Validation of Fenestrations Positioning by Numerical Simulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-26

Study Completion Date

2019-09-22

Brief Summary

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Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks… The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

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Detailed Description

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The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

The goal of this study is to compare fenestrations positioning obtained by two different processes, the actual one at Vascutek and the one by numerical simulation performed by Predisurge company.

Conditions

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Abdominal Aortic Aneurysms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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abdominal aortic aneurysms treated by fenestrated endovascular

Patients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included. Predisurge society will perform numerical simulation.

numerical simulation

Intervention Type OTHER

After patients have been treated by fenestrated endovascular of society Vascutek data will be collected by society Vascutek and send to Predisurge society. They will perform numerical simulation and compare with the method of Vascutek.

Interventions

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numerical simulation

After patients have been treated by fenestrated endovascular of society Vascutek data will be collected by society Vascutek and send to Predisurge society. They will perform numerical simulation and compare with the method of Vascutek.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- abdominal aortic aneurysms suitable for treatment using Fenestrated AnacondaTM (Vascutek) device

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)
* stent-graft setup implanted during the surgical procedure has been modified compared to preoperative planning
* patient refusing to participate to the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No