Thoraflex Hybrid Post-Market Study
This study is checking how well a specific medical device, called the Thoraflex Hybrid, performs in patients who have certain conditions affecting their aorta. The aorta is the body's main artery, carrying blood from the heart to the rest of the body. Conditions like aortic aneurysm (a bulge in the aorta) or dissection (a tear in the aorta) can be very serious. The Thoraflex Hybrid is used in a type of surgery that combines open surgery with a less invasive technique to repair these problems. This study is important because it gathers more information about the device's safety and effectiveness in many patients across different hospitals, helping doctors understand its long-term benefits.
At a glance
What is this study about?
This study is looking at a special medical device called the Thoraflex Hybrid. Imagine your body has a 'main pipeline' for blood called the aorta. Sometimes, this pipeline can get damaged, perhaps by developing a weak, bulging spot (called an aneurysm) or a tear in its wall (called a dissection). These are serious conditions that need treatment.
Traditionally, major surgery was often needed to fix these problems. However, doctors have developed new ways to repair the aorta. The Thoraflex Hybrid is one of these newer tools. It's used in an advanced surgical procedure that combines traditional open surgery with a modern, less invasive technique. This combined approach aims to fix the damaged part of the aorta more effectively.
The Thoraflex Hybrid device has been used in many patients worldwide. This particular study is designed to gather more information about how well it works and how safe it is over time, after it has already been approved for use. It's a way for doctors and manufacturers to keep learning and ensure that patients are getting the best possible care with this device.
Key takeaways
- This study is observing how well a device called Thoraflex Hybrid works.
- It helps doctors understand the device's long-term safety and effectiveness.
- You won't receive new treatments, only participate in data collection.
- Participation involves answering a quality of life questionnaire.
- It's for adults 18 and over with specific aorta conditions.
Who may be eligible?
To join this study, you need to be at least 18 years old. It's also important that you're willing and able to follow all the study instructions and attend any necessary appointments. You, or someone legally allowed to make decisions for you, must also agree in writing to take part.
This study is for people who have certain conditions affecting their aorta. This includes people with conditions like an acute thoracic aortic syndrome (a sudden, serious problem in the chest part of the aorta), a subacute or chronic aortic dissection (a tear in the aorta that has been present for a while), or an aortic aneurysm (a bulge in the aorta).
Specifically, if you have one of these conditions and doctors believe you need the Thoraflex Hybrid device for repair or replacement of parts of your aorta, you might be eligible. Your doctor will be able to tell you if your specific situation fits the study's requirements.
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 willing and able to attend study visits and follow instructions?
- Have you or your representative given written consent to participate?
- Do you have an acute thoracic aortic syndrome, subacute/chronic aortic dissection, or an aortic aneurysm?
What does participation involve?
If you join this study, you won't be given any new treatments or medicines. Instead, the study will simply collect information about your health using a questionnaire. This questionnaire is called the EQ-5D-5L and it asks about your quality of life – how you feel physically and mentally, and how your condition affects your daily activities. This is usually a short survey that helps doctors understand the overall impact of your treatment. The study will track your progress over time, but the specific number of visits and the total duration isn't mentioned, so you would need to ask your doctor for those details.
Potential risks and benefits
Locations (7)
- London Health Sciences Centre, University HospitalVerified postcodeLondon, Canada
- University of Ottawa Heart InstituteVerified postcodeOttawa, Canada
- Toronto General HospitalVerified postcodeToronto, Canada
- University of FreiburgVerified postcodeFreiburg im Breisgau, Germany
- Hannover Medical SchoolVerified postcodeHanover, Germany
- Policlinico S.Orsola-MalpighiVerified postcodeBologna, Italy
- St Antonious HospitalVerified postcodeNieuwegein, Netherlands
Common questions
What is the Thoraflex Hybrid device?
It's a special medical implant used in surgery to repair serious problems in the aorta, your body's main blood vessel.
Why is this study being done?
The study aims to gather more information about how safe and effective the Thoraflex Hybrid device continues to be for patients in everyday use.
Will I receive new treatment if I join?
No, you will receive your standard medical care. This study only collects information about your health using a questionnaire.
What is an aortic aneurysm or dissection?
An aneurysm is a dangerous bulge in the aorta, while a dissection is a tear in its wall. Both are serious conditions needing treatment.
What does a 'quality of life' questionnaire involve?
It asks you simple questions about your general health, how you feel, and how your condition affects your daily activities.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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