RecruitingOBSERVATIONAL

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)

This study, called RE-PROVE, is looking at how a medical device called the GORE VIABAHN VBX stent works after it's been used in patients. This stent is a small, flexible tube that doctors put into blood vessels that are blocked or damaged, for example, in the tummy or legs. The goal is to see how well it works and if it's safe in everyday medical care. They will follow about 240 patients for a year, collecting information on their health and asking them about their quality of life. This helps doctors understand more about how devices like this help people with blood vessel problems.

At a glance

Status

Recruiting

Sponsor

W.L.Gore & Associates

Enrolment target

240

Start

08 May 2026

Estimated completion

01 Jan 2031

Aorto-iliac Occlusive Disease (AIOD)Visceral Artery Occlusive Disease (VAOD)Isolated Artery Aneurysms (IAA)Trauma or Iatrogenic Vessel Injury

What is this study about?

Imagine your body's blood vessels are like tiny pipes carrying blood everywhere. Sometimes, these pipes can get blocked or damaged, which can cause serious health problems. Doctors can use a special device called a 'stent' to open up these blocked vessels or repair damaged ones. The GORE VIABAHN VBX stent is one such device.

This study, named RE-PROVE, is like a careful observation to see how this particular stent works in real patients after doctors have decided to use it as part of their regular treatment. It's not testing a new device, but rather gathering more information about how an already approved device performs. Doctors will be looking at people who have problems like narrowed or blocked blood vessels in their legs or tummy, or even those who have had a blood vessel injured.

By following these patients for about a year, doctors can learn more about the stent's long-term safety and how well it helps people get better and improve their daily lives. This information is really important because it helps improve future care for patients with similar conditions.

Key takeaways

This study observes an existing medical device, the GORE VIABAHN VBX stent.
It aims to understand how the stent works for people with blocked or damaged blood vessels.
About 240 patients will be followed for one year after their stent procedure.
The study focuses on real-world results and patient quality of life.
Participation involves routine follow-up appointments and answering questionnaires.

Who may be eligible?

To join this study, you need to be at least 18 years old and agree to take part by signing a form. Your doctor must also think that the GORE VIABAHN VBX stent is the right treatment for your blood vessel condition. You also need to be willing to come to all your follow-up appointments.

There are some reasons why you might not be able to join. For example, if you're already in another study that might affect the results of this one, or if you have a known allergy to parts of the stent or the dye used during the procedure. You also can't join if you're pregnant or breastfeeding, or if your doctor believes you have other serious health issues that might make it hard to understand the study results, or if your life expectancy is less than 12 months.

Don't worry if you're not sure about any of these points; your doctor will go through everything with you carefully to see if this study is suitable for you.

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 suggested the GORE VIABAHN VBX stent for your condition?
Are you able to attend all necessary follow-up appointments for about a year?
Are you not currently pregnant or breastfeeding?
Do you have good overall health, without other serious conditions that might make it hard to understand the study results?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be one of approximately 240 patients across Europe. You'll receive the GORE VIABAHN VBX stent as part of your normal treatment. After the procedure, the study team will follow your health progress for about a year. This means you'll have regular check-ups, just like you normally would after this type of procedure, and at these visits, you'll be asked to fill out some questionnaires about your quality of life. There won't be any extra medications given specifically for the study; it's all about observing how the stent works with your usual care.

Potential risks and benefits

Taking part in this study means doctors will be closely watching your health after you receive the GORE VIABAHN VBX stent, which could provide a clearer picture of how well it's working for you. However, as with any medical procedure, there are potential risks associated with placing the stent, such as infection or issues with the stent itself, but these are part of the standard procedure and not extra risks from being in the study. You're always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

TUM Klinikum
Verified postcode
Munich, Germany· Recruiting

Common questions

What is a stent?

A stent is a small, flexible tube that doctors place inside a blood vessel to keep it open, especially if it's been narrowed or blocked.

Why is this study being done?

This study is being done to collect more information on how well the GORE VIABAHN VBX stent works in real patients and how safe it is over time, as part of their regular medical care.

Will I get special treatment in this study?

No, you will receive the stent as part of your usual treatment. The study is about observing how the stent performs, not about giving different or experimental treatments.

How long will I be in the study?

You will be followed for about 12 months (1 year) after you have the stent procedure.

What if I change my mind about participating?

You can leave the study at any time, for any reason. This will not affect the medical care you receive from your doctors.

How to find out more

Cagla Selvan

cselvan@wlgore.com +31 627 294 665 Official trial record

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