Active not recruitingOBSERVATIONAL

French Registry Conducted on E-vita OPEN NEO

This study, called 'French Registry Conducted on E-vita OPEN NEO', is about understanding how people in France recover after having a special surgical repair for serious artery problems called vascular aneurysms. Doctors are using a device called E-vita OPEN NEO. They are looking at patient information collected from 2020 until March 2024. The main aim is to see how many people pass away in the hospital after the treatment. They are also checking on other health issues and recovery over one and three years. This isn't a trial where people get different treatments; it's an observational study where doctors simply record how patients treated with E-vita OPEN NEO are doing in their normal care.

At a glance

Status

Active not recruiting

Sponsor

JOTEC GmbH

Enrolment target

130

Start

11 Jan 2023

Estimated completion

31 Aug 2027

Vascular Aneurysm

What is this study about?

This study is about a medical device called E-vita OPEN NEO, which is used to treat serious problems with the body's main artery, called the aorta. These problems are often referred to as 'vascular aneurysms', which means there's a bulge or weakness in the artery wall. The study is observing patients in France who have had this device implanted as part of their standard care since 2020 up until March 2024.

The main goal of this study is to look closely at what happens to patients immediately after this surgery. Specifically, it wants to understand how many patients pass away in the hospital after being treated with the E-vita OPEN NEO device. This helps doctors learn more about the immediate safety and outcomes of this treatment in real-world settings.

The study will also follow patients for one and three years after their surgery. This longer-term check-up helps doctors understand other important things, like any new health problems that might come up, how well the device continues to work, and if there are any issues with how the device fits or blocks blood flow over time. This information is very valuable for improving care for future patients with similar conditions.

Key takeaways

This study is observing how people recover after surgery for serious artery problems using a device called E-vita OPEN NEO.
It's happening in France and gathers information from patients treated between 2020 and March 2024.
The main goal is to understand how many patients pass away in the hospital after this treatment.
It also checks for other health issues and how the device works over one and three years.
Participation involves sharing information from your routine medical records, not extra procedures.

Who may be eligible?

You might be included in this study if you are a patient in France who has received the E-vita OPEN NEO device for a serious artery problem. This includes both men and women, regardless of your age.

The most important thing for joining is that you agree to your medical information being collected for the study. If you prefer that your information isn't used for this research, then you would not be included.

There aren't any other specific medical conditions or characteristics that would stop you from being included, apart from your personal choice not to participate.

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.

Have you had the E-vita OPEN NEO device implanted for a serious artery condition?
Were you treated in France?
Did your treatment happen between 2020 and March 2024?
Are you happy for your medical information from your standard care to be used for research?

Answer every question to see your result.

What does participation involve?

If you are already a patient who has received the E-vita OPEN NEO device in France, participating in this study means that your doctors will share information from your routine medical records with the study team. You won't need extra visits or special tests just for the study; all the information comes from your regular check-ups and hospital stays. Your involvement would simply mean allowing the study to look at your medical observations collected during your normal care. The study aims to follow patients' progress for up to three years after their procedure, with all patient follow-up ending in 2027.

Potential risks and benefits

This study doesn't involve any new treatments or procedures, so there are no direct extra risks for you beyond those of your standard medical care. The benefit is that by allowing insights from your treatment to be collected, you're helping doctors better understand the E-vita OPEN NEO device and improve future care for others with similar health problems. Your decision to participate is voluntary, and you have the right to withdraw your consent for your data to be used at any time without affecting your medical treatment.

Locations (23)

CHU Amiens-Picardie
Verified postcode
Amiens, France
Centre Hospitalo-Universitaire d'Angers
Verified postcode
Angers, France
Centre Hospitalier Annecy Genevois
Verified postcode
Annecy, France
CHU Besançon
Verified postcode
Besançon, France
Clinique Saint-Augustin
Verified postcode
Bordeaux, France
Hôpital de La Cavale Blanche - Brest
Verified postcode
Brest, France
Hôpital Louis PRADEL
Verified postcode
Bron, France
Hôpital Privé Saint-Martin
Verified postcode
Caen, France
Clinique de l'Infirmerie Protestante
Verified postcode
Caluire-et-Cuire, France
Hôpital Gabriel Montpied
Verified postcode
Clermont-Ferrand, France
Chu Henri Mondor
Verified postcode
Créteil, France
CHU le Bocage - CHU de Dijon
Verified postcode
Dijon, France

Common questions

What is a vascular aneurysm?

A vascular aneurysm is a bulge or weak spot in the wall of an artery, which is a blood vessel that carries blood from your heart to the rest of your body. It can be serious if it gets too big or bursts.

What is the E-vita OPEN NEO device?

It's a special medical implant used during surgery to fix serious problems with the aorta, your body's main artery, often related to aneurysms.

Will I have extra tests or appointments if I'm in this study?

No, this study only collects information from your existing medical records from your standard care. You won't have any extra tests or appointments just because of the study.

Who is running this study?

This study is a 'registry', meaning it's collecting information from multiple medical centres across France. The details about who is sponsoring it would be available from your doctor.

Will my personal information be kept private?

Yes, all studies are required to protect your personal information and keep it confidential. Your privacy is very important.