Validation of Fenestrations Positioning by Numerical Simulation

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Abdominal aortic aneurysm
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Brief Title

Validation of Fenestrations Positioning by Numerical Simulation

Official Title

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

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.

Study Type

Observational

Primary Outcome

Vascutek in vitro validation test and the numerical simulation

Secondary Outcome

 initial and final stent-graft designs obtained from Vascutek

Condition

Abdominal Aortic Aneurysms

Intervention

numerical simulation

Study Arms / Comparison Groups

 abdominal aortic aneurysms treated by fenestrated endovascular
Description:  Patients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included. Predisurge society will perform numerical simulation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

50

Start Date

June 15, 2018

Completion Date

October 30, 2020

Primary Completion Date

September 30, 2020

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Bertrand CHAVENT, MD, ,

Location Countries

Austria

Location Countries

Austria

Administrative Informations

NCT ID

NCT03469245

Organization ID

IRBN762017

Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

 Predisurge Society

Study Sponsor

Bertrand CHAVENT, MD, Principal Investigator, CHU SAINT-ETIENNE

Verification Date

January 2021