Active not recruitingNAINTERVENTIONAL

Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae

This study is investigating a new type of balloon, called a Drug Coated Balloon (Lutonix 035), for treating problems in a specific type of blood vessel connection called an arteriovenous fistula (AV fistula). AV fistulae are often created in the arm for people needing dialysis due to kidney failure. Sometimes, these fistulae can narrow or develop other issues, making them less effective. This study, which is taking place globally, including in the UK, aims to understand how safe and effective this special balloon is when used in everyday medical practice. It's particularly looking at people whose arm AV fistulae are not working as they should, potentially improving their treatment options.

At a glance

Status

Active not recruiting

Phase

Sponsor

C. R. Bard

Enrolment target

213

Start

07 Aug 2018

Estimated completion

01 Apr 2030

Arteriovenous Fistula

What is this study about?

This study is about a particular treatment for a blood vessel problem called an arteriovenous fistula, often shortened to AV fistula. An AV fistula is a connection made by doctors between an artery and a vein, usually in the arm. It's often created for people who need regular kidney dialysis, as it provides a good way to access their bloodstream.

Sometimes, these AV fistulae can develop issues, such as narrowing or blockages, which can make them dysfunctional and harder to use for dialysis. When this happens, doctors need to treat the problem to keep the fistula working well. This study is looking at a new type of treatment using a special balloon called the Lutonix 035 Drug Coated Balloon. This balloon is coated with medicine that is released into the blood vessel when the balloon is inflated. The idea is that this medicine might help prevent the vessel from narrowing again after it's been widened.

This study, which is happening in different places around the world, including the UK, wants to better understand how safe and helpful this drug-coated balloon is in real-life situations. The information gathered will help doctors decide where and when this treatment might be most beneficial for patients whose AV fistulae are not working as they should. It's an important step in improving care for people who rely on these fistulae for their health.

Key takeaways

This study evaluates a special drug-coated balloon for AV fistula problems.
It aims to improve treatment for people with kidney disease needing dialysis.
The study looks at safety and how well the treatment works in real-life situations.
It's for people with AV fistulae in their arm that aren't working properly.
Participation involves a procedure and follow-up checks.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. If you're a woman, you shouldn't be pregnant or breastfeeding. You must have an AV fistula in your arm that isn't working properly and needs some treatment. Your doctor will use special guidelines to decide if your fistula is suitable.

The specific problem in your fistula must be treatable with the special drug-coated balloon, and it shouldn't be in a spot too high up in your shoulder area. Before using the special balloon, your doctor will first widen the narrowed part of your fistula with a standard, uncoated balloon. This must go smoothly, meaning there are no significant tears in the vessel and the narrowing is reduced by a lot.

There are also some reasons why you wouldn't be able to join. For example, if you're already in another medical study, have a severe allergy to the dye used in these procedures, or if your doctor believes another medical condition might make the study information unclear or mean you wouldn't be able to finish the study. Also, if your fistula has recently clotted or had surgery, or if the problem area is within a stent from a previous procedure, you wouldn't be eligible.

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?
Do you have an AV fistula in your arm that isn't working as it should?
Are you able to attend follow-up visits?
Are you able to have the narrowed part of your fistula widened successfully with a standard balloon first?
Are you not pregnant, breastfeeding, or allergic to contrast dye?
Have you not had recent surgery or a clot in your fistula (within the last month or week respectively)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, after you give your informed consent, your doctor will perform a procedure to treat your AV fistula using the special Lutonix drug-coated balloon. This involves guiding a thin tube with the balloon into your blood vessel and inflating it to widen the narrowed area. You'll then have follow-up visits with your doctor or the study team to check on how your fistula is doing and ensure you're recovering well. The total duration of your participation will involve the initial procedure and these planned follow-up appointments.

Potential risks and benefits

Taking part in this study means you might receive a new treatment that could potentially help keep your AV fistula working for longer compared to standard approaches. However, as with any medical procedure, there are potential risks, such as bleeding, infection, or damage to the blood vessel. The special balloon releases medicine, and there's always a small chance of unexpected reactions to new medicines. You will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Flowers Hospital
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Dothan, United States
St. Joseph Hospital of Orange
Verified postcode
Orange, United States
Kaiser Permanente
Verified postcode
San Diego, United States
Yale University
Verified postcode
New Haven, United States
University of Iowa Hospital and Clinics
Verified postcode
Iowa City, United States
University of Louisville
Verified postcode
Louisville, United States
Ochsner Health System
Verified postcode
New Orleans, United States
Ochsner Louisiana State University Health
Verified postcode
Shreveport, United States
MedStar Health Research Institute
Verified postcode
Annapolis, United States
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States
University of Michigan
Verified postcode
Ann Arbor, United States

Common questions

What is an AV fistula?

An AV fistula is a special connection made by doctors between an artery and a vein, usually in the arm, often for people who need kidney dialysis.

Why would my AV fistula need treatment?

Sometimes, an AV fistula can narrow or have other problems, making it difficult to use for dialysis. This study aims to find better ways to treat these issues.

What is a Drug Coated Balloon (DCB)?

It's a special balloon used during a procedure that has a medicine coating. When inflated, it releases this medicine into the blood vessel to help prevent it from narrowing again.

Is this a new treatment?

The Lutonix Drug Coated Balloon is being studied to understand its real-world safety and effectiveness for AV fistula problems in a wider group of patients after initial approval.

What happens if I decide not to join the study?

Your decision not to participate will not affect your regular medical care in any way. Your doctors will continue to provide the best treatment options available to you.