RecruitingNAINTERVENTIONAL

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

This study is looking at two types of medical devices, called stent grafts, used to treat a condition called Abdominal Aortic Aneurysm (AAA). An AAA is a bulge in the main artery that runs through your tummy. The devices being compared are the Medtronic Endurant II/IIs and the Gore Excluder/Excluder Conformable systems. The main goal is to understand which device might be better at shrinking the aneurysm over five years. People taking part will be randomly assigned to receive one of these devices and will have regular check-ups with scans to see how well their aneurysm is healing.

At a glance

Status

Recruiting

Phase

Sponsor

Medtronic Cardiovascular

Enrolment target

600

Start

05 Jan 2023

Estimated completion

01 May 2031

Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)

What is this study about?

You might have been told you have an Abdominal Aortic Aneurysm, often shortened to AAA. This is where the main blood vessel in your tummy, called the aorta, bulges out. If this bulge gets too big, it can be serious. Doctors often treat this with a procedure that involves placing a special tube, called a stent graft, inside the bulging artery. This helps to reinforce the artery and stop it from getting bigger or bursting.

This particular study is comparing two commonly used stent graft systems: the Medtronic Endurant II/IIs and the Gore Excluder/Excluder Conformable. Both are widely used, and this study aims to gather more information on how effective each one is at treating AAA. Specifically, the researchers want to see which of these devices does a better job at shrinking the aneurysm over a five-year period.

About 600 people from around the world are expected to take part. If you join, you will be randomly assigned to receive one of the two devices. This means which device you get is decided by chance, much like flipping a coin. After your procedure, you will have regular follow-up appointments and scans for five years to see how the device is working. This is all to help doctors understand the best ways to treat AAA in the future.

Key takeaways

Compares two common devices for Abdominal Aortic Aneurysm (AAA) treatment.
Aims to see which device best shrinks the aneurysm over five years.
Patients are randomly assigned one of two established devices.
Involves regular follow-up visits and scans for five years.
Participation helps improve future AAA treatment options.

Who may be eligible?

To join this study, you would need to be an adult, and your doctor would determine if your Abdominal Aortic Aneurysm is of a certain size – generally, at least 5cm if you are a woman, or 5.5cm if you are a man (or as otherwise specified for your region). Your specific situation must also be suitable for *both* types of stent grafts being tested in this study.

You would not be able to join if you have a very short life expectancy (less than 3 years), or if your aneurysm is in a different part of the aorta, or if it relates to a specific illness like Marfan syndrome. Also, if you have already had surgery for an aneurysm in that area, or if your aneurysm is causing symptoms or has ruptured, you would not 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 an adult with an Abdominal Aortic Aneurysm (AAA)?
Is your AAA at least 5cm (if female) or 5.5cm (if male)?
Has your doctor confirmed your AAA is suitable for *both* types of stent grafts in the study?
Do you have a life expectancy of at least 3 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first need to read and sign a consent form, making sure you understand everything involved. If chosen, you will then have your procedure where one of the two stent grafts will be implanted. Afterwards, you'll have check-ups at regular intervals: soon after the procedure when you are discharged from the hospital, then at 30 days, and then once a year for five years. Each follow-up visit will likely involve imaging scans to see how the stent graft is working. The total study duration for each participant is five years, from the time of their procedure.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. The potential benefit here is that you would receive an established treatment for your Abdominal Aortic Aneurysm from an experienced medical team. The information gathered may also help improve care for future patients. Potential risks are generally those associated with the standard procedure itself, and your medical team will discuss these with you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (68)

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

Loma Linda University Medical Center
Verified postcode
Loma Linda, United States· Recruiting
Hoag Hospital
Verified postcode
Newport Beach, United States· Recruiting
University of California Irvine Medical Center
Verified postcode
Orange, United States· Recruiting
University of California Davis Medical Center
Verified postcode
Sacramento, United States· Withdrawn
University of California San Francisco UCSF Medical Center
Verified postcode
San Francisco, United States· Recruiting
Denver Health Medical Center
Verified postcode
Denver, United States· Recruiting
Yale Center for Clinical Investigation
Verified postcode
New Haven, United States· Recruiting
Medstar Washington Hospital Center
Verified postcode
Washington D.C., United States· Recruiting
Mayo Clinic Jacksonville
Verified postcode
Jacksonville, United States· Recruiting
Sarasota Memorial Hospital
Verified postcode
Sarasota, United States· Recruiting
Northside Hospital Forsyth
Verified postcode
Atlanta, United States· Recruiting
Northshore University Health System
Verified postcode
Skokie, United States· Recruiting

Common questions

What is an Abdominal Aortic Aneurysm (AAA)?

It's a bulge in the main blood vessel in your tummy, the aorta. If it gets too big, it can be serious.

What is a stent graft?

It's a special tube placed inside the bulging artery to strengthen it and help prevent it from growing or bursting.

Will I know which device I receive?

You will be assigned one of the two devices randomly, like flipping a coin. Your doctor will know which one you receive.

How long will I be in the study?

If you join, you'll have follow-up visits and scans for five years after your procedure.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

ADVANCE Trial Clinical Study Team

rs.advancestudy@medtronic.com 763-514-4000 Official trial record

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