Active not recruitingNAINTERVENTIONAL

International Subarachnoid Aneurysm Trial II

This study, called ISAT II, is looking at the best ways to treat a type of bleeding in the brain caused by a burst aneurysm. An aneurysm is a weak, bulging spot in a blood vessel, which can burst and cause bleeding. Doctors usually treat this with either surgery, where they place a small clip on the aneurysm, or a less invasive procedure called coiling, where they fill the aneurysm with tiny coils. A previous study, ISAT, suggested coiling was better, but mainly for smaller aneurysms. ISAT II wants to see which treatment is better for different types of aneurysms and patients that weren't included in the first study. The goal is to make sure people get the most effective treatment for this serious condition.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

1,724

Start

12 Nov 2012

Estimated completion

01 Dec 2024

Intracranial Hemorrhage Ruptured Aneurysm

What is this study about?

You might be reading this because you, or someone you know, has had a brain aneurysm rupture, which is a very serious condition. This is sometimes called a subarachnoid haemorrhage. When this happens, doctors need to act quickly to stop the bleeding.

There are two main ways doctors treat a burst brain aneurysm: surgery (called 'clipping') or a less invasive procedure (called 'coiling'). In clipping, surgeons open the skull and place a tiny clip on the aneurysm to seal it off. In coiling, doctors insert a thin tube (catheter) into a blood vessel, usually in the leg, and guide it up to the brain to fill the aneurysm with soft coils, blocking blood flow into the bulging part.

A big study called ISAT in the past found that coiling might be better for certain types of aneurysms. However, that study mostly looked at smaller aneurysms. Doctors are still unsure which treatment is best for patients with different kinds of aneurysms, especially those that are larger or in different parts of the brain. This new study (ISAT II) aims to compare clipping and coiling specifically for these other types of aneurysms. The goal is to provide clear answers so that doctors can make the best choices for each patient, ensuring they get the most effective treatment possible.

Some doctors also worry about how long the coiling treatment lasts compared to clipping. This study will help us understand if one treatment is more durable over the long term. By comparing these treatments carefully, researchers hope to improve how doctors care for people who have had a burst brain aneurysm.

Key takeaways

This study compares surgery (clipping) and a less invasive procedure (coiling) for burst brain aneurysms.
It's looking for the best treatment for specific types of aneurysms not covered by an earlier study.
Participation means you'd be randomly assigned to receive either clipping or coiling.
The aim is to improve future care and treatment decisions for people with this condition.
All participants must be at least 18 years old and have had a burst aneurysm within the last month.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, at least 18 years old. You must have had a burst aneurysm inside your head within the last month (30 days). The bleeding in your brain should not be too severe, meaning your medical team thinks you are in a reasonable state to consider both treatment options.

Crucially, the medical team treating you must believe that both surgical clipping and endovascular coiling are possible and suitable options for your specific aneurysm and condition. This means your doctors shouldn't have a strong medical reason to rule out one treatment over the other straight away.

However, there are some reasons why you might not be able to join. For example, if you can't have certain types of medical scans that use dyes, or if your aneurysm is linked to another condition called an AVM. Also, if your aneurysm is located in a very specific spot at the base of the brain (called the basilar apex), you might not be eligible. Your doctor will be able to tell you if you meet all the requirements.

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?
Have you had a burst brain aneurysm within the last 30 days?
Do your doctors think both surgery (clipping) and coiling are suitable for you?
Do you *not* have any specific conditions that prevent you from having certain scans or types of aneurysms (like those linked to AVMs or at the basilar apex)?

Answer every question to see your result.

What does participation involve?

The information provided does not detail the specific visits, assessments, medication, or follow-up schedule for participants. However, if you were to participate in a study like this, it would generally involve being closely monitored by your medical team after your aneurysm rupture. You would undergo various medical tests and scans to assess your condition and the aneurysm. You would be randomly assigned to receive either the surgical clipping or the endovascular coiling procedure, whichever option the study determined for you.

After your initial treatment, you would likely have regular follow-up appointments, including check-ups and further scans, to monitor your recovery and the effectiveness of the treatment. The total duration of your participation would depend on the study's design, but similar studies often involve follow-up for at least a year, and sometimes much longer, to see the long-term results.

Potential risks and benefits

Participating in this study means you would receive one of two established treatments for a burst aneurysm, both aimed at saving your life and improving your recovery. The potential benefit is that by carefully comparing these treatments across a range of patients, doctors will gain clearer information that could lead to better global care for people like you in the future. As with any medical procedure, there are potential risks associated with both surgical clipping and endovascular coiling, such as bleeding, infection, stroke, or other complications, and your medical team will discuss these thoroughly with you. You would always have the right to withdraw from the study at any time, even if you initially agreed to participate, without affecting your standard care.

Locations (6)

Montefiore Medical Center
Verified postcode
The Bronx, United States
Foothills Medical Centre
Verified postcode
Calgary, Canada
University of Alberta Hospital
Verified postcode
Edmonton, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Verified postcode
Montreal, Canada
Vall d'Hebron Hospital
Verified postcode
Barcelona, Spain
University of Valladolid
Verified postcode
Valladolid, Spain

Common questions

What is a 'burst brain aneurysm'?

It's when a weak, bulging spot in a blood vessel in the brain bursts, causing bleeding. This is a very serious medical emergency.

What are the two main treatments being compared?

One is surgery ('clipping'), which involves placing a small clip on the aneurysm. The other is a less invasive procedure ('coiling'), where tiny coils are placed inside the aneurysm using a thin tube.

Why is this new study (ISAT II) important?

A previous study didn't cover all types of aneurysms. This new study aims to find out which treatment is best for other specific kinds of aneurysms and patients, to improve decisions for doctors.

Will I get to choose my treatment if I join?

No, if you join, you would be randomly assigned to either surgical clipping or endovascular coiling. This helps ensure the study results are fair and unbiased.

What does being 'randomly assigned' mean?

It means a computer system, or similar, would decide which treatment you receive, like flipping a coin. Neither you nor your doctor would choose, ensuring scientific fairness.