Active not recruitingOBSERVATIONAL

Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)

This study, called WRAP, is investigating a special device called the Merit WRAPSODY Endoprosthesis. This device is a type of stent, which is a small mesh tube, designed to help improve blood flow in people undergoing kidney dialysis. Specifically, it's for those who have narrowed or blocked veins in the part of their body where they receive dialysis treatment (an AV fistula or graft). The main goal is to understand more about how safe and effective this device is for patients in real-world situations. It’s an 'observational' study, meaning doctors will watch how patients do over time after receiving the device.

At a glance

Status

Active not recruiting

Sponsor

Merit Medical Systems, Inc.

Enrolment target

500

Start

23 Jun 2022

Estimated completion

15 Oct 2027

Venous Stenosis Venous Occlusion

What is this study about?

When someone has kidney failure and needs dialysis, doctors often create a special connection in their arm called an AV fistula or graft. This connection helps to make the dialysis treatment easier and more successful. However, sometimes these connections can get blocked or narrowed over time, which makes it harder for the dialysis machine to do its job. This study is looking at a device called the WRAPSODY Endoprosthesis, which is a type of stent. It's designed to be placed inside these narrowed or blocked veins to open them up and keep them open, allowing blood to flow better for dialysis.

The WRAP study wants to find out more about how well this WRAPSODY device works in real everyday situations. They also want to make sure it's safe for people to use. By gathering information from many patients, doctors can learn more about how to best help people on dialysis. This kind of research is important because it helps improve treatments and care for people in the future.

This study is what's called an 'observational study'. This means doctors will follow patients who receive the WRAPSODY device as part of their regular care. They will collect information about how patients are doing, rather than giving out new treatments specifically for the study. By observing many people over a period, researchers can get a clear picture of the device's benefits and any potential issues.

Key takeaways

This study evaluates a device called WRAPSODY for kidney dialysis patients.
It helps open narrowed or blocked veins used for dialysis.
The study aims to understand its safety and effectiveness in real patients.
It's an 'observational' study, meaning patient progress is tracked over time.
Participation involves ongoing follow-up for up to 24 months.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) who is currently receiving kidney dialysis. The dialysis access in your arm (the AV fistula or graft) must have been used successfully at least once before. Importantly, you would need to have a narrowing or blockage in this dialysis access that your doctor plans to treat using the WRAPSODY device. You should also be willing to attend follow-up appointments for up to two years.

There are some reasons why you might not be able to join. For example, if you have a known infection in your dialysis access area, or if you have a bleeding disorder that can't be corrected. If you're allergic to a metal called nickel titanium alloy (which is in the device), or if you're planning to have a kidney transplant or switch to a different type of dialysis within the next six months, you wouldn't be able to participate. Also, if your doctor plans to abandon your current dialysis access soon, or if the narrowing is in a very specific large vein in your chest, you wouldn't be suitable.

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?
Are you currently on kidney dialysis?
Do you have a narrowing or blockage in your dialysis access (AV fistula or graft)?
Is your doctor considering the WRAPSODY device to treat this?
Are you willing to attend regular medical check-ups for about two years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the WRAPSODY device would be used as part of your standard medical care to treat the narrowing or blockage in your dialysis access. After the procedure, you would be asked to attend check-up appointments as part of your regular care, which will be tracked for the study. These follow-up visits will involve your doctor examining you and potentially doing scans to see how the device is working. This tracking will continue for about two years to see how you're doing in the long term. You won't be given any extra medications specifically for the study.

Potential risks and benefits

Taking part might offer the benefit of receiving a device designed to improve your dialysis access and blood flow, which could make your dialysis treatment more effective. However, as with any medical procedure involving a stent, there are potential risks such as infection, bleeding, or the device not working as expected. These will be discussed fully by your doctor. It's important to remember that joining a study is always your choice, and you can withdraw at any time without affecting your usual medical care.

Locations (35)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Monash Health
Verified postcode
Clayton, Australia
Liverpool Hospital
Verified postcode
Liverpool, Australia
Fiona Stanley Hospital
Verified postcode
Murdoch, Australia
Sir Charles Gairdner Hospital
Verified postcode
Nedlands, Australia
Princess Alexandra Hospital
Verified postcode
Woolloongabba, Australia
Hospital Felicio Rocho
Verified postcode
Belo Horizonte, Brazil
Afya Hospital
Verified postcode
Brasília, Brazil
Hospital Santa Lucia
Verified postcode
Brasília, Brazil
Hospital Vera Cruz
Verified postcode
Campinas, Brazil
Instituto Pro Renal
Verified postcode
Curitiba, Brazil
Complexo Hospitalar de Niterói
Verified postcode
Niterói, Brazil
Parana Medical Research Center
Verified postcode
Paranã, Brazil

Common questions

What is an AV fistula or graft?

It's a special connection made in your arm (a fistula joins an artery and vein, a graft uses a plastic tube) for easier and more effective kidney dialysis treatments.

What does 'stenosis or occlusion' mean?

Stenosis means a narrowing of a blood vessel, and occlusion means it's completely blocked. Both can make dialysis difficult.

What is the WRAPSODY Endoprosthesis?

It's a special mesh tube, called a stent, that is placed inside a narrowed or blocked vein to open it up and keep blood flowing well for dialysis.

Will I be given any new treatments if I join?

No, the WRAPSODY device would be used as part of your normal care to treat your condition. The study is observing how you do with it.

How long will I be involved in the study?

The study will track your progress for about two years after you receive the WRAPSODY device through your regular doctor's appointments.