RecruitingOBSERVATIONAL

European Aortic Data Collection Project

This study, called the European Aortic Data Collection Project, is gathering real-world information about special medical devices used to treat problems with the aorta, your body's largest blood vessel. These conditions include various types of aneurysms (weak bulges in the aorta) and aortic dissection (a tear in the aorta's wall). Doctors use special devices, called stent-grafts, which are custom-made by Cook, to fix these issues from inside your blood vessels. The study wants to see how safe and effective these devices are in everyday use. The information collected will help make sure these devices can continue to be available to patients and to help improve future treatments.

At a glance

Status

Recruiting

Sponsor

Cook Research Incorporated

Enrolment target

600

Start

31 May 2023

Estimated completion

01 Dec 2030

Complex Abdominal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm Aortic Arch Aneurysm Chronic Aortic Dissection

What is this study about?

This study is gathering important information about a type of treatment called endovascular aortic treatment. This is a less invasive way to fix problems with your aorta, which is the main blood vessel that carries blood from your heart to the rest of your body. Conditions like aortic aneurysms (where the aorta bulges out) or aortic dissection (where there's a tear in the aorta) can be very serious.

Instead of major open surgery, endovascular treatments involve inserting a small tube with a special device, called a stent-graft, into your blood vessel through a small cut, usually in your groin. This stent-graft helps to strengthen or repair the affected part of your aorta. The devices being looked at in this study are custom-made by a company called Cook, meaning they are designed specifically for the individual patient's needs.

The main purpose of this study is to see how well these custom-made stent-grafts work in real patients and to check their safety. Information from this study will help ensure that these important medical devices can continue to be used and improved for patients in the future. It also helps the manufacturer meet their requirements for monitoring how their products perform once they are on the market.

Key takeaways

This study helps make sure medical devices for aortic problems are safe and effective.
It collects information on how custom-made stent-grafts work in real patients.
Participation means your routine treatment information is used to help improve future care.
You'll receive standard treatment; no extra procedures are done for the study.
Your privacy is protected, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you must be a patient who is going to be treated with a Cook Custom-Made Stent-graft device for an aortic condition.

There are a few reasons why you might not be able to join. Firstly, if you know you won't be able to come to all your follow-up appointments after your treatment, you wouldn't be able to participate. Also, if you or your legal representative don't want your health information to be used for the study, or if you're not willing to sign the consent form, then you wouldn't be able to join.

This study includes people of all ages and both men and women, as long as they meet the criteria above.

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.

Am I being treated with a Cook custom-made stent-graft device?
Am I able to attend all my planned future clinic appointments?
Am I happy for my medical information to be used for this study?
Am I willing to sign a consent form to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it means that information about your treatment with the Cook custom-made stent-graft will be collected. This includes details about your procedure and how you recover afterwards. You won't be given any extra treatments or medications specifically for the study; you'll receive the same care you would normally.

The main commitment for you would be to attend your planned follow-up appointments, which your doctor will schedule as part of your usual care. During these visits, your medical team will assess how you're doing and how the device is performing. The study will essentially collect this routine information. The total duration of your participation would be for as long as your clinical follow-up is scheduled by your doctor.

Potential risks and benefits

Participating in this study does not change the treatment you receive, so any potential benefits or risks are those associated with the endovascular treatment itself, which your doctor will discuss with you. The main benefit of participating in the study is that the information collected from your treatment will help improve our understanding of these devices, potentially benefiting future patients. There are no additional risks from participating beyond those of your standard clinical care, as the study only involves collecting existing medical information. You have the right to withdraw from the study at any time, meaning your data would no longer be collected or used, without affecting your medical care.

Locations (18)

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

Aarhus University Hospital
Verified postcode
Aarhus, Denmark· Recruiting
Rigshospitalet
Verified postcode
Copenhagen, Denmark· Recruiting
Hopital Marie Lannelongue
Verified postcode
Le Plessis-Robinson, France· Recruiting
CHU de Lille
Verified postcode
Lille, France· Recruiting
University Hospital Hamburg Eppendorf
Verified postcode
Hamburg, Germany· Recruiting
LMU Klinikum Munich
Verified postcode
Munich, Germany· Recruiting
St. Franzikus-Hospital Munster
Verified postcode
Münster, Germany· Recruiting
Klinnikum Nurnberg
Verified postcode
Nuremberg, Germany· Recruiting
PoliclinicoS Orsola Malpighi
Verified postcode
Bologna, Italy· Recruiting
Orsola Maplighi
Verified postcode
Bologna, Italy· Recruiting
Ospedal Policlinico San Martino-HSM
Verified postcode
Genova, Italy· Recruiting
IRCCS San Raffaele Hospital
Verified postcode
Milan, Italy· Recruiting

Common questions

What exactly is an aorta?

The aorta is the largest blood vessel in your body. It comes directly from your heart and carries oxygen-rich blood to all parts of your body. Problems with it, like bulges or tears, can be very serious.

What is a 'stent-graft'?

A stent-graft is a special tube-like device, often made of fabric and metal mesh. It's used to repair or strengthen a weak or damaged part of your aorta from the inside, preventing it from bursting or leaking.

Will taking part in this study change my treatment?

No, taking part in this study will not change the treatment you receive. You will still get the best care for your condition, and the study will simply collect information about that care.

Who is making these devices?

The custom-made stent-graft devices being studied are made by a medical company called Cook.

What happens to my personal information if I join?

Your medical information will be collected for the study, but it will be handled carefully to protect your privacy. Only necessary information will be used to understand how the devices perform.

How to find out more

Gregoire Masliah

gregoire.masliah@cookmedical.com +41 795 490 954 Official trial record

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