ClinicalTrials.gg
RecruitingNCT03481075AAA2D3DIIIUpdated Feb 19, 2025

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

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.

Primary conditionAortic Aneurysm, AbdominalRegistry: Aortic AneurysmReclassifiedWhy we changed it
Registry
Aortic Aneurysm — the first condition term the registry derived for this study.
ClinicalTrials.gg
Aortic Aneurysm, Abdominal
Why
  1. The study's title name Aortic Aneurysm, Abdominal, a narrower term within Aortic Aneurysm.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Oct 2020; still recruiting 6 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Sex
All
01

Study 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.

Read the detailed description

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:

  1. Build a simulation model dataset based on existing patient data.
  2. Compare simulation on per-operative data and improve the results accuracy over the large dataset by integrating the needed biomechanical properties and constitutive models.
  3. Propose a workflow compatible with the Siemens architecture that implements the simulation output overlay
  4. Based on the investigators existing biomechanical model, identify geometric, biomechanical and patient specific parameters such as tortuosity, calcification degree and distribution, presence and morphology of thrombus, material elastic properties of the incorporated structures and contact mechanics with surrounding structures.
  5. Develop a mathematical tool to deform a vascular model to recreate the numerical mechanical behaviour.
  6. Extend the simulation transfer method to a generic solution that can be adapted for interventions for other anatomic territories (ie neurovascular intervention: vessel deformation from coils and flow diverters)
02

Conditions studied

  • Aortic Aneurysm

Browse trials for

Keywords

  • Aortic Aneurysm, Abdominal
  • Imaging, Three-Dimensional
  • Tomography Scanners, X-Ray Computed
  • Angiography, Digital Subtraction
  • Endovascular Procedures
  • Radiography, Interventional
03

In context

Aortic Aneurysm, Abdominal Reclassified

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 →

Lead sponsor

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 →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • to endovascular repair
  • \< 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).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Rigid and Elastic registration softwares

    Other: Biomechanical computer program

Interventions

  • OtherBiomechanical computer program

    Fusion assisting software for image-guided intervention

06

What researchers measure

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.

    Time frame: DAY 0

Secondary outcomes

  1. Fluoroscopy time

    Measure of the procedural fluoroscopy time and when using the prototype during surgery

    Time frame: DAY 0

  2. Contrast agent used

    Measure of the total amount of contrast agent when using the prototype during surgery

    Time frame: DAY 0

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2018
First posted
Mar 29, 2018
StartActual
Oct 1, 2020
Primary completionEst.
Sep 29, 2025
CompletionEst.
May 29, 2026
Last update
Feb 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03481075
Collaborators
Siemens Corporation, Corporate Technology, Natural Sciences and Engineering Research Council, Canada, MedTeq
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Oct 1, 2020
Primary completion
Sep 29, 2025 (estimated)
Completion
May 29, 2026 (estimated)
Last update
Feb 19, 2025

Study contacts

Jennifer Satterthwaite, MSc
Contact
jennifer.satterthwaite.chum@ssss.gouv.qc.ca
514-890-8000 ext. 23483
Andrée Cliche, MSc
Contact
andree.cliche.chum@ssss.gouv.qc.ca
514-890-8000 ext. 28212
Gilles Soulez, MD,MSc
principal investigator · Centre hospitalier de l'Université de Montréal (CHUM)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion