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Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair (AAA2D3DIII)

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ClinicalTrials.gov Identifier: NCT03481075
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : September 21, 2018
Sponsor:
Collaborators:
Siemens Corporation, Corporate Technology
Natural Sciences and Engineering Research Council, Canada
MEDTEQ
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.


Condition or disease Intervention/treatment Phase
Aortic Aneurysm Other: Biomechanical computer program Not Applicable

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:

  1. Build a simulation model dataset based on existing patient data.
  2. Compare simulation on per-operative data and improve the results accuracy over the large dataset by integrating the needed biomechanical properties and constitutive models.
  3. Propose a workflow compatible with the Siemens architecture that implements the simulation output overlay
  4. 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.
  5. Develop a mathematical tool to deform a vascular model to recreate the numerical mechanical behaviour.
  6. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair
Estimated Study Start Date : November 18, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rigid and Elastic registration softwares Other: Biomechanical computer program
Fusion assisting software for image-guided intervention




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Fluoroscopy time [ Time Frame: DAY 0 ]
    Measure of the procedural fluoroscopy time and when using the prototype during surgery

  2. Contrast agent used [ Time Frame: DAY 0 ]
    Measure of the total amount of contrast agent when using the prototype during surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481075


Contacts
Contact: Jennifer Satterthwaite, MSc 514-890-8000 ext 23483 jennifer.satterthwaite.chum@ssss.gouv.qc.ca
Contact: Andrée Cliche, MSc 514-890-8000 ext 28212 andree.cliche.chum@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre Hospitalier de l'université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 3E4
Contact: Jennifer Satterthwaite, MSc    514-890-8000 ext 23483    jennifer.satterthwaite.chum@ssss.gouv.qc.ca   
Contact: Andrée Cliche, MSc    514-890-8000 ext 28212    andree.cliche.chum@ssss.gouv.qc.ca   
Sub-Investigator: Eric Therasse, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Siemens Corporation, Corporate Technology
Natural Sciences and Engineering Research Council, Canada
MEDTEQ
Investigators
Principal Investigator: Gilles Soulez, MD,MSc Centre hospitalier de l'Université de Montréal (CHUM)

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03481075     History of Changes
Other Study ID Numbers: 17.310
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Aortic Aneurysm, Abdominal
Imaging, Three-Dimensional
Tomography Scanners, X-Ray Computed
Angiography, Digital Subtraction
Endovascular Procedures
Radiography, Interventional

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases