RecruitingOBSERVATIONAL

Terumo Aortic Global Endovascular Registry

This study, called the Terumo Aortic Global Endovascular Registry, is designed to understand how safe and effective certain medical devices are in real-world patients. These devices are special tubes, called grafts, used to fix problems in the main artery of the body, either in the chest or tummy, known as aortic aneurysms. The study gathers information from many hospitals about how patients get on after having these grafts, including how they feel and if there are any problems. It also looks at the economic side of things. This helps doctors learn more about how well these CE-marked (approved for use in Europe) and custom-made grafts work for different people in everyday medical practice.

At a glance

Status

Recruiting

Sponsor

Vascutek Ltd.

Enrolment target

1,000

Start

17 Dec 2019

Estimated completion

01 Nov 2030

Abdominal Aortic Aneurysm Thoracic Aortic Aneurysm Surgery

What is this study about?

Imagine your body's largest blood vessel, called the aorta, is like a hose. If part of the hose starts to bulge or weaken, that's called an aneurysm. It can be serious if it bursts. Doctors can fix this with a special tube called an endovascular graft that re-lines the weakened section, strengthening it. This study is like a large, ongoing logbook for patients who have received a specific type of these grafts made by a company called Terumo Aortic.

The main goal of this study is to see how well these grafts perform in real life, after they've already been approved for use. Researchers want to know if they are safe, if they fix the problem effectively, and how patients feel after the procedure. They also gather information on how long patients stay healthy and the costs involved. This is important because it helps medical professionals and the company understand the long-term success of these treatments and how to make them even better.

This isn't a typical clinical trial where new treatments are tested for the first time. Instead, it's a 'registry' which simply collects information from many different hospitals about patients who are already being treated with these grafts as part of their regular care. By putting all this real-world information together, doctors can get a clearer picture of how these treatments work for a wide range of patients, rather than just in controlled research settings.

Key takeaways

This study is observing how well Terumo Aortic grafts work for aortic aneurysms.
It collects real-world safety and performance information after the grafts are approved.
Participation involves sharing your medical information from your routine care.
There are no new treatments or medications given for this study.
The study helps improve understanding and future care for patients with aneurysms.
You can withdraw from the study at any time without affecting your medical treatment.

Who may be eligible?

To be able to join this study, you would generally need to be an adult, and your doctor would need to decide that you require a specific type of repair for an aortic aneurysm using a Terumo Aortic graft that has been approved for use, or a custom-made version. You must also be able to understand what the study involves and agree to take part.

Even if you need emergency treatment for an injury, you might still be able to join. In these urgent situations, there are special rules that allow consent to be given after your treatment, or by a close family member who can make decisions for you.

You would not be able to join if you are unable or unwilling to come for your follow-up appointments, or if your doctor believes, for any medical, social, or psychological reasons, that taking part would not be suitable or safe for you.

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 an adult?
Do I need an aortic aneurysm repair with a Terumo Aortic graft?
Am I willing to come for my regular follow-up appointments?
Can I understand and agree to take part in the study?
Has my doctor said I can join without any medical concerns?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this registry, it means that information about your treatment with the Terumo Aortic graft will be collected and looked at by the researchers. This includes details about your procedure, how you recover, and how you feel over time. You will need to attend regular follow-up appointments, which are part of your routine medical care anyway, so that doctors can monitor your health and the graft. There are no new medications given as part of this study; it's about observing how patients do with their existing treatment. The duration of your participation will depend on how long your doctor monitors your graft and overall health, as per standard practice.

Potential risks and benefits

The main benefit of taking part in this registry is helping to improve medical understanding of these grafts, which can ultimately lead to better care for future patients. There are no direct personal benefits or risks beyond what you would experience from your routine medical treatment and follow-up for your aneurysm. You will be receiving the same care you would if you weren't in the study. All medical treatments carry some risks, and your doctor will discuss these with you as part of your normal care. Joining the study is completely voluntary, and you are free to withdraw your consent at any time without it affecting your medical care.

Locations (58)

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

Long Beach Memorial Medical Center
Verified postcode
Long Beach, United States· Recruiting
University of Colorado Anschutz Medical Campus
Verified postcode
Aurora, United States· Recruiting
UC Health Memorial Hospital Center
Verified postcode
Colorado Springs, United States· Recruiting
Yale University
Verified postcode
New Haven, United States· Recruiting
MedStar Washington Hospital Center
Verified postcode
Washington D.C., United States· Recruiting
University of Florida
Verified postcode
Gainesville, United States· Recruiting
Loyola University of Chicago (Loyola)
Verified postcode
Chicago, United States· Recruiting
Ascension St. Vincent Heart Center
Verified postcode
Indianapolis, United States· Recruiting
University of Michigan
Verified postcode
Ann Arbor, United States· Recruiting
Cooper University Hospital
Verified postcode
Camden, United States· Recruiting
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
University of Pittsburgh
Verified postcode
Pittsburgh, United States· Recruiting

Common questions

What is an aortic aneurysm?

It's a bulge or weak spot in the wall of your aorta, the body's main artery. It can be in your chest (thoracic) or tummy (abdominal).

What is an endovascular graft?

It's a special fabric-covered tube that doctors place inside your weakened aorta to strengthen it, usually without needing major open surgery.

Will I get different treatment if I join the study?

No, you will receive the same standard medical care and treatment for your aneurysm that your doctors recommend, whether you join the study or not.

What information will the study collect about me?

The study will collect details about your surgery, your recovery, any follow-up appointments, and how you feel over time, to understand how the graft performs.

Can I change my mind and leave the study?

Yes, you can choose to withdraw from the study at any time without your medical care being affected in any way.

How to find out more

Michelle Durnan

m.durnan@terumoaortic.com +44 141 343 0195 Official trial record

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