Active not recruitingOBSERVATIONAL

Endurant CHevAr New Indication Trial: ENCHANT

This research is a follow-up study looking at how effective and safe a new procedure called the 'Endurant Chimney Graft Technique' is. This technique is used to treat a condition called an abdominal aortic aneurysm (AAA), which is a bulge or swelling in the body’s main blood vessel in the tummy, particularly when this bulge is close to the kidney arteries. Doctors are using a combination of existing medical devices (Endurant Stent Graft Systems with a balloon-expandable covered stent graft) in a specific way – like creating a 'chimney' – to support the blood vessel and stop it from bursting. The study aims to see how patients get on with this treatment in everyday medical practice, focusing on their well-being and the success of the procedure.

At a glance

Status

Active not recruiting

Sponsor

Medtronic Cardiovascular

Enrolment target

150

Start

26 Oct 2017

Estimated completion

01 Jul 2030

AAA - Abdominal Aortic Aneurysm

What is this study about?

This study is about a medical condition called an abdominal aortic aneurysm (AAA). This is when the main blood vessel, the aorta, which carries blood from your heart to the rest of your body, develops a weak spot and bulges in your tummy area. If this bulge gets too big, it can be very serious. Often, these aneurysms can be treated with a keyhole procedure where a special tube, called a stent graft, is placed inside the aorta to strengthen it.

However, some aneurysms are tricky to treat because they are very close to other important blood vessels, like those going to your kidneys. This study is looking at a specific technique called the 'Endurant Chimney Graft Technique' for these difficult-to-treat aneurysms. It involves using a special combination of stents and grafts to create a 'chimney' alongside the main graft, ensuring that blood flow to the surrounding vital organs, like the kidneys, is maintained.

The main goal of this study is to see how well this 'chimney graft' technique works in real patients and whether it is safe. Doctors will be carefully observing patients who receive this treatment to understand its long-term benefits and any potential challenges, helping to improve care for people with this type of aneurysm.

Key takeaways

This study evaluates a special technique for treating abdominal aortic aneurysms (AAAs) near the kidneys.
It aims to understand the safety and effectiveness of the 'chimney graft' method.
Participation involves receiving the treatment and attending follow-up appointments.
You must be 18 or older and have a specific type of AAA to be eligible.
You can withdraw from the study at any time.
The study focuses on improving AAA treatment options.

Who may be eligible?

To join this study, you need to be at least 18 years old and scheduled to have your abdominal aortic aneurysm treated for the first time using this specific 'chimney graft' technique. The aneurysm must be located near your kidneys. You should be able and willing to follow all the study instructions and attend all follow-up appointments. You will also need to give your written consent to participate.

There are several reasons why you might not be able to join. For example, if you are already taking part in another study that could affect the results of this one, or if you have a life expectancy of less than two years. You also can't take part if your aneurysm is in a different location (above the kidneys, only in your leg arteries), or if it's due to an infection, inflammation, or injury. If you need urgent treatment for your aneurysm, or if you've had surgery for an abdominal aortic aneurysm before, you won't be eligible. Women who could become pregnant and don't rule out pregnancy, or if you have severe kidney problems or an active COVID-19 infection (or were recently very unwell with it), would also not be able to participate. Lastly, if you have severe allergies to common medical treatments like blood thinners or dyes used in scans, this study might not be suitable.

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?
Are you scheduled for your first treatment for an abdominal aortic aneurysm (AAA) near your kidneys?
Can you attend all required follow-up appointments?
Do you have a life expectancy of more than two years?
Do you not have an active COVID-19 infection or recent serious illness from it?
Are you not allergic to common medical treatments like blood thinners or scan dyes?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the 'Endurant Chimney Graft Technique' as your treatment for the abdominal aortic aneurysm. Following your procedure, you will have regular medical appointments and check-ups. These appointments will involve various assessments, which might include scans and blood tests, to monitor your health and how well the treatment is working. The study will track your progress over time, so you'll need to attend scheduled follow-up visits as requested by the study team. The full duration of your participation in the study, including all follow-up, will be explained by the study team before you agree to take part.

Potential risks and benefits

Participating in this study means you will receive a specific treatment for your abdominal aortic aneurysm, which could help manage your condition. However, as with any medical procedure, there are potential risks, which will be fully explained by your medical team and in the study's information sheets. These might include risks associated with surgery, anaesthesia, or the devices used. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

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

Ordensklinikum Linz GmbH / Elisabethinen
Verified postcode
Linz, Austria
CHU de Bordeaux - Centre Universitaire Pellegrin
Verified postcode
Bordeaux, France
Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré
Verified postcode
Boulogne-Billancourt, France
Klinikum Chemnitz gGmbH
Verified postcode
Chemnitz, Germany
Elisabeth Krankenhaus Essen GmbH
Verified postcode
Essen, Germany
Universitäts Klinikum Frankfurt - Goethe-Universität
Verified postcode
Frankfurt am Main, Germany
Universitätsklinikum Heidelberg
Verified postcode
Heidelberg, Germany
St. Franziskus-Hospital Münster GmbH
Verified postcode
Münster, Germany
Evaggelismos General Hospital of Athens
Verified postcode
Athens, Greece
University Hospital of Larissa
Verified postcode
Larissa, Greece
Ippokrateio General Hospital of Thessaloniki
Verified postcode
Thessaloniki, Greece
Azienda Ospedaliera di Cosenza
Verified postcode
Cosenza, Italy

Common questions

What is an abdominal aortic aneurysm (AAA)?

It's a bulge or swelling in the main blood vessel (aorta) in your tummy. If it gets too big, it can be serious.

What is the 'Endurant Chimney Graft Technique'?

It's a special way of using medical devices (stents and grafts) to treat an AAA, especially when it's close to your kidney arteries, to ensure blood flow to your kidneys is maintained.

Why is this study being done?

The study aims to see how safe and effective this new 'chimney graft' technique is for patients in real-life situations.

Will I receive a special medication if I join?

This study focuses on a medical procedure using specific devices, not a new medication. Any medications you receive would be part of your standard care or related to the procedure.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point without it affecting your medical care.