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Completed

NCT Number: NCT04244188

Simulation of Stent-graft Deployment in Aortic Arch Aneurysms

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne, Saint-Etienne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of datas

Other

Collection of datas: pre- and postoperative scanner and endoprosthesis characteristics

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2020
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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