RecruitingOBSERVATIONAL

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

This study is called the Gore Together Aortic Registry and focuses on patients who have had surgery for a condition called an Abdominal Aortic Aneurysm (AAA). This happens when the main blood vessel in your tummy (the aorta) weakens and bulges out. Doctors use special devices to fix this, and this study aims to collect information on how well two specific devices – the GORE® EXCLUDER® Conformable AAA Endoprosthesis or the GORE® EXCLUDER® Iliac Branch Endoprosthesis – work in everyday medical practice. This means doctors decide the best treatment for each patient, just like they normally would. The study will follow patients for up to 10 years to see how they're doing with these devices.

At a glance

Status

Recruiting

Sponsor

W.L.Gore & Associates

Enrolment target

2,000

Start

07 May 2024

Estimated completion

30 Sep 2042

AAA - Abdominal Aortic Aneurysm

What is this study about?

This study is a bit different from many others because it's not testing a brand new treatment. Instead, it's about gathering information on how certain medical devices work for people in their everyday lives. The devices are called the GORE® EXCLUDER® Conformable AAA Endoprosthesis and the GORE® EXCLUDER® Iliac Branch Endoprosthesis. They are used to treat a serious condition called an Abdominal Aortic Aneurysm, or AAA. This is when the main blood vessel in your tummy, called the aorta, gets weak and starts to bulge out, which can be dangerous.

Doctors have different ways to fix an AAA, and these devices are one option. This study will follow patients who have had one of these devices implanted as part of their usual care. It's like collecting 'real-world' facts about how these devices perform outside of strict research settings. The main goal is to understand their long-term effectiveness and safety.

The information collected will help doctors and medical companies better understand how these devices work for a wide range of patients over time. This can lead to improvements in treatment and patient care in the future. Importantly, your doctor will still make all decisions about your treatment based on what's best for you, just as they normally would.

Key takeaways

This study collects real-world information on AAA devices.
It follows patients who receive common treatments for Abdominal Aortic Aneurysm.
You'll attend your regular check-ups as part of the study.
The study aims to improve understanding of device performance over time.
Participation can last up to 10 years, matching standard follow-up care for AAA.
Your doctor will still make all decisions about your treatment.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older. The main requirement is that you are either about to be, or have already been, treated with one of the specific GORE® EXCLUDER® devices mentioned in the study for your AAA.

You or a legal guardian would also need to agree to take part in the study and sign an agreement that explains everything. This is called giving your 'informed consent'.

There are a few reasons why you might not be able to join. For example, if it's unlikely you'll be able to attend your regular follow-up appointments, or if you're already taking part in another study involving a drug or device right now, or plan to in the next year. Also, any local laws about who can join studies would apply.

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?
Are you being treated with one of the specific GORE® EXCLUDER® devices for your AAA?
Are you able to attend your regular follow-up appointments?
Are you able to sign a consent form to agree to take part?
Are you currently not in another drug or device study, or planning to be within the next 12 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given any special treatments or medicines just for the study, as your doctor will decide your treatment as part of your normal care. Your part in the study will mainly involve attending your regular check-up appointments as requested by your surgeon. These appointments are important for monitoring your health and how the device is working. During these visits, information about your health and the device will be collected.

You should also tell your surgeon or doctor about any problems or concerns you have related to the device or your surgery at any time. The study aims to collect information for up to 10 years following your procedure, so your participation could last for some time, aligning with your routine long-term follow-up care.

Potential risks and benefits

Taking part in this study doesn't introduce new medical risks beyond those typically associated with your AAA treatment and usual follow-up care, as it's observing treatments doctors would provide anyway. The main benefit is knowing that information about your treatment could help improve care for other patients in the future. As with any study, you have the right to withdraw at any time without it affecting your medical care.

Locations (90)

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

Central Arkansas Veteran's Healthcare System
Verified postcode
Little Rock, United States· Recruiting
University of California - Irvine
Verified postcode
Irvine, United States· Recruiting
University of Southern California
Verified postcode
Los Angeles, United States· Recruiting
University of Southern California
Verified postcode
Los Angeles, United States· Recruiting
Stanford University School of Medicine
Verified postcode
Palo Alto, United States· Recruiting
Stanford University School of Medicine
Verified postcode
Stanford, United States· Recruiting
Mount Sinai Vascular Institute
Verified postcode
Miami Beach, United States· Recruiting
University of South Florida
Verified postcode
Tampa, United States· Recruiting
University of South Florida
Verified postcode
Tampa, United States· Recruiting
VA Medical Center- Atlanta
Verified postcode
Atlanta, United States· Recruiting
Emory Saint Joseph's Hospital
Verified postcode
Atlanta, United States· Recruiting
Augusta University Medical Center
Verified postcode
Augusta, United States· Recruiting

Common questions

What is an Abdominal Aortic Aneurysm (AAA)?

It's when the main blood vessel in your tummy (aorta) bulges out. It can be serious and needs treatment.

Am I getting a new or experimental treatment?

No, this study looks at how existing, approved devices work in real patients. Your doctor will choose your treatment as usual.

How long will I be in the study?

The study collects information for up to 10 years, aligning with your regular long-term check-ups after your procedure.

What do I need to do if I join?

You just need to attend your normal follow-up appointments and tell your doctor about any issues you have with the device or surgery.

Can I leave the study at any time?

Yes, you are free to stop participating whenever you want, and it won't affect your medical care.

How to find out more

Karen Martin

kgmartin@wlgore.com 928-864-2223 Official trial record

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