Simulation of Stent-graft Deployment in Aortic Arch Aneurysms

Completed

• Conditions: Aortic Arch Aneurysm
• Interventions: Other: Collection of datas

• Registration Number: NCT04244188
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated for aortic arch aneurysms	Collection of datas	Patients treated for aortic arch aneurysms by double branched endovascular repair (Bolton Medical) will be included.

Primary Outcome Measures

Name	Time	Method
In vitro versus stimulation test	Day 0	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

Trial Locations

Locations (2)

Rinjstate Hopital; 🇳🇱 Arnhem, Netherlands

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France