RecruitingNAINTERVENTIONAL

Middle Cerebral Artery Aneurysm Trial

This study is investigating the best treatment for a brain aneurysm located on the middle cerebral artery (MCA). An aneurysm is a weak, bulging spot in a blood vessel, which can be very serious if it bursts. Doctors are trying to find out whether surgery, which involves opening the skull to clip the aneurysm, or a less invasive procedure called endovascular treatment (where a catheter is guided through blood vessels to seal the aneurysm from the inside) is better. Currently, there's no clear answer, as previous studies haven't fully focused on this specific type of aneurysm. This research aims to provide clearer evidence to help doctors and patients make informed decisions about treatment.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

400

Start

15 May 2022

Estimated completion

01 Jan 2038

Middle Cerebral Artery Aneurysm

What is this study about?

This study is about a particular type of brain aneurysm — a weak, bulging spot in a blood vessel — that forms on the middle cerebral artery, or MCA. While aneurysms can appear in different parts of the brain, those on the MCA are considered a bit special. Many doctors believe that surgery, where a surgeon opens the skull to place a tiny clip on the aneurysm, might be a better option for these MCA aneurysms.

On the other hand, newer, less invasive treatments, known as endovascular treatments, are becoming more common for aneurysms in general. These involve guiding a tiny tube (catheter) through your blood vessels to your brain, and then using small coils, stents, or other devices to block off the aneurysm. However, MCA aneurysms can sometimes have shapes that make these endovascular methods more tricky.

Because there's no strong evidence yet showing which method is truly best for MCA aneurysms, doctors are still trying to figure it out. This study aims to compare surgery and endovascular treatments for MCA aneurysms to see which approach leads to better outcomes for patients. Previous research has provided some clues, but didn't specifically focus enough on MCA aneurysms to give a clear answer.

Key takeaways

This study compares surgery vs. endovascular (internal) treatment for a specific type of brain aneurysm.
It focuses on aneurysms located on the middle cerebral artery (MCA).
There's currently no clear ‘best’ treatment for MCA aneurysms, making this research important.
Participation involves either surgical or endovascular treatment, with follow-up.
The study aims to gather evidence to improve future patient care.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. You need to have an aneurysm (either already burst or not yet burst) on the middle cerebral artery of your brain. If your aneurysm has burst, it shouldn't be too severe (doctors use a specific grading system called WFNS, and you would need to be grade 4 or less).

It's also important that the doctors involved in the study believe that both surgery and endovascular treatment are suitable options for your specific aneurysm. If you have an aneurysm caused by another condition called AVM, this study is not for you.

Finally, you won't be able to join if you have a known allergy or problem with contrast dye (a special medicine used in scans), or if you or your caregiver aren't able to understand and give permission to take part.

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 18 years old or older.
I have an aneurysm on my middle cerebral artery (MCA) in my brain.
My doctors think both surgery and endovascular treatment are options for me.
I do not have a problem with contrast dye used in scans.
My aneurysm is not due to a condition called AVM.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to receive either surgical management or endovascular management for your brain aneurysm. The specific number of visits and assessments will depend on which treatment you receive and your individual recovery. You will have follow-up appointments to monitor your aneurysm and overall health. The total duration of your participation will involve the treatment itself and subsequent check-ups over a period of time to see how well the treatment is working and how you are recovering.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and potential risks. The potential benefit here is that you would receive active treatment for your brain aneurysm as part of a careful research study, which could help advance our understanding of the best approach for MCA aneurysms. However, both surgery and endovascular procedures carry their own risks, including complications like bleeding, infection, or stroke. These will be fully explained by the medical team. You also have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University of Alberta
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is a middle cerebral artery (MCA) aneurysm?

It's a weak, bulging spot in a blood vessel located on a specific artery in your brain called the middle cerebral artery. If it bursts, it can cause a serious type of stroke.

What are the main treatments being compared?

The study is comparing traditional surgery (where the aneurysm is clipped) with a less invasive procedure called endovascular treatment (where devices are used inside the blood vessel to block off the aneurysm).

Why is this study important?

Doctors don't have clear evidence yet on which treatment is best for MCA aneurysms. This study aims to provide that evidence to help improve care for future patients.

Will I get to choose my treatment?

No, if you join this study, you will be assigned to either surgery or endovascular treatment. This is to ensure fair comparison between the two approaches.

What does 'unruptured' vs. 'ruptured' aneurysm mean?

A 'ruptured' aneurysm has burst and caused bleeding in the brain. An 'unruptured' aneurysm has not yet burst, but still needs treatment because of the risk that it might.

How to find out more

Sudeshna Bhattacharyna

sbhattac@ualberta.ca 7804990974 Official trial record

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