Aortic AneurysmAAA2D3DIIINCT03481075
Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair
A study testing Biomechanical computer program in people with Aortic Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Biomechanical computer program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2020to 29 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 informed consent
Who cannot join
- Contraindication to endovascular repair
- Creatinine clearance < 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Satterthwaite, MSc contact
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'université de Montréal
Montreal, Quebec, H2X 3E4
Jennifer Satterthwaite, MSc, 514-890-8000 ext. 23483, jennifer.satterthwaite.chum@ssss.gouv.qc.ca
Andrée Cliche, MSc, 514-890-8000 ext. 28212, andree.cliche.chum@ssss.gouv.qc.ca
About this study
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:
- Build a simulation model dataset based on existing patient data.
- Compare simulation on per-operative data and improve the results accuracy over the large dataset by integrating the needed biomechanical properties and constitutive models.
- Propose a workflow compatible with the Siemens architecture that implements the simulation output overlay
- 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.
- Develop a mathematical tool to deform a vascular model to recreate the numerical mechanical behaviour.
- 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)
- Conditions
- Aortic Aneurysm
- Being tested
- Biomechanical computer program
- Keywords
- Aortic Aneurysm, Abdominal, Imaging, Three-Dimensional, Tomography Scanners, X-Ray Computed, Angiography, Digital Subtraction, Endovascular Procedures, Radiography, Interventional
- Medical subject headings
- Aortic Aneurysm, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomechanical computer programOther
Fusion assisting software for image-guided intervention
| Study group | Role | What they receive |
|---|---|---|
| Rigid and Elastic registration softwares | Experimental | Not described Receives: Other: Biomechanical computer program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: DAY 0
Secondary outcomes (2)
Fluoroscopy time
Measure of the procedural fluoroscopy time and when using the prototype during surgery
Measured: DAY 0
Contrast agent used
Measure of the total amount of contrast agent when using the prototype during surgery
Measured: DAY 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Oct 2020
- Primary completion29 Sep 2025 (estimated)
- Study completion29 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology, Natural Sciences and Engineering Research Council, Canada, MedTeq
- Responsible party
- Sponsor
- Investigators
- Gilles Soulez, MD,MSc, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481075
- Sponsor's protocol ID
- 17.310
- Acronym
- AAA2D3DIII
- Status last verified
- Feb 2025
- First submitted
- 8 Mar 2018
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair
- ClinicalTrials.gov ID
- NCT03481075
- Acronym / sponsor ID
- AAA2D3DIII / 17.310
- Conditions
- Aortic Aneurysm
- Keywords
- Aortic Aneurysm, Abdominal, Imaging, Three-Dimensional, Tomography Scanners, X-Ray Computed, Angiography, Digital Subtraction, Endovascular Procedures, Radiography, Interventional
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology, Natural Sciences and Engineering Research Council, Canada, MedTeq
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 29 Sep 2025 (estimated)
- Study completion
- 29 May 2026 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Build a simulation model dataset based on existing patient data.
- Compare simulation on per-operative data and improve the results accuracy over the large dataset by integrating the needed biomechanical properties and constitutive models.
- Propose a workflow compatible with the Siemens architecture that implements the simulation output overlay
- 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.
- Develop a mathematical tool to deform a vascular model to recreate the numerical mechanical behaviour.
- 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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rigid and Elastic registration softwares | Experimental | Other: Biomechanical computer program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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 informed consent
Key exclusion criteria (4 listed)
- Contraindication to endovascular repair
- Creatinine clearance < 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomechanical computer programFusion assisting software for image-guided intervention | Other | Rigid and Elastic registration softwares |
Primary outcome
Clinical validation of the biomechanical prototype software
Time frame: DAY 0
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.
2 secondary outcomes
Fluoroscopy time
Time frame: DAY 0
Contrast agent used
Time frame: DAY 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Satterthwaite, MSc contact
Gilles Soulez, MD,MSc principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomechanical computer program in people with Aortic Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Satterthwaite, MSc (514-890-8000 ext. 23483, jennifer.satterthwaite.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical validation of the biomechanical prototype software (time frame: DAY 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.