NCT03481075 Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair
| NCT ID | NCT03481075 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Aortic Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2025-09-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2020-10-01 with a primary completion date of 2025-09-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Gilles Soulez, MD,MSc
PRINCIPAL INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Frequently Asked Questions
Who can join the NCT03481075 clinical trial?
This trial is open to participants of all sexes, studying Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03481075 currently recruiting?
Yes, NCT03481075 is actively recruiting participants. Contact the research team at jennifer.satterthwaite.chum@ssss.gouv.qc.ca for enrollment information.
Where is the NCT03481075 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT03481075 clinical trial?
NCT03481075 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Gilles Soulez, MD,MSc at Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 20 participants.