Clinical trial NCT04244188: Simulation of Stent-graft Deployment in Aortic Arch Aneurysms
Official title: Simulation of Stent-graft Deployment in Aortic Arch Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Arch Aneurysm
Keywords: Numerical simulation
stent-graft
aortic arch aneurysms
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for aortic arch aneurysms by double branched endovascular repair (Bolton Medical) will be included.

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.

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

Primary outcomes:
measure: In vitro versus stimulation test
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
city: Arnhem
country: Netherlands
facility: Rinjstate Hopital
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Noël ALBERTINI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Derycke L, Perrin D, Cochennec F, Albertini JN, Avril S. Predictive Numerical Simulations of Double Branch Stent-Graft Deployment in an Aortic Arch Aneurysm. Ann Biomed Eng. 2019 Apr;47(4):1051-1062. doi: 10.1007/s10439-019-02215-2. Epub 2019 Jan 31.