Biomechanical Modeling for Abdominal Aortic Aneurysm

(AAA2D3DIII Trial)

Recruiting at 1 trial location

Overseen By Jennifer Satterthwaite, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Contraindication to EVAR, Low creatinine clearance, Severe allergy to contrast, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new biomechanical computer program designed to guide the repair of abdominal aortic aneurysms (a bulge in the main blood vessel from the heart). The program aims to make the procedure safer and more effective by using a model that adjusts to each patient in real-time during surgery. Individuals planning to undergo endovascular repair for an abdominal aortic aneurysm and who have had a specific type of CT scan might be suitable candidates for this study. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could improve surgical outcomes for future patients.

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 prior data suggests that this biomechanical modeling tool is safe for endovascular procedures?

Studies have shown that computer programs used to study abdominal aortic aneurysms (AAA) are safe and well-tolerated. Research indicates that these programs can predict aneurysm growth or rupture by analyzing patient data.

No reports of negative side effects exist because this approach involves a computer program, not medication or surgery. Instead, it aids doctors in planning surgeries by creating models based on each patient's data, enhancing the safety and effectiveness of procedures.

Overall, current research suggests that using these computer programs for AAA is safe. There is no known risk to patients because it is non-invasive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to revolutionize how we assess abdominal aortic aneurysms using biomechanical computer modeling. Unlike traditional methods that rely on imaging and size measurement to gauge aneurysm risk, this innovative approach uses advanced software for biomechanical analysis. This could provide a more precise understanding of the aneurysm's behavior and risk of rupture, potentially leading to more personalized and timely interventions. If successful, this technology could significantly enhance patient outcomes by offering a more dynamic and informative assessment tool than the current standard.

What evidence suggests that this biomechanical computer program is effective for abdominal aortic aneurysm?

Research shows that computer programs can effectively simulate the endovascular repair (EVAR) procedure for abdominal aortic aneurysms (AAA). In this trial, participants will be evaluated using the Rigid and Elastic registration software, which predicts future problems by analyzing the aneurysm's physical properties. Advanced modeling techniques, sometimes enhanced with machine learning, improve predictions of aneurysm growth or rupture. This method allows for better planning and potentially safer treatments by customizing the simulation to each patient's needs. Overall, these models enhance the precision and effectiveness of EVAR procedures. ^{1 2 4 6 7}

Who Is on the Research Team?

Gilles Soulez, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Biomechanical computer program

Trial Overview The 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.

How Is the Trial Designed?

Group I: Rigid and Elastic registration softwares Experimental Treatment 1 Intervention

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of material model in wall stress prediction in abdominal aortic aneurysms. Polzer, S., Gasser, TC., Bursa, J., et al.[2013]

The study provides a comprehensive dataset of CT images and patient-specific geometries for 19 patients with Abdominal Aortic Aneurysm (AAA), which can be used to analyze the relationship between wall stress and symptoms of AAA.

Using the open-source software BioPARR, researchers can perform detailed computational analyses, including stress computations on AAA walls, which may help in predicting symptoms and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image, geometry and finite element mesh datasets for analysis of relationship between abdominal aortic aneurysm symptoms and stress in walls of abdominal aortic aneurysm. Wittek, A., Mufty, H., Catlin, A., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Profiling in Real-Life Abdominal Aortic Aneurysms in Different Clinical Scenarios. Gonzalez-Urquijo, M., Cárdenas Castro, HM., Jáuregui Chávez, D., et al.[2023]

The study proposes a new intraoperative navigation interface that enhances the accuracy of endovascular repair for abdominal aortic aneurysms by addressing limitations of traditional 2-D fluoroscopic imaging, which can lead to errors and lacks information on arterial wall quality.

The approach involves a finite-element-based simulation of tool-tissue interactions, which was initially tested on ten patients and further assessed on eight additional patients, showing promise in improving the matching of preoperative and intraoperative data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finite-element-based matching of pre- and intraoperative data for image-guided endovascular aneurysm repair. Duménil, A., Kaladji, A., Castro, M., et al.[2021]

Endovascular aneurysm repair (EVAR) has significantly reduced the risks associated with traditional open surgery for aortic aneurysms, but it still faces complications like device migration and endoleaks that can lead to serious health issues.

This study developed a new computational framework to analyze the mechanics of endograft stability in a three-dimensional setting, which could help improve the long-term performance of these devices by understanding how they interact with the aorta under real physiological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computational framework for investigating the positional stability of aortic endografts. Prasad, A., Xiao, N., Gong, XY., et al.[2021]

Biomechanical factors are crucial in understanding abdominal aortic aneurysms (AAAs) and how they respond to treatments, highlighting the need for better data and patient-specific models.

Current research has advanced our knowledge of the mechanics and biology of AAAs, but there is still a significant gap in computational models that can accurately predict the progression and characteristics of these lesions, which is essential for improving treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanics, mechanobiology, and modeling of human abdominal aorta and aneurysms. Humphrey, JD., Holzapfel, GA.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-specific computational modeling of endovascular aneurysm repair: State of the art and future directions. Avril, S., Gee, MW., Hemmler, A., et al.[2022]

In a study of 15 symptomatic and 28 asymptomatic patients with abdominal aortic aneurysms (AAA), peak wall stress (PWS) was found to be significantly higher in symptomatic patients, indicating a greater risk of rupture.

The study suggests that measuring PWS could be a useful tool for estimating individual rupture risk in AAA patients, although further research with larger sample sizes is necessary to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finite element analysis in symptomatic and asymptomatic abdominal aortic aneurysms for aortic disease risk stratification. Soto, B., Vila, L., Dilmé, J., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03481075

Patient Specific Biomechanical Modeling of Abdominal ... This project is aiming at the integration of a biomechanical computer program with a guidance code to simulate the endovascular repair (EVAR) procedure of ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cnm.3529

Patient‐specific computational modeling of endovascular ... In this review, we address some of the difficulties and successes associated with computational modeling of EVAR procedures.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12118978/

Numerical study on the biomechanics mechanism of Type II ... This paper develops an idealized AAA model using both CFD and FSI to investigate blood flow patterns within the aneurysmal sac under transient branch vessel ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1078588420301581

Biomechanical Assessment Predicts Aneurysm Related ... This is the first prospective study to test whether a biomechanical assessment of abdominal aortic aneurysm at baseline predicts future events. It has been ...

5. nature.com nature.com/articles/s41598-021-96512-3

Geometric and biomechanical modeling aided by machine ... Geometric and biomechanical modeling aided by machine learning improves the prediction of growth and rupture of small abdominal aortic aneurysms.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7676745/

Biomechanical rupture risk assessment of abdominal aortic ... We present a data-informed, highly personalized, probabilistic approach for the quantification of abdominal aortic aneurysm (AAA) rupture risk.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0895796724000437

Computational surgery in the management of patients with ... Several key areas of AAA care delivery, including patient-specific modelling, virtual surgery simulation, intraoperative imaging-guided surgery, and predictive ...