Active not recruitingOBSERVATIONAL

Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study

This study is gathering information about a medical device called the Ankura™ TAA Stent Graft System and a Super Stiff Guidewire. These are used to treat conditions affecting the main artery that carries blood from your heart down through your chest – specifically, a 'thoracic aneurysm' (a bulge in the artery) or a 'Type B aortic dissection' (a tear in the artery wall). The main goal is to see how patients who receive this system are doing, to check its safety and how well it performs. This will help build evidence for its use in patients with these conditions. The study collects data on patient outcomes over a period, following strict guidelines to make sure it's done safely and correctly.

At a glance

Status

Active not recruiting

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Enrolment target

147

Start

03 May 2023

Estimated completion

30 Dec 2030

Aneurysm Thoracic Dissection of Thoracic Aorta

What is this study about?

This medical study is focused on a special treatment for two serious conditions that affect your aorta, which is the body's largest blood vessel, carrying blood from your heart to the rest of your body. These conditions are a 'thoracic aneurysm', which is a dangerous bulge in the part of your aorta in your chest, or a 'Type B aortic dissection', which is a tear in the wall of this same part of the artery. Both of these need careful medical attention.

Doctors sometimes treat these conditions using a procedure called endovascular repair, which is less invasive than open surgery. This study is specifically looking at a device called the Ankura™ TAA Stent Graft System. This device is a small, mesh-like tube (a stent graft) that is carefully placed inside the aorta to strengthen the weakened or torn area. A special wire, called the Surpass Super Stiff Guidewire, helps doctors guide the stent into the correct position.

The main aim of this study is to collect information on how well the Ankura™ system works and if it's safe for patients over a long period. By gathering this 'real-world' data after the device has been approved for use, researchers can better understand the long-term effects and benefits for people needing this type of treatment. This helps doctors continue to improve care for patients with these serious heart conditions.

Key takeaways

This study is for heart artery conditions: aneurysms or tears in the chest aorta.
It uses a special Ankura™ stent to fix the artery.
The goal is to check the device's safety and how well it works over time.
Patients in the study will be followed for three years.
Participation helps improve future patient care.

Who may be eligible?

To be considered for this study, you would typically be between 18 and 85 years old and need treatment for either a descending thoracic aortic aneurysm (a bulge in your main chest artery) or a Type B aortic dissection (a tear in it). Doctors will check that putting in the special stent graft is a suitable option for you based on the exact shape and size of your aorta.

There are also some criteria that might mean you can't join. For example, if you have a current serious infection, if other devices in your heart area would get in the way of the procedure, or if you have severe allergies to the materials used in the device. The medical team will check all these details carefully with you. You also need to be able to understand the study and agree to follow all the instructions, including a three-year check-up period.

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 between 18 and 85 years old?
Do you have a descending thoracic aortic aneurysm or Type B aortic dissection needing repair?
Do you anticipate living for at least another year?
Are you able to agree to attend follow-up appointments for three years?
Have trained medical staff confirmed your artery shape is suitable for this type of repair?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be treated with the Ankura™ TAA Stent Graft System. After the procedure, you will need to attend regular follow-up appointments with your medical team. These check-ups will likely involve various assessments to monitor your health and how the device is performing over time. The study requires you to commit to these follow-up visits for a total duration of three years. You'll be given full details about the specific schedule and what each visit will involve.

Potential risks and benefits

Taking part in this study means you would receive treatment for your condition, which could improve your health. The information gathered will also help improve care for future patients. However, as with any medical procedure, there are potential risks, including those associated with the stent graft system itself, the procedure to implant it, and the follow-up tests. Your medical team will explain all these possible risks thoroughly. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Asklepios Klinik Nord Heidberg
Verified postcode
Hamburg, Germany
St. Franziskus Hospital Münster
Verified postcode
Münster, Germany
Evaggelismos General Hospital
Verified postcode
Athens, Greece
General Hospital of Athens - Georgios Gennimatas
Verified postcode
Athens, Greece
University General Hospital - Attikon
Verified postcode
Attiki, Greece
A.O. Ordine Mauriziano di Torino
Verified postcode
Turin, Italy
Petrovsky National Research Centre of Surgery
Verified postcode
Moscow, Russia
Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre
Verified postcode
Saint Petersburg, Russia
Ankara Bilkent City Hospital
Verified postcode
Ankara, Turkey (Türkiye)
Ankara Etlik City Hospital
Verified postcode
Ankara, Turkey (Türkiye)
Ankara University Hospital Heart Center
Verified postcode
Ankara, Turkey (Türkiye)
Erzurum University Hospital
Verified postcode
Erzurum, Turkey (Türkiye)

Common questions

What is an aneurysm or aortic dissection?

An aneurysm is a dangerous bulge in a blood vessel, and a dissection is a tear in its wall. In this study, we're looking at these problems in your aorta, the main artery from your heart.

What is the Ankura™ system?

It's a special mesh-like tube (stent graft) that doctors place inside your aorta to fix a bulge or tear, helping to strengthen the artery.

How long does the study follow people?

If you join, the study will follow your health and the device's performance for three years after your treatment.

Will I get normal medical care if I join?

Yes, taking part in the study means you will receive care tailored to your condition, just as you would normally, but with extra monitoring for the study.

Can I leave the study at any time?

Yes, you are free to leave the study whenever you want, and your decision won't affect your future medical treatment.