RecruitingOBSERVATIONAL

Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System

This study is gathering information on patients who have received a special medical device called the NEXUS Aortic Arch Stent Graft. This device is used to treat serious conditions like aneurysms in the main artery that leaves your heart, called the aorta. Researchers want to understand how safe and effective these devices are in real-world healthcare settings. They'll be looking at things like patient recovery after the procedure, how well the device works over time, and any problems that might come up. The study will collect information for up to five years to get a full picture of the device's performance, helping doctors make informed decisions about this treatment in the future.

At a glance

Status

Recruiting

Sponsor

Endospan Ltd.

Enrolment target

Start

09 Nov 2022

Estimated completion

01 Jul 2030

AAT9

What is this study about?

This study is focused on a specific medical device called the NEXUS Aortic Arch Stent Graft System. Think of it like a tiny, flexible tube reinforced with mesh that doctors can place inside a major blood vessel, the aorta, near your heart. The aorta is the biggest artery in your body, carrying blood from your heart to the rest of your body, and sometimes it can develop bulges (aneurysms) or other problems that need fixing.

The purpose of this study is not to test a new device, but to carefully watch how patients who have already received this device are doing. Doctors want to understand its long-term safety and how well it continues to work. They'll be gathering information on patients' health after the procedure, how long they stay in hospital, and how the device performs over several years. This kind of study, called an observational study, is really important for getting a clear picture of how treatments work in everyday medical care.

By collecting this information for up to five years, researchers can better understand the full journey of patients treated with the NEXUS device. This helps to confirm its effectiveness and safety, and provides valuable insights that can improve care for future patients needing similar procedures.

Key takeaways

This study collects information about an existing medical device, not a new one.
It helps doctors understand the long-term safety and effectiveness of the NEXUS stent graft.
Participation means sharing your medical records, not having new treatments.
Data will be collected for up to five years based on your regular check-ups.
Your information helps improve future care for patients with similar conditions.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, aged 18 or over. This study is mainly looking at people who have already had the NEXUS Aortic Arch Stent Graft System fitted recently, specifically since February 2019, because of a condition that affected their aorta near the heart. You would have received this device as part of your regular medical treatment, not specifically for this study.

It's important that you are well enough to participate and that your doctors believe you will live for at least another year. You shouldn't be pregnant or planning to become pregnant. Also, doctors will check that your kidneys are working steadily and that you haven't had any major heart attacks, strokes, or big heart operations very recently that might make it difficult to take part.

Finally, you must be willing and able to understand what the study involves and give your permission to share your medical information for this research. You also shouldn't be part of another medical study that would get in the way of this one.

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 old or older?
Have you already had the NEXUS Aortic Arch Stent Graft System implanted since February 2019?
Are you able and willing to give permission for your medical information to be used for research?
Are you not currently pregnant or planning to become pregnant?
Does your doctor believe you have a life expectancy of more than one year?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be undergoing any new treatments specifically for the research. Instead, your doctors will continue to treat you as they normally would, following the usual care plans for your condition. The main thing that changes is that your medical information will be collected and reviewed by the study team. This includes details from your hospital stays and your follow-up appointments.

The study aims to collect information for up to five years after you had the NEXUS device fitted. This means that if you're already receiving regular check-ups relating to your condition, the study will simply gather data from these appointments. You won't have extra visits or procedures specifically for the study, but rather your existing medical records will be used.

Potential risks and benefits

Taking part in this study doesn't involve any new medical procedures or medicines, so there are no direct extra medical risks from participating. Your treatment will be exactly the same as if you weren't in the study. The main benefit is that your information will help doctors understand more about how the NEXUS device works over time, potentially improving care for others in the future. You always have the right to withdraw from the study at any time, and this will not affect the medical care you receive.

Locations (18)

Cliniques universitaires Saint Luc
Verified postcode
Brussels, Belgium· Recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Recruiting
Aretaieio Hospital
Verified postcode
Nicosia, Cyprus· Recruiting
APHP Henri Mondor
Verified postcode
Paris, France· Recruiting
Hôpital Européen Georges Pompidou
Verified postcode
Paris, France· Recruiting
Immanuel Klinikum Brandenburg, Herzzentrum Brandenburg
Verified postcode
Bernau bei Berlin, Germany· Recruiting
University Hospital Duesseldorf
Verified postcode
Düsseldorf, Germany· Recruiting
German Heart Center
Verified postcode
Berlin, Germany· Recruiting
University Hospital Bonn
Verified postcode
Bonn, Germany· Recruiting
Evaggelismos General Hospital
Verified postcode
Athens, Greece· Recruiting
Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia
Verified postcode
Brescia, Italy· Not yet recruiting
University Hospital Padoua
Verified postcode
Padova, Italy· Recruiting

Common questions

What is the NEXUS Aortic Arch Stent Graft System?

It's a special medical implant, like a reinforced tube, used to fix problems in the main artery leaving your heart (the aorta).

Am I being given a new treatment in this study?

No, this study is looking at patients who have already received this device as part of their standard care. You won't get any new or different treatments because of the study.

How long will I be involved?

The study collects information from your medical records for up to five years after you had the device fitted, using details from your existing follow-up appointments.

What kind of information will they collect about me?

They will look at details about your recovery, how long you stayed in hospital, and how the device performs over time.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

Natali Yosef

natali@endospan.com +972507599447 Official trial record

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