RecruitingNAINTERVENTIONAL

Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck

The HERCULES study is an important research project investigating the best treatment for a common condition called an abdominal aortic aneurysm (AAA). This is when the main blood vessel in your tummy (the aorta) bulges or widens. The study specifically looks at AAAs that have a wider 'neck' – the part closest to the heart. Researchers want to compare two ways of fixing these aneurysms using a special tube called a stent. One method uses the stent by itself, while the other adds tiny 'anchors' to help secure the stent. The aim is to see if adding these anchors leads to better long-term results for patients with wider-necked aneurysms. This will help doctors make more informed decisions about treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Rijnstate Hospital

Enrolment target

300

Start

26 May 2023

Estimated completion

01 Apr 2033

Aortic Aneurysm, Abdominal

What is this study about?

Imagine the main blood vessel in your body, called the aorta, like a garden hose. Sometimes, a weak spot might cause a bulge or balloon in this hose – that's what we call an aneurysm. If this happens in your tummy area, it's called an abdominal aortic aneurysm, or AAA. If left untreated, these bulges can become dangerous, so doctors often recommend fixing them.

Modern medicine has a way of fixing these aneurysms using a special tube called a 'stent graft'. This stent acts like a new lining inside the bulging blood vessel, reinforcing it. There are two main ways doctors might use this stent for AAAs with a wider 'neck' – the section closest to where the bulge begins. One way is to simply put the stent in place. The other way involves using the stent but also adding tiny 'anchors' to help secure it firmly against the blood vessel wall.

This study, called HERCULES, wants to find out which of these two methods works best for people whose aneurysms have these wider necks. Doctors already use both the stent and the anchors, but they don't yet have enough information directly comparing their effectiveness for this specific group of patients. By carefully comparing the two approaches in this study, doctors hope to gain a clearer understanding of which treatment provides the best and longest-lasting results for patients with wider-necked AAAs.

Key takeaways

The study compares two ways to fix abdominal aortic aneurysms (stent only vs. stent with anchors).
It focuses on aneurysms with a specific 'wide neck' measurement.
The goal is to find which treatment works best for this patient group.
Participation involves regular follow-up appointments and scans for five years.
Both treatments are already approved for use.
Your involvement helps improve future care for AAA patients.

Who may be eligible?

For this study, we are looking for adults aged 18 or older who have an abdominal aortic aneurysm (AAA) that doctors believe needs treatment. Your aneurysm must also have a specific measurement for its 'neck' – the part closest to your heart – between 28mm and 32mm wide. You'll need to be in good enough health for the planned treatment and not have any other medical conditions that might make taking part risky or interfere with the study results.

There are certain reasons why someone might not be able to join. For example, if you've recently had a stroke or heart attack, or if you have severe kidney problems, you wouldn't be suitable. The study also can't include people who are pregnant, have an active infection, or who have already had a stent put in their aortic arteries before. If you're involved in another medical study that might affect these results, you also can't take part.

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 abdominal aortic aneurysm (AAA) that needs treatment?
Has your doctor confirmed your AAA has a 'neck' width between 28mm and 32mm?
Are you generally in good health and able to have surgery?
Are you NOT pregnant (if applicable) and don't have a current serious infection?
Have you NOT had a stroke or heart attack in the last three months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the HERCULES study, you would first have a thorough check-up to make sure you're suitable. Once you're enrolled, you'd be randomly assigned to receive one of two types of treatment for your aneurysm: either with the special stent alone, or with the stent plus additional 'anchors'. The treatment procedures are standard medical practices, but your progress will be closely monitored.

After your procedure, you'll have regular follow-up appointments. These typically include checks at about one month after your treatment, and then once a year for five years. These appointments will involve check-ups and scans, usually CT scans, to see how your aneurysm is doing and how the stent is holding up. The total duration of your active participation, including these follow-up visits, would be five years.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is receiving careful, state-of-the-art treatment and close monitoring for your abdominal aortic aneurysm. Your information will also contribute valuable knowledge that could improve care for future patients. However, like any medical procedure, there are risks associated with the treatments themselves, such as bleeding, infection, or issues with the stent. The study aims to compare two approved treatments, but every individual's reaction can vary. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (36)

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

Washington Regional Medical Center
Verified postcode
Washington, United States· Recruiting
Mt Sinai Med Ctr
Verified postcode
Miami Beach, United States· Recruiting
Loyola
Verified postcode
Maywood, United States· Recruiting
Henry Ford Hospital
Verified postcode
Detroit, United States· Not yet recruiting
Beaumont University Hospital
Verified postcode
Royal Oak, United States· Recruiting
Alina Health
Verified postcode
Minneapolis, United States· Recruiting
University of Missouri
Verified postcode
Columbia, United States· Recruiting
Barnes-Jewish Hospital
Verified postcode
St Louis, United States· Recruiting
Robert Wood Johnson University Medical Center
Verified postcode
New Brunswick, United States· Recruiting
Sisters of Charity hospital
Verified postcode
Buffalo, United States· Recruiting
Stony Brook University Medical Center
Verified postcode
Stony Brook, United States· Recruiting
NC Heart& Vascular
Verified postcode
Raleigh, United States· Recruiting

Common questions

What is an abdominal aortic aneurysm (AAA)?

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

What are 'stent graft' and 'anchors'?

A stent graft is a special tube inserted to reinforce the weak blood vessel. Anchors are small devices that can be added to help secure the stent.

Why is this study important?

It's helping doctors understand if adding anchors to the stent provides better long-term results for patients with wider aneurysm 'necks'.

How long will I be in the study?

If you join, you would have follow-up appointments and scans for up to five years after your treatment.

Will I get to choose my treatment?

No, you'd be randomly assigned to one of the two treatment groups (stent only, or stent with anchors) to ensure fair comparison.

How to find out more

Suzanne Holewijn, PhD

herculestrial@rijnstate.nl 0031880057282 Official trial record

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