Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels
This study, called a registry, is looking at how a specific medical device, the GORE VIABAHN VBX Stent Graft, performs in people who have circulation issues in their legs or other peripheral blood vessels. These are conditions where blood flow is restricted, often due to narrowed or blocked arteries. The main goal is to collect information on how safe and effective this stent is once it’s being used more widely beyond initial clinical trials. Doctors will be observing patients who receive this stent as part of their regular treatment. The information gathered will help medical professionals better understand the stent's real-world use and how it helps patients over time. This isn't a typical drug trial, but rather a way to monitor an already approved device in everyday medical practice.
At a glance
Results
Results from this study
Posted February 2024Results have been published for this study.
What is this study about?
This registry is designed to keep track of patients who receive a special medical device called the GORE VIABAHN VBX Balloon Expandable Endoprosthesis, often shortened to VBX Stent Graft. This stent is a small, mesh-like tube that doctors can place inside blood vessels to help keep them open, improving blood flow. It's used for people with conditions where their peripheral blood vessels – which are outside of the heart and brain, like those in the legs or arms – are narrowed or blocked.
The main purpose of this study is to see how well this stent works and how safe it is once it's used in many different people as part of their regular treatment. Think of it like a quality check for the stent in real-world situations, after it has already gone through initial testing. It helps medical experts gather more information on its long-term performance and any potential issues that might come up.
By collecting data from many patients, this registry helps to build a more complete picture of the stent's performance. This information is really important because it helps doctors make informed decisions about patient care and allows the manufacturers to understand how their device is working in everyday medical practice. It’s a way to continuously learn and improve medical treatments for conditions affecting blood flow in the body.
Key takeaways
- This study is a registry for a medical device called the GORE VIABAHN VBX Stent Graft.
- It aims to collect data on the stent's safety and how well it works in real-world use.
- It's for people with circulation problems in their peripheral blood vessels (like in legs).
- Participation involves allowing your medical information to be collected during your standard treatment and follow-up.
- You must be 18 or older and your doctor must decide this stent is right for you.
- This is about gathering information, not testing a new, unproven device.
Who may be eligible?
To take part in this registry, you need to be at least 18 years old and agree to participate by signing a consent form. Your doctor must believe that this specific stent is the right treatment for your circulation problems, based on what's best for your health. It's also important that you don't plan to have any other stents put in the same blood vessels that will receive this one, and you must be willing to attend your regular follow-up appointments.
There are some reasons why you might not be able to join. For example, if you are allergic to heparin (a blood thinner) or have had a serious reaction to it in the past. Women who are pregnant or breastfeeding cannot participate. You also wouldn't be able to join if you're taking part in another study that might affect the results of this registry, unless cleared by the study team. If doctors expect you to live for less than 12 months due to other health issues, you wouldn't be eligible.
Finally, this specific stent is not being studied for certain conditions or in certain parts of the body in this registry. For instance, if your circulation problem is in specific arteries leading to your heart, lungs, brain, or main body artery (aorta), or if it's for a specific type of blockage in your main leg artery (iliac), you wouldn't be included.
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 18 years old or older?
- Has your doctor said the GORE VIABAHN VBX Stent Graft is the right treatment for your circulation problems?
- Are you willing to attend all your regular follow-up appointments?
- Are you not pregnant or breastfeeding?
- Do you not have a known allergy or serious reaction to heparin (a blood thinner)?
What does participation involve?
If you participate in this registry, it means that if your doctor decides the GORE VIABAHN VBX Stent Graft is the best treatment option for you, information about your treatment and your health journey will be collected. This typically involves allowing the study team to record details about your medical procedure, how the stent was placed, and your recovery. You won't receive extra medication specifically for the study, as the stent is part of your standard care.
The main part of your involvement will be attending your usual follow-up appointments with your doctor. During these visits, your doctor will check how you're doing, how the stent is performing, and if there are any issues. The study team will then collect this information from your medical records. The total duration of your participation would depend on how long your doctor typically monitors patients after this type of procedure, as it follows standard medical practice.
Potential risks and benefits
Locations (11)
- Hôpital Marie LannelongueVerified postcodeParis, France
- University Hospital HeidelbergVerified postcodeHeidelberg, Germany
- St. Franziskus HospitalVerified postcodeMünster, Germany
- Azienda Ospedaliera Policlinico Sant'Orsola MalpighiVerified postcodeBologna, Italy
- Fondazione PoliambulanzaVerified postcodeBrescia, Italy
- Azienda Ospedaliero-Universitaria di PadovaVerified postcodePadova, Italy
- Ospedale di Circolo e Fondazione MacchiVerified postcodeVarese, Italy
- University Medical Center GroningenVerified postcodeGroningen, Netherlands
- Erasmus Medical CenterVerified postcodeRotterdam, Netherlands
- Hospital Universitario Central de Asturias (HUCA)Verified postcodeOviedo, Spain
- University Hospital of Santiago de CompostelaVerified postcodeSantiago de Compostela, Spain
Common questions
What is a stent graft?
A stent graft is like a small, flexible metal mesh tube covered with fabric. Doctors place it inside a blood vessel to keep it open and improve blood flow, especially when the vessel is narrow or blocked.
What are 'peripheral vessels'?
Peripheral vessels are the blood vessels in your body that are outside of your heart and brain. This often includes arteries in your legs, arms, and other parts of your body, which can sometimes become narrowed.
Why is this a 'registry' and not a 'clinical trial'?
A registry collects information about how a medical device (like this stent) works in real-world patients after it's already approved and being used. A clinical trial usually tests a new device or treatment for the first time.
Will I get special treatment in this registry?
No, you will receive the standard medical care your doctor thinks is best for you, which may include this stent. The registry just collects information about how that standard care works for you.
Does being in the registry mean I'm a 'human guinea pig'?
No, absolutely not. You are receiving an approved medical treatment recommended by your doctor. The registry is simply a way to learn more about the stent's performance in many patients, helping to improve future care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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