Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair (AAA2D3DIII)
Primary Purpose
Aortic Aneurysm
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Biomechanical computer program
Sponsored by
About this trial
This is an interventional supportive care trial for Aortic Aneurysm focused on measuring Aortic Aneurysm, Abdominal, Imaging, Three-Dimensional, Tomography Scanners, X-Ray Computed, Angiography, Digital Subtraction, Endovascular Procedures, Radiography, Interventional
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Sites / Locations
- Centre Hospitalier de l'université de MontréalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rigid and Elastic registration softwares
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Fluoroscopy time
Measure of the procedural fluoroscopy time and when using the prototype during surgery
Contrast agent used
Measure of the total amount of contrast agent when using the prototype during surgery
Full Information
NCT ID
NCT03481075
First Posted
March 8, 2018
Last Updated
September 29, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Siemens Corporation, Corporate Technology, Natural Sciences and Engineering Research Council, Canada, MedTeq
1. Study Identification
Unique Protocol Identification Number
NCT03481075
Brief Title
Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair
Acronym
AAA2D3DIII
Official Title
Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 29, 2024 (Anticipated)
Study Completion Date
May 29, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Siemens Corporation, Corporate Technology, Natural Sciences and Engineering Research Council, Canada, MedTeq
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm
Keywords
Aortic Aneurysm, Abdominal, Imaging, Three-Dimensional, Tomography Scanners, X-Ray Computed, Angiography, Digital Subtraction, Endovascular Procedures, Radiography, Interventional
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rigid and Elastic registration softwares
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Biomechanical computer program
Intervention Description
Fusion assisting software for image-guided intervention
Primary Outcome Measure Information:
Title
Clinical validation of the biomechanical prototype software
Description
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.
Time Frame
DAY 0
Secondary Outcome Measure Information:
Title
Fluoroscopy time
Description
Measure of the procedural fluoroscopy time and when using the prototype during surgery
Time Frame
DAY 0
Title
Contrast agent used
Description
Measure of the total amount of contrast agent when using the prototype during surgery
Time Frame
DAY 0
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Satterthwaite, MSc
Phone
514-890-8000
Ext
23483
Email
jennifer.satterthwaite.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Andrée Cliche, MSc
Phone
514-890-8000
Ext
28212
Email
andree.cliche.chum@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Soulez, MD,MSc
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Satterthwaite, MSc
Phone
514-890-8000
Ext
23483
Email
jennifer.satterthwaite.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Andrée Cliche, MSc
Phone
514-890-8000
Ext
28212
Email
andree.cliche.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Eric Therasse, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair
We'll reach out to this number within 24 hrs