
 
 
 
 
 
 
 
 
 
 
*Eligible for follow-up = previous eligible for follow-up – (previous death + conversion + LTF + not due). 
** Subjects still within follow-up window, but data not yet available. 
*** Not the number of subjects with these reported events; the number with adequate imaging, such as 
paired size data to evaluate aneurysm growth.   
 
Additionally, the sponsor will send an Interim Report for every five patients 
regardless of study arm, and within the report divide those 5 into their respective primary 
or expanded selection cohorts. 
 
These reports will include basic information on the number of patients enrolled 
and treated and information on observed adverse events for any subgroups (e.g., 
device types, extents of disease, lesion types).   These interim progress reports are 
meant to be summaries and not complete progress reports.  Details will be 
captured in any adverse event reports and annual reports to the IDE. 
Table 9: Enrollment summary*           
 
column for each 
subgroup 
Total 
Enrolled 
 
Treated 
 
Awaiting treatment 
 
Withdrawn (state reason) 
 
* A subject is considered enrolled after the device enters the body.     
 
Summary 

 
 
 
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For each subgroup of patients, a brief narrative description of the procedures 
completed to date (e.g., how many had devices implanted successfully), any need 
for additional interventions, and the outcomes of any additional interventions will 
be provided.    
Table 10: Treatment summary   
                                                 
Adverse Events 
 
Comments on the most commonly observed challenges or adverse events will be 
provided. 
Table 6: Adverse Events    
 
 
Study subjects who had multiple complications will be designated using symbols 
(#, *, +) or numbers. 
 
 
Number of patients 
Procedural success 
Perioperative death 
One branch 
 
Two branches 
 
Three branches 
 
Four branches 
 
Total 
 
The following table is an example of how 
adverse event numbers may be presented for 
each subgroup.  The list will include events 
observed in the study, not necessarily all that 
are listed in this example                      
1st 5 
2nd 5 
Additional 
groups 
All 
Aortic dissection 
 
 
 
 
Branch vessel embolism (renal, celiac, SMA, etc.) 
 
 
 
 
Branch vessel occlusion (renal, celiac, SMA, etc.)  
 
 
 
 
Branch vessel dissection (renal, celiac, SMA, etc.) 
 
 
 
 
External iliac dissection           
 
 
 
 
Interval iliac occlusion 
 
 
 
 
Ischemic colitis/Colon necrosis                    
 
 
 
 
Late related death 
 
 
 
 
Late unrelated death                  
 
 
 
 
Leg ischemia      
 
 
 
 
Lower extremity embolism    
 
 
 
 
Lower extremity paralysis        
 
 
 
 
MI     
 
 
 
 
Perioperative death                         
 
 
 
 
Renal failure/impairment                           
 
 
 
 
Respiratory failure             
 
 
 
 
Stroke                                   
 
 
 
 
Wound necrosis                        
 
 
 
 

 
 
 
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Lessons Learned 
The lessons learned from the beginning of the study (e.g., with respect to patient 
selection, methods to minimize adverse events) will be summarized.  Procedures 
proposed or implemented to mitigate any risks or challenges that were observed during 
the study will be discussed, as well as any changes in outcomes based on experienced 
gained during the study. 
 
Recalls and device dispositions: The sponsor-investigator will notify FDA and all 
reviewing IRB’s of any request that a sponsor-investigator return, repair, or dispose of 
any unit of an investigational device. The notice will be made within 30 working days 
after the request is made and will state why the request was made. 
Final report: The sponsor-investigator will notify FDA and all reviewing IRBs within 30 
working days of the completion or termination of the investigation. The sponsor-
investigator will also submit a final report to FDA and all reviewing IRBs and 
participating investigators within 6 months after the completion or termination of the 
investigation. The suggested format for final IDE reports will be utilized in preparing the 
final report as described at:  
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYo
urDevice/InvestigationalDeviceExemptionIDE/ucm046717.htm#sugforforidefin 
Clinical Trial Database report: The sponsor-investigator with an applicable study 
registered with the National Institutes of Health (NIH) National Library of Medicine’s 
(NLM) ClinicalTrials.gov will report results of the study within 12 months of the trial 
reaching its completion data regardless of outcomes or if the study is terminated early.    

 
 
 
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Failure to obtain informed consent: The sponsor-investigator will submit a report of 
the use of a device without first obtaining informed consent. The report will be made to 
FDA within 5 working days after receipt of the notice of such use. 
Other reports: The sponsor-investigator will provide accurate, complete, and current 
information about any aspect of the investigation upon request from the reviewing IRB or 
FDA. 
4.8 Oversight 
 This study will have oversight by a Data Safety Monitoring Board (DSMB) consisting of 
independent scientific and bio-statistical expertise, who are not participating as investigators in 
the study.  The DSMB will monitor and evaluate the safety of subjects and progress of the study. 
The board will meet after every 5th patient enrolled in the primary study arm receiving the 
investigational device and annually during the follow-up period to review subject data.  The 
board will also meet at unscheduled times according to clinical necessity. The data safety reports 
reviewed at each meeting will contain enrollment data and all documented adverse events 
experienced by the participants and treatment outcomes.  The focus of the analysis is to 
determine whether enrollment should continue or be closed and whether the trials should 
continue as originally designed or require modification/amendment.    
4.9 Definitions 
Aortic aneurysm enlargement: >5mm as compared to any previous CT measure using 
orthogonal (i.e., perpendicular to the centerline) measurements  
Aortoiliac aneurysm: aneurysm of the abdominal aorta and including one or both of the iliac 
arteries  

 
 
 
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Aneurysm-related mortality: 
Death occurring within 30 days or during hospitalization following the index procedure, 
unless there is evidence of accidental or self-inflicted death; 
Death occurring within 30 days or during hospitalization following conversion to open 
repair or a secondary intervention for migration, Type I and III endoleaks, device 
integrity failure (e.g., fracture), or patency-related events (i.e., device stenosis or 
occlusion and embolic events), unless there is evidence of accidental or self-inflicted 
death;  
Death occurring within 30 days or during hospitalization for a complication of the 
aneurysm or a complication associated with the device, such as:  
• aortic rupture 
• fistula formation (e.g., aorto-enteric) 
• embolization 
• malperfusion of organ(s) or limb(s) 
Arterial fistula formation: formation of an abnormal connection or passageway between an 
artery and adjacent structures 
Conversion to Open, Early: any open repair within 30 days of the index procedure involving 
the vasculature in the abdomen and/or pelvis. 
Conversion to Open, Late: any open surgical repair involving stentgraft removal after 30days 
post index procedure 

 
 
 
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Chronic Obstructive Pulmonary Disease (COPD): forced expiratory volume (FEV1) < 1.0 
liter or receiving home oxygen  
Crawford Type IV TAAA: aneurysmal dilatation originating within 5cm of the celiac artery 
Disabling stroke: Modified Rankin Score MRS >2 
Distal landing zone: aortic fixation site furthest from the heart  
Embolization: dislodging of an upstream particle that travels downstream causing blockage of 
free flow further downstream. Embolization could result in malperfusion 
Embolus: blood clot that forms at one location (presumably from the aneurysmal sac, aortic 
neck, or adjacent vessels) and is dislodged to another location resulting in ischemic changes  
Emergent:  an aneurysm requiring immediate treatment 
Endoleak:  
Type I: leak occurring at the proximal or distal fixation site, including leakage around 
fenestrations  
Type Ia: leak occurring at the proximal fixation zone of the stent-graft  
Type Ib: leak occurring at the distal fixation zone of the stent graft  
Type Ic: leak occurring at the distal fixation zone of the covered stents in the visceral 
vessels incorporated by the fenestrations  
Type II: leak caused by retrograde flow from patent lumbar or inferior mesenteric 
arteries  

 
 
 
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Type IIIa: leak caused by a defect in the graft fabric 
 Type IIIb: leak caused by inadequate seal between modular graft components  
Type IV:  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 after device deployment  
Endoleak, Late: any endoleak observed later than 30 days after deployment that was not 
documented during the first 30 days after deployment  
Estimated Glomerular Filtration Rate (eGFR): estimated GFR (mL/min/1.73 m2) = 175 x 
(Serum creatinine)-1.154 x (Age)-0.203x (0.743 if female) x (1.210 if African-American)  
Limb occlusion: the presence of thrombus within any graft limb that creates occlusion  
Major adverse events: all-cause mortality, bowel ischemia (requiring medical or surgical 
management), myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke 
• All-Cause Mortality: any death occurring within the first 30 days post procedure 
• Bowel Ischemia: Bowel ischemia due to limb or arterial occlusion, graft placement, or 
embolization. 
• Myocardial infarction: raised levels of cardiac biomarkers or ECG changes  
• Paraplegia: spinal cord ischemic event resulting in complete loss of motor function with 
or without loss of sensation in the lower extremities 

 
 
 
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• Renal Failure: acute or progressive renal insufficiency leading to the need for dialysis or 
hemofiltration 
• Respiratory failure: Prolonged intubation (>48 hours after spinal drain removal or >72 
hours total) and/or reintubation.  This definition does not put the patient at any increased 
risk.  The high risk patient population being treated in this study is prone to pre-existing 
comorbidities, including COPD and decreased respiratory function, and may require 
extended ventilator support while in the supine position for spinal drainage.   
• Stroke: neurological deficit that lasts > 24 hours 
Malperfusion of organ(s) or limb(s): loss of flow through a particular vascular bed has been 
partially or completely compromised leaving the said organ or limb ischemic 
Migration, clinically significant: antegrade or retrograde migration that requires surgical or 
endovascular intervention 
Paraparesis: spinal cord ischemic event resulting in partial neurologic deficit in the lower 
extremities 
Parietal arteries (branches): inferior phrenic, lumbars and middle sacral arteries  
Patency: the state of a vessel that has unimpeded flow into and out of the vessel   
Proximal landing zone: the aortic fixation site closest to the heart 
Proximal fixation length: the aortic fixation site measured from the proximal edge of the graft 
to the start of the aneurysm  
Renal insufficiency: rise in serum creatinine of more than 50% above pre-procedure level which 
results in a serum creatinine >2.0 mg/dl that does not spontaneously resolve  
Technical success:   

 
 
 
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• successful delivery (i.e., ability to deliver the implant to the intended 
implantation site, without the need for unanticipated  corrective intervention 
related to delivery); 
• successful  and accurate deployment, defined as: 
 deployment of the endovascular stent-graft at the intended 
implantation site; 
 patency of all endovascular graft and stent components; absence of 
device deformations (e.g., kinks, stent eversion, mal-deployment, 
misaligned deployment) requiring unplanned placement of an 
additional device;  
 absence of inadvertent covering of aortic branch vessels; and 
• successful withdrawal (i.e., successful withdrawal of the delivery system, 
without need for unanticipated  corrective intervention related to withdrawal) 
Thrombus: a blood clot that forms due to injury of a vessel. If the thrombus becomes dislodged 
and travels it is referred to as an embolus  
Treatment success:  a composite of technical success and freedom from the following: 
• aneurysm enlargement i.e. >10-mm as compared to any previous CT measuring 
orthogonal (i.e., perpendicular to centerline) measurements 
• aneurysm-related mortality 
• aneurysm rupture 

 
 
 
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• conversion to open repair 
• secondary intervention for migration, type I and III endoleaks, device integrity failure 
(i.e., fracture), and patency-related events (i.e., device stenosis or occlusion and embolic 
events) 
• Renal failure 
Type B – Chronic Dissection:  a dissection that takes off distal to the left subclavian artery that 
is greater than 30 days old 
Type B – Subacute Dissection:  a dissection that takes of distal to the left subclavian artery that 
is 15-30 days old 
Urgent:  An aneurysm requiring repair within 1 week 
Visceral arteries (branches): celiac, superior mesenteric, inferior mesenteric, renal arteries 

 
 
 
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5. Manufacturing Information  
The Valiant™ Thoracoabdominal Stent Graft System utilizes the Medtronic TAAA 
Debranching Stent Graft System.  Therefore, the manufacturing information for the system is 
listed in the following Medtronic regulatory submission:   
MAF-2551, Medtronic, TAAA Debranching Stent Graft System Master File 
6. Investigator Agreement and Certification 
The investigator that will be participating in the study includes Dr. Thomas Maldonado.  I 
certify that all participating investigators will sign the investigator agreement and no investigator 
will be added until the agreement is signed in accordance with 21 CFR 812.29(b)(5). 
The names and addresses of investigators will be provided upon request by the FDA and 
in accordance with 21 CFR 812.150(b) (4). 
7. IRB Information 
Helen Panageas, CIP  
New York University Institutional Review Board 
One Park Avenue, 6th Floor 
New York, New York 10016 
 
8. Amount to be charged 

 
 
 
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The amount charged for the devices used in this investigation will be consistent with the 
amount charged by the manufacturers of the devices to the hospitals.    
9. Labeling 
The Valiant Thoracoabdominal Stent Graft System utilizes the Medtronic TAAA 
Debranching Stent Graft System.  Therefore, the manufacturing information for the system is 
listed in the following Medtronic regulatory submission:   
MAF-2551, Medtronic, TAAA Debranching Stent Graft System Master File 
10. Medicare Generalizability  
The Valiant™ Thoracoabdominal Stent Graft System is intended to treat 
thoracoabdominal aortic aneurysms and the highest incidence of this disease is observed in 
Medicare eligible patients.  A 2013 market survey of inpatient data revealed that 79.8% 
(1642/2058) of all thoracoabdominal aortic aneurysms occurred in patients over the age of 65.  In 
that same survey, Medicare was the principal payer in 76.3% of those cases and the secondary 
payer in 82.6% of those cases61.   
Aneurysmal degeneration occurs more commonly in the aging population.  Aging may 
lead to weakening of the aortic wall due to changes in the collagen and elastin. Additionally, 
comorbidities that may increase the risk for aneurysm formation are smoking, chronic 
obstructive, pulmonary disease, hypertension, atherosclerosis, male gender, older age, high body 
mass, genetic disorders, and family history62.   

 
 
 
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11. References 
1. 
Kelly PW. New Stent Grafts for the Thoracic and Thoracoabdominal Segment: The Valiant 
Thoracoabdominal Design. J Vasc Surg. 2016;63(6):228S-229S. 
2. 
Anderson J, Remund T, Pohlson K, Kelly P. Description of a new technique for repairing chronic 
type B dissections that involve visceral branches being fed by both true and false lumen by using 
both lumens as conduits. Vascular. 2016;24(1):103-105. 
3. 
Standring S. Gray's Anatomy: The Anatomical Basis of Clinical Practice. 40th Edition. Churchill-
Livingstone, Elsevier; 2008. 
4. 
Dapunt OE, Galla JD, Sadeghi AM, et al. The natural history of thoracic aortic aneurysms. The 
Journal of thoracic and cardiovascular surgery. 1994;107(5):1323-1332; discussion 1332-1323. 
5. 
Cambria RA, Gloviczki P, Stanson AW, et al. Outcome and expansion rate of 57 
thoracoabdominal aortic aneurysms managed nonoperatively. American journal of surgery. 
1995;170(2):213-217. 
6. 
cronenwett JL SS, Wall MH. Variables that affect the expansion rate and outcome of small 
abdominal aortic aneurysms. Journal of vascular surgery. 1990;11:260-269. 
7. 
Cronenwett JL, Murphy TF, Zelenock GB, et al. Actuarial analysis of variables associated with 
rupture of small abdominal aortic aneurysms. Surgery. 1985;98(3):472-483. 
8. 
Bickerstaff LK, Pairolero PC, Hollier LH, et al. Thoracic aortic aneurysms: a population-based 
study. Surgery. 1982;92(6):1103-1108. 
9. 
McNamara JJ, Pressler VM. Natural history of arteriosclerotic thoracic aortic aneurysms. The 
Annals of thoracic surgery. 1978;26(5):468-473. 
10. 
Pressler V, McNamara JJ. Thoracic aortic aneurysm: natural history and treatment. The Journal 
of thoracic and cardiovascular surgery. 1980;79(4):489-498. 
11. 
Crawford ES, DeNatale RW. Thoracoabdominal aortic aneurysm: observations regarding the 
natural course of the disease. Journal of vascular surgery. 1986;3(4):578-582. 
12. 
Moreno-Cabral CE, Miller DC, Mitchell RS, et al. Degenerative and atherosclerotic aneurysms of 
the thoracic aorta. Determinants of early and late surgical outcome. The Journal of thoracic and 
cardiovascular surgery. 1984;88(6):1020-1032. 
13. 
de Bakey ME, McCollum CH, Graham JM. Surgical treatment of aneurysms of the descending 
thoracic aorta: long-term results in 500 patients. The Journal of cardiovascular surgery. 
1978;19(6):571-576. 
14. 
Cooke JC, Cambria RP. Simultaneous tracheobronchial and esophageal obstruction caused by a 
descending thoracic aneurysm. Journal of vascular surgery. 1993;18(1):90-94. 
15. 
Zanetti PP, Krasoń M, Walas R, et al. “Open” repair of ruptured thoracoabdominal aortic 
aneurysm (experience of 51 cases). Kardiochirurgia i Torakochirurgia Polska = Polish Journal of 
Cardio-Thoracic Surgery. 2015;12(2):119-125. 
16. 
Piazza M, Ricotta JJ, 2nd. Open surgical repair of thoracoabdominal aortic aneurysms. Annals of 
vascular surgery. 2012;26(4):600-605. 
17. 
Rectenwald JE, Huber TS, Martin TD, et al. Functional outcome after thoracoabdominal aortic 
aneurysm repair. Journal of vascular surgery. 2002;35(4):640-647. 
18. 
Schepens MA, Heijmen RH, Ranschaert W, Sonker U, Morshuis WJ. Thoracoabdominal aortic 
aneurysm repair: results of conventional open surgery. European journal of vascular and 
endovascular surgery : the official journal of the European Society for Vascular Surgery. 
2009;37(6):640-645. 

 
 
 
IP 01-001 Version 8 
                                                                                                                                                              Page 105 of 107              
 
19. 
Wong DR, Parenti JL, Green SY, et al. Open repair of thoracoabdominal aortic aneurysm in the 
modern surgical era: contemporary outcomes in 509 patients. Journal of the American College of 
Surgeons. 2011;212(4):569-579; discussion 579-581. 
20. 
Bensley RP, Curran T, Hurks R, et al. Open repair of intact thoracoabdominal aortic aneurysms in 
the American College of Surgeons National Surgical Quality Improvement Program. Journal of 
vascular surgery. 2013;58(4):894-900. 
21. 
Nathan DP, Brinster CJ, Woo EY, Carpenter JP, Fairman RM, Jackson BM. Predictors of early and 
late mortality following open extent IV thoracoabdominal aortic aneurysm repair in a large 
contemporary single-center experience. Journal of vascular surgery. 2011;53(2):299-306. 
22. 
Menard MT, Nguyen LL, Chan RK, et al. Thoracovisceral segment aneurysm repair after previous 
infrarenal abdominal aortic aneurysm surgery. Journal of vascular surgery. 2004;39(6):1163-
1170. 
23. 
Coselli JS, Bozinovski J, LeMaire SA. Open surgical repair of 2286 thoracoabdominal aortic 
aneurysms. The Annals of thoracic surgery. 2007;83(2):S862-864; discussion S890-862. 
24. 
Tabayashi K, Saiki Y, Kokubo H, et al. Protection from postischemic spinal cord injury by 
perfusion cooling of the epidural space during most or all of a descending thoracic or 
thoracoabdominal aneurysm repair. General thoracic and cardiovascular surgery. 
2010;58(5):228-234. 
25. 
Messe SR, Bavaria JE, Mullen M, et al. Neurologic outcomes from high risk descending thoracic 
and thoracoabdominal aortic operations in the era of endovascular repair. Neurocritical care. 
2008;9(3):344-351. 
26. 
Coselli JS, LeMaire SA, Miller CC, 3rd, et al. Mortality and paraplegia after thoracoabdominal 
aortic aneurysm repair: a risk factor analysis. The Annals of thoracic surgery. 2000;69(2):409-
414. 
27. 
Archer W, Hoch, and Kranner. Cardiac function is a risk factor for paralysis in thoracoabdominal 
aortic replacement. Journal of vascular surgery. 1998;27(5):821-830. 
28. 
Greenberg RK, Lu Q, Roselli EE, et al. Contemporary analysis of descending thoracic and 
thoracoabdominal aneurysm repair: a comparison of endovascular and open techniques. 
Circulation. 2008;118(8):808-817. 
29. 
Safi HJ, Estrera AL, Azizzadeh A, Coogan S, Miller CC, 3rd. Progress and future challenges in 
thoracoabdominal aortic aneurysm management. World journal of surgery. 2008;32(3):355-360. 
30. 
Cambria RP, Clouse WD, Davison JK, Dunn PF, Corey M, Dorer D. Thoracoabdominal aneurysm 
repair: results with 337 operations performed over a 15-year interval. Annals of surgery. 
2002;236(4):471-479; discussion 479. 
31. 
Dorsey C, Chandra V, Lee JT. The "Terrace Technique"-Totally Endovascular Repair of a Type IV 
Thoracoabdominal Aortic Aneurysm. Annals of vascular surgery. 2014. 
32. 
Cariati M, Mingazzini P, Dallatana R, Rossi UG, Settembrini A, Santuari D. Endovascular 
treatment of a symptomatic thoracoabdominal aortic aneurysm by chimney and periscope 
techniques for total visceral and renal artery revascularization. Cardiovascular and 
interventional radiology. 2014;37(1):251-256. 
33. 
Cariati M, Rossi UG. Letter REPLY Re: "Endovascular Treatment of a Symptomatic 
Thoracoabdominal Aortic Aneurysm by Chimney and Periscope Techniques for Total Visceral 
and Renal Artery Revascularization". Cardiovascular and interventional radiology. 2014. 
34. 
Pecoraro F, Pfammatter T, Mayer D, et al. Multiple periscope and chimney grafts to treat 
ruptured thoracoabdominal and pararenal aortic aneurysms. Journal of endovascular therapy : 
an official journal of the International Society of Endovascular Specialists. 2011;18(5):642-649. 
35. 
Scali ST, Feezor RJ, Chang CK, et al. Critical analysis of results after chimney endovascular aortic 
aneurysm repair raises cause for concern. Journal of vascular surgery. 2014. 

 
 
 
IP 01-001 Version 8 
                                                                                                                                                              Page 106 of 107              
 
36. 
Moulakakis KG, Mylonas SN, Avgerinos E, et al. The chimney graft technique for preserving 
visceral vessels during endovascular treatment of aortic pathologies. Journal of vascular surgery. 
2012;55(5):1497-1503. 
37. 
Kasirajan K. Branched grafts for thoracoabdominal aneurysms: off-label use of FDA-approved 
devices. Journal of endovascular therapy : an official journal of the International Society of 
Endovascular Specialists. 2011;18(4):471-476. 
38. 
Lobato AC, Camacho-Lobato L. A new technique to enhance endovascular thoracoabdominal 
aortic aneurysm therapy--the sandwich procedure. Seminars in vascular surgery. 
2012;25(3):153-160. 
39. 
Oderich GS, Ricotta JJ, 2nd. Modified fenestrated stent grafts: device design, modifications, 
implantation, and current applications. Perspectives in vascular surgery and endovascular 
therapy. 2009;21(3):157-167. 
40. 
Oderich GS, Fatima J, Gloviczki P. Stent graft modification with mini-cuff reinforced fenestrations 
for urgent repair of thoracoabdominal aortic aneurysms. Journal of vascular surgery. 
2011;54(5):1522-1526. 
41. 
Haulon S, Greenberg RK. Part Two: Treatment of type IV thoracoabdominal aneurysms--
fenestrated stent-graft repair is now the best option. European journal of vascular and 
endovascular surgery : the official journal of the European Society for Vascular Surgery. 
2011;42(1):4-8. 
42. 
Oderich GS, Mendes BC, Correa MP. Preloaded guidewires to facilitate endovascular repair of 
thoracoabdominal aortic aneurysm using a physician-modified branched stent graft. Journal of 
vascular surgery. 2014;59(4):1168-1173. 
43. 
Benjelloun A, Henry M, Ghannam A, et al. Endovascular treatment of a tuberculous 
thoracoabdominal aneurysm with the Multilayer stent. Journal of endovascular therapy : an 
official journal of the International Society of Endovascular Specialists. 2012;19(1):115-120. 
44. 
Vaislic CD, Fabiani JN, Chocron S, et al. One-year outcomes following repair of thoracoabdominal 
aneurysms with the multilayer flow modulator: report from the STRATO trial. Journal of 
endovascular therapy : an official journal of the International Society of Endovascular Specialists. 
2014;21(1):85-95. 
45. 
Sultan S, Hynes N. One-year results of the multilayer flow modulator stent in the management 
of thoracoabdominal aortic aneurysms and type B dissections. Journal of endovascular therapy : 
an official journal of the International Society of Endovascular Specialists. 2013;20(3):366-377. 
46. 
Lazaris AM, Maheras AN, Vasdekis SN. A multilayer stent in the aorta may not seal the 
aneurysm, thereby leading to rupture. Journal of vascular surgery. 2012;56(3):829-831. 
47. 
Ferrero E, Gibello L, Ferri M, Viazzo A, Nessi F. Aortic arch rupture after multiple multilayer stent 
treatment of a thoracoabdominal aneurysm. Journal of vascular surgery. 2013. 
48. 
Cavalcante RN, Nishinari K, Yazbek G, Krutman M, Bomfim G, Wolosker N. Severe visceral 
ischemia and death after multilayer stent deployment for the treatment of a thoracoabdominal 
aortic aneurysm. Journal of vascular surgery. 2014. 
49. 
de Vries JP. Treatment of complex thoracoabdominal or juxtarenal aortic aneurysms with a 
Multilayer stent. Journal of endovascular therapy : an official journal of the International Society 
of Endovascular Specialists. 2012;19(1):125-127. 
50. 
Sherif Sultan NH, and Mohamed Sultan. When not to implant the multilayer flow modulator: 
lessons learned from application outside the indications for use in patients wtih 
thoracoabdominal pathologies. Journal of Endovascular Therapy. 2014;21:96-112. 
51. 
O'Callaghan A, Mastracci TM, Eagleton MJ. Staged endovascular repair of thoracoabdominal 
aortic aneurysms limits incidence and severity of spinal cord ischemia. Journal of vascular 
surgery. 2015;61(2):347-354.e341. 

 
 
 
IP 01-001 Version 8 
                                                                                                                                                              Page 107 of 107              
 
52. 
Banga PV, Oderich GS, Reis de Souza L, et al. Neuromonitoring, Cerebrospinal Fluid Drainage, 
and Selective Use of Iliofemoral Conduits to Minimize Risk of Spinal Cord Injury During Complex 
Endovascular Aortic Repair. Journal of endovascular therapy : an official journal of the 
International Society of Endovascular Specialists. 2016;23(1):139-149. 
53. 
Fratesi F, Handa A, Uberoi R, Sideso E. Chimney-Graft as a Bail-Out Procedure for Endovascular 
Treatment of an Inflammatory Juxtarenal Abdominal Aortic Aneurysm. Case reports in vascular 
medicine. 2015;2015:531017. 
54. 
Oderich GS, Mendes BC, Kanamori KS. Technique of implantation and bail-out maneuvers for 
endovascular fenestrated repair of juxtarenal aortic aneurysms. Perspectives in vascular surgery 
and endovascular therapy. 2013;25(1-2):28-37. 
55. 
Roselli EE, Greenberg RK, Pfaff K, Francis C, Svensson LG, Lytle BW. Endovascular treatment of 
thoracoabdominal aortic aneurysms. The Journal of thoracic and cardiovascular 
surgery.133(6):1474-1482.e1471. 
56. 
Taylor Suess JA, Laura Danielson, Katie Pohlson, Tyler Remund PhD, Elizabeth Blears MD, 
Stephen Gent PhD, and Patrick Kelly MD. Examination of near wall hemodynamic parameters in 
the renal bridging stent of various stent graft configurations for repairing visceral branched aortic 
aneurysms.  . Journal of vascular surgery.In Press. 
57. 
Mohabbat W, Greenberg RK, Mastracci TM, Cury M, Morales JP, Hernandez AV. Revised duplex 
criteria and outcomes for renal stents and stent grafts following endovascular repair of 
juxtarenal and thoracoabdominal aneurysms. Journal of vascular surgery. 2009;49(4):827-837; 
discussion 837. 
58. 
Registry. BSfETatGCoAS-GTfARG. Early results of fenestrated endovascular repair of juxtarenal 
aortic aneurysms in the United Kingdom. Circulation. 2012;125(22):2707-2715. 
59. 
Greenberg R, Eagleton M, Mastracci T. Branched endografts for thoracoabdominal aneurysms. 
The Journal of thoracic and cardiovascular surgery. 2010;140(6 Suppl):S171-178. 
60. 
Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, Reilly LM. Endovascular treatment of 
thoracoabdominal aortic aneurysms. Journal of vascular surgery. 2008;47(1):6-16. 
61. 
MarketScan Inpatient View by Truven Health Analytics d. 
62. 
Frederick JR, Woo YJ. Thoracoabdominal aortic aneurysm. Annals of cardiothoracic surgery. 
2012;1(3):277-285.