Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair

NCT03481075 | Recruiting

• 1 other identifier: 17.310
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical validation of the biomechanical prototype software

  Measure of the mean 2D error of renal artery marker position (z direction) on the first DSA acquisition performed after insertion of the main body delivery device as describe in the clinical validation of the biomechanical prototype software.

  DAY 0

Secondary Outcomes (2)

• Fluoroscopy time

  DAY 0

• Contrast agent used

  DAY 0

Study Arms (1)

Rigid and Elastic registration softwares

EXPERIMENTAL

Other: Biomechanical computer program

Interventions

Biomechanical computer program OTHER

Fusion assisting software for image-guided intervention

Rigid and Elastic registration softwares

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and capable of providing informed consent

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Siemens Corporation, Corporate Technology: collaborator
• Natural Sciences and Engineering Research Council, Canada: collaborator
• MedTeq: collaborator

Study Sites (1)

Centre Hospitalier de l'université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Gilles Soulez, MD,MSc

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Satterthwaite, MSc

CONTACT

514-890-8000; jennifer.satterthwaite.chum@ssss.gouv.qc.ca

Andrée Cliche, MSc

CONTACT

514-890-8000; andree.cliche.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 29, 2018
• Study Start: October 1, 2020
• Primary Completion: September 29, 2025
• Study Completion (Estimated): May 29, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)