RecruitingNAINTERVENTIONAL

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

The SOCRATES study is looking at two advanced treatments for a condition called an abdominal aortic aneurysm (AAA). An AAA is a bulge in the main artery that runs through your tummy. This study focuses on patients whose aneurysm is close to the kidneys, meaning they have a 'short aortic neck' (between 4mm and 15mm long). Standard procedures might not be suitable for these cases. Researchers want to compare two types of 'endografts' (stent-like devices put inside the artery): one called ESAR, which uses a special stent with tiny anchors to hold it in place, and another called FEVAR, which uses custom-designed stents. The goal is to find out which of these newer methods is safer and more effective for treating AAAs in this specific group of patients, avoiding the need for traditional open surgery.

At a glance

Status

Recruiting

Phase

Sponsor

FCRE (Foundation for Cardiovascular Research and Education)

Enrolment target

204

Start

21 May 2021

Estimated completion

01 Jun 2032

Aortic Aneurysm, Abdominal

What is this study about?

Imagine the main blood vessel in your tummy, called the aorta, is like a garden hose. Sometimes, part of this hose can weaken and bulge outwards, like a balloon. This bulge is called an abdominal aortic aneurysm, or AAA. If it gets too big, it can be dangerous. Doctors often fix AAAs by putting a special tube, called an endograft, inside the aorta to reinforce it and stop the bulge from growing.

However, some people have their AAA very close to where the main artery branches off to the kidneys. This area is called the 'aortic neck', and in these cases, it might be very short. This can make it tricky to properly fit a standard endograft, as there isn't enough healthy artery to secure it safely. That's why this study, SOCRATES, is so important.

SOCRATES is comparing two newer, more advanced ways to treat these 'short neck' AAAs. One method, called ESAR, uses a standard endograft but adds tiny 'anchors' (like screws) to make sure it stays firmly in place. The other method, called FEVAR, uses specially made endografts that are custom-designed to fit around the kidney arteries. By comparing these two treatments, doctors hope to find the best way to keep people with these challenging AAAs safe and healthy, without needing more invasive open surgery.

Key takeaways

This study evaluates advanced treatments for abdominal aortic aneurysms.
It focuses on patients with a challenging 'short aortic neck' anatomy.
Compares two procedures: ESAR (stent with anchors) and FEVAR (custom-made stent).
Aims to find the safest and most effective solution for this specific patient group.
Participation involves ongoing monitoring after the procedure.

Who may be eligible?

To join this study, you need to be at least 18 years old and planned to have your abdominal aortic aneurysm treated. Crucially, your aneurysm must be in a position where the healthy part of your aorta (the 'neck') is quite short, between 4mm and 15mm. This study is specifically for people whose aneurysm anatomy means that standard stent treatments might not work well.

You cannot be pregnant or of childbearing age if there's any chance you could be pregnant. You also can't join if you have very poor kidney function, have recently had a heart attack or stroke (within the last three months), or have certain rare conditions affecting your body's tissues. If you've already had surgery or a stent for your aneurysm, or if you need urgent treatment, you won't be able to 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 that needs treatment?
Has your doctor told you your aneurysm has a 'short neck' (between 4mm and 15mm)?
Are you able and willing to attend follow-up appointments?
Are you not pregnant and not of child-bearing potential if pregnancy cannot be ruled out?

Answer every question to see your result.

What does participation involve?

If you decide to join the SOCRATES study, you will first have some detailed scans to check if your aneurysm meets the specific requirements. If you do, you'll be assigned to one of the two treatment groups (either ESAR or FEVAR). You will then undergo the endovascular procedure for your aneurysm.

After your procedure, you will have regular follow-up appointments, which will likely involve scans and check-ups with your doctor. These appointments are important for the researchers to monitor how well the treatment is working and to ensure your safety. The exact number and timing of these visits will be explained to you, but typically, these studies involve ongoing monitoring for several years to track long-term results.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new, advanced treatment specifically designed for your complex aneurysm, potentially offering a better outcome than standard options. However, as with any medical procedure, there are potential risks, such as those associated with surgery, anaesthesia, or the devices used. These will be fully explained to you by your doctor. You should remember that taking part is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (33)

UCSD Medical Center Hillcrest
Verified postcode
La Jolla, United States· Recruiting
Stanford University
Verified postcode
Stanford, United States· Recruiting
University of Florida
Verified postcode
Gainesville, United States· Recruiting
Corewell Health (Spectrum)
Verified postcode
Grand Rapids, United States· Recruiting
Mount Sinai Hospital
Verified postcode
New York, United States· Recruiting
Oklahoma Heart
Verified postcode
Tulsa, United States· Recruiting
Providence Portland Medical Center
Verified postcode
Portland, United States· Recruiting
Allegheny General Hospital
Verified postcode
Pittsburgh, United States· Recruiting
Sentara Norfolk General Hospital
Verified postcode
Norfolk, United States· Recruiting
Hospital Ottakring, Institute for Vascular Surgery
Verified postcode
Vienna, Austria· Recruiting
CRC thoracic Vascular Surgery, ZOL Genk
Verified postcode
Genk, Belgium· Recruiting
Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde
Verified postcode
Ghent, Belgium· Recruiting

Common questions

What is an abdominal aortic aneurysm?

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

What does 'short aortic neck' mean?

It means the healthy section of your aorta just above the aneurysm is shorter than usual, making some treatments harder.

What are ESAR and FEVAR treatments?

They are both types of 'stent graft' procedures that use modern internal tubes to fix the aneurysm, with specific differences in how they are secured or designed.

Will I get to choose my treatment?

No, you will be randomly assigned to one of the two study treatments, like flipping a coin, to ensure a fair comparison.

How long will I be followed in the study?

Study participants are typically followed for several years to understand the long-term results of the treatments.

How to find out more

Karlotta Knuth

info@fcre.eu +4915785318893 Official trial record

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