Active not recruitingOBSERVATIONAL

Thoraflex Hybrid and Relay Extension Post-Approval Study

This study is designed to observe how well a medical device called the Thoraflex Hybrid works in people with serious conditions affecting their aorta, the body's largest blood vessel. These conditions can include aneurysms (bulging weakened areas) or dissections (tears in the wall) in different parts of the aorta. Sometimes, the Thoraflex Hybrid is used on its own, and sometimes it's combined with another device, the RelayPro NBS, to treat larger areas of the aorta. The study will follow patients for 10 years after they have this treatment. It aims to gather information on how these devices are used in standard care and how patients recover and live their lives afterwards, helping doctors understand the long-term effects.

At a glance

Status

Active not recruiting

Sponsor

Vascutek Ltd.

Enrolment target

352

Start

17 Mar 2023

Estimated completion

01 Mar 2036

Thoracic Diseases Aortic Aneurysm Aortic Dissection Thoracic Aortic Aneurysm Thoracic Aortic Dissection

What is this study about?

This study is focusing on certain serious conditions that affect the aorta, your body's main blood vessel that carries blood from your heart to the rest of your body. These conditions include an aortic aneurysm, where a part of the aorta bulges out and can be weak, and an aortic dissection, where there's a tear in the wall of the aorta. Both can be very serious and need careful treatment.

The study is looking at a specific medical device called the Thoraflex Hybrid. This device is used to help repair the aorta, particularly when these conditions affect the arch (the curved part at the top) and the descending aorta (the part that goes down through your chest), sometimes also involving the ascending aorta (the part coming directly out of the heart). For some patients, where a longer section of the aorta needs treatment, the Thoraflex Hybrid might be used along with another device called the RelayPro NBS stent-graft. This study isn't testing new treatments; instead, it's observing how these devices are used by doctors in their routine care and how patients get on afterwards.

The main goal is to follow patients for a long time – 10 years – to understand the real-world experiences and long-term results of people who have been treated with the Thoraflex Hybrid, either alone or with the RelayPro NBS. By collecting this information, doctors can learn more about how effective and safe these treatments are over many years, which can help improve care for future patients with similar conditions.

Key takeaways

This study looks at a device called Thoraflex Hybrid for aortic conditions.
It aims to understand long-term results over 10 years.
Participation involves no extra visits or experimental treatments.
Patients must be treated with the Thoraflex Hybrid device.
Information from the study helps improve future patient care.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. It's really important that you, or a close family member if you're unable, are willing and able to understand what the study involves and agree in writing to take part. You also need to be able to make it to all the study appointments and follow any instructions given.

Crucially, this study is for people who are going to receive or have just received treatment with the Thoraflex Hybrid device. If your doctors decide you also need the RelayPro NBS device to extend the repair, you'd still be eligible. This extra step might happen during your initial operation or at a later date.

However, you wouldn't be able to join the study if your doctor believes that any other health issues, social reasons, or psychological reasons would make this treatment or taking part in the study unsuitable or difficult for you. The medical team will carefully review your overall health to decide if the study is right for you.

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 all your regular medical appointments?
Are you having or have you recently had treatment with a Thoraflex Hybrid device?
Are you (or a family member for you) able to give written agreement to join the study?
Has your doctor confirmed there are no other medical or social reasons preventing your participation?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will last for a total of 10 years, starting from the day you have your Thoraflex Hybrid device fitted. There won't be any extra tests or appointments specifically for the study. Instead, the study will simply follow your usual medical care and check-ups related to your aortic condition. This means your doctors will continue to monitor you as they normally would, and the study will collect information from these routine visits. You won't be given any new medication as part of the study; your treatment will be decided by your medical team based on what's best for your health.

Potential risks and benefits

Because this study is observational, meaning it just watches your standard care, there are no additional risks from participating beyond those inherent in your normal medical treatment. You will not receive any experimental medications or procedures as part of the study. The potential benefit is that the information gathered from your experience, alongside many other patients, will help doctors better understand the long-term effectiveness and safety of the Thoraflex Hybrid and RelayPro NBS devices. This could lead to improved care for future patients. You are free to withdraw from the study at any time without affecting your medical care.

Locations (27)

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

University of Alabama in Birmingham Medical Center
Verified postcode
Birmingham, United States
Cedars-Sinai Medical Centre
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Los Angeles, United States
Keck Medical Centre of USC
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Los Angeles, United States
University of Colorado
Verified postcode
Aurora, United States
Hartford Hospital
Verified postcode
Hartford, United States
Medstar Washington Hospital Centre
Verified postcode
Washington D.C., United States
Northwestern University
Verified postcode
Chicago, United States
Ascension St. Vincent Heart Center
Verified postcode
Indianapolis, United States
University of Maryland
Verified postcode
Baltimore, United States
Massachusetts General Hospital
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Boston, United States
Washington University/Barnes Jewish Hospital
Verified postcode
St Louis, United States
Weill Cornell medicine
Verified postcode
New York, United States

Common questions

What is the aorta?

The aorta is the largest blood vessel in your body. It carries oxygen-rich blood from your heart to the rest of your body.

What is a Thoraflex Hybrid device?

It's a special medical implant used by surgeons to repair serious problems with the aorta, like bulges or tears.

Will I have extra doctor's appointments if I join?

No, you won't have any extra appointments. The study will use information from your regular medical check-ups and care.

How long will I be part of the study?

Your involvement in the study will last for 10 years, starting from when you have the Thoraflex Hybrid device fitted.

Can I stop being part of the study if I change my mind?

Yes, you can leave the study at any time, and it won't affect the medical care you receive.