Active not recruitingNAINTERVENTIONAL

BGP+ Stent as Bridging Stent in BEVAR

This research study is investigating a special type of stent called the BGP+ Stent. This stent is used in a specific operation called branched endovascular aortic repair (BEVAR) for people who have a condition called a thoracoabdominal aortic aneurysm. This is a weakness in the main blood vessel that carries blood from your heart to your body. The study wants to see how safe and effective the BGP+ Stent is when used as a 'bridging stent' – meaning it helps connect the main repair to smaller blood vessels. It’s important because it could offer a new way to treat this complex problem, helping to improve people's health and well-being. The study will carefully check how patients recover and how well the stent performs.

At a glance

Status

Active not recruiting

Phase

Sponsor

Marc Bosiers, MD

Enrolment target

118

Start

09 Sep 2020

Estimated completion

31 Jul 2025

Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture

What is this study about?

This study is about a new way to help people who have a serious condition affecting their main artery, called a thoracoabdominal aortic aneurysm. An aneurysm is like a ballooning or bulging weak spot in the artery wall. If it gets too big, it can be very dangerous. Currently, there are operations to fix this, and one common method is called BEVAR, which is a keyhole surgery approach using special tubes called stent grafts.

In this study, researchers are focusing on a particular type of stent called the BGP+ Stent. They want to see if using this stent as a 'bridging stent' – which helps connect the main stent graft to smaller arteries near the aneurysm – is safe and performs well. This type of bridging is important for ensuring good blood flow to vital organs.

The main goal of this research is to fully understand how safe and effective the BGP+ Stent is for people having this kind of repair. The information gathered will help doctors decide if this new approach can become a standard way to treat complex aortic aneurysms, potentially making these important operations safer and more successful for future patients.

Key takeaways

This study is testing a new stent (BGP+) for a serious artery condition.
It aims to make aneurysm surgery safer and more effective.
Participation involves surgery and follow-up checks.
You must be over 55 and meet specific health requirements.
Your safety and well-being are the top priority throughout the study.

Who may be eligible?

To be able to join this study, patients generally need to be at least 55 years old and have a specific type of aneurysm that doctors believe can be treated with this particular repair method. Patients must also be able to understand the study and agree to take part, and be able to come for all the necessary follow-up appointments.

There are also some specific medical requirements related to the size and shape of the blood vessels being treated, ensuring that the BGP+ stent can be safely and effectively placed. For example, certain blood vessels need to be of a specific size to make sure the new stent fits properly, and there shouldn't be other issues like previous stents in those areas or certain bleeding problems.

Patients would not be able to join if they have had a stent in the target blood vessel before, or if they have certain conditions that make taking blood-thinning medicines unsafe. Women who could become pregnant and are not using effective birth control would also not be able to participate.

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.

Am I at least 55 years old?
Do I have an aneurysm that my doctor thinks fits this study?
Am I willing and able to attend all follow-up appointments?
Do I understand what the study involves and agree to take part?
Have I had a previous stent in the same blood vessel as the aneurysm?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the BGP+ stent during your aneurysm repair surgery. After your operation, you would have several follow-up appointments. These check-ups are important for the research team to monitor your health and how the stent is performing over time. They will involve various tests and scans, which will be explained to you in detail.

These appointments will be scheduled at specific times after your surgery. The exact number and timing of visits will be clearly outlined, but likely include checks at a few months, and then yearly for a period. Throughout the study, medical staff will be available to answer any questions you have and address any concerns. You would continue to take any other necessary medications as advised by your doctor.

Potential risks and benefits

Participating in this study means you would receive treatment for your aneurysm, potentially with a new stent that could be very effective. However, like any medical procedure, there are potential risks, including those associated with surgery and the implantation of a stent. The doctors will carefully explain all potential risks and benefits to you. Your well-being is the top priority, and you are free to withdraw from the study at any time without affecting your standard medical care.

Locations (10)

Prof. Dr. med. Dittmar Böckler - Klinik für Gefäßchirurgie und Endovaskuläre Chirurgie
Verified postcode
Heidelberg, Germany
Prof. Dr. Jost Philipp Schäfer Klinik für Radiologie und Neuroradiologie
Verified postcode
Kiel, Germany
Alexander Gombert
Verified postcode
Aachen, Germany
University Hospital Eppendorf, UKE Hamburg
Verified postcode
Hamburg, Germany
University Hospital Leipzig
Verified postcode
Leipzig, Germany
University Hospital LMU Munich
Verified postcode
Munich, Germany
St. Franziskus Hospital
Verified postcode
Münster, Germany
Klinikum Nürnberg Süd
Verified postcode
Nuremberg, Germany
Karin Pfister
Verified postcode
Regensburg, Germany
Hospital Stuttgart
Verified postcode
Stuttgart, Germany

Common questions

What is an aneurysm?

An aneurysm is a weak, bulging spot in the wall of a blood vessel, similar to a balloon. If it gets too large, it can be dangerous.

What is the BGP+ Stent?

It's a special tube-like device that helps support the blood vessel walls and directs blood flow. In this study, it acts as a 'bridge' during surgery.

What kind of surgery is involved?

The stent is used during a keyhole surgery called BEVAR (branched endovascular aortic repair), which is a less invasive way to fix aneurysms.

Will I have to pay to be in the study?

No, you will not have to pay for the study treatment or extra tests related to the study. Your standard NHS care continues as normal.

Can I leave the study at any time?

Yes, absolutely. Your decision to participate is voluntary, and you can withdraw at any time without it affecting your medical care.