20 Participants Needed

Biomechanical Modeling for Abdominal Aortic Aneurysm

(AAA2D3DIII Trial)

AC
JS
Overseen ByJennifer Satterthwaite, MSc
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Biomechanical computer program, Patient Specific Biomechanical Modeling Tool, EVAR Simulation Program for Abdominal Aortic Aneurysm?

The research suggests that using computational modeling in endovascular aneurysm repair (EVAR) can help doctors choose better strategies for treatment, potentially reducing complications. Although more work is needed to validate these models, they show promise in improving the design and stability of devices used in EVAR, which could lead to better long-term outcomes for patients.12345

Is the Biomechanical Modeling for Abdominal Aortic Aneurysm treatment safe for humans?

The research articles provided do not contain specific safety data for the Biomechanical Modeling treatment in humans, as they focus on the technical aspects and predictive capabilities of the models rather than safety outcomes.23467

How does biomechanical modeling for abdominal aortic aneurysm treatment differ from other treatments?

Biomechanical modeling for abdominal aortic aneurysm (AAA) treatment is unique because it uses advanced computer simulations to understand the mechanical environment of the aneurysm, which can help predict how the aneurysm will behave and respond to treatments. This approach focuses on creating patient-specific models to improve treatment planning and outcomes, unlike traditional methods that may not account for individual variations in aneurysm mechanics.23458

Research Team

GS

Gilles Soulez, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

This trial is for individuals who need a procedure called EVAR/FEVAR to repair an abdominal aortic aneurysm and can give informed consent. They must have suitable anatomy as seen on a recent enhanced CT scan and good kidney function (creatinine clearance above 30ml/min). People with severe allergies to iodinated contrast or those without the required type of CT scan are not eligible.

Inclusion Criteria

I am a candidate for a specific type of surgery to repair an abdominal aortic aneurysm based on my CT scan results.
I am willing and able to give my consent for treatment.

Exclusion Criteria

I cannot undergo procedures involving catheters in my blood vessels.
My kidney function is reduced with a creatinine clearance below 30ml/min.
You have had a serious allergic reaction to iodinated contrast.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular repair (EVAR) procedure with biomechanical modeling and software assistance

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the EVAR procedure

4 weeks

Treatment Details

Interventions

  • Biomechanical computer program
Trial OverviewThe study tests a biomechanical computer program designed to simulate and improve the endovascular repair process for abdominal aortic aneurysms in real-time, using patient-specific data from clinical interventions and preoperative imaging.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Rigid and Elastic registration softwaresExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Siemens Corporation, Corporate Technology

Industry Sponsor

Trials
23
Recruited
9,400+

MedTeq

Industry Sponsor

Trials
8
Recruited
520+

Natural Sciences and Engineering Research Council, Canada

Collaborator

Trials
63
Recruited
3,000+

Findings from Research

Endovascular aortic repair (EVAR) is less invasive than open surgery and has lower in-hospital mortality rates (1%-2% vs. 3%-5%), but its early advantages diminish after 3 years due to higher complication rates.
Computational modeling of stent-graft deployment in EVAR can help personalize treatment strategies and improve long-term outcomes, although further validation and development of real-time algorithms are needed before widespread clinical application.
Patient-specific computational modeling of endovascular aneurysm repair: State of the art and future directions.Avril, S., Gee, MW., Hemmler, A., et al.[2022]
Different constitutive models for the abdominal aortic aneurysm (AAA) wall lead to significantly different predictions of wall stress, highlighting the importance of model selection in biomechanical simulations.
Using patient-specific wall properties derived from biaxial testing provides more accurate stress predictions compared to uniaxial testing, which can overestimate wall stress by 67%, indicating that highly nonlinear models are preferable for assessing AAA response to increased blood pressure.
Importance of material model in wall stress prediction in abdominal aortic aneurysms.Polzer, S., Gasser, TC., Bursa, J., et al.[2013]
This study analyzed the biomechanical properties of abdominal aortic aneurysms (AAAs) in three patients with different conditions (ruptured, symptomatic, and asymptomatic) using advanced computer fluid dynamics, revealing significant differences in wall shear stress (WSS) and pressure across the aneurysms.
The findings indicated that unruptured aneurysms had higher overall WSS compared to the ruptured one, suggesting that biomechanical factors like WSS and pressure gradients play a crucial role in the behavior and potential rupture risk of AAAs.
Biomechanical Profiling in Real-Life Abdominal Aortic Aneurysms in Different Clinical Scenarios.Gonzalez-Urquijo, M., Cárdenas Castro, HM., Jáuregui Chávez, D., et al.[2023]

References

Patient-specific computational modeling of endovascular aneurysm repair: State of the art and future directions. [2022]
Importance of material model in wall stress prediction in abdominal aortic aneurysms. [2013]
Biomechanical Profiling in Real-Life Abdominal Aortic Aneurysms in Different Clinical Scenarios. [2023]
A computational framework for investigating the positional stability of aortic endografts. [2021]
Mechanics, mechanobiology, and modeling of human abdominal aorta and aneurysms. [2021]
Image, geometry and finite element mesh datasets for analysis of relationship between abdominal aortic aneurysm symptoms and stress in walls of abdominal aortic aneurysm. [2020]
Finite element analysis in symptomatic and asymptomatic abdominal aortic aneurysms for aortic disease risk stratification. [2019]
Finite-element-based matching of pre- and intraoperative data for image-guided endovascular aneurysm repair. [2021]