RecruitingOBSERVATIONAL

Neurovascular Product Surveillance Registry

This study is a registry that tracks Medtronic medical devices used to treat two serious conditions: brain aneurysms and a type of stroke called ischemic stroke. A brain aneurysm is a bulge in a blood vessel in your brain that could burst, and an ischemic stroke happens when a blood clot blocks blood flow to your brain. This study isn't about trying new treatments; instead, it's about checking how well existing Medtronic devices work in real-world patients. Doctors will observe patients who receive these treatments from Medtronic to make sure they are safe and effective over time. This helps medical companies and regulators understand the long-term performance of these products.

At a glance

Status

Recruiting

Sponsor

Medtronic Neurovascular Clinical Affairs

Enrolment target

4,000

Start

01 Dec 2016

Estimated completion

01 Aug 2032

Intracranial Aneurysm Stroke, Ischemic

What is this study about?

This study, called the Neurovascular Product Surveillance Registry, is designed to keep a close eye on certain medical devices made by Medtronic. These devices are used to treat two potentially life-threatening conditions: intracranial aneurysms and ischemic strokes. An intracranial aneurysm is essentially a weak, bulging spot in a blood vessel in the brain, while an ischemic stroke occurs when a blood clot blocks blood flow to the brain, causing damage.

It's important to understand that this isn’t a study where doctors are testing new, experimental treatments. Instead, it’s about collecting information on devices that are already approved and being used in hospitals. Think of it like a follow-up program, where medical professionals gather ongoing information about how these products perform after they've been used in many patients. This helps ensure that the devices continue to be safe and effective over time.

The main goal is to check both the safety and how well these Medtronic products work for patients with these conditions. By collecting information from many different hospitals, researchers can build a broad picture. This ongoing check helps doctors and medical companies better understand the long-term effects of these treatments, which ultimately helps improve patient care in the future.

Key takeaways

This study observes Medtronic devices used for brain aneurysms and strokes.
It's a way to track the safety and effectiveness of approved treatments.
Participation involves monitoring your health, not new treatments.
You must be at least 18 years old to join.
Your contribution helps improve future patient care.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be at least 18 years old. You would be considered if you are about to receive, or have already received, a treatment involving a specific Medtronic device for a brain aneurysm or a stroke that cuts off blood flow (ischemic stroke).

There are certain reasons why you might not be able to take part. For example, if it's thought that you might not be able to come in for follow-up appointments, or if you are pregnant, breastfeeding, or planning to become pregnant during the study period. You also can't join if you are already in another study that tests medicines or devices, as this could make it harder to understand the results of this particular study. Your doctor will carefully check 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 or older?
Are you being treated with a Medtronic device for a brain aneurysm or ischemic stroke?
Are you able to attend any necessary follow-up appointments?
Are you pregnant, breastfeeding, or planning to become pregnant?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part, your doctor will explain everything clearly and ask for your permission, often called consent. This study largely involves keeping track of your health and recovery after you've received a Medtronic treatment for a brain aneurysm or ischemic stroke. You won't be given any new or experimental medications or treatments as part of this study. Instead, the doctors will simply observe your progress and collect information about how you're doing with the Medtronic device you already have or are about to receive. This might involve looking at your medical records and possibly having follow-up visits or assessments as part of your standard care, which will then be recorded for the study. The total duration of your participation will depend on how long your doctor needs to monitor your progress, but it will be thoroughly explained to you upfront.

Potential risks and benefits

The main benefit of taking part in this study is contributing to our understanding of how existing Medtronic devices work for brain aneurysms and strokes. This information can help improve treatments for future patients. Since this is an observational study, meaning you're already receiving standard care, there are very few additional risks specific to the study itself. Any risks you experience would generally be those related to your medical condition and the treatment you are already receiving. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (99)

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

ENERI
Verified postcode
Buenos Aires, Argentina· Recruiting
Gold Coast University Hospital
Verified postcode
Southport, Australia· Active not recruiting
Universitätsklinikum Christian Doppler Klinik Salzburg
Verified postcode
Salzburg, Austria· Recruiting
Ziekenhuis Oost Limburg - Campus Sint-Jan
Verified postcode
Genk, Belgium· Completed
Universitair Ziekenhuis Gent
Verified postcode
Ghent, Belgium· Completed
Xuanwu Hospital Capital Medical University
Verified postcode
Beijing, China· Completed
Chongqing University Three Gorges Hospital
Verified postcode
Chongqing, China· Completed
First Affiliated Hospital of Jiamusi University
Verified postcode
Jiamusi, China· Terminated
The Affiliated Hospital of Jinggangshan University
Verified postcode
Ji’an, China· Completed
Kaifeng Central Hospital
Verified postcode
Kaifeng, China· Terminated
Liaocheng People's Hospital
Verified postcode
Liaocheng, China· Terminated
Lishui Municipal Central Hospital
Verified postcode
Lishui, China· Terminated

Common questions

What is a registry study?

A registry study collects information about patients who are receiving a particular treatment or have a specific condition. It helps doctors understand how treatments work in real-world situations.

Am I trying a new treatment in this study?

No, this study only looks at Medtronic devices that are already approved and in use. You won't be trying any new or experimental treatments.

What medical conditions does this study focus on?

This study is for patients being treated for brain aneurysms and a type of stroke called ischemic stroke.

How long would I be in the study?

The length of time you'd be in the study will vary, as it involves observing your recovery over time with the Medtronic device. Your doctor will provide you with specific details for your situation.

Will taking part affect my regular medical care?

No, taking part in this study should not affect the medical care you receive for your condition. You will continue to get the best treatment for you.

How to find out more

Wouter Fabry

wouter.fabry@medtronic.com +32496165078 Official trial record

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