RecruitingNAINTERVENTIONAL

EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn

This study is investigating a new device called the Allay Aortic Stent. It's for people in the UK who have a condition called Type B aortic dissection, which is a tear in the main artery leaving the heart. Standard treatment often involves a procedure called TEVAR, using a stent graft. This study wants to see if adding the Allay Aortic Stent after the main TEVAR procedure can help prevent future complications. Specifically, researchers will be looking at whether it reduces the chance of the aorta growing larger, needing further surgery, or tearing within 12 months. They will also track any serious problems that happen within 30 days of getting the new stent. The goal is to see if this additional stent can make the treatment even better for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Intressa Vascular SA

Enrolment target

Start

30 Oct 2024

Estimated completion

01 Jun 2031

Type B Aortic Dissection

What is this study about?

Imagine the body's largest blood vessel, called the aorta, which carries blood from your heart to the rest of your body. Sometimes, a tear can happen in the inner layer of this vessel, causing blood to flow between the layers. This is called an aortic dissection. When this tear happens in a specific part of the aorta, it's called a Type B aortic dissection.

Doctors often treat this condition with a procedure called TEVAR (Thoracic Endovascular Aortic Repair). This involves placing a special tube, called a stent graft, inside the aorta to cover the tear and help the vessel heal. While TEVAR is very effective, some people can still have problems later on, like the aorta getting larger or even potentially tearing again. This study is looking into whether adding another type of stent, called the Allay Aortic Stent, after the initial TEVAR procedure can help prevent these later problems.

The main idea is to see if this extra stent makes the treatment more robust and reduces the need for more operations down the line. The researchers will be carefully observing people in the study for a year to see how well the Allay Aortic Stent works and if it helps keep the aorta stable and healthy.

Key takeaways

This study is testing a new device called the Allay Aortic Stent.
It's for people with a specific condition called Type B aortic dissection.
The stent is used in addition to standard treatment to prevent future problems.
Researchers will check for reduced aorta growth and re-operations over 12 months.
The study also monitors for any significant problems after the stent is placed.

Who may be eligible?

To join this study, people need to have a specific type of tear in their aorta (a Type B aortic dissection) that reaches a certain point in their belly. You must also be suitable for the standard stent graft treatment (TEVAR) as decided by your doctor and local hospital guidelines. This standard treatment should have been planned within 90 days of your dissection symptoms starting.

There are also some reasons why you couldn't join. For example, you must be 18 years old or older and not be pregnant, breastfeeding, or planning to get pregnant during the study. You also wouldn't be able to join if you can't or won't follow the study's instructions, or if you're already in another study that might affect the results. If you have certain serious medical problems, such as a ruptured aorta, severe kidney disease, a very short life expectancy, active cancer, or certain connective tissue diseases, you also wouldn't be eligible.

Additionally, if you have known allergies to certain metals used in the device or to contrast dye (unless it can be managed with medication), or if you have a serious infection, you won't be able to take part. Doctors will carefully review all these points to make sure the study is safe and appropriate 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.

Do I have a Type B aortic dissection involving a specific part of my aorta?
Am I suitable for the standard TEVAR procedure, as decided by my doctor?
Am I 18 years old or older, and not pregnant or breastfeeding?
Do I have any serious medical conditions that might prevent my participation?
Am I willing and able to attend all study appointments and follow instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first receive the standard stent graft treatment (TEVAR). This is followed by the placement of the Allay Aortic Stent in the same area. You will have regular check-ups and assessments, which may include scans, to monitor your aorta and your overall health. The main goal is to see how well this additional stent works over 12 months. The study will track any serious problems for 30 days after the Allay Aortic Stent is put in, and then continue to monitor for significant changes in your aorta for a full year. This means you would have follow-up visits and tests to make sure everything is going well and to assess the success of the treatment.

Potential risks and benefits

Participating in this trial might offer potential benefits, as the Allay Aortic Stent could potentially reduce the chances of your aorta getting larger or tearing in the future, possibly leading to fewer further operations. However, as with any medical procedure, there are potential risks, including those associated with the stent placement itself, such as infection, bleeding, or issues related to the device. These will be explained in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (10)

Ziekenhuis Oost-Limburg
Verified postcode
Genk, Belgium· Not yet recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Not yet recruiting
CHU Liège
Verified postcode
Liège, Belgium· Recruiting
Acibadem City Clinic University Hospital and Cardiovascular Center
Verified postcode
Sofia, Bulgaria· Not yet recruiting
Hopital Européen Georges Pompidou AP-HP
Verified postcode
Paris, France· Not yet recruiting
Universitätsklinikum Schleswig-Holstein
Verified postcode
Kiel, Germany· Recruiting
Universitätsklinikum Leipzig AöR
Verified postcode
Leipzig, Germany· Recruiting
University Hospital of Münster
Verified postcode
Münster, Germany· Not yet recruiting
University Clinical Centre of Serbia
Verified postcode
Belgrade, Serbia· Not yet recruiting
Republican Research Centre of Emergency Medicine
Verified postcode
Tashkent, Uzbekistan· Recruiting

Common questions

What is a Type B aortic dissection?

It's a serious condition where there's a tear in the inner lining of the aorta, the body's main artery, in a specific section. This tear can cause blood to flow between the layers of the artery wall.

What is a 'stent'?

A stent is a small, mesh-like tube that doctors place inside a blood vessel to help keep it open and support its walls. In this case, it helps repair the tear in the aorta.

What is the Allay Aortic Stent?

It's an experimental stent being studied as an additional treatment for Type B aortic dissection, used after the initial standard stent graft has been put in place.

What are the main things the study is looking for?

The study wants to see if the Allay Aortic Stent reduces the chances of the aorta getting bigger, needing more surgery, or tearing within one year. It also tracks any serious problems shortly after the stent is put in.

How long does the study follow up for?

The main follow-up for the study will be for 12 months after the Allay Aortic Stent is implanted.

How to find out more

Virginie Martin

virginie.martin@intressavascular.com +3281 71 99 41 Official trial record

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