CompletedPhase IIIInterventional

Comparing x-ray to artificial intelligence guidance in keyhole aortic aneurysm surgery

An abdominal aortic aneurysm is a bulge in the body's main blood vessel. To prevent it from bursting, surgeons often perform keyhole surgery to place a supportive tube called a stent-graft inside the artery. Normally, doctors rely on flat, two-dimensional X-rays to guide this tube into position. This trial is testing a software system called Cydar EV. It works by overlaying detailed 3D scans taken before surgery onto live X-ray images in the operating room. Researchers want to see if this helps surgeons work more accurately and quickly. Around 340 patients across ten UK hospitals will be randomly placed into two groups: one having the standard X-ray guided operation, and the other having surgery guided by Cydar EV. The study will check if this technology reduces operation times, lowers radiation exposure, and cuts the amount of anaesthetic patients need.

At a glance

Status

Completed

Phase

Phase III

Enrolment target

340

Start

01 Feb 2022

Estimated completion

30 Jan 2024

Abdominal aortic aneurysm

What is this study about?

The aorta is the largest artery in your body, carrying blood from your heart to the rest of your organs. Sometimes, the wall of the aorta weakens and swells like a balloon, causing an aortic aneurysm. If it grows too large, it can burst, which is a medical emergency. To stop this from happening, doctors can insert a fabric-covered metal tube called a stent-graft through small cuts in the groin. This keyhole procedure is known as endovascular aneurysm repair, or EVAR.

Before the operation, doctors take detailed three-dimensional (3D) CT scans to plan the treatment and pick the right size stent. However, during the surgery itself, surgeons normally have to rely on flat, two-dimensional (2D) X-rays to position the stent. Because flat X-rays show less detail than 3D pictures, placing the stent precisely can be tricky and time-consuming.

This study tests a new technology called Cydar EV. It uses intelligent computer software to merge the patient's 3D planning scans with the live 2D X-rays on the operating screen. By giving surgeons a clearer, more complete view inside the body, researchers hope to find out if the system makes the operation faster, lowers the amount of radiation used, and improves recovery.

Key takeaways

Tests an AI software called Cydar EV that blends 3D scans with live X-rays during keyhole aneurysm surgery.
Aims to make operations quicker, use less anaesthetic, and lower radiation exposure.
Involves 340 patients across ten NHS hospitals in the UK.
Follow-up lasts for one year and fits into your routine NHS clinic appointments.
Participation is entirely voluntary and you can leave the study at any time.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with an abdominal or thoracoabdominal aortic aneurysm. To take part, your medical team must have already decided that keyhole repair (EVAR) is the best and safest treatment option for you.

Your surgical team will check that you are healthy enough for the procedure. They will also make sure that your pre-operation CT scans have the right level of detail and quality needed for the computer guidance system to work properly.

To join, you must be able to understand the study details and give your own written consent in English. People who cannot give informed consent will not 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.

I am aged 18 or older.
I have been diagnosed with an aortic aneurysm in my abdomen or chest.
My surgical team has agreed that keyhole repair (EVAR) is suitable for me.
I am fit enough to undergo the keyhole operation.
I can read, understand, and give written consent in English.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly placed into one of two groups by a computer. One group will have standard keyhole surgery guided by traditional 2D X-rays. The other group will have their surgery guided using the Cydar EV system. Both methods use the same approved stents and surgical techniques.

During your procedure, the team will record standard details like the time taken, the amount of radiation used, and the anaesthetic given. After the operation, you will have a routine CT scan to check that your stent is sitting in the right position.

You will attend regular follow-up clinic visits between 4 to 12 weeks after surgery, and again at one year. At your operation and during both clinic visits, you will be asked to fill in a brief quality-of-life questionnaire containing six simple questions. This takes about five minutes. In total, your participation in the study lasts for about one year.

Potential risks and benefits

Taking part may help improve how aneurysm surgeries are performed across the NHS. Smaller studies suggest Cydar EV can cut radiation exposure in half, shorten operating times, and reduce the time you spend asleep under general anaesthetic. However, these benefits are not guaranteed. The main extra requirement is spending 5 to 10 extra minutes at your appointments to answer brief questions. Depending on your hospital's routine practice, you may also have one additional CT scan, which involves a very small amount of extra medical radiation. Joining the study is completely voluntary, and you can leave at any time without your regular NHS care being affected.

Locations (11)

Leeds General Infirmary
Approximate
Leeds, England
St Mary's Hospital
Approximate
London, England
Royal Liverpool University Hospital
Approximate
Liverpool, England
Royal Sussex County Hospital
City only
Brighton, East Sussex, England
Southampton General Hospital
Approximate
Southampton, England
Royal Derby Hospital
Unverified
Derby, England
Manchester Royal Infirmary
Unverified
Manchester, England
Southmead Hospital
Unverified
Bristol, England
Frimley Park Hospital
Unverified
Camberley, England
St Thomas’ Hospital
Unverified
London, England
Musgrove Park Hospital
Unverified
Taunton, England

Common questions

What is an aortic aneurysm?

It is a widening or swelling in the aorta, the main blood vessel running through your chest and tummy. If left untreated, large aneurysms can burst, which is life-threatening.

Can I choose which surgical method I receive?

No. A computer will randomly assign you to either the standard X-ray group or the Cydar EV group so that researchers can fairly compare the results.

Is the Cydar EV system safe?

Yes. Cydar EV is an approved medical software system that works in the background to assist your surgeon. It does not replace the doctor's expert judgment.

Will taking part require lots of extra hospital visits?

No. The follow-up appointments at 4 to 12 weeks and at one year are part of routine NHS care. Your visits will just be about 5 to 10 minutes longer to complete a short questionnaire.

What happens if I change my mind later?

You are free to withdraw from the study at any point. Your decision will not change the quality of care or treatment you receive from the hospital team.

How to find out more

Izabela Pilecka

izabela.pilecka@kcl.ac.uk - Official trial record

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