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RecruitingNAINTERVENTIONAL

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

This research aims to create a new computer program that helps surgeons fix a serious condition called an abdominal aortic aneurysm. This is a bulge in the body's main artery. During a keyhole operation (endovascular repair), surgeons currently rely on X-rays. This new program will use your pre-surgery scans to create a detailed, moving 3D map of your blood vessels. This map will appear on the X-ray screen, showing the surgeon exactly where to go and how the tools are affecting your body, in real-time. The goal is to make these operations safer, reduce the amount of X-ray dye needed, shorten surgery time, and improve how well the operation works. It's about using smart technology to guide surgeons more precisely.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrolment target
20
Start
01 Oct 2020
Estimated completion
29 May 2026

What is this study about?

Imagine you have a weak spot, like a bulge, in the main blood vessel that goes through your tummy – this is called an abdominal aortic aneurysm. If it bursts, it can be very dangerous. Surgeons can fix this using a special keyhole operation called Endovascular Aneurysm Repair (EVAR). They insert tiny tools and a repair tube (stent graft) through your blood vessels to fix the bulge from the inside.

Currently, during this operation, surgeons use X-ray videos to see what they're doing. However, these X-rays mostly show bones, and they need to use a special dye to briefly see your blood vessels. This dye, while useful, can be harmful if too much is used over time. This research project is trying to make this process much better and safer for patients.

The team is working with Siemens Healthineers to develop a clever computer program. This program will take detailed scans you have before your operation and turn them into a live, moving 3D map of your blood vessels. This map will then show up on the X-ray screen during surgery. The really smart part is that it will also predict and show how your blood vessels will move or change shape as the surgeon uses their tools. This means the surgeon will have a much clearer, real-time view, helping them guide the tools more precisely without relying as much on the special dye or guesswork. It's like having a super-accurate sat nav guiding the surgeon inside your body, making the whole procedure more efficient and safer for you.

Key takeaways

  • Developing smart computer software to guide surgeons during aneurysm repair.
  • Aims to make keyhole aneurysm surgery safer and more precise.
  • Uses pre-surgery scans to create a live, 3D map during the operation.
  • Could reduce X-ray dye use and shorten surgery time.
  • No new treatments or extra procedures for participants.
  • Data from your existing medical care helps improve future surgeries.

Who may be eligible?

This study is looking for people who need to have a specific type of keyhole operation called EVAR to fix a bulge in their main tummy artery (abdominal aortic aneurysm). To be considered, your pre-operative scans must show that this operation is suitable for you. You must also be able to understand the study and agree to take part by giving your informed consent.

There are also some reasons why you might not be able to join. For example, if there's a medical reason why the keyhole operation isn't suitable for you in general, or if your kidney function isn't good enough (creatinine clearance below 30ml/min). Also, if you’ve had a severe allergic reaction to the special X-ray dye in the past, or if your recent CT scans aren’t detailed enough for the study’s needs, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do you need to have an EVAR operation for an abdominal aortic aneurysm?
  2. Do your doctors say EVAR is a suitable procedure for you?
  3. Are you able to understand and agree to take part in the study?
  4. Do you have good kidney function?
  5. Have you had detailed CT scans recently that are suitable for planning EVAR?
Answer every question to see your result.

What does participation involve?

This study doesn't ask you to do anything extra. If you meet the criteria, information from your usual pre-operative scans and data from your planned EVAR operation will be used for the research. There are no additional visits, assessments, medications, or follow-up appointments beyond what is already part of your standard medical care.

Potential risks and benefits

The main benefit of taking part is that your medical information will help researchers create a new computer program that could make future aneurysm operations safer and more accurate for many patients, potentially reducing the need for X-ray dye and shortening surgery time. Since this study uses existing data and standard procedures, there are no direct additional risks to you from your participation. You are always free to change your mind and withdraw your consent at any point, without affecting your medical care.

Locations (1)

  • Centre Hospitalier de l'université de Montréal
    Verified postcode
    Montreal, Canada· Recruiting

Common questions

What is an abdominal aortic aneurysm?

It's a weak spot and bulge in the body's main artery (the aorta) in the tummy area. If it gets too big, it can be dangerous.

What is EVAR surgery?

EVAR stands for Endovascular Aneurysm Repair. It's a keyhole operation to fix an aneurysm using small tubes and a special repair device inserted through blood vessels.

Does this study involve new treatments or medications?

No, this study is about improving the guidance systems for existing EVAR surgery using computer software, not new treatments or medications for you.

Will I have extra tests or appointments if I join?

No, your participation uses information from your already planned scans and surgery. You won't have any extra tests or appointments.

Will my doctors know I'm participating in the study?

Yes, your medical team will be aware if you choose to participate, as they will be sharing your de-identified data for the research.

How to find out more

Jennifer Satterthwaite, MSc

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Patient Specific Biomechanical Modeling of Abdominal Aortic …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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