RecruitingNAINTERVENTIONAL

Thoracoabdominal Artery Stent Graft System Exploratory Study

This study is exploring a new, less invasive way to treat serious conditions called thoracoabdominal aortic aneurysms. These are dangerous bulges in the main blood vessel (aorta) that carries blood from your heart to your body, specifically where it passes through your chest and tummy. Currently, surgery for these conditions can be very complex with significant risks. The study will test a special kind of internal support tube, called a stent graft system, to see if it can be safely and effectively placed inside the aorta using small incisions. This aims to avoid major open surgery, potentially leading to fewer complications and a quicker recovery for patients. It's an early-stage study to see if this new method is possible.

At a glance

Status

Recruiting

Phase

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Enrolment target

Start

24 Jul 2025

Estimated completion

30 Jun 2032

Thoracoabdominal Aortic Aneurysms

What is this study about?

Imagine the main pipeline carrying water to your house suddenly developed a dangerous bulge that could burst. This is similar to what a thoracoabdominal aortic aneurysm is – a dangerous weak spot and swelling in your body's main blood vessel, the aorta, where it runs through your chest and belly. These aneurysms are especially tricky because many important arteries, which supply blood to vital organs like your kidneys and digestive system, branch off from this section of the aorta.

Traditionally, fixing these aneurysms has involved major open surgery, which means a large cut across the chest and tummy. This kind of surgery can be very difficult for patients, carrying risks of complications like breathing problems or kidney issues, and a long recovery. There's also a different type of surgery called a 'hybrid' approach, which still involves some open surgery first.

This study is looking at a newer, less invasive method that doesn't require big cuts. Instead, doctors would insert a special covered tube, called a 'stent graft', through smaller entry points, usually in the groin. This stent graft is designed to reinforce the weak spot in the aorta and ensure blood flows safely through it, bypassing the aneurysm. The goal is to see if this 'Thoracoabdominal Artery Stent Graft System' can be a safer and more effective way to treat these complex aneurysms, especially for patients who might be too ill for major surgery.

Key takeaways

This study is testing a new, less invasive way to fix dangerous swellings in your body's main blood vessel (aorta).
It uses a special internal tube (stent graft) to strengthen the blood vessel, avoiding large open surgery.
The treatment aims to reduce recovery time and cut down on serious complications linked with traditional surgery.
This is an early-stage study to see if the new method is safe and possible.
Participation involves placing the device and attending regular follow-up checks.

Who may be eligible?

To join this study, participants generally need to be between 18 and 80 years old. You would need to have been diagnosed with a thoracoabdominal aortic aneurysm that meets specific size or growth criteria (for example, if it's larger than 50mm, or has grown quickly). Your doctor would also consider if you're experiencing symptoms like tummy or back pain related to the aneurysm.

There are also important details about the shape and size of your blood vessels that would need to be suitable for placing the special stent graft. This includes specific measurements of sections of your aorta and the arteries leading to your organs. For example, the areas where the stent graft would sit (called 'landing zones') need to be wide enough and long enough.

Certain conditions would prevent someone from joining. For instance, if your aneurysm has already burst, if you have a tear in your aorta (called a dissection), or if you have any serious infections that could make the procedure risky, you wouldn't be able to take part. You also need to be willing to follow the study's instructions and attend follow-up appointments.

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 80 years old?
Have you been diagnosed with a thoracoabdominal aortic aneurysm that is at least 50mm wide or has grown quickly?
Are your blood vessels suitable for placing the special stent graft, as determined by a doctor?
Are you able to attend follow-up appointments as required by the study?
Do you NOT have a recently burst aneurysm or any serious infections?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a detailed discussion with the study team to make sure you understand everything and give your consent. Most likely, you would undergo the procedure to implant the stent graft. Following the procedure, you would have regular check-ups with the study team to monitor your health and the success of the stent graft. These check-ups will involve various medical assessments, which could include scans (like CT scans) to check the position and function of the stent graft, and blood tests. You might also need to answer questions about your well-being. The total length of your participation, including follow-up appointments, would be explained to you in detail by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a new, less invasive treatment for a complex condition, which could lead to a faster recovery and fewer complications compared to traditional open surgery. However, as with any medical procedure, there are potential risks, including those related to the stent graft placement (such as infection, bleeding, or issues with the device itself) and general risks of a medical procedure. Your doctors will carefully weigh these against the potential benefits. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Asklepios Klinik Nord Heidberg
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is a thoracoabdominal aortic aneurysm?

It's a dangerous swelling or bulge in the main blood vessel (aorta) where it runs through your chest and tummy, which can be life-threatening if it bursts.

What is a stent graft?

It's a special fabric tube supported by a metal mesh that is placed inside your blood vessel to reinforce the weakened area and help blood flow properly.

Why is this new treatment being studied?

Current surgeries for this condition are very complex. This study hopes to find a simpler, less invasive way to treat it, potentially leading to safer outcomes and quicker recovery.

Will I need major surgery?

The goal of this new treatment is to avoid major open surgery by using a 'minimally invasive' approach, meaning smaller cuts to place the stent graft.

Is this treatment proven?

This is an 'exploratory' study, meaning it's an early stage to check if the new device and method are possible and safe, rather than being a widely used treatment yet.

How to find out more

Rae Gong

gongrui@lifetechmed.com (86-755)-86026250-6957 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.