Simulation of Stent-graft Deployment in Aortic Arch Aneurysms

Study Overview
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Brief Summary
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Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Accurate SG deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. In that context, the investigators aim is to develop a computational tool able to predict SG deployment in such highly complex situations. Four patient-specific cases will be performed with complete deployment of the DB and its bridging stents in aneurysmal aortic arch. Deviations of simulation predictions from actual stent positions will be estimated based on post-operative scan and a sensitivity analysis will be performed to assess the effects of material parameters. If good agreement between simulation and reality is obtained, numerical simulations will show their ability to successfully predict the DB deployment in complex anatomy. The results will emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.

Detailed Description
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The process of numerical simulation of double-branched device in aortic arch aneurysm involves: (i) aortic arch segmentation with data from the preoperative CT-scan (ii) numerical modeling of the actual stentgraft used to treat the patient (iii) simulation of stentgraft deployment in aortic arch (iv) validation of simulation results based on post-operative CT scan images The goal of this study is to develop a numerical model of stentgraft deployment able to predict the actual deployement of the double branched device in aortic arch aneurysm.

Official Title
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Simulation of Stent-graft Deployment in Aortic Arch Aneurysms

Conditions
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Aortic Arch Aneurysm

Intervention / Treatment
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* Other: Collection of datas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aortic arch aneurysms suitable for treatment using double-branched device Bolton Exclusion Criteria: Failure to generate an adequate FE model of patient arteries (no preoperative multidetector contrast-enhanced CT-scan available, preoperative CT-scan slice thickness greater than 1mm, preoperative CT- scan with artifacts) dissected aneurysm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated for aortic arch aneurysms<br>Patients treated for aortic arch aneurysms by double branched endovascular repair (Bolton Medical) will be included. | Other: Collection of datas<br>* Collection of datas: pre- and postoperative scanner and endoprosthesis characteristics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vitro versus stimulation test | To compare Vascutek in vitro validation test to the simulation of this test, the proportion of fLenestrations where |L3 - L2| and |C3 - C2| are less or equal to 2.5mm will be analysed. L3=distal edge of celiac trunk (L) after first simulation, stent-graft deployment in rigid aorta L2=distal edge of celiac trunk (L) after final custom stent-graft design, after in vitro tests | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Numerical simulation, stent-graft, aortic arch aneurysms