RecruitingOBSERVATIONAL

Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance

This study is checking how well a specific medical device, called the GORE® TAG® Conformable Thoracic Stent Graft, works for patients over many years. This device is used to treat serious problems in the body's main artery (the aorta) in the chest, such as tears or weak spots. It's a 'registry' study, which means doctors are simply observing and collecting information from people who have already had this device fitted as part of their usual care. They want to gather long-term details, up to 10 years, to make sure this treatment continues to be a safe and effective option for carefully chosen patients. The study aims to reassure us about the device's performance in real-world settings.

At a glance

Status

Recruiting

Sponsor

W.L.Gore & Associates

Enrolment target

1,500

Start

19 Jun 2025

Estimated completion

01 Aug 2038

Vascular Disease Dissection Dissection Aortic Aneurysm Dissection of Aorta Aneurysm Thoracic Aneurysm Dissecting Transection Aorta Intramural Hematoma

What is this study about?

Imagine the body's main blood vessel, called the aorta, like a large, important pipe that carries blood from your heart to the rest of your body. Sometimes, this pipe can develop problems, like tears, weak spots, or bulges (aneurysms) in the part that runs through your chest. These problems can be very serious and need treatment.

One way doctors can fix these issues is by using a special device called a stent graft. It's like putting a new, strong lining inside the damaged section of the aorta to reinforce it and allow blood to flow smoothly. The specific device this study is interested in is the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System. This study is not testing a new treatment; instead, it's carefully watching people who have already had this particular device fitted as part of their standard medical care.

Doctors want to understand how well this device works over a long time, up to 10 years after it's been put in. They'll be collecting information during your regular check-ups to see if it remains a safe and effective way to treat these conditions in the chest aorta. This kind of study helps make sure that current treatments continue to be good options for people needing this type of care.

Key takeaways

This study is observing an existing device, not testing a new one.
It collects long-term information (up to 10 years) on the device's performance.
It helps understand how a specific stent graft works for serious aorta problems.
Participation means sharing information from your regular medical appointments.
You won't have extra procedures or visits because of the study.
Your contribution helps improve care for future patients.

Who may be eligible?

To be part of this study, you would generally need to meet a few key points.

Firstly, you must be 18 years old or older. You also need to have received, or be planned to receive, the specific GORE® TAG® Conformable Thoracic Stent Graft device as part of your normal treatment. This decision would have been made by your doctor based on your medical needs. It's important that you, or a legal representative, agree in writing to take part in the study and for your medical information to be collected.

There are also a few reasons why someone might not be able to join. For example, if it's unlikely you'd be able to attend your regular follow-up appointments, or if you're already involved in certain other medical studies that are testing new drugs or devices. The study also needs to follow any local laws or rules that might 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?
Have you had, or are you about to have, the GORE® TAG® Conformable Thoracic Stent Graft fitted?
Can you attend your regular medical check-ups?
Are you willing to give written permission for your health information to be used?

Answer every question to see your result.

What does participation involve?

If you take part in this study, it's mainly about allowing the study team to collect information during your regular hospital visits and check-ups. You won't be given any new or different treatments because of the study; you'll just receive your usual care, including any medication your doctor prescribes.

The main thing involved is that the study team will keep track of your health over time, specifically focusing on how the stent graft is working. This information will be gathered during your routine appointments, scans, and tests that you would have anyway. They will follow your progress for up to 10 years. There are no extra visits specifically for the study, just the collection of data during your standard care. This helps doctors understand the long-term performance of the device in real-life situations.

Potential risks and benefits

Because this study only collects information from people receiving their usual medical care, there are generally no extra medical risks associated with participating. You won't be undergoing any additional procedures or treatments just for the study. The main benefit is that your information will help doctors and researchers better understand the long-term success of this device, potentially improving care for future patients. You are free to withdraw from the study at any time without affecting your medical care.

Locations (37)

University of Arizona
Verified postcode
Tucson, United States· Recruiting
University of Southern California
Verified postcode
Los Angeles, United States· Recruiting
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Leland Stanford Junior University
Verified postcode
Stanford, United States· Recruiting
MedStar Health, MedStar Washington Hospital Center
Verified postcode
Washington D.C., United States· Not yet recruiting
University of Florida - Gainesville
Verified postcode
Gainesville, United States· Recruiting
University of South Florida
Verified postcode
Tampa, United States· Recruiting
Augusta University
Verified postcode
Augusta, United States· Recruiting
Indiana University School of Medicine
Verified postcode
Indianapolis, United States· Recruiting
University of Maryland - Baltimore
Verified postcode
Baltimore, United States· Recruiting
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States· Not yet recruiting
The Hitchcock Foundation at Dartmouth Hitchcock Medical Center
Verified postcode
Lebanon, United States· Recruiting

Common questions

What is a 'stent graft'?

It's a tube-like device placed inside a blood vessel (like the aorta) to strengthen it or fix a problem, allowing blood to flow properly.

Is this study testing a new treatment?

No, this study is observing how an existing and approved device works in patients over a long time. It's not a trial of a new treatment.

What kind of problems does the device treat?

It's used for serious problems in the main artery of the chest (aorta), such as tears, weak spots, or bulges (aneurysms).

Will I have extra doctor visits if I join?

No, you will continue with your usual medical appointments. The study team will just collect information during those routine visits.

How long will the study follow me?

The study aims to collect information about your health and the device's performance for up to 10 years.

How to find out more

Ashley Hoedt, MS

ahoedt@wlgore.com +1 928-864-3987 Official trial record

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