Not yet recruitingNAINTERVENTIONAL

DRug-Eluting BallOOn Versus Primary Polymer-coated Paclitaxel Eluting STenting for Femoro-popliteal Lesions

This research is looking at two ways to treat narrowed or blocked leg arteries (femoro-popliteal lesions), which can cause pain or difficulty walking. One method uses a 'drug-coated balloon' (DCB) to open the artery and deliver medicine. The other uses a 'drug-eluting stent' (SEDES), which is a small mesh tube that stays in place and releases medicine. The main goal is to find out if the drug-coated balloon treatment is just as good as the drug-eluting stent at keeping the artery open for at least a year. The study will also look at safety, how well the treatments work over longer periods, and their effect on quality of life.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

402

Start

01 May 2025

Estimated completion

01 Dec 2028

Femoropopliteal Lesion

What is this study about?

Imagine your leg arteries are like pipes that carry blood to your muscles. Sometimes, these pipes can get narrowed or blocked, often due to a condition called peripheral arterial disease. This can cause pain, especially when walking. Doctors have different ways to try and open these blockages.

This study is comparing two common treatments for these blocked leg arteries, specifically in the area above the knee. One treatment uses a special balloon coated with medicine, called a 'drug-coated balloon' (DCB). This balloon is inflated inside the artery to open it up, and the medicine helps prevent it from narrowing again. The other treatment uses a 'drug-eluting stent' (SEDES), which is like a tiny, mesh tube that is left in the artery to keep it open and slowly releases medicine.

Both of these treatments have been shown to work well. However, doctors aren't sure which one is better in the long run, or if one is just as good as the other. For example, a stent stays in your body permanently, which can sometimes lead to issues later. A drug-coated balloon leaves nothing behind in the artery, but sometimes the artery might narrow again early on. This study aims to directly compare these two approaches to help doctors understand the best way to treat these blockages, making sure people get the most effective and safe treatment possible.

Key takeaways

This study compares two treatments for blocked leg arteries: drug-coated balloons and drug-eluting stents.
The main goal is to see if drug-coated balloons work just as well as stents in keeping arteries open for a year.
Participation involves a procedure and follow-up visits over two years.
The study aims to improve understanding of the best treatment for leg artery disease.
Your health and quality of life will be checked regularly during the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with narrowing or blockages in the main artery above your knee (femoro-popliteal lesion). Your symptoms should be causing you moderate to severe pain when walking, or even pain at rest, and your doctor must be able to confirm that the blood flow to your lower leg and ankle is sufficient from at least one artery.

You wouldn't be able to join if you're pregnant or breastfeeding, or if you have certain medical conditions like clotting disorders or severe allergies to specific medicines (like paclitaxel) or materials (like nitinol) used in the treatments. Also, if you need other major artery procedures at the same time, or if your artery is completely blocked and too difficult to pass a wire through, you wouldn't be suitable for this study. The study also cannot include individuals who have previously had a bypass surgery in the same leg or have already received a drug-eluting stent in the affected area.

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 narrowing or blockages in your leg artery above the knee?
Are your symptoms causing you pain when walking or at rest?
Are you able to take blood-thinning medication if needed?
Are you *not* pregnant or breastfeeding?
Have you *not* had a bypass surgery or a drug-eluting stent in the affected leg before?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a medical check-up to see if the study is right for you. If you qualify and agree to participate, you'll be assigned to receive either the drug-coated balloon or the drug-eluting stent procedure. Doctors will make sure you receive the correct treatment based on the study design.

After your procedure, you'll have several follow-up appointments over two years. These visits will typically happen at 1, 6, 12, 18, and 24 months. During these visits, the medical team will check your leg using an ultrasound scan, assess your walking ability, and ask you about your general health and quality of life. This helps them understand how well the treatment is working and if there are any issues. The study will continue for a total of two years from your procedure.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from close medical monitoring and receiving one of two established treatments for your condition. However, there are potential risks associated with any medical procedure, such as bleeding, infection, or complications related to the devices used. The research team will explain all known risks specific to your situation. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP
Verified postcode
Boulogne-Billancourt, France

Common questions

What is a 'femoro-popliteal lesion'?

It's a medical term for narrowing or blockages in the main artery that runs from your thigh down behind your knee.

What's the difference between a drug-coated balloon and a drug-eluting stent?

A drug-coated balloon opens the artery and leaves medicine behind, but doesn't leave a permanent device. A drug-eluting stent is a small mesh tube that stays in the artery and slowly releases medicine.

Why are they doing this study?

Doctors want to find out which of these two common treatments is better or if they are equally effective at keeping leg arteries open and improving patients' health.

Will I know which treatment I receive?

In this type of study, you will know which procedure you receive (either the balloon or the stent) as it's a direct comparison.

How long will I be involved in the study?

If you participate, you'll be followed up by the study team for two years after your procedure.

How to find out more

Raphaël COSCAS, MD, PhD

raphael.coscas@aphp.fr + 33 1 49 09 55 85 Official trial record

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