Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis
This study is like keeping a close eye on how a specific medical device, called the GORE® TAG® Thoracic Branch Endoprosthesis, performs in people who have had it fitted. This device is used to treat serious conditions affecting the body's main artery, called the aorta, such as aneurysms (bulges) or dissections (tears). We want to understand how well it works and if it's safe when used in everyday medical care. Doctors will decide who gets the device and how their care is managed, just as they normally would. If you take part, you'll have regular check-ups with your doctor, who will monitor your health and how the device is working.
At a glance
What is this study about?
This study is called a 'registry.' It's like a watch group that collects information over time from people who have received a specific medical device. The device in question is the GORE® TAG® Thoracic Branch Endoprosthesis. This special device is designed to treat serious conditions of the aorta, which is the largest blood vessel in your body and carries blood from your heart to the rest of your body. Conditions it helps with include aneurysms (where the aorta bulges out dangerously) and dissections (where the aorta's wall tears).
The main goal is to understand how well this device works and how safe it is for patients in real-world situations, rather than in a highly controlled experiment. Doctors will use the device and manage patient care just as they usually would, based on their best medical judgment. The study isn't telling doctors what to do, but rather observing what happens.
By gathering this information, we hope to learn more about the long-term effects of the GORE® TAG® Thoracic Branch Endoprosthesis. This knowledge can help improve care for future patients with similar aortic conditions. It’s important because it adds to what we know about how well this device helps people stay healthy.
Key takeaways
- This study observes how a specific medical device, the GORE® TAG® Thoracic Branch Endoprosthesis, performs in real patients.
- It aims to understand the safety and effectiveness of the device when used for conditions like aortic aneurysms.
- Participation involves attending your regular follow-up appointments as part of your standard medical care.
- No new treatments or procedures are given specifically for the study.
- The information collected will help improve future care for patients with similar aortic problems.
- You can withdraw from the study at any time without affecting your medical treatment.
Who may be eligible?
To be part of this study, you must be at least 18 years old. You also need to have already received, or be planned to receive, the GORE® TAG® Thoracic Branch Endoprosthesis as part of your normal medical treatment for an aortic condition.
Before joining, you or someone legally allowed to make decisions for you will need to give written permission. This shows you understand what the study involves and agree to take part.
Some reasons you might not be able to join include if it's unlikely you can attend your regular follow-up appointments, or if you're already participating in other studies involving new medicines or medical devices within a certain timeframe.
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 going to have, the GORE® TAG® Thoracic Branch Endoprosthesis for an aortic condition?
- Are you able to attend your regular follow-up appointments with your doctor?
- Are you not currently involved in another study testing a new drug or medical device?
What does participation involve?
If you decide to take part in this study, it means you'll have regular follow-up visits with your doctor or surgeon. These visits will be scheduled as part of your usual medical care after you've received the GORE® TAG® Thoracic Branch Endoprosthesis. During these appointments, your healthcare team will check on your health and how the device is working. You'll be asked to report any concerns or problems you might have related to your device or surgery to your doctor. There are no additional medications or special treatments given specifically for this study; it simply involves observing your health and the device’s performance during your standard care. The total duration of your participation will be decided by your ongoing medical needs and your doctor's recommendations for follow-up.
Potential risks and benefits
Locations (20)
- Medizinische Universität WienVerified postcodeVienna, Austria· Recruiting
- Rigshospitalet University HospitalVerified postcodeCopenhagen, Denmark· Recruiting
- Universitätsklinikum Carl Gustav Carus DresdenVerified postcodeDresden, Germany· Suspended
- University of HeidelbergVerified postcodeHeidelberg, Germany· Active not recruiting
- Universitätsklinikum Schleswig-HolsteinVerified postcodeKiel, Germany· Not yet recruiting
- Universitätsklinikum MünsterVerified postcodeMünster, Germany· Active not recruiting
- Evangelismos General HospitalVerified postcodeAthens, Greece· Recruiting
- Laiko General hospital of AthensVerified postcodeAthens, Greece· Active not recruiting
- Policlinico di Sant'OrsolaVerified postcodeBologna, Italy· Active not recruiting
- ASST Spedali Civili di BresciaVerified postcodeBrescia, Italy· Recruiting
- IRCCS Ospedale Policlinico San MartinoVerified postcodeGenova, Italy· Recruiting
- AOU PadovaVerified postcodePadova, Italy· Not yet recruiting
Common questions
What is an aneurysm?
An aneurysm is a dangerous bulge or ballooning in the wall of a blood vessel, like the main artery from your heart called the aorta. It can be serious if it gets too big or bursts.
What is the GORE® TAG® Thoracic Branch Endoprosthesis?
It's a special medical implant, like a reinforced tube, that doctors use to repair problems in the aorta, such as aneurysms, without needing major open surgery.
Will I get special treatment in this study?
No, you will receive your usual medical care decided by your doctor. This study just collects information about how the device works in real life.
Who is paying for this study?
The company that makes the device, GORE®, is supporting this study to gather information about its real-world performance.
Can I change my mind after joining?
Yes, you can decide to stop being part of the study at any time. Your medical care will not be affected by this decision.
How to find out more
Gabrielle Valle Diekmann
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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