Active not recruitingNAINTERVENTIONAL

Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

This study is looking at a new way to treat a serious condition called a thoracoabdominal aortic aneurysm. This is when the main blood vessel in your body, the aorta, develops a dangerous bulge in the area of your chest and tummy where important arteries branch off to your organs. The study uses a special tube device, called the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, which is inserted into the artery to reinforce the weak area. This is a less invasive procedure than traditional open surgery. Researchers want to find out how safe and effective this new device is. The study involves looking at different types of these aneurysms and will follow participants over time to check their health and how well the device is working. It's designed to see if this new approach can become a good treatment option for patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

W.L.Gore & Associates

Enrolment target

102

Start

17 Jun 2019

Estimated completion

01 Jan 2030

Thoracoabdominal Aortic Aneurysm

Results

Results from this study

Posted August 2024

Results have been published for this study.

Primary outcome

Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event

Percent of Subjects with Device Technical Success Composite Event and freedom from Procedural Safety Composite Event. Device Technical Success Composite Events during Index Procedure: Successful Access and Delivery Successful and Accurate Deployment Successful Withdrawal Procedural Safety during 30 days of Index Procedure: Stented Segment Aortic Rupture Lesion-Related Mortality Permanent Paraplegia Permanent Paraparesis New Onset Renal Failure Requiring Dialysis Severe Bowel Ischemia Disabling Stroke

Full results on the registry

What is this study about?

Imagine the main artery that carries blood from your heart, called the aorta, like a garden hose. Sometimes, a section of this hose can get a bulge, like a weak spot. When this bulge, called an aneurysm, happens in the part of your aorta that runs through your chest and tummy, it's called a thoracoabdominal aortic aneurysm. This can be very serious because important arteries that go to your kidneys, liver, and intestines branch off from this section.

This study is testing a new way to fix these bulges using a special device. Instead of major open surgery, which involves a large cut, doctors can insert this device, called an endoprosthesis, through smaller cuts into your blood vessels. This device is like a reinforced tube that fits inside your aorta at the weak spot, making it stronger and preventing it from bursting. It also has special branches that go into the arteries leading to your organs.

The main goal of this study is to see how well this new device works and if it's safe for people with these types of aneurysms. Doctors want to understand if it can successfully repair the aneurysm and protect your organs. The study will involve a number of patients and follow their progress carefully to gather important information about this new treatment option.

Key takeaways

Tests a new, less invasive device for a serious aortic problem.
Aims to fix bulges in the main artery in your chest and tummy.
Could offer an alternative to major open surgery.
Requires regular follow-up appointments to monitor health.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, people need to have an aortic aneurysm in their chest and tummy area that affects the arteries going to their organs. The aneurysm must meet certain size or growth requirements, meaning it's either large enough, still growing quickly, or has an unusual shape. The doctors will also need to be able to access your blood vessels in your groin or arm to put the device in.

You must be at least 19 years old. Importantly, the doctors believe that using this device through smaller cuts (an 'endovascular' approach) is a better choice for you than traditional open surgery. You'll also need to be able to come to follow-up appointments and sign a consent form. There are also specific requirements about the size and shape of your blood vessels to make sure the device will fit properly and work safely.

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.

Do you have a bulge in your main artery (aorta) in your chest and tummy?
Is this bulge affecting the arteries that go to vital organs (like kidneys)?
Are you at least 19 years old?
Do your doctors think a less invasive procedure is best for you?
Can you attend regular follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis device. You'll have regular hospital visits and tests after the procedure to check on your health and how well the device is working. This could involve scans and other examinations as scheduled by the study team. The overall time you'll be involved in the study can vary, typically involving follow-up appointments over several years, but the exact duration will be explained by the study team. You will not receive any study medication as part of this trial.

Potential risks and benefits

Taking part in this study could potentially offer you a new, less invasive way to treat your aneurysm, which might lead to a faster recovery compared to traditional open surgery. However, like any medical procedure, there are potential risks, including those related to the procedure itself (such as bleeding, infection, or issues with the blood vessels), and potential complications with the device over time. The study team will explain all known risks and benefits in detail. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (44)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Mayo Clinic Arizona
Verified postcode
Scottsdale, United States
Keck Medical Center of USC
Verified postcode
Los Angeles, United States
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States
Kaiser Permanente San Francisco Medical Center
Verified postcode
San Francisco, United States
Stanford University
Verified postcode
Stanford, United States
MedStar Health Research Institute - MedStar Washington Hospital
Verified postcode
Washington D.C., United States
University of Florida - Gainesville
Verified postcode
Gainesville, United States
University of South Florida
Verified postcode
Tampa, United States
Emory University Hospital
Verified postcode
Atlanta, United States
Northwestern University
Verified postcode
Chicago, United States
Indiana University
Verified postcode
Indianapolis, United States

Common questions

What is an 'aortic aneurysm'?

It's a dangerous bulge or weak spot in the main blood vessel (aorta) that carries blood from your heart to the rest of your body.

What does 'endovascular' mean?

It means the treatment is done from inside your blood vessels using special tools and tubes inserted through small cuts, rather than large open surgery.

Is the device permanent?

Yes, the GORE® EXCLUDER® device is designed to stay in place permanently to strengthen your aorta.

Will I have to pay to be in the study?

No, costs related to the study device and procedures are covered by the study. You should check if transport or other related costs are covered.

Can I still get my normal medical care while in the study?

Yes, taking part in a study will not affect your right to receive your usual medical care.