Clinical trial NCT03469245: Validation of Fenestrations Positioning by Numerical Simulation
Official title: Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysms
Keywords: Endovascular
Fenestrated endovascular repair
numerical simulation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Predisurge Society
First posted: 2018-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included.

Brief summary: Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks... The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

Detailed description: The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

The goal of this study is to compare fenestrations positioning obtained by two different processes, the actual one at Vascutek and the one by numerical simulation performed by Predisurge company.

Eligibility criteria: Inclusion Criteria:

- abdominal aortic aneurysms suitable for treatment using Fenestrated AnacondaTM (Vascutek) device

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)
* stent-graft setup implanted during the surgical procedure has been modified compared to preoperative planning
* patient refusing to participate to the study

Primary outcomes:
measure: Vascutek in vitro validation test and the numerical simulation
timeFrame: Months: 18
Secondary outcomes:
measure: initial and final stent-graft designs obtained from Vascutek
timeFrame: Months: 18
measure: stent-graft designs obtained from simulation of deployment
timeFrame: Months: 18
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Wilhelminen hospital
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Lyon
country: France
facility: CHU Lyon
city: Metz
country: France
facility: Hôpitaux privés de Metz
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
city: Berlin
country: Germany
facility: University Hospital, Campus Benjamin Franklin
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Utrecht
country: Netherlands
facility: University Hospital Utrecht
city: Derby
country: United Kingdom
facility: Derby Hospital
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Bertrand CHAVENT, MD
role: PRINCIPAL_INVESTIGATOR
References: