Active not recruitingOBSERVATIONAL

Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms

This study, called the EXCeL Registry, is exploring a new way to treat Abdominal Aortic Aneurysms (AAAs). An AAA is a bulge in your body's main artery in the tummy area. Doctors are always looking for better and safer ways to fix these, and this study focuses on a device called the GORE® EXCLUDER® Conformable AAA Endoprosthesis. The main goal is to see how well this device works and how safe it is for patients, especially those whose aneurysms might be tricky to treat with current methods. By studying 150 patients across Europe, this research aims to show that this new device could be a good choice for more people with AAAs, helping more patients get the treatment they need.

At a glance

Status

Active not recruiting

Sponsor

Marc van Sambeek

Enrolment target

156

Start

11 Sep 2018

Estimated completion

31 Jan 2026

Abdominal Aortic Aneurysm (AAA)

What is this study about?

Imagine the main blood vessel in your tummy is like a hose. Sometimes, part of this hose can swell up – this is called an Abdominal Aortic Aneurysm, or AAA. It's a serious condition, but treatments are available.

Doctors have a treatment called EVAR, which uses a special tube (called an endoprosthesis) to fix the swollen part of the blood vessel from the inside, without needing major open surgery. This study is looking at a new type of endoprosthesis, the GORE® EXCLUDER® Conformable AAA Endoprosthesis. The aim is to see if this new device is a safe and effective option for treating AAAs, particularly for patients whose aneurysms have shapes that are sometimes difficult to treat with existing devices. The hope is that this new option could help more people get the treatment they need.

This study is an 'observational registry', meaning doctors will record how patients fare after receiving this specific device as part of their normal care. It's happening in several hospitals across Europe and will follow 150 patients. The information collected will help doctors understand more about how well the device works for different people and if it can expand the number of patients who can benefit from EVAR treatment.

Key takeaways

This study looks at a new device for Abdominal Aortic Aneurysms (AAAs).
It aims to see how safe and effective the GORE® EXCLUDER® Conformable AAA Endoprosthesis is.
The study focuses on helping people with challenging AAA shapes.
Doctors will observe patients' results during normal follow-up care.
It's an observational study, meaning no extra tests or treatments are involved.
Information from this study could help more people with AAAs in the future.

Who may be eligible?

To be considered for this study, you would typically have an AAA that is 50mm (about 2 inches) or larger, or one that has grown quickly. Your doctors will also check if your aneurysm and blood vessels are suitable for this specific device. This involves checking the size and shape of certain parts of your main blood vessel.

You would need to be at least 18 years old and generally expected to live for more than two years. You must be able to attend follow-up appointments. This study is open to men and women who cannot become pregnant (for example, if they've had a hysterectomy or are post-menopausal for over a year).

However, some conditions might mean you can't join. For instance, if your aneurysm is infected or has ruptured, or if you have severe kidney problems, certain connective tissue disorders like Marfan syndrome, or known allergies to the device materials, you wouldn't be eligible. Also, if you're taking part in another clinical trial or need other major surgery around the same time, you might not be able to participate.

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.

Is your AAA usually 50mm or larger, or growing quickly?
Are you at least 18 years old?
Are you able to attend regular follow-up appointments?
Do you have suitable blood vessel anatomy for this type of repair?
Do you have any severe kidney problems or other serious health conditions mentioned?
Are you currently involved in another device study?

Answer every question to see your result.

What does participation involve?

If you join this study, it means your doctors have decided the GORE® EXCLUDER® Conformable AAA Endoprosthesis is the right treatment for your aneurysm, and you've agreed to have your information collected. The study itself doesn't change your usual treatment plan. You'll still have your routine check-ups after the procedure, typically at 1 month, 12 months, and then once a year, as doctors normally recommend.

These follow-up appointments are crucial to see how well the device is working and how you are recovering. The study will collect information during these visits, but your doctors will decide the exact schedule of your follow-up scans and tests based on what's best for your health. Occasionally, you might get a phone call to gather any missing information. The study aims to gather this information over several years, as long as you continue with your regular follow-up care.

Potential risks and benefits

Like any medical procedure, having an aneurysm repair carries some potential risks, which your doctor will discuss with you in detail. This specific study involves a device that is already approved for use, and the goal is to carefully observe its safety and how well it works in a wider range of patients. Taking part might not directly benefit you, but the information gathered will help improve future treatments for people with similar conditions. You are free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (8)

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

APHP Hopital Européen
Verified postcode
Paris, France
San Martino Hospital
Verified postcode
Genova, Italy
Rijnstate Hospital
Verified postcode
Arnhem, Netherlands
Catharina Hospital
Verified postcode
Eindhoven, Netherlands
ETZ
Verified postcode
Tilburg, Netherlands
San Carlos Hospital
Verified postcode
Madrid, Spain
Complexo Hospitalario de Orense
Verified postcode
Ourense, Spain
North Bristol NHS Trust
Verified postcode
Bristol, United Kingdom

Common questions

What is an Abdominal Aortic Aneurysm (AAA)?

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

What is the GORE® EXCLUDER® Conformable AAA Endoprosthesis?

It's a special tube, or 'stent-graft', that doctors can put inside your swollen blood vessel to reinforce it without major open surgery.

Will my treatment change if I join this study?

No, the study won't change your medical decisions. You'll get the standard care your doctor recommends, and the study will just collect information during your regular check-ups.

How long will I be followed in the study?

You'll have follow-up appointments at 1 month, 12 months, and yearly after that. This follows the usual recommendations for aneurysm repair.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, and this will not affect your medical care.