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Biomechanical Modeling for Abdominal Aortic Aneurysm (AAA2D3DIII Trial)

N/A
Recruiting
Led By Gilles Soulez, MD,MSc
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Contraindication to endovascular repair
Creatinine clearance < 30ml/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at using a computer program to help guide surgeons during a procedure to fix an abdominal aortic aneurysm.

Who is the study for?
This trial is for individuals who need a procedure called EVAR/FEVAR to repair an abdominal aortic aneurysm and can give informed consent. They must have suitable anatomy as seen on a recent enhanced CT scan and good kidney function (creatinine clearance above 30ml/min). People with severe allergies to iodinated contrast or those without the required type of CT scan are not eligible.
What is being tested?
The study tests a biomechanical computer program designed to simulate and improve the endovascular repair process for abdominal aortic aneurysms in real-time, using patient-specific data from clinical interventions and preoperative imaging.
What are the potential side effects?
Since this trial involves testing software rather than drugs or medical procedures, traditional side effects are not applicable. However, there may be risks associated with inaccuracies in simulation leading to less optimal surgical outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a candidate for a specific type of surgery to repair an abdominal aortic aneurysm based on my CT scan results.
Select...
I am willing and able to give my consent for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot undergo procedures involving catheters in my blood vessels.
Select...
My kidney function is reduced with a creatinine clearance below 30ml/min.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical validation of the biomechanical prototype software
Secondary study objectives
Contrast agent used
Fluoroscopy time

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Rigid and Elastic registration softwaresExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Siemens Corporation, Corporate TechnologyIndustry Sponsor
22 Previous Clinical Trials
9,412 Total Patients Enrolled
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,500 Total Patients Enrolled
3 Trials studying Aortic Aneurysm
100 Patients Enrolled for Aortic Aneurysm
MedTeqIndustry Sponsor
7 Previous Clinical Trials
498 Total Patients Enrolled

Media Library

Biomechanical computer program Clinical Trial Eligibility Overview. Trial Name: NCT03481075 — N/A
Aortic Aneurysm Research Study Groups: Rigid and Elastic registration softwares
Aortic Aneurysm Clinical Trial 2023: Biomechanical computer program Highlights & Side Effects. Trial Name: NCT03481075 — N/A
Biomechanical computer program 2023 Treatment Timeline for Medical Study. Trial Name: NCT03481075 — N/A
~4 spots leftby Nov 2025
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