RecruitingNAINTERVENTIONAL

EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)

This study is investigating a new approach to prevent a common issue called a 'Type II Endoleak' after a keyhole operation for a bulging blood vessel in the tummy, known as an abdominal aortic aneurysm (AAA). AAAs are often treated by putting a special tube (stent-graft) inside the artery. Sometimes, small blood vessels connected to the bulge don't seal properly, causing a leak. These leaks can make the bulge grow or even burst. This study aims to see if placing tiny metal coils inside the bulge during the initial operation can effectively stop these leaks from happening, potentially preventing future problems and the need for more complex treatments.

At a glance

Status

Recruiting

Phase

Sponsor

Christoph Knappich

Enrolment target

100

Start

15 Jan 2023

Estimated completion

30 Apr 2026

Abdominal Aortic Aneurysm Endoleak

What is this study about?

When you have an abdominal aortic aneurysm (AAA), it means there's a weak spot in the main blood vessel that runs down your tummy, causing it to bulge like a balloon. If this bulge gets too big, it can be dangerous. One common way to fix it is through a keyhole operation called EVAR. In this procedure, doctors put a special tube, called a stent-graft, inside the artery to reinforce it and stop blood from flowing into the bulge.

However, sometimes after the EVAR operation, blood can still find its way into the old bulge from small blood vessels that connect to it. This is called a Type II Endoleak, and it happens to about a quarter of patients. These leaks can be a problem because they might cause the bulge to grow again or, in rare cases, even burst, which could lead to further operations.

This study is looking into a way to prevent these Type II Endoleaks. Doctors have found that if they put small metal coils into the aneurysm bulge at the same time they do the EVAR operation, it might stop these leaks from happening. The study wants to find out if this coil placement is an effective way to keep the bulge sealed off and reduce the risk of future complications for patients.

Key takeaways

This study aims to prevent a common leak after AAA surgery.
It tests placing coils inside the aneurysm during the initial operation.
This might reduce the need for future complex treatments.
Participation involves standard surgery plus coil placement and follow-up scans.
It's for people with specific risks of developing a Type II Endoleak.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must also have an abdominal aortic aneurysm that's at least 50 millimetres (about two inches) wide and suitable for the keyhole EVAR operation, as determined by your doctor and in line with the instructions for the equipment used.

The study is specifically looking for people who are more likely to develop a Type II Endoleak. This means you would need to have certain features seen on your CT scan, like having five or more specific small blood vessels showing up or if the aneurysm contains less than 40% old blood clot at its widest point.

However, you can't join if your aneurysm has already burst, or if you need a more complex type of EVAR operation called fenestrated or branched EVAR. You also can't take part if you have another aneurysm in your iliac artery, if you are pregnant, or if you wouldn't be able to stick to the follow-up appointments. Of course, you also need to agree to be part of the study.

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?
Do you have an AAA that is at least 50mm wide?
Are you planned for an EVAR operation?
Do your scans show features that increase your risk for a Type II Endoleak?
Are you able to attend all follow-up appointments?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the standard EVAR operation for your abdominal aortic aneurysm. Additionally, during that same operation, the doctors would place small metal coils into the aneurysm sac to help prevent future leaks.

After your operation, you would have regular check-ups, which would involve scans (like CT scans) to monitor your recovery and ensure the aneurysm remains sealed. The frequency and duration of these follow-up appointments would be clearly explained to you, and it's important that you are able to attend them. There are no extra medications involved beyond what you would normally receive for your condition and operation.

Potential risks and benefits

Taking part in this study might offer a potential benefit by reducing your risk of developing a Type II Endoleak after your EVAR operation, which could mean fewer complications later on and potentially avoiding future procedures. As with any medical procedure, there are always some risks involved, including those associated with the EVAR operation itself and the added step of placing coils. These risks would be fully discussed with you by the medical team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
Verified postcode
Munich, Germany· Recruiting

Common questions

What is an abdominal aortic aneurysm (AAA)?

It's a bulge in the main blood vessel (aorta) in your tummy that can be dangerous if it gets too big.

What is an EVAR operation?

It's a keyhole surgery where doctors put a special tube (stent-graft) inside the aneurysm to fix it.

What is a Type II Endoleak?

It's when blood still leaks into the aneurysm bulge after an EVAR operation from small blood vessels.

What are 'sac embolization coils'?

These are small metal coils that doctors place into the aneurysm bulge to block blood leaks.

Will taking part change my normal treatment?

You'll still get the standard EVAR operation, but with the added step of coil placement to prevent leaks.

How to find out more

Christoph Knappich, PD Dr. med.

christoph.knappich@mri.tum.de 0049-894140 Official trial record

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