RecruitingNAINTERVENTIONAL

Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant

This study is designed for people who experience leg pain when walking, a condition often called "intermittent claudication." This pain happens when arteries in the legs become narrowed or blocked, particularly in an artery called the superficial femoral artery. If you have a long blockage (between 15 and 25 cm) in this artery, you might be eligible. The study aims to compare two common treatments: bypass surgery and a less invasive procedure called an endovascular procedure (which involves clearing the blockage from inside the artery, often using a balloon or stent). Currently, we don't have enough clear evidence comparing these two options for long blockages, so this study is important to find out which one offers the best long-term results for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

290

Start

20 Jan 2025

Estimated completion

20 May 2030

Lesion; Femoral

What is this study about?

If you experience leg pain, cramping, or tiredness when you walk, it could be due to a condition where the arteries in your legs become narrowed or blocked. This is often called peripheral arterial disease (PAD). This study focuses on a specific type of blockage in a major leg artery called the superficial femoral artery, especially when these blockages are quite long (between 15 and 25 centimetres, which is about 6 to 10 inches).

Doctors have two main ways to treat these kinds of blockages: one is a surgical bypass, where they create a new route for blood to flow around the blockage. The other is a less invasive 'endovascular' procedure, where they typically use a thin tube (catheter) to go inside the artery and clear the blockage, possibly using a balloon to open it or a small mesh tube (stent) to keep it open. Both of these treatments are used regularly, but for longer blockages, we don't have enough research directly comparing them to see which one works better in the long run.

This is why this study is so important. It aims to directly compare these two treatment options for long blockages in the superficial femoral artery. By doing this, we hope to gain clearer evidence about which procedure offers the best outcomes for patients, helping doctors make more informed decisions about treatment plans in the future. Your participation could help improve care for many people with this condition.

Key takeaways

This study compares bypass surgery vs. a less invasive procedure for leg artery blockages.
It targets long blockages (15-25 cm) in the superficial femoral artery.
The goal is to find out which treatment works best for these specific blockages.
Participation involves being randomly assigned to one of the two treatments.
Studies like this help doctors improve future treatments for leg pain when walking.

Who may be eligible?

To join this study, you must be an adult aged 18 or over. You should have leg pain when walking (what doctors call 'intermittent claudication') due to a blockage in your superficial femoral artery, which is a specific artery in your leg. This blockage needs to be between 15 and 25 centimetres long. It's important that you could have either a bypass operation or the less invasive endovascular procedure, and that the blood flow to your leg from higher up in your body (your 'iliac flow') is good or has been fixed.

You also need to have at least one working artery below your knee. If you are a woman who could become pregnant, you must agree to use effective contraception throughout the study. We also need you to understand what the study involves and sign a form to show you agree to take part. The study cannot include you if you are pregnant or breastfeeding, or if you've already had surgery or a stent in the affected artery in your leg. Additionally, certain existing medical conditions or allergies, like severe kidney problems or an allergy to certain dyes used in scans, might prevent you from joining.

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 experience leg pain when walking because of a blocked leg artery?
Has your doctor told you the blockage is in your superficial femoral artery and is quite long (15-25 cm)?
Are you able to have both bypass surgery and the less invasive endovascular procedure?
If you're a woman who could become pregnant, are you able to use reliable contraception during the study?
Are you willing to participate and sign an informed consent form?

Answer every question to see your result.

What does participation involve?

The specific details of your participation, including the number of visits, what assessments you'll have, medications, and follow-up, will be fully explained by the study team. However, generally, if you join this study, you will be assigned to receive either the bypass surgery or the endovascular procedure for your leg blockage. This decision will be made randomly, like flipping a coin, to ensure a fair comparison between the treatments.

You will have several appointments for check-ups and tests both before and after your procedure. These follow-up appointments are crucial for the research team to monitor how well each treatment works over time. You will be told exactly how long you need to be followed up, which will typically involve visits to the clinic and possibly some scans or other tests to check the blood flow in your leg. You will also be given clear instructions regarding any medication you need to take, such as blood thinners. The total duration of your participation could span several months or even a few years, depending on the long-term follow-up plan for the study.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving state-of-the-art treatment for your leg condition and closely monitored medical care. You'll be helping doctors learn more, which could improve treatments for future patients. However, as with any medical procedure, there are potential risks associated with both bypass surgery and endovascular procedures, including infection, bleeding, or issues with anaesthesia. The study team will explain all the specific risks related to your assigned procedure. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

CHU - Hôpitaux de Bordeaux
Verified postcode
Bordeaux, France· Active not recruiting
Hôpital Ambroise Paré, APHP
Verified postcode
Boulogne-Billancourt, France· Active not recruiting
Hôpital de la Cavale Blanche
Verified postcode
Brest, France· Active not recruiting
Centre hospitalier René Dubos
Verified postcode
Cergy-Pontoise, France· Active not recruiting
Hôpital Henri Mondor, APHP
Verified postcode
Créteil, France· Recruiting
Hôpital François Mitterrand
Verified postcode
Dijon, France· Recruiting
Hôpital Edouard Herriot
Verified postcode
Lyon, France· Active not recruiting
Hôpital de la Timone, APHP
Verified postcode
Marseille, France· Not yet recruiting
CHU de Nice
Verified postcode
Nice, France· Active not recruiting
CHU Carémeau
Verified postcode
Nîmes, France· Not yet recruiting
Hôpital Européen Georges Pompidou, APHP
Verified postcode
Paris, France· Active not recruiting
Hôpital Bichat - Claude Bernard, APHP
Verified postcode
Paris, France· Active not recruiting

Common questions

What is 'intermittent claudication'?

It's a type of leg pain, aching, or cramping that you feel when you walk or exercise, which usually goes away when you rest. It happens because there isn't enough blood flow to your leg muscles.

What is the 'superficial femoral artery'?

This is one of the main blood vessels that runs down your thigh, carrying blood to your lower leg and foot. If it gets blocked, it can cause the leg pain mentioned above.

What's the difference between bypass surgery and an endovascular procedure?

Bypass surgery involves creating a new path for blood to flow around the blockage, using either a part of another blood vessel from your body or a synthetic tube. An endovascular procedure is less invasive, using thin wires and tubes inserted into the artery, often to clear the blockage with a balloon or hold it open with a small mesh tube called a stent.

Will I get to choose which treatment I receive?

No, if you join the study, the treatment you receive (bypass or endovascular) will be chosen randomly, like drawing lots. This helps ensure the study results are fair and unbiased.

Why is this study important?

Currently, doctors don't have enough clear evidence comparing these two treatments for long blockages in the leg artery. This study aims to find out which treatment gives the best long-term results, helping improve future care for people with this condition.

How to find out more

Joseph TOUMA, MD, PhD

joseph.touma@aphp.fr + 33 6 30 03 10 93 Official trial record

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