Ignite Creation Date:
2024-05-06 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03469245
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2018-02-19
Brief Title:
Validation of Fenestrations Positioning by Numerical Simulation
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FenSim
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None