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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0

Awards & highlights

AAA2D3DIII Trial 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.Check my eligibility

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.See study design

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.

AAA2D3DIII Trial 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.

AAA2D3DIII Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical validation of the biomechanical prototype software

Secondary outcome measures

Contrast agent used

Fluoroscopy time

AAA2D3DIII Trial Design

1Treatment groups

Experimental Treatment

Group I: Rigid and Elastic registration softwaresExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Siemens Corporation, Corporate TechnologyIndustry Sponsor

21 Previous Clinical Trials

9,446 Total Patients Enrolled

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,617 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently in the process of locating participants?

"Affirmative. The information listed on clinicaltrials.gov indicates that the trial is currently accruing participants, with revisions having been made most recently on November 10th 2022. This medical study seeks to recruit 20 subjects from a single medical centre."

Answered by AI

What is the current sample size for this clinical research project?

"Indeed, the information posted on clinicaltrials.gov demonstrates that this medical investigation is open for recruitment. The trial was initially published on October 1st 2020 and has been most recently modified on November 10th 2022. As of right now, 20 volunteers are required across one research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03481075.

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