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NCT04244188

Simulation of Stent-graft Deployment in Aortic Arch Aneurysms

Completed Last updated 18 November 2023
What this trial tests

trial testing Collection of datas in Aortic Arch Aneurysm in 4 participants. Completed in 31 January 2019.

Timeline
1 January 2019
Primary endpoint
31 January 2019
31 January 2019

Quick facts

Lead sponsorCentre Hospitalier Universitaire de Saint Etienne
StatusCompleted
Study typeOBSERVATIONAL
Enrollment4
Start date1 January 2019
Primary completion31 January 2019
Estimated completion31 January 2019
Sites2 locations across France, Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

18 and older, any sex, with Aortic Arch Aneurysm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Collection of datas

Trials testing the same drug.

Other recruiting trials for Aortic Arch Aneurysm

Currently open trials in the same condition.

Other Centre Hospitalier Universitaire de Saint Etienne trials

Trials by the same sponsor.

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Data sources for this page

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