Biomechanical Modeling for Abdominal Aortic Aneurysm

(AAA2D3DIII Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Gilles Soulez, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

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

No Placebo Group

Approved in 1 Jurisdiction

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Centre Hospitalier de l'université de Montréal Montréal, Canada

Who Is Running the Clinical Trial?

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

Siemens Corporation, Corporate Technology Industry Sponsor

MedTeq Industry Sponsor

Natural Sciences and Engineering Research Council, Canada Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Patient-specific computational modeling of endovascular aneurysm repair: State of the art and future directions. [2022] Endovascular aortic repair (EVAR) has become the preferred intervention option for aortic aneurysms and dissections. This is because EVAR is much less invasive than the alternative open surgery repair. While in-hospital mortality rates are smaller for EVAR than open repair (1%-2% vs. 3%-5%), the early benefits of EVAR are lost after 3 years due to larger rates of complications in the EVAR group. Clinicians follow instructions for use (IFU) when possible, but are left with personal experience on how to best proceed and what choices to make with respect to stent-graft (SG) model choice, sizing, procedural options, and their implications on long-term outcomes. Computational modeling of SG deployment in EVAR and tissue remodeling after intervention offers an alternative way of testing SG designs in silico, in a personalized way before intervention, to ultimately select the strategies leading to better outcomes. Further, computational modeling can be used in the optimal design of SGs in cases of complex geometries. In this review, we address some of the difficulties and successes associated with computational modeling of EVAR procedures. There is still work to be done in all areas of EVAR in silico modeling, including model validation, before models can be applied in the clinic, but much progress has already been made. Critical to clinical implementation are current efforts focusing on developing fast algorithms that can achieve (near) real-time solutions, as well as ways of dealing with inherent uncertainties related to patient aortic wall degradation on an individualized basis. We are optimistic that EVAR modeling in the clinic will soon become a reality to help clinicians optimize EVAR interventions and ultimately reduce EVAR-associated complications.

2. England pubmed.ncbi.nlm.nih.gov

Importance of material model in wall stress prediction in abdominal aortic aneurysms. [2013] Results of biomechanical simulation of the abdominal aortic aneurysm (AAA) depend on the constitutive description of the wall. Based on in vitro and in vivo experimental data several constitutive models for the AAA wall have been proposed in the literature. Those models differ strongly from each other and their impact on the computed stress in biomechanical simulation is not clearly understood.

3. Netherlands pubmed.ncbi.nlm.nih.gov

Biomechanical Profiling in Real-Life Abdominal Aortic Aneurysms in Different Clinical Scenarios. [2023] The aim of this study was to demonstrate the biomechanical properties in different abdominal aortic aneurysm (AAA) presentations of real-life patients. We used the actual 3D geometry of the AAAs under analysis and a realistic, nonlinearly elastic biomechanical model.

4. Germany pubmed.ncbi.nlm.nih.gov

A computational framework for investigating the positional stability of aortic endografts. [2021] Endovascular aneurysm repair (Greenhalgh in N Engl J Med 362(20):1863-1871, 2010) techniques have revolutionized the treatment of thoracic and abdominal aortic aneurysm disease, greatly reducing the perioperative mortality and morbidity associated with open surgical repair techniques. However, EVAR is not free of important complications such as late device migration, endoleak formation and fracture of device components that may result in adverse events such as aneurysm enlargement, need for long-term imaging surveillance and secondary interventions or even death. These complications result from the device inability to withstand the hemodynamics of blood flow and to keep its originally intended post-operative position over time. Understanding the in vivo biomechanical working environment experienced by endografts is a critical factor in improving their long-term performance. To date, no study has investigated the mechanics of contact between device and aorta in a three-dimensional setting. In this work, we developed a comprehensive Computational Solid Mechanics and Computational Fluid Dynamics framework to investigate the mechanics of endograft positional stability. The main building blocks of this framework are: (1) Three-dimensional non-planar aortic and stent-graft geometrical models, (2) Realistic multi-material constitutive laws for aorta, stent, and graft, (3) Physiological values for blood flow and pressure, and (4) Frictional model to describe the contact between the endograft and the aorta. We introduce a new metric for numerical quantification of the positional stability of the endograft. Lastly, in the results section, we test the framework by investigating the impact of several factors that are clinically known to affect endograft stability.

5. United States pubmed.ncbi.nlm.nih.gov

Mechanics, mechanobiology, and modeling of human abdominal aorta and aneurysms. [2021] Biomechanical factors play fundamental roles in the natural history of abdominal aortic aneurysms (AAAs) and their responses to treatment. Advances during the past two decades have increased our understanding of the mechanics and biology of the human abdominal aorta and AAAs, yet there remains a pressing need for considerable new data and resulting patient-specific computational models that can better describe the current status of a lesion and better predict the evolution of lesion geometry, composition, and material properties and thereby improve interventional planning. In this paper, we briefly review data on the structure and function of the human abdominal aorta and aneurysmal wall, past models of the mechanics, and recent growth and remodeling models. We conclude by identifying open problems that we hope will motivate studies to improve our computational modeling and thus general understanding of AAAs.

6. Netherlands 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. [2020] These datasets contain Computed Tomography (CT) images of 19 patients with Abdominal Aortic Aneurysm (AAA) together with 19 patient-specific geometry data and computational grids (finite element meshes) created from these images applied in the research reported in Journal of Surgical Research article "Is There A Relationship Between Stress in Walls of Abdominal Aortic Aneurysm and Symptoms?"[1]. The images were randomly selected from the retrospective database of University Hospitals Leuven (Leuven, Belgium) and provided to The University of Western Australia's Intelligent Systems for Medicine Laboratory. The analysis was conducted using our freely-available open-source software BioPARR (Joldes et al., 2017) created at The University of Western Australia. The analysis steps include image segmentation to obtain the patient-specific AAA geometry, construction of computational grids (finite element meshes), and AAA stress computation. We use well-established and widely used data file formats (Nearly Raw Raster Data or NRRD for the images, Stereolitography or STL format for geometry, and Abaqus finite element code keyword format for the finite element meshes). This facilitates re-use of our datasets in practically unlimited range of studies that rely on medical image analysis and computational biomechanics to investigate and formulate indicators and predictors of AAA symptoms.

7. Italy pubmed.ncbi.nlm.nih.gov

Finite element analysis in symptomatic and asymptomatic abdominal aortic aneurysms for aortic disease risk stratification. [2019] Advanced biomechanical models can provide additional information concerning rupture risk in abdominal aortic aneurysms (AAA). Here we evaluated the predictive value of finite element analysis (FEA) to assess AAA rupture risk.

8. United States pubmed.ncbi.nlm.nih.gov

Finite-element-based matching of pre- and intraoperative data for image-guided endovascular aneurysm repair. [2021] Endovascular repair of abdominal aortic aneurysms is a well-established technique throughout the medical and surgical communities. Although increasingly indicated, this technique does have some limitations. Because intervention is commonly performed under fluoroscopic control, 2-D visualization of the aneurysm requires the injection of a contrast agent. The projective nature of this imaging modality inevitably leads to topographic errors, and does not give information on arterial wall quality at the time of deployment. A specially adapted intraoperative navigation interface could increase deployment accuracy and reveal such information, which preoperative 3-D imaging might otherwise provide. One difficulty is the precise matching of preoperative data (images and models) and intraoperative observations affected by anatomical deformations due to tool-tissue interactions. Our proposed solution involves a finite-element-based preoperative simulation of tool-tissue interactions, its adaptive tuning regarding patient specific data, and the matching with intraoperative data. The biomechanical model was first tuned on a group of ten patients and assessed on a second group of eight patients.