RecruitingNAINTERVENTIONAL

The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices

The RISE Trial is studying the best ways to treat certain types of brain aneurysms, known as intracranial aneurysms. These are weakened, bulging spots in a blood vessel in the brain. Some of these, especially 'wide-necked bifurcation aneurysms', can be challenging to treat. This trial is comparing existing treatments like surgical clips or coils, and a new device called WEB (Woven EndoBridge). The WEB device is a small mesh that is placed inside the aneurysm to redirect blood flow and help it heal, without needing some of the strong blood-thinning medicines often used with other devices. Researchers want to find out which treatment leads to the best results for patients with these specific kinds of aneurysms.

At a glance

Status

Recruiting

Phase

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

250

Start

18 Jul 2019

Estimated completion

01 Jan 2026

Intracranial Aneurysm Brain Aneurysm Unruptured Cerebral Aneurysm Ruptured Cerebral Aneurysm Cerebral Aneurysm

What is this study about?

You might have heard about a brain aneurysm, which is a weak spot in a blood vessel in your brain that bulges out like a tiny balloon. The RISE Trial is looking into different ways to treat these. Some aneurysms, particularly those with a wide opening (doctors call them 'wide-necked bifurcation aneurysms'), can be more difficult to treat safely and effectively using standard methods.

Doctors have developed various ways to repair aneurysms, including surgery to 'clip' them, or using tiny coils inserted into the aneurysm to block blood flow. There's also a newer device called the WEB (Woven EndoBridge). This is a special mesh device that's placed inside the aneurysm to help blood flow bypass it, encouraging the aneurysm to heal. A key benefit of the WEB device is that it might not need you to take strong blood-thinning medicines that are sometimes required with other types of treatments.

This study aims to discover which of these treatment options – traditional methods or the new WEB device – gives the best results for people with suitable aneurysms. By comparing these treatments in a careful study, doctors hope to find better ways to help patients in the future.

Key takeaways

Compares different treatments for brain aneurysms.
Focuses on a new device called WEB (Woven EndoBridge).
Aims to find the best treatment for specific aneurysm types.
Suitable for adults (18+) with certain aneurysm characteristics.
Involves established and new treatment methods.
Participation includes regular follow-up and scans.

Who may be eligible?

This study is for adults, aged 18 and over, who have a brain aneurysm. Your doctor might suggest this study if they think the new WEB device could be a good treatment option for your specific aneurysm.

Generally, your aneurysm should be between 4mm and 11mm in size. This can include aneurysms that have come back after previous treatment, as long as your doctor believes they are suitable. Even if you've recently had a ruptured aneurysm (meaning it has bled), you might still be able to join, depending on how unwell you are.

You wouldn't be able to join if you have a medical condition that makes surgery or this type of treatment too risky for you, or if you're unable to understand and agree to take part. Also, aneurysms that are either very small (smaller than 4mm) or very large (larger than 11mm) generally won't be included.

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.

Are you 18 years old or older?
Do you have a brain aneurysm that your doctor thinks might be suitable for the 'WEB device'?
Is your aneurysm between 4mm and 11mm in size?
Do you understand what taking part in a study means and can you give your permission?
Do you have any medical conditions that would make surgery or this type of procedure unsafe for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the RISE Trial, your initial treatment will be chosen from the options being studied. This means you might receive surgical clipping, coiling, a stent with coiling, a flow diversion device, or the WEB device. All these are standard ways of treating aneurysms. After your treatment, you will have regular check-ups with your medical team. This will involve appointments and scans to monitor your recovery and how well the treatment is working. The specific number of visits and scans will be explained by the study team, and you will be followed up over a period of time to track your long-term health and the success of the treatment.

Potential risks and benefits

Taking part in this study means you'll receive a treatment for your aneurysm, and it might be a newer option like the WEB device that could potentially offer a good outcome. However, as with any medical procedure, there are potential risks involved with each treatment investigated in this study, such as bleeding, infection, or stroke, which your doctor will discuss with you. You should also know that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

University of Alberta Hospital
Verified postcode
Edmonton, Canada· Recruiting
University of Manitoba Hospital
Verified postcode
Winnipeg, Canada· Recruiting
Hamilton Health Sciences - McMaster University
Verified postcode
Hamilton, Canada· Recruiting
Centre Hospitalier de l'Université de Montréal
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is a brain aneurysm?

It's a weak, bulging spot on a blood vessel in your brain, like a tiny balloon.

What is the 'WEB device'?

It's a special mesh device placed inside the aneurysm to help it heal, often without strong blood thinners.

Who can join this study?

Adults (18+) with a specific type and size of brain aneurysm that their doctor thinks is suitable for the WEB device.

What kinds of treatments are being studied?

The study compares surgery (clipping), coiling, stents, flow diversion, and the WEB device.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without affecting your medical care.

How to find out more

daniela E Iancu, MD

daniela.iancu.med@ssss.gouv.qc.ca 514-890-8450 Official trial record

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