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Completed

NCT Number: NCT03469245

Validation of Fenestrations Positioning by Numerical Simulation

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.

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Key information

Conditions

Abdominal Aortic Aneurysms Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wilhelminen hospital, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

numerical simulation

Other

After patients have been treated by fenestrated endovascular of society Vascutek data will be collected by society Vascutek and send to Predisurge society. They will perform numerical simulation and compare with the method of Vascutek.

Primary outcomes

  1. Vascutek in vitro validation test and the numerical simulation

    Time frame: Months: 18

    To compare Vascutek in vitro validation test and the numerical simulation (Predisurge). The proportion of fenestrations is less or equal to 2.5mm will be calculated.

Secondary outcomes

  1. initial and final stent-graft designs obtained from Vascutek

    Time frame: Months: 18

    To study differences between initial and final stent-graft designs obtained from Vascutek process, the differences between L2 and L1 and C2 to C1 will be computed:

    L = for each fenestration, the longitudinal distance between centre of fenestration and top of fabric C = for each fenestration, circumferential angular distance between O° line and center of fenestration

    Current Vascutek protocol:

    • Initial custom Stent Graft design, right before in vitro testing = L1 and C1
    • Final custom Stent Graft design, after in vitro tests and subsequent design changes =L2 and C2

  2. stent-graft designs obtained from simulation of deployment

    Time frame: Months: 18

    To study differences between stent-graft designs obtained from simulation of deployment in the polymer model and from simulation of deployment in the patient, the differences between L4 and L3 and C4 to C3 will be computed:

    L = for each fenestration, the longitudinal distance between centre of fenestration and top of fabric C = for each fenestration, circumferential angular distance between O° line and center of fenestration

    Simulation for fenestration positioning:

    • Initial custom Stent Graft design, right before in vitro testing = L3 and C3
    • Final custom Stent Graft design, after in vitro tests and subsequent design changes =L4 and C4

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Predisurge Society

Registry information

Official study title

Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms

Acronym: FenSim

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2018
Registry last updated
Jun 22, 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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