Active not recruitingNAINTERVENTIONAL

The Merit WRAPSODY AV Access Efficacy Study (WAVE)

This study is for people who are having kidney dialysis and have blood vessels in their arm (called an AV fistula or graft) that have become narrowed or blocked. It's testing a special device called a Merit WRAPSODY Endovascular Stent Graft. This stent graft is like a tiny mesh tube that is put inside the narrowed part of the blood vessel to help keep it open. Researchers want to find out if this new device is safe and effective in preventing the blood vessels from narrowing or blocking again, especially when compared to a standard treatment called PTA (angioplasty which uses a small balloon to open the vessel). The study hopes to improve how well these important dialysis access sites work.

At a glance

Status

Active not recruiting

Phase

Sponsor

Merit Medical Systems, Inc.

Enrolment target

357

Start

09 Mar 2021

Estimated completion

01 Jan 2026

Venous Stenosis Venous Occlusion

What is this study about?

When someone has kidney failure and needs dialysis, doctors create a special way to access their blood, often in the arm. This is called an AV fistula or AV graft. Over time, these blood vessels can sometimes get narrow or even blocked, which can make dialysis difficult or impossible. This study is looking at a new device called the Merit WRAPSODY Endovascular Stent Graft to help keep these important blood vessels open.

Imagine a tiny, flexible tube made of a special material. This is what the stent graft is. If your blood vessel has become narrowed or blocked, doctors may suggest putting this stent graft inside the affected area. It acts like a scaffold to hold the vessel open and help blood flow smoothly for your dialysis treatments. The study wants to see how well this particular stent graft works compared to a common treatment where a small balloon is used to open up the vessel (this is called PTA).

The main goal of this research is to see if the Merit WRAPSODY stent graft is both safe to use and effective at keeping the dialysis access working well. Finding better ways to manage these blood vessel problems could mean fewer procedures and a better experience for people relying on dialysis.

Key takeaways

This study is for adults on kidney dialysis with narrowed or blocked arm blood vessels.
It tests a new device called a Merit WRAPSODY Endovascular Stent Graft.
The goal is to see if the stent graft safely keeps dialysis access vessels open.
It compares the new stent graft to a standard balloon treatment (PTA).
You'll need an AV fistula or graft in your arm with a specific type of narrowing.
Regular follow-up visits will be required to monitor your progress.

Who may be eligible?

This study is looking for adults aged 18 or over who are currently receiving ongoing kidney dialysis. You would need to have an AV fistula or AV graft in your arm that doctors use for your dialysis treatments.

Crucially, the blood vessel in your arm that is used for dialysis must have a new narrowing or a narrowing that has come back after a previous treatment (but not if it's already got a stent in it). This narrowed area needs to be at least 50% blocked and the blood vessel itself should be between 5mm and 14mm wide.

You wouldn't be able to join if you have an infection at your dialysis access site or a general body infection. Also, if you've had a stroke in the last three months, or a heart attack or unstable chest pain in the last two months, you wouldn't qualify. Pregnant or breastfeeding women, or those planning to become pregnant in the next year, also cannot take part.

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 long-term kidney dialysis?
Do you have an AV fistula or graft in your arm for dialysis?
Has your dialysis access vessel become newly narrowed or narrowed again (not with an existing stent)?
Have you *not* had a stroke in the last 3 months, or a heart attack/unstable chest pain in the last 2 months?
Are you not pregnant, breastfeeding, or planning to become pregnant within the next year?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will have the Merit WRAPSODY Endovascular Stent Graft placed into your narrowed dialysis access vessel, or you will receive the standard PTA (balloon) treatment. The study will likely involve several visits to the clinic for check-ups and tests. These tests may include scanning your blood vessels to see how they are working.

You would need to be willing to attend all these follow-up appointments. The doctors will monitor your health and how well your dialysis access is working over time. The exact number of visits and the full duration of your participation would be explained in detail by the study team, but it's important to know there's a commitment to attend follow-up assessments.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new device that could improve the lifespan and function of your dialysis access, potentially leading to fewer procedures. However, as with any medical procedure, there are potential risks, including those associated with placing the stent graft or performing PTA, such as bleeding, infection, or damage to the blood vessel. The study team will explain all known risks to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (43)

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

Southwest Kidney institute (SKI) Vascular Center
Verified postcode
Tempe, United States
Pima Heart and Vascular
Verified postcode
Tucson, United States
St. Joseph Hospital
Verified postcode
Orange, United States
Vascular Care Connecticut
Verified postcode
Darien, United States
Nephrology Associates
Verified postcode
Newark, United States
First Coast Cardiovascular Institute
Verified postcode
Jacksonville, United States
Open Access Miami, LLC
Verified postcode
Miami, United States
Leesburg Vascular Access Center & Discovery Medical Research
Unverified
Oscala, United States
Coastal Vascular and Interventional
Verified postcode
Pensacola, United States
Chicago Access Center
Verified postcode
Chicago, United States
Northwestern Medical Center
Verified postcode
Chicago, United States
Indiana University Hospital and Methodist Hospital
Verified postcode
Indianapolis, United States

Common questions

What is an AV fistula or AV graft?

These are special connections made in your arm's blood vessels to make it easier and safer to get dialysis treatment for kidney failure.

What does a 'stent graft' do?

A stent graft is like a small, flexible lined tube that doctors place inside a narrowed blood vessel to hold it open and help blood flow better.

What does 'PTA' mean?

PTA stands for Percutaneous Transluminal Angioplasty. It's a common procedure where a small balloon is used to open up a narrowed blood vessel.

Will I know if I'm getting the stent graft or the balloon treatment?

This would depend on the study design, which the study team would explain. In some studies, you might not know which treatment you receive initially.

How long will I be in the study?

The study aims to follow participants for a period to see how well the treatments work. The exact duration will be explained by the study team.