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Clinical Trials/NCT04244188
NCT04244188
Completed
Not Applicable

Simulation of Stent-graft Deployment in Aortic Arch Aneurysms

Centre Hospitalier Universitaire de Saint Etienne2 sites in 2 countries4 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Arch Aneurysm
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
4
Locations
2
Primary Endpoint
In vitro versus stimulation test
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
January 31, 2019
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

In vitro versus stimulation test

Time Frame: 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

Study Sites (2)

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