Improving Aortic Endovascular Repair with Personalized Biomechanical Modeling
Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair
This study is testing a new computer program that helps doctors perform safer and more effective surgeries for abdominal aortic aneurysms by using personalized imaging of each patient's blood vessels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT03481075 on ClinicalTrials.gov |
What this trial studies
This project integrates a biomechanical computer program with guidance code to simulate the endovascular repair (EVAR) procedure for abdominal aortic aneurysms (AAA). By utilizing preoperative CT scans and real-time fluoroscopy, the study aims to create a deformable vascular geometry tool that adapts to the patient's anatomy during surgery. This innovative approach seeks to reduce the need for toxic contrast agents, minimize intervention time, and enhance surgical outcomes through improved visualization of vascular structures. The methodology involves mathematical functions to compute vessel shapes influenced by endovascular tools, based on extensive biomechanical simulations.
Who should consider this trial
Good fit: Ideal candidates are patients with a clinical indication for EVAR/FEVAR of AAA who meet specific anatomical criteria on preoperative CT scans.
Not a fit: Patients with contraindications to endovascular repair or severe allergies to iodinated contrast may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective endovascular repairs for patients with abdominal aortic aneurysms.
How similar studies have performed: While biomechanical simulations have been used in various medical applications, this specific approach to real-time endovascular repair is innovative and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Gilles Soulez, MD,MSc — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Jennifer Satterthwaite, MSc
- Email: jennifer.satterthwaite.chum@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.