Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm: Clinical Pivotal Trial
Conditions: Abdominal Aortic Aneurysm
Sponsor: Azienda Ospedaliero-Universitaria di Modena

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1. TITLE  
“Clinical effectiveness of an off-the-shelf single REnal Scalloped sTent-graft for HOstile NEck 
infrarenal abdominal aortic aneurysm: clinical pivotal trial.”. 
 
NCT number ### 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2. FUNDING 
The study is physician-sponsored. The medical device to perform endovascular exclusion of 
the AAA will be provided by the national health system. The clinical workup, hospitalization, 
and operation costs will be delivered under the national health system without any additional 
cost compared to standard care. A specific insurance for the patients being part of the study 
will not be required.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3. STUDY STAFF 
Principal Investigator (PI): 
Dr. Stefano Gennai, MD 
Unit of Vascular Surgery department, Ospedale Civile di Baggiovara (Via Pietro Giardini, 1355, 
41126 Baggiovara MO, Italy), Azienda Ospedaliero-Universitaria di Modena, Dipartimento di 
Scienze Biomediche, Metaboliche e Neuroscienze, Università di Modena e Reggio Emilia. 
PI will be responsible for funding. PI will supervise all clinical and research phases (enrollment, 
treatment, clinical follow-up, data collection, data analyses, validation of the results, and 
publication). 
 
Investigators: 
Prof. Roberto Silingardi, MD 
Head of the Unit of Vascular Surgery department, Ospedale Civile di Baggiovara (Via Pietro 
Giardini, 1355, 41126 Baggiovara MO, Italy), Azienda Ospedaliero-Universitaria di Modena, 
Dipartimento di Scienze Biomediche, Metaboliche e Neuroscienze, Università di Modena e 
Reggio Emilia. 
Role: Validation of the results and publication. The Investigator will be part of the data 
monitoring committee.  
 
Dr. Mattia Migliari 
Unit of Vascular Surgery, Ospedale Civile di Baggiovara (Via Pietro Giardini, 1355, 41126 
Baggiovara MO, Italy), Azienda Ospedaliero-Universitaria di Modena. 

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Role: protocol writing, clinical screening, enrollment, treatment, data collection, clinical 
follow-up, data analyses, and publication. The Investigator will be part of the data monitoring 
Dr. Nicola Leone, MD 
Unit of Vascular Surgery, Ospedale Civile di Baggiovara (Via Pietro Giardini, 1355, 41126 
Baggiovara MO, Italy), Azienda Ospedaliero-Universitaria di Modena. 
Role: protocol writing, clinical screening, enrollment, treatment, data collection, clinical 
follow-up, data analyses, and publication. The Investigator will be part of the data monitoring 
committee and the second data manager 
 
Dr. Francesco Andreoli, MD 
Unit of Vascular Surgery, Ospedale Civile di Baggiovara (Via Pietro Giardini, 1355, 41126 
Baggiovara MO, Italy), Azienda Ospedaliero-Universitaria di Modena. 
Role: protocol writing, clinical screening, enrollment, treatment, data collection, clinical 
follow-up, data analyses, and publication. The Investigator will be the first data manager.  
 
 
 
 
 
 
 
 
 
 

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4. BACKGROUND 
Endovascular aneurysm repair (EVAR) is currently the preferred choice to treat the 
abdominal aortic aneurysms (AAA) with a feasible anatomy1,2.  However, approximately 40-
60% of AAA patients presented unfavorable characteristics for EVAR, mainly due to a 
“hostile neck anatomy”3–5. In ‘‘real-world’’ clinical practice, up to 44% of EVAR cases are 
performed outside Instruction For Use (IFU) for an adverse neck anatomy6. Short (<15-mm), 
angulated (>60°), and wide (>28-mm) aortic necks are the main features concurring to the 
proximal HNA6.   
The recourse to standard EVAR is currently routine for patients who are not eligible for OR, 
with acceptable short- and mid-term outcomes, but the long-term durability of EVAR 
depends on maintaining proper sealing between the endograft and the aortic neck as well 
as the iliac arteries7. HNAs demonstrated worse results when compared to “favorable” ones 
in terms of technical success (94% vs. 98%) and type-Ia endoleak rate (10% vs. 2%).6    The 
issue linked to an unfavorable anatomy can be addressed with more complex techniques, 
but these are limited by high production costs and considerable complexity. 8-9 .  
TREO (Terumo Aortic, Inchinnan, Renfrewshire, UK; formerly Treovance, Bolton Medical, 
Sunrise, Fla) is a standard bifurcated, modular stent-graft that has shown compelling early- 
and mid-term results10-11. It seems clear that several physicians are still looking for a feasible 
solution for HNA patients to keep the complexity of the procedure comparable to standard 
EVAR while yielding improved results. 
Moreover, there is a lack of publications addressing the issue of mismatched take-off of the 
renal arteries (RAs). This morphology seems to influence the sealing length and could justify 

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the introduction of dedicated devices. A recent study from our group currently under review 
for publication demonstrated that 25% of patients eligible for EVAR presented with 
mismatched RAs and that a dedicated device could improve sealing significantly. The study 
group sealing zone’s length increased by about 25% when applying a hypothetical prototype 
with a single 10x10mm (wide x high) renal scallop. The same approach could be applied to 
the sealing surface with similar results. 
The present study aims to evaluate the clinical effectiveness of an off-the-shelf standardized 
single renal scalloped stent-graft (Treo, Terumo Aortic) to treat infrarenal AAA. The final 
objective will be to employ the data obtained in this cohort for a future eventual 
development of an “off-the-shelf” device dedicated to patients with mismatched renal 
arteries. Such an endograft could keep the complexity of the procedure as similar as 
possible to standard EVAR while improving sealing.  
 
 
 
 
 
 
 
 
 
 
 
 

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5. STUDY AIM  
 
BASIC RESEARCH  
To evaluate the clinical effectiveness of EVAR with an “off-the-shelf” single-renal-
scallop endograft (TREO, Terumo Aortic) in the treatment of AAA patients with mismatched 
renal arteries. These data will be used to evaluate the clinical advantages of the adoption of 
a dedicated device for this kind of patients. See the protocol below for methods.  
 
CLINICAL STUDY 
To assess the real-world, in-vivo, clinical effectiveness of the use of a single-renal scallop 
endograft to treat infrarenal AAA. The study population is subjects with infrarenal AAA eligible 
for EVAR, of both sexes, aged 18>years, and with mismatched renal arteries. The mismatch 
was defined by a distance between the takeoff of the two proper renal arteries ³ of 10mm. 
The study group is intended for patients receiving EVAR with the pre-mentioned dedicated 
custom-made endograft (from now called Prototype). The clinical intervention will be 
performed in the study participating centers and for our competence at the Unit of Vascular 
Surgery (Ospedale Civile di Baggiovara, Azienda Ospedaliero-Universitaria di Modena, Via 
Pietro Giardini, 1355, 41126 Baggiovara MO, Italy). 
 
Expected results and risk/benefit considerations 
The results will demonstrate whether the “Prototype” is effective for the treatment of AAA 
with mismatched RAs. The effectiveness will be evaluated in terms of technical and clinical 

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success. Other objectives are the evaluation of procedure-related adverse events and re-
interventions, as well as operative details.  
The use of fenestrated and branched endograft has already been demonstrated to be safe 
and feasible for the treatment of HNA AAA13-14. However, the complexity of the repair, the 
high costs, and the significant risk of renal and neurological injury limited the widespread of 
these techniques8,9, 15.  On the other hand, standard EVAR has been used in HNA AAA with 
acceptable results in short- and mid-term period11-12. The actual challenge is to improve the 
outcomes of patients with unfavorable anatomy for standard EVAR keeping the complexity 
as low as possible.  
Literature evaluating the mismatch of renal arteries in AAA patients is lacking and a recent 
study carried out in our unit demonstrated that about one-third of these presented an 
infrarenal distance of more than 10mm.  These particular anatomical characteristics seem to 
influence the length of sealing and justify the evaluation of a dedicated device. 
The benefits could be relevant for the patients in terms of reduction of procedure-related 
adverse events such as endoleaks and related re-interventions. Furthermore, the use of 
custom-made standardized devices could produce a significant reduction in costs for health 
care providers and in the feature, it could be the base for an “off-the-shelf” endograft. 
Procedure-related complications were expected to be similar to standard EVAR and reduced 
in comparison with literature reporting adverse events in more complex techniques. To 
confirm this forecast all adverse events will be reported in our CRF and prospectively 
monitored. Moreover, complications directly imputable to device defects will be promptly 
communicated to the regulatory authority and managed following law dispositions. 
 
 

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6. STUDY DESIGN 
This study is a multi-center non-randomized prospective observational post-marketing cohort 
study. The cohort of patients will be followed up for a minimum of 5 years after the treatment. 
The study aimed to test the EVAR with the “prototype” device in mismatched renal arteries 
AAA.  
Inclusion/exclusion criteria were reported above. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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7. METHODS 
Setting 
Patients affected by AAA with an inter-renal distance ³ 10mm and eligible for EVAR within 
standard TREO (Terumo Aortic) IFU will be prospectively enrolled at the Unit of Vascular 
Surgery of the Ospedale Civile di Baggiovara (Azienda Ospedaliero-Universitaria di Modena) 
and in the participating centers. The Investigators (3 experts Vascular surgeons9 will screen 
the patients for inclusion. Once the patient’s eligibility will be stated, informed consent will 
be collected and the study could take place. 
 
Inclusion criteria: 
• Patients affected by infrarenal AAA ³ 50mm 
• Treated in election for non-symptomatic AAA 
• Anatomy inside Treo (Terumo Aortic) instruction to use (IFU) 
• Distance between renal arteries ³10mm on aortic center-lumen-line 
• Age ³ 18 
• Patient fit to plead 
• Both sex 
• Written informed consent 
• Treated in the coordinator center or in one of the study’s participating centers 
• Minimum follow-up requested: 3-months, 12-18 months and 5-years CTA; clinical and 
DUS examination at 6- and 12- and 36-months after the intervention and yearly 
thereafter 

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Exclusion criteria: 
• Patients with aortic pathologies different from AAA (aortic ulcers, dissection, pseudo-
aneurysm etc) 
• Treated in urgent/emergent setting for symptomatic or ruptured AAA 
• AAA < 50mm 
• Outside TREO (Terumo Aortic) IFU 
• With an inter-renal distance measured of the center-lumen-line <10mm 
• Age <18 
• Unfit to plead 
• Refused to sign the informed consent 
• Treated outside the coordinator centers or in one of the study’s participating center’s 
• Refusal to adhere to the requested follow-up 
 
Device description  
TREO (Terumo Aortic) was described in different papers.100-11 It is a tri-modular device 
composed of self-expanding nitinol Z-stents sutured to woven polyester graft fabric. The 
stent-graft has a proximal bare stent with each edge presenting barbs. The second row of 
barbs is placed at the external surface of the proximal edge of the fabric. The barbs are 
nitinol, caudally-directed, sealing adjuncts promoting a better fixation.  
The Manufacturer allows customization of the standard design. The investigational endograft 
was ideated with a single renal scallop (10x10-mm and 15x10-mm, height and width, 

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respectively). Three highly visible platinum-Iridium markers were placed around the 
fenestration to improve visibility and precision during deployment. The clock position of the 
scallop should be at 15 o’clock (45° on anteroposterior view). The remaining design 
characteristics and delivery systems features  
 
Pre-operative work-up 
The subjects will undergo a complete clinical examination, including pathological and 
pharmacological anamnesis. A complete doppler ultrasound examination will be performed 
before admission to the ward. 
High-quality CTA scans (6th rib to groin spanning and 1-mm slice thickness) not older than 6 
months from the scheduled intervention is mandatory for every included patient. 
The mentioned CTA will be carefully evaluated independently by two vascular surgeon 
experts in endovascular aortic procedures. Multiplanar and curved reconstructions were 
obtained for each CTA in a dedicated workstation plugged with Therenva Endosize 
reconstruction software (Therenva, Rennes, France). All the measures were based on the 
orthogonal centerline reconstruction.  
The aortic measurements taken were reported above: 
• Diameters – measured intima-intima. The measures were taken at different levels: 
the inferior edge of the upper RA’s ostium (D1), the inferior edge of the lower RA’s 
ostium (D2), and the distal end of the proximal sealing zone (D3); 
• Lengths – measured with the lower edge of the RA as reference. Polar RAs were 
assumed as “proper renal” if the diameter was >4mm; if not, they were ignored. do 
not differ from the standard TREO. Infra-renal (L1) was the length between the lower 
RA and the distal end of the proximal sealing zone. Inter-renal length (IRL; L2) was 

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the distance between renal arteries’ lower limits. L3 resulted by coupling L1 and L2 
and represented the hypothetical sealing length available in patients suitable for 
investigational devices. 
• Angulations – Alpha angle (or suprarenal) was the inflection point between the neck 
and suprarenal aortic axes. Beta angle (or infra-renal) was the inflection point 
between the neck axis and the aortic sac axis.  
All the measurements were used to plan the interventions and to engineer the proper 
“prototype” device. The device description and characteristics were detailed above. 
All supra-mentioned data were collected in a dedicated eCRF. 
According to our standard clinical practice all the patients were admitted to ward the evening 
before surgery day to exclude possible acuity. 
 
Surgical procedure  
All the procedure were carried out in a standard operating room equipped with a mobile C-
Arm, or in a Hybrid theater under local sedation or general anesthesia on the basis of 
comorbidity and/or surgeon preference. A bilateral percutaneous access was obtained, even 
if based on the specific case a cut-down and contralateral percutaneous access is possible. 
Hemostasis was achieved using the Proglide/Prostyle (Abbott Vascular, Abbott Park, IL, USA) 
if percutaneous access was used. Intraoperative heparin dosing varied by the center. 
However, generally, heparin was administered to maintain an activated clotting time > 250 
seconds, when possible. 
 Techniques for delivery and deployment of the standard device have been well described by 
different papers10-12, but for the “prototype” some attention is required.  

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Once the device was advanced at the level of the lowest RA the C-Arm has been moved to 
correct the parallax effect and positioned orthogonally to the origin of the artery. This 
procedure permits perfectly matching the scallop with the artery takeoff. 
A selective angiogram was performed to assure the patency of the lower RA. 
After the deployment of the main body proper iliac extensions were delivered to completely 
exclude the aneurysm as standard practice.  
The complete exclusion of the AAA was checked with a final angiography and then all devices 
were removed. Heparin was antagonized with the appropriate dose of protamine and access 
was closed.  
According to our standard of care, patients are discharged on the second postoperative day 
on either aspirin or clopidogrel, if not already on one of these medications. 
 
Follow-up 
The first clinical evaluation (before surgery) was performed before discharge primarily to 
check the femoral access. All the patients will be assessed clinically and with a high-quality 
CTA (from 6th rib to groin) within 3 months from surgery and yearly for 5 years thereafter for 
a total of seven evaluations. All the visits will be performed by Investigators.  
The patients will be followed up via telephone call to strictly adhere to the present scheme. 
A telephone number of the Vascular Surgery Unit will be daily available for any patient’s 
clinical issue during the study period. The clinical and radiological follow-up will continue 
regularly as a standard practice also in case of patients’ voluntary withdrawal.  
 
Endpoints 

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Primary endpoint: Clinical effectiveness measured in terms of technical and clinical success. 
Technical success was defined as defined on an intent-to-treat basis and requires the 
successful introduction and deployment of the device in the absence of surgical conversion 
or mortality, type I or III endoleaks, or graft limb obstruction. A technical success thus implies 
the following qualifying details: 1. Successful access to the arterial system using a remote site 
(ie, the femoral, external iliac, common iliac, or brachiocephalic arteries with or without the 
use of a temporary or permanent prosthetic conduit to access these arteries); 2. successful 
deployment of the endoluminal graft with secure proximal and distal fixation; 3. absence of 
either a type I or III endoleak; 4. patent endoluminal graft without significant twist, kinks, or 
obstruction (>30% luminal stenosis or a pressure gradient >10 mm Hg) by intraoperative 
measurements; 5 patency of both renal arteries and at least one hypogastric artery. Primary 
technical success can include the use of additional modular components, stents, angioplasty, 
and adjunctive surgical procedures. However, if unplanned endovascular or surgical 
procedures are necessitated it must be noted. 
Clinical success requires the successful deployment of the endovascular device at the 
intended location without death as a result of aneurysm-related treatment, type I or III 
endoleak, graft infection or thrombosis, aneurysm expansion (diameter >5 mm, or volume 
>5%), aneurysm rupture, or conversion to open repair, occlusion of the renal arteries. The 
clinical success was measured at every follow-up interval. Any additional maneuvers, planned 
or unplanned, aimed to maintain clinical success must be carefully reported. 
 
Secondary endpoints:  
 
• Evaluation of the intra-operative and peri-operative (within 30 days) adverse events 

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• Collection of eventual adverse events related to the treatment procedure and 
eventual post-hoc analysis 
• Evaluation of reintervention (time elapsed since index operation, type, and 
indication);  
• Evaluation of potential risk factors (baseline, anatomical features, procedural 
technique) potentially related to adverse events 
• Evaluation of the main procedural and fluoroscopy time, evaluation of the average 
contrast medium (CM) dose as well as Dose Area Product (DAP) (mGym3). 
Adverse events are defined as any systemic or local complication directly related to the 
procedure. Adverse events that occurred in the first 30-day were considered procedure-
related, unless differently demonstrated. 
Any surgical, open, or endovascular, procedure aimed to address adverse events was named 
re-intervention.   
The secondary endpoints represent specific technical aspects related to the procedure and 
the endograft.  
Treatment-related adverse events and re-interventions are important to state the safety of 
the procedure over time and its external reproducibility. 
The procedure and fluoroscopy time, as well as the contrast-medium dose, will be used to 
evaluate the complexity of the procedure, comparing it with the same reported in the 
literature for standard EVAR. 
 
Timeline 
Months 1-3 
 
Organization and logistic set-up. 
Months 3-15  
Subjects enrollment, data collection, treatments, clinical follow-up. 

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Months 15-18  
Conclusion of recruitment, first (3 months) follow-up end for every 
patient, ad-interim analysis 
Month 27-39                2-year follow-up end, mid-term analysis 
  
Month 63-75  
Conclusion of the follow-up, analysis of the results and their validation, 
statistical analysis, project completion and analysis for further work, dissemination of the 
results 
Gannt chart: 
 
Sample size 
No statistical analysis of the sample size was carried out. Considering the number of AAA 
responding to the inclusion criteria treated in the participating centers and the enrollment 
period (1 year) a sample size of 50 patients was estimated. This number should be sufficient 
to evaluate the endpoints reported in the appropriate section.  
The estimated number of patients recruited for the present center is 15 patients 
 
Recruitment 
All the involved centers represent the third referral level of complex Abdominal Aortic 
Aneurysms. 
Months
Organization and logistic set-up.
Subjects enrollment
Treatments
Data collection
Clinical-follow-up
3-months follow-up
Ad-interim analysis
1-year follow-up
2-year follow-up
Mid-term analysis
3-year follow-up
4-year follow-up
5-year follow-up
Conclusion of the study
Results'analysis and validation
Statistical analysis
Project completion and analysis for further work
dIssemination of the results
84
12
24
36
48
60
72

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For what concerns our center all patients affected by AAA responding criteria for treatment 
were evaluated at the Vascular Surgery Unit of the Azienda Ospedaliero Universitaria di 
Modena. Those meeting the inclusion criteria will be singularly recruited.  
Taking into account a mean of 120 endovascular procedures on the abdominal aortic and 10 
complex procedures with custom-made devices, a safety 12-month recruitment should be 
considered. The entire Medical staff of the department is informed about the present project 
and will refer the potential subjects to the Investigators. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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8. MANAGEMENT OF THE DATA 
The collected data will be managed into a dedicated electronic case report form (CRF). The 
CRFs will be stored on a dedicated and validated website. Only the Investigators will have 
access to the data with a personal password. Only the PI and the first data manager will be 
able to see all the data, while the other investigators will have permission to manage only the 
data of the patients enrolled in their center.  
 To ensure the correct data collection two Investigators will perform the clinical and 
radiological assessment at each follow-up visit. Before the conclusion of the visit, a double-
check will be performed by the Investigators. The CRF will be completed at the time of 
enrollment and each follow-up visit thereafter. The CRF required data are declared below. 
A personal code will be generated at the enrollment. The CRF will be filled anonymously. The 
following anamnestic data: age, sex, comorbidities (hypertension, cardiopathy, 
hyperlipidemia, peripheral arterial disease, previous surgery, etc). Procedure planning details 
were detailed previously. The procedure details: planned and unplanned adjunctive 
procedure, the adverse events, the skin-to-skin time, the fluoroscopy time and DAP, the type 
of anesthesia, the dose, and characteristics of CM used.  Primary and secondary endpoints 
will be registered as defined previously.  
The following indicators will also be collected: time of recovery from the intervention and the 
number of an hour passed in the Intensive Care Unit if needed. 

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In case of the patient’s voluntary withdrawal, the CRF will be discontinued. The patient will 
undergo standard clinical practice follow-up.  
In case of device-related adverse-events, a detailed description of the event will be performed 
to inform the regulatory authority. The clinical follow-up and the CRF proceed as stated. 
In case of death, the study personnel will investigate the cause and any eventual relation with 
the treatment or device will be declared to the regulatory authority and carefully reported on 
the eCRF.  
 
Statistical methods 
Continuous variables will be expressed as mean, andstandard deviation, and differences 
tested with the two-sided t-test or the Mann–Whitney U-test, if appropriate. Categorical 
variables will be expressed as counts and percentages and the chi-square test or Fisher’s 
exact test will be used for analysis. All data will be entered into the logistic regression model 
if they had a univariable P-value of <0.05. Data resulting significative in this model will be 
put in a multivariate one. In the multivariable analyses, clinical factors or potential 
confounding variables will be expressed as odds ratios with 95% confidence interval (CI). 
The goodness of fit of the logistic regression models will have been assessed by calculating 
the C-statistic. Survival analysis and freedom from adverse events will be assessed through 
the Kaplan-Meier analysis with their relative 95% CI. A P-value< 0.05 defined the statistical 
significance The analysis was carried out using STATA 15.1 (StataCorp College Station, Texas, 
USA). 
. 
 
 

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9. MONITORING 
The monitoring committee will be composed of Investigators. The PI will supervise the 
committee. The committee will monthly revise the data until the end of the study. The 
committee will collectively resolve any issues related to the data collection.  
The committee will produce ad interim analyses. Eventual adverse events (mild and/or 
severe) will be internally investigated by the monitoring committee and externally 
communicated according to the local regulatory authority disposition. The auditing process 
will be independent. 
The study will be stopped in case of early signs of arm. The PI will decide on the early 
interruption. The PI will communicate the decision within 15-day as the local regulatory 
authority advise (DM 21.12.2007). The interruption will be conducted under the local 
regulatory authority.  
The Investigators will diffuse the data even in case of early interruption.  
 
 
 
 
 
 
 

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10. ETHICAL ASPECTS AND DISSEMINATION 
The study will be registered on Clinicaltrial.gov and conducted under the principles of the 
Helsinki Declaration and the Local Ethics Committee approval (CE AVEN, Comitato Etico 
dell’Area Vasta Emilia-Nord). The Investigators will promptly communicate to the CE AVEN 
any changes to the present protocol. The CE AVEN will decide on ad-interim modification. The 
patients’ enrollment will require informed consent collection. The consent could be provided 
by a legal guardian. The Investigators will be responsible for the signed document collection. 
The informed consent will specify the possibility to be treated with the investigational device, 
basic research analyses, and clinical follow-up adherence. The procedures will be delivered in 
an eligible setting. So, emergent patients are not the object of the present investigation. The 
study data will be managed anonymously. Only the Investigators will have access to the data. 
The electronically gathered data will be depersonalized aiming for anonymous analysis and 
interpretation. All Investigators have no disclosure to declare. All Investigators will have 
access to the final database as well as the regulatory authorities on reasonable request. The 
study will not provide specific insurance. The eventual clinical complications will be managed 
under national health insurance. Results of the study will be disseminated by scientific 
publications, congress presentations, and medical meetings. The dissemination will proceed 
to the general audience through general journals, and hospital and university websites. The 
dissemination will be anonymous. Publication costs are not expected to exceed 3000 euros. 
The authorship will be defined by the PI based on each publication. The Investigators will be 

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included among the authors of the scientific publications. Medical writer, it is not expected. 
The dataset will be shared in a data repository according to the journal's requirements for 
publication.   
 
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1.  
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Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice 
Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J 
Vasc Endovasc Surg Off J Eur Soc Vasc Surg. 2019 Jan;57(1):8–93.  
2.  
Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, et al. 
The Society for Vascular Surgery practice guidelines for the care of patients with an 
abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2.  
3.  
Marone EM, Freyrie A, Ruotolo C, Michelagnoli S, Antonello M, Speziale F, et al. 
Expert Opinion on Hostile Neck Definition in Endovascular Treatment of Abdominal 
Aortic Aneurysms (a Delphi Consensus). Ann Vasc Surg. 2020 Jan;62:173–82.  
4.  
Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of 
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Surg. 2018 Jun;67(6):1699–707.  
5.  
Speziale F, Sirignano P, Setacci F, Menna D, Capoccia L, Mansour W, et al. Immediate 
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different commercially available devices. analysis of the experience of two Italian 
vascular centers. Ann Vasc Surg. 2014 Nov;28(8):1892–900.  
6.  
Stather PW, Wild JB, Sayers RD, Bown MJ, Choke E. Endovascular Aortic Aneurysm 
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7.      AbuRahma AF, DerDerian T, AbuRahma ZT, et al. Comparative study of clinical 
outcome of endovascular aortic aneurysms repair in large diameter aortic necks 
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