Recruiting

Biomechanical Modeling

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT03481075

Conditions

Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biomechanical computer program

Study Details

Brief summary:

This project is aiming at the integration of a biomechanical computer program with a guidance code to simulate the endovascular repair (EVAR) procedure of abdominal aortic aneurysm (AAA). The computational time associated with finite element simulation generally renders its usage impractical for real-time application. Based on data collected during clinical interventions and a priori knowledge of AAA and endovascular device mechanical modeling, the investigators are proposing a deformable registration between preoperative CT-scans and per-operative fluoroscopy that will take into account prior simulations of participant specific EVAR procedures. To avoid the computational cost of a full finite element simulation, the investigators propose a simplified and real-time compliant repetitive mechanical behaviour based on participant specific parameters.

The results of this research will provide the Canadian industry with the first realistic deformable vascular geometry tool for live endovascular intervention guidance. The proposed biomechanical modeling can be translated to other vascular intervention procedure by adjusting the biomechanical parameters.

Conditions

Aortic Aneurysm

Study ID

NCT03481075

Start date

Oct 1, 2020

Status verified date

Feb, 2025

Completion date

May 29, 2026

Anticipated

Primary completion date

Sep 29, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with a clinical indication for EVAR/FEVAR of AAA and meeting anatomic inclusion criteria on preoperative enhanced CT-scan compatible with an endovascular repair.
  • Willing and capable of providing informed consent

Exclusion Criteria:

  • Contraindication to endovascular repair
  • Creatinine clearance < 30ml/min
  • History of severe allergy to iodinated contrast (anaphylaxis, bronchospasm)
  • Absence of recent previous thin-slice enhanced CT-scanner examination (stent planning based on MRI examination or non-enhanced CT examination).

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Rigid and Elastic registration softwares

Interventions

Biomechanical computer program

Fusion assisting software for image-guided intervention

Primary outcome measure

  • Clinical validation of the biomechanical prototype software [ Time Frame: DAY 0 ]

Central Contacts and Locations

Locations

Centre Hospitalier de l'université de Montréal

Recruiting

Montréal, Quebec, Canada, H2X 3E4

Contacts

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Feb 19, 2025

Last verified

Feb, 2025

Keywords

  • Aortic Aneurysm, Abdominal
  • Imaging, Three-Dimensional
  • Tomography Scanners, X-Ray Computed
  • Angiography, Digital Subtraction
  • Endovascular Procedures
  • Radiography, Interventional

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-02-19.