Prospective, Non-Randomised Clinical Trial to Investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System Treating Aortic-iliac Occlusive Disease
This study is looking at new medical devices called 'stent grafts' for a condition where the main blood vessels from your tummy to your legs get blocked or narrowed. This condition is called aorto-iliac occlusive disease. The study is checking how safe and effective two specific types of stent grafts, the BeGraft Aortic and BeGraft Peripheral systems, are when used in a special procedure called CERAB. This procedure involves placing these coated tubes inside your blood vessels to open them up and improve blood flow, without major surgery. We want to understand if these new stents can help people with severely blocked leg arteries feel better.
At a glance
What is this study about?
Imagine the main blood pipes leading from your heart down into your legs get narrowed or even blocked, making it hard for blood to flow properly. This condition is called 'aorto-iliac occlusive disease' and can cause pain, especially when walking. Doctors often try to fix this by putting in small mesh tubes called 'stents' to hold the blood vessels open.
This study is testing two new types of these tubes, called 'stent grafts', which are stents covered with a special material. They are designed to be used in a particular way known as the 'CERAB procedure'. This procedure involves placing these covered stents through a small cut, usually in the groin, to create a new, clear pathway for blood to flow from your tummy down into both legs. The main goal is to see if these new stents are safe to use and if they do a good job at keeping the blood vessels open and improving your symptoms.
By taking part, you would be helping doctors understand if these specific stent grafts are a good option for treating this condition. The information gathered from this study could help many other people in the future who have similar blockages in their blood vessels.
Key takeaways
- This study tests new covered stents for blocked leg arteries.
- It aims to improve blood flow and reduce symptoms.
- The procedure involves placing stents inside blood vessels.
- Participation requires regular check-ups after the procedure.
- It's for people with specific, severe blood vessel blockages.
- You can stop participating at any time.
Who may be eligible?
To join this study, people generally need to have a specific type of blockage in the blood vessels from their tummy to their legs that needs treatment. You should also be experiencing symptoms from this blockage, such as pain even when resting, or sores that aren't healing on their own. You need to be at least 18 years old and expected to live for at least two more years.
Your blood vessels also need to look a certain way on scans for the treatment to be possible using these specific stents. For example, the blockage shouldn't be too close to your kidney arteries, and there shouldn't be any fresh blood clots. If you've recently had a heart attack, stroke, or surgery on these specific blood vessels, you likely won't be able to join.
Also, if you're taking part in another study that tests new medical treatments, or if you're a woman who could have children and not using reliable birth control, then you wouldn't be able to join this study.
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.
- Do experts say your leg artery blockage needs treatment?
- Are you experiencing current pain or unhealed sores in your legs?
- Are you aged 18 or older?
- Do you not have an active infection or fresh blood clots?
- Have you not had a recent heart attack, stroke, or surgery on these specific blood vessels?
- Are you able and willing to attend follow-up appointments?
What does participation involve?
If you decide to take part, you would first have a detailed check-up to make sure you're suitable for the study. If you are, you would then have the CERAB procedure, which involves placing the stent grafts into your blood vessels. This procedure is usually done through a small cut, often in your groin.
After the procedure, you'll need to attend regular follow-up visits. These visits are important so doctors can check how you're recovering and how well the stent grafts are working. They will likely involve physical examinations and perhaps some scans to look at your blood vessels. You'll need to be willing and able to come to all these planned appointments. The study does not specify an exact total duration, but follow-up appointments would likely be over several months to a year or more. You wouldn't be given any experimental medication, just the stent grafts as the intervention.
Potential risks and benefits
Locations (15)
- Sankt Gertrauden-KrankenhausVerified postcodeBerlin, Germany· Recruiting
- Universitätsklinikum FrankfurtVerified postcodeFrankfurt, Germany· Recruiting
- University Medical Center GoettingenVerified postcodeGöttingen, Germany· Recruiting
- Universitätsklinikum HeidelbergVerified postcodeHeidelberg, Germany· Recruiting
- Marienhospital LünenVerified postcodeLünen, Germany· Not yet recruiting
- St. Franziskus-Hospital GmbHVerified postcodeMünster, Germany· Recruiting
- Krankenhaus Barmherzige Brüder RegensburgVerified postcodeRegensburg, Germany· Recruiting
- Uniklinikum RegensburgVerified postcodeRegensburg, Germany· Recruiting
- Klinikum der Landeshauptstadt Stuttgart gKAöRVerified postcodeStuttgart, Germany· Recruiting
- Noordwest Ziekenhuisgroep AlkmaarVerified postcodeAlkmaar, Netherlands· Recruiting
- Ziekenhuis Rijnstate ArnhemVerified postcodeArnhem, Netherlands· Recruiting
- Martini ZiekenhuisVerified postcodeGroningen, Netherlands· Recruiting
Common questions
What is 'aorto-iliac occlusive disease'?
It's when the main blood vessels from your tummy to your legs become blocked or narrowed, reducing blood flow.
What is a 'stent graft'?
It's a small, covered tube placed inside a blood vessel to hold it open and allow blood to flow through.
What is the 'CERAB procedure'?
It's a way to use covered stents to rebuild the main blood vessel split where it goes into both legs, improving blood flow without major surgery.
Will I have to stay in hospital?
The procedure itself usually requires a hospital stay, and you'll have follow-up appointments afterwards, but these are typically outpatient visits.
Is this a new treatment?
The stent grafts themselves are new versions being tested, and the study is evaluating their safety and how well they perform.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.