About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Single group
Treatments tested in this trial
Biomechanical computer program
Other interventionFusion assisting software for image-guided intervention
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Fluoroscopy time
Measure of the procedural fluoroscopy time and when using the prototype during surgery
Contrast agent used
Measure of the total amount of contrast agent when using the prototype during surgery
Sponsors and contacts
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Siemens Corporation, Corporate Technology
Collaborator
Natural Sciences and Engineering Research Council, Canada
Collaborator
MedTeq
Collaborator