Active not recruitingOBSERVATIONAL

LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment

This study is looking at a treatment for brain aneurysms using two medical devices: the LVIS Evo and the HydroCoil Embolic System. A brain aneurysm is a bulge in a blood vessel in your brain that can sometimes be dangerous. This study aims to see how safe and effective this combined treatment is for preventing problems and helping patients recover well. Researchers will follow about 200 patients for one year after their procedure to check if the aneurysm is properly sealed and if there are any side effects. This research provides important information to ensure that these advanced treatments are working as they should.

At a glance

Status

Active not recruiting

Sponsor

Microvention-Terumo, Inc.

Enrolment target

206

Start

14 Jan 2022

Estimated completion

01 Dec 2026

Intracranial Aneurysm

What is this study about?

This study is investigating a specific way to treat brain aneurysms using a combination of two medical devices: the LVIS Evo and the HydroCoil Embolic System. A brain aneurysm happens when a blood vessel in your brain bulges outwards. Sometimes these bulges can burst, which is very serious. This treatment aims to seal off the aneurysm to prevent it from bursting or to help it heal if it has already bled, but not recently.

The LVIS Evo is a type of small mesh tube, like a tiny scaffold, called a stent, which is placed inside the blood vessel at the opening of the aneurysm. The HydroCoil Embolic System involves placing very thin, soft coils inside the aneurysm itself. When these two are used together, the stent helps to keep the coils in place and reshape the blood vessel, while the coils fill the aneurysm and encourage it to seal off. This study wants to confirm that this combined approach is both safe and effective for patients.

Researchers will follow about 200 patients who receive this treatment. They will check on the patients for about one year after the procedure. The main things they will be looking for are how well the aneurysm has been sealed, whether there are any complications like narrowing of the blood vessel, or if the aneurysm starts to reopen. They will also assess how well patients are doing overall and if they experience any major health problems. This kind of study is important to make sure medical treatments are working well and are safe for patients.

Key takeaways

This study uses two devices, LVIS Evo and HydroCoil, to treat brain aneurysms.
It aims to confirm the treatment is safe and effective for patients.
About 200 patients will be followed for one year after their procedure.
Eligibility depends on your age, aneurysm characteristics, and health conditions.
Taking part means your regular medical care will be followed closely for research.
You can stop participating at any time without affecting your medical treatment.

Who may be eligible?

To take part in this study, you must be 18 years old or older. You should be suitable for treatment with the LVIS Evo and HydroCoil Embolic System, and your brain aneurysm should be 12mm or smaller. It's okay if your aneurysm hasn't burst or if it burst more than 30 days ago. You also need to be willing to come to all your follow-up appointments and understand what the study involves.

There are certain reasons why you might not be able to join. For example, if you've had a brain bleed in the last 30 days, or if your aneurysm has a specific shape called "fusiform," you wouldn't be eligible. You also can't have been treated with a stent for the same aneurysm before. If you have other serious conditions that could cause bleeding, or if you're allergic to certain medicines, contrast dyes, or materials used in the devices, you might not be able to participate.

This study is not for you if doctors plan to use a different type of stent, if you need more than one aneurysm treated at the same time in a complex way, or if you have certain other blood vessel problems. The aim is to ensure the study is looking at the effects of this specific treatment safely and clearly.

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?
Is your brain aneurysm 12mm (about half an inch) or smaller?
Has it been more than 30 days since your aneurysm might have burst, or has it not burst at all?
Are you suitable for treatment with the LVIS Evo and HydroCoil systems?
Are you able to attend follow-up appointments for approximately one year?
Do you not have an aneurysm that was recently treated with a stent?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your treatment and follow-up care will mostly be the same as what you would normally receive from your doctors. This means you will undergo the procedure to treat your brain aneurysm using the LVIS Evo and HydroCoil Embolic System. After the procedure, you will have regular check-ups and tests, such as scans, to monitor your recovery and how well the treatment is working. The study team will collect information from these visits.

Researchers will be particularly interested in how your aneurysm looks on scans at around 12 months after your treatment. They will be checking if the aneurysm is completely sealed. They will also monitor for any safety concerns, such as any narrowing of your blood vessels, or if the aneurysm needs further treatment. You will also be asked about your general health and well-being. The total duration of your active participation in collecting data for this study will be for about one year, which includes your procedure and follow-up appointments during that time.

Potential risks and benefits

Taking part in this study means you will receive a treatment that your doctors believe is suitable for your condition. Potential benefits include effective sealing of your aneurysm using established medical devices, which could help prevent future serious health problems. However, like any medical procedure, there are potential risks, such as bleeding, infection, allergic reactions to materials, or complications related to the devices themselves, including the possibility of a stroke or the need for further treatment. You'll be given detailed information about these risks before you agree to join. You are completely free to withdraw from the study at any time, for any reason, without it affecting the quality of your medical care.

Locations (19)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Charleroi University Hospital
Verified postcode
Charleroi, Belgium
Brest University Hospital
Verified postcode
Brest, France
Limoges University Hospital
Verified postcode
Limoges, France
Lyon University Hospital
Verified postcode
Lyon, France
Marseille University Hospital
Verified postcode
Marseille, France
Fondation Rothschild
Verified postcode
Paris, France
Rouen University Hospital
Verified postcode
Rouen, France
Universitätsklinikum Augsburg
Verified postcode
Augsburg, Germany
Universitätsklinikum Knappschaftskrankenhaus
Verified postcode
Bochum, Germany
Alfried Krupp Krankenhaus
Verified postcode
Essen, Germany
Universitätsklinikum Münster
Verified postcode
Münster, Germany
Azienda Ospedaliera Cannizzaro
Verified postcode
Catania, Italy

Common questions

What is a brain aneurysm?

A brain aneurysm is a weak, bulging spot on a blood vessel in the brain, similar to a bubble. It could potentially leak or burst, leading to serious health issues.

What do LVIS Evo and HydroCoil do?

The LVIS Evo is a small mesh tube (stent) that helps support the blood vessel, and HydroCoil is made of very thin coils that are placed inside the aneurysm to help seal it off.

How long will I be followed in this study?

You will be followed for about one year after your treatment, with check-ups and scans to see how you are doing and how the aneurysm has healed.

Can I still join if my aneurysm has burst recently?

No, if your aneurysm burst less than 30 days ago, you would not be able to join this particular study.

What will doctors be checking for?

They will mainly check if your aneurysm is completely sealed, and they will monitor for any side effects or complications, as well as your general health.