Brief Title
Validation of Fenestrations Positioning by Numerical Simulation
Official Title
Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms
Brief Summary
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.
Detailed Description
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.
Study Type
Observational
Primary Outcome
Vascutek in vitro validation test and the numerical simulation
Secondary Outcome
initial and final stent-graft designs obtained from Vascutek
Condition
Abdominal Aortic Aneurysms
Intervention
numerical simulation
Study Arms / Comparison Groups
abdominal aortic aneurysms treated by fenestrated endovascular
Description: Patients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included. Predisurge society will perform numerical simulation.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
50
Start Date
June 15, 2018
Completion Date
October 30, 2020
Primary Completion Date
September 30, 2020
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bertrand CHAVENT, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT03469245
Organization ID
IRBN762017
Responsible Party
Sponsor
Study Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Predisurge Society
Study Sponsor
Bertrand CHAVENT, MD, Principal Investigator, CHU SAINT-ETIENNE
Verification Date
January 2021