An interventional study of Biomechanical computer program in Aortic Aneurysm, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Supportive care
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.
Endovascular surgery requires of special surgical tools inserted and navigated through the vascular system to reach the site of a disease remotely. This navigation and treatment are perform under video X-Ray imager called fluoroscopy. This low-power X-Ray reveals only the bones, even though the surgery is performed on the vessels. Chemical agent dye can paint momentarily the vessel, but this agent is toxic when used in high dosage.
In order to help the surgeon navigate its way, the investigators are developing with Siemens Healthineers an enhance visualization software that displays on the fluoroscopic image the vascular structures of the patient and adapts its shape by the deformation force of the endovascular tools. This can reduce the use of contrast agent, reduce the intervention time (thus reducing radiation exposure) and generally improve the surgical outcomes.
To deform the vascular structure without its visualization, the investigators will use a mathematical function to compute the vessel shape when subjected to endovascular tools influence. This function will be based on biomechanical computer simulations performed on a large database of interventional images. Tissues of the entire abdominal region will be simplified and modeled to achieve the most realistic behaviour. Biomechanical simulations have been used in numerous medical applications as a validation tool. The investigators want to innovate and bring this complex simulation result to a live and reactive application. This technological innovation will improve substantially the performances and reliability of image fusion assisting software and set a new standard in medical care practices.The main objectives of this collaborative research project are:
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's planned enrollment of 20 is below the median of 66 across 228 interventional studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
Compared within Aortic Aneurysm, Abdominal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aortic Aneurysm. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Biomechanical computer program
Fusion assisting software for image-guided intervention
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.
Time frame: DAY 0
Fluoroscopy time
Measure of the procedural fluoroscopy time and when using the prototype during surgery
Time frame: DAY 0
Contrast agent used
Measure of the total amount of contrast agent when using the prototype during surgery
Time frame: DAY 0
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2020 (actual). Primary completion is estimated for Sep 2025, 59 months after the start.
Of 51 non-industry interventional studies with no phase under Aortic Aneurysm, Abdominal, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 61. This study's planned 59 months is above that.
Counting every sponsor, half of 94 studies reached it within 43 months; a quarter within 23 and three quarters within 65.
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