Active not recruitingOBSERVATIONAL

Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

This study, called Zenith Thoracic Alpha (ZTA) Post-Market Data Collection, is looking at how a specific medical device, the Zenith Alpha Thoracic Endovascular Graft (ZTA), performs in real-world use. This device is used to treat serious conditions affecting a large blood vessel in the chest called the aorta, specifically Thoracic Aortic Aneurysm and Penetrating Aortic Ulcer. Because the device is already approved and on the market, this study aims to check its continued safety and how well it helps patients over time. It collects information from people who have already had the treatment, as well as some who will have it in the future, to make sure it's working as expected throughout its lifetime.

At a glance

Status

Active not recruiting

Sponsor

Cook Research Incorporated

Enrolment target

300

Start

06 Jul 2023

Estimated completion

01 Dec 2034

Thoracic Aortic Aneurysm Penetrating Aortic Ulcer

What is this study about?

This study, called Zenith Thoracic Alpha (ZTA) Post-Market Data Collection, is all about gathering information on a medical device that's already being used in hospitals. The device is a special tube called the Zenith Alpha Thoracic Endovascular Graft (ZTA), and it's used to treat problems with a major blood vessel in your chest called the aorta. These problems include a 'thoracic aortic aneurysm,' where the aorta bulges, or a 'penetrating aortic ulcer,' which is a deep sore in the aorta's wall.

The main goal of this study is to make sure this device continues to be safe and effective for patients in the long run. Since the ZTA graft is already available and doctors are using it, this study is a way to keep track of how people are doing after they've had the treatment. It helps doctors and manufacturers understand the real-world performance of the device throughout a patient's life.

To do this, the study looks at information from patients treated with the ZTA graft since January 2019. It includes details from their medical records, whether they were treated in the past or are about to receive the treatment. This helps build a complete picture of how the device performs over many years, ensuring its ongoing quality and safety for everyone who uses it.

Key takeaways

This study collects information on an existing medical device, the ZTA graft.
It aims to check the long-term safety and performance of the device.
Participation involves letting researchers use your medical records.
There are no extra hospital visits or new treatments involved.
Your contribution helps improve care for future patients.

Who may be eligible?

To be part of this study, you would either have already been treated with the ZTA device since January 2019, or your doctor was planning to use it for you. It's important that the treatment followed the usual medical practices at the time.

A key part of joining is that you must be happy to take part and give your permission. This usually means signing a form that says you agree to your medical information being collected for the study. If you're not able to give your consent, or if you don't want to, then you can't join.

There are a couple of reasons why you might not be able to join. For example, if your treatment involved a special, custom-made version of the graft (not just the standard ZTA), or if it wouldn't be possible for the study team to follow up with you, perhaps because you live outside the UK. Everyone considered for the study is an adult, regardless of their age or gender.

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.

Have you been treated with the ZTA device since January 2019, or are you planned to be?
Are you happy to let the study team collect information from your medical records?
Was your treatment with a standard ZTA device, not a custom-made one?
Is it possible for the study team to follow up with you in the future (e.g., you don't plan to move abroad)?
Are you an adult?

Answer every question to see your result.

What does participation involve?

If you're eligible and agree to take part, the participation involves allowing researchers to collect information from your existing medical records related to your ZTA treatment. For some patients, there might also be ongoing data collection during your regular follow-up appointments. There are no extra hospital visits or new medications to take specifically for this study. The study aims to gather information over the long term, reflecting the expected lifetime of the device. You would simply be allowing your health information to contribute to understanding how the device works over many years.

Potential risks and benefits

The main benefit of taking part is that your health information helps improve the understanding of the ZTA device for future patients. This helps ensure its continued safety and effectiveness. Since this study only involves collecting data from your existing medical records and routine follow-up appointments, there are no additional medical procedures or changes to your treatment, so no direct medical risks from participating. Your privacy and the confidentiality of your health data will be protected. You are free to withdraw your consent and stop participating in the study at any time without affecting your medical care.

Locations (10)

CHU Dijon Bourgogne
Verified postcode
Dijon, France
Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph
Verified postcode
Le Plessis-Robinson, France
Centre Hospitalier Regional Universitaire de Lille
Verified postcode
Lille, France
Universitätsklinikum Hamburg-Eppendorf
Verified postcode
Hamburg, Germany
Universitätsklinikum der LMU München
Verified postcode
München, Germany
St. Franzikus Hospital Munster
Verified postcode
Münster, Germany
IRCCS-University Hospital Sant'Orsolo Polyclinic
Verified postcode
Bologna, Italy
IRCCS Ospedale San Raffaele
Verified postcode
Milan, Italy
Maastricht University Medical Center
Verified postcode
Maastricht, Netherlands
Radboud UMC
Verified postcode
Nijmegen, Netherlands

Common questions

What is the ZTA device?

The ZTA device is a special tube (called a stent graft) that doctors use to fix dangerous problems in a large blood vessel in your chest called the aorta.

Why is this study being done?

This study is gathering real-world information to make sure the ZTA device continues to be safe and works well for patients over many years, just as expected.

Will I have extra doctor's appointments?

No, you won't have any extra appointments because of this study. It just uses information from your regular medical care.

Will I need to take new medicine?

No, this study doesn't ask you to take any new medicines. It's only about collecting information from your past and ongoing treatment.

Can I change my mind about taking part?

Yes, you can decide to stop participating at any time without it affecting your medical care.