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Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Wilhelminen hospital
Vienna, Austria
CHU Bordeaux
Bordeaux, France
CHU Lyon
Lyon, France
Hôpitaux privés de Metz
Metz, France
Chu Saint-Etienne
Saint-Etienne, France
University Hospital, Campus Benjamin Franklin
Berlin, Germany
Rijnstate Hospital
Arnhem, Netherlands
University Hospital Utrecht
Utrecht, Netherlands
Derby Hospital
Derby, United Kingdom
Start Date
April 26, 2018
Primary Completion Date
September 4, 2019
Completion Date
September 22, 2019
Last Updated
June 22, 2023
50
ACTUAL participants
numerical simulation
OTHER
Lead Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
NCT07184723
NCT06710938
NCT06884397
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