Biomechanical Modeling for Abdominal Aortic Aneurysm
(AAA2D3DIII Trial)
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo endovascular repair (EVAR) procedure with biomechanical modeling and software assistance
Follow-up
Participants are monitored for safety and effectiveness after the EVAR procedure
Treatment Details
Interventions
- Biomechanical computer program
Find a Clinic Near You
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