RecruitingOBSERVATIONAL

Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).

This study is gathering information about a medical device called the Penumbra System. It's used to treat a serious condition called acute ischemic stroke, which happens when a blood clot blocks blood flow to the brain. The main goal is to see how well the Penumbra System works and if it's safe when used in everyday medical practice. This is a "real-world" study, involving up to 200 patients across different hospitals. We hope to learn more about the device's performance to help improve future stroke treatment. It's not testing a new drug or device; it's about understanding an existing one better.

At a glance

Status

Recruiting

Sponsor

Penumbra Inc.

Enrolment target

200

Start

01 Nov 2025

Estimated completion

01 Apr 2028

Acute Ischemic Stroke (AIS)

What is this study about?

Imagine your brain is like a very busy city, and blood vessels are the roads that carry essential supplies. An acute ischemic stroke happens when one of these roads gets blocked by a clot, stopping blood from reaching part of the brain. This is a medical emergency that needs quick action.

Doctors use different treatments to try and remove these clots. One such treatment involves a special medical device called the Penumbra System. This study is all about understanding how well this system performs and how safe it is for people who have had this type of stroke when used in standard care. It's not a trial of a new, experimental treatment, but rather a way to gather more information about how an existing device works in a variety of real-life situations.

By taking part, you would be helping doctors and researchers learn more about the Penumbra System. This information can be really valuable for improving stroke care for many patients in the future. We're looking at things like whether the device successfully removes the clot and if there are any side effects.

Key takeaways

This study collects information about the Penumbra System for stroke treatment.
It aims to understand how well the device works and its safety in real patients.
It's for people aged 18-75 who have had a specific type of stroke.
Participation involves routine care with the Penumbra System and follow-up for 90 days.
Your involvement helps improve future stroke care.

Who may be eligible?

To be considered for this study, you would generally need to be between 18 and 75 years old and have been quite independent before your stroke. This means you were able to manage most daily tasks on your own without much help.

The most important thing is that you've had an acute ischemic stroke and your doctors believe the Penumbra System is the right treatment for you. You must also be able to understand the study and agree to take part.

There are some reasons why you might not be able to join. For example, if your stroke has caused severe damage in certain brain areas, or if you have other serious health problems that might make it unsafe for you to complete the study or make it hard for doctors to follow up on your progress.

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 between 18 and 75 years old?
Were you quite independent before your stroke?
Have you had an acute ischemic stroke that your doctor thinks could be treated with the Penumbra System?
Can you understand the study information and agree to take part?
Do you feel well enough to attend follow-up appointments for about 3 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it means your doctors will use the Penumbra System as the main treatment for your stroke, as they normally would. The study will then involve collecting information about how well the treatment worked and how you recover. This will include having regular check-ups and assessments, likely through hospital visits or perhaps phone calls.

The main follow-up period will last for about 90 days (around three months) after your stroke. During this time, doctors will want to see how you're doing and complete some assessments. The study itself doesn't involve new medications or extra procedures beyond what your doctor thinks is best for your stroke treatment. It's mainly about carefully recording your progress.

Potential risks and benefits

Taking part in this study means your doctors will use the Penumbra System, which is a treatment for stroke already approved for use by doctors. The potential benefits are that doctors will learn more about how this system works in real patients, which could help improve stroke care for others in the future. As with any medical procedure, there are always potential risks linked to the treatment itself; your doctor will explain these to you fully. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (10)

Sir Charles Gairdner Hospital
Verified postcode
Nedlands, Australia· Recruiting
CHU de Bordeaux - Hôpital Pellegrin
Verified postcode
Bordeaux, France· Recruiting
CHU de Brest - Hôpital de la Cavale Blanche
Verified postcode
Brest, France· Recruiting
Hôpital Pierre-Paul Riquet
Verified postcode
Toulouse, France· Recruiting
TUM Klinikum rechts der Isar
Verified postcode
München, Germany· Recruiting
Knappschaft Kliniken Vest Recklinghausen
Verified postcode
Recklinghausen, Germany· Recruiting
Universitätsklinikum Augsburg
Verified postcode
Augsburg, Germany· Recruiting
Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck
Verified postcode
Lübeck, Germany· Recruiting
Universitätsspital Basel
Approximate
Basel, Switzerland· Recruiting
Inselspital Universitätsklinik für Neurologie
Verified postcode
Bern, Switzerland· Recruiting

Common questions

What is an acute ischemic stroke?

It's a type of stroke caused by a blood clot blocking blood flow to part of your brain, stopping oxygen and nutrients from getting through.

What is the Penumbra System?

It's a medical device that doctors use to try and remove blood clots that are causing an acute ischemic stroke.

Will I get a new or experimental treatment?

No, this study is looking at how an existing, approved device (the Penumbra System) performs in normal medical practice, not a new or experimental one.

How long will I be involved in the study?

You'll be followed for about 90 days (around three months) after your stroke to see how you're recovering.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating at any time, and it will not affect your medical care.

How to find out more

Celina Wang

cwang1@penumbrainc.com +49 175 1938 209 Official trial record

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