Active not recruitingNAINTERVENTIONAL

Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

This study is investigating a new way to treat unruptured brain aneurysms, which are weak bulges in blood vessels. It focuses on a device called a 'flow diverter' that helps redirect blood flow away from the aneurysm. Researchers are comparing a newer version of this device (p64 MW HPC) that has a special coating and is used with a single blood-thinning medicine, against an earlier version (p64 MW) that is used with two blood-thinning medicines. The main goal is to find out if the newer coated device, with simpler medication, works safely and effectively for patients. This could mean a more straightforward and potentially safer treatment option for some people with brain aneurysms.

At a glance

Status

Active not recruiting

Phase

Sponsor

Phenox GmbH

Enrolment target

171

Start

03 Sep 2021

Estimated completion

01 Dec 2025

Intracranial Aneurysm

What is this study about?

This research study is about finding the best way to treat a type of brain condition called an 'intracranial aneurysm.' An aneurysm is essentially a weakness or bulge in one of the blood vessels in your brain, similar to a bubble on a tyre. If it bursts, it can cause serious problems, so doctors often suggest treating them before that happens.

The study is focusing on a particular treatment method called 'flow diversion.' Imagine a tiny, mesh-like tube that doctors carefully place inside the blood vessel where the aneurysm is located. This tube helps to change the way blood flows, encouraging it to bypass the aneurysm and eventually allowing the aneurysm to heal and shrink. This study is comparing two slightly different versions of this flow diverter device.

Specifically, they are looking at a newer device (called p64 MW HPC) that has a special coating, and they want to see how well it works when patients only take one type of blood-thinning medicine. This is compared to an older version of the device (p64 MW) which usually requires patients to take two blood-thinning medicines. The main goal is to understand if the new, coated device is safe and effective with fewer blood-thinning medicines, which could simplify treatment and potentially reduce side effects for patients.

Key takeaways

A study looking at a new brain aneurysm treatment device.
Compares a coated device with one blood-thinner to an uncoated device with two blood-thinners.
Focuses on unruptured brain aneurysms.
Aims to find out if the new device is safe and effective with simpler medication.
Participation involves aneurysm treatment and follow-up check-ups.
You can discuss with your doctor if this study might be right for you.

Who may be eligible?

To join this study, you must be at least 18 years old and have a specific type of brain aneurysm that hasn't burst, or one that has been treated before but reappeared. You would need to have been chosen for this specific 'flow diversion' treatment by your doctors already. You also need to be able to understand the study information and give your written permission to participate.

There are several reasons why you might not be able to join. For example, if you're already taking certain long-term blood-thinning medicines, have had recent surgery (within the last month), or a bleeding in the brain within the last month. If your aneurysm has already been treated with a stent or flow diverter, or if you have certain other types of aneurysms or a specific narrowing in your blood vessels, you wouldn't be eligible. Also, if you have a severe allergy to the special dye used in scans, you couldn't 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.

Are you 18 years old or older?
Do you have an unruptured brain aneurysm or one that has come back after previous treatment?
Has your doctor already suggested a 'flow diversion' treatment for your aneurysm?
Are you able to understand study information and give written permission to take part?
Are you not currently on long-term blood-thinning medication?
Have you not had any recent bleeding in the brain or surgery within the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors will treat your aneurysm using one of the flow diverter devices. This procedure is similar to a standard operation to treat an aneurysm. You will have regular check-ups and scans to monitor how the device is working and how your aneurysm is healing. You will also be asked to take specific blood-thinning medication as directed by the study doctors. The study will track your recovery and well-being through these visits, which will involve assessments of your health status. The total duration of your participation in the study will depend on the follow-up schedule required to fully assess the device.

Potential risks and benefits

Participating in this study might offer you a chance to receive treatment with a potentially improved device for your aneurysm. The new device, along with a simpler medication regimen, could lead to fewer side effects associated with the blood-thinning medicines. However, as with any medical procedure, there are potential risks, including those related to the aneurysm treatment itself or the medications. You will be fully informed of all known and potential risks before making a decision. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

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

CHU Bordeaux
Verified postcode
Bordeaux, France
Hôpital Bicêtre
Verified postcode
Le Kremlin-Bicêtre, France
CHU de Lyon
Verified postcode
Lyon, France
CHU de Montpellier
Verified postcode
Montpellier, France
CHU Reims - Hôpital Maison Blanche
Verified postcode
Reims, France
Universitätsklinikum Augsburg
Verified postcode
Augsburg, Germany
Helios Klinikum Erfurt
Verified postcode
Erfurt, Germany
Universitätsklinikum Halle (Saale)
Verified postcode
Halle, Germany
Klinikum der LMU München
Verified postcode
München, Germany
Klinikum Nürnberg Süd
Verified postcode
Nuremberg, Germany
Klinikum Vest Recklinghausen
Verified postcode
Recklinghausen, Germany
Klinikum Stuttgart
Verified postcode
Stuttgart, Germany

Common questions

What is a brain aneurysm?

A brain aneurysm is a weak bulge in a blood vessel in your brain, similar to a small balloon. It can sometimes, but not always, cause serious problems if it bursts.

What is a 'flow diverter'?

A flow diverter is a small, mesh-like tube that doctors place inside a blood vessel to redirect blood flow away from the aneurysm, helping it to heal.

Why are they comparing two different devices?

Researchers want to see if a newer version of the flow diverter, which has a special coating and is used with fewer blood-thinning medicines, is as safe and effective as the older version.

Will I know which device I'm getting?

The study design will determine whether you know which device you receive. This will be fully explained to you by the study team.

What are blood-thinning medicines for?

Blood-thinning medicines help prevent blood clots, which can be important when a device is placed inside a blood vessel.