Active not recruitingNAINTERVENTIONAL

BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery

This study is looking at the best ways to treat Peripheral Arterial Disease (PAD), a condition where blood vessels in your legs become narrowed or blocked. It focuses on complex blockages in a main artery in your thigh. Doctors are comparing two different approaches: one uses special balloons coated with medicine to open the artery, trying to avoid putting in a permanent stent. The other approach uses stents, which are small mesh tubes, some of which also have medicine on them, to keep the artery open. This research aims to understand which method is more effective at keeping the artery open and which is safer for patients over time, ultimately helping doctors decide the best treatment for similar cases.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Leipzig

Enrolment target

120

Start

01 Jan 2019

Estimated completion

01 Jul 2026

Peripheral Arterial Disease

What is this study about?

This study, called BEST SFA, is investigating the best way to treat a common problem called Peripheral Arterial Disease (PAD). PAD happens when a major artery in your leg, specifically one called the superficial femoral artery (SFA), gets narrowed or blocked. This can reduce blood flow to your leg and affect your daily life.

Doctors often use procedures to open these blocked arteries, but for more complicated blockages, it's not always clear which method is best. This study is comparing two main strategies: one where doctors try to avoid leaving a permanent stent in your artery, often using special balloons coated with medicine to open the blockage. The other strategy involves using stents, which are small mesh tubes, to keep the artery open. Some of these stents also release medicine. The main goal is to see which approach works better at keeping the artery clear and which has fewer problems for patients, especially for complex blockages.

Understanding which treatment is better for these challenging blockages is very important. The results of this study will help healthcare professionals make more informed decisions about how to treat PAD in the future, aiming to improve outcomes and quality of life for many people living with this condition.

Key takeaways

Compares two treatments for complex leg artery blockages (PAD): medicine-coated balloons vs. stents.
Aims to find the most effective and safest approach for patients.
Involves a 2-year follow-up with regular check-ups and a 5-year phone follow-up.
Only for specific types of leg artery blockages in the thigh.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have Peripheral Arterial Disease (PAD) with a specific type of blockage in your thigh artery. The blockage must be quite significant and meet certain measurements. You shouldn't have had a stent in that exact spot before, and your doctor must think both treatment options in the study are suitable for you. Also, you need to have good blood flow to your ankle through at least one major blood vessel.

There are several reasons why you might not be able to join. For example, if the blocked artery can't be cleared with a guidewire, or if the artery shows very severe hardening (calcification) that makes a stent-avoiding approach difficult. You also can't be in the study if you have certain types of artery bulges (aneurysms), have fresh blood clots, or if you've recently had a stroke or heart attack. If you're involved in another medical study that might interfere or have a very short life expectancy, you also won't be able to participate.

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 Peripheral Arterial Disease (PAD) in your leg?
Has your doctor confirmed that both treatment options in the study are suitable for your specific blockage?
Do you have good blood flow from your ankle, and have you not had a stent in the area being studied before?
Have you not had a stroke or heart attack in the last 3 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two treatment groups: either the group trying to avoid a stent (using a medicine-coated balloon) or the group using a stent (which may also have medicine on it). You will have your procedure, and then you'll be carefully monitored for two years. This will involve follow-up visits at 6, 12, and 24 months after your procedure. During these visits, doctors will use a special ultrasound scan to check if your artery has remained open and to look for any major problems. You'll also have telephone check-ups at 1, 36, 48, and 60 months to keep track of your health. The total duration of active follow-up visits is 24 months, with longer-term telephone check-ins.

Potential risks and benefits

Participating in this study could offer the potential benefit of receiving one of two modern treatments for your Peripheral Arterial Disease, and you'll be closely monitored by medical professionals. However, like all medical procedures, there are potential risks involved with both types of treatments, such as discomfort, bleeding, infection, or the possibility that the artery might narrow again. Your medical team will discuss these in detail. You have the right to withdraw from the study at any time without affecting your standard medical care.

Locations (1)

University Clinic Leipzig
Verified postcode
Leipzig, Germany

Common questions

What is Peripheral Arterial Disease (PAD)?

PAD is a common condition where narrowed arteries reduce blood flow to your limbs, most commonly your legs. This can cause pain when walking or other symptoms.

What's the difference between 'stent-avoiding' and 'stent-based' treatments?

Stent-avoiding typically means using a special balloon coated with medicine to open the artery and relying on the artery to stay open without a permanent mesh tube. Stent-based means a small, permanent mesh tube (stent) is placed to hold the artery open, sometimes with medicine on it.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of the two groups, like flipping a coin. This helps doctors fairly compare the treatments.

How long will I be followed up?

You will have in-person follow-up visits for 24 months (2 years) and telephone check-ups for up to 60 months (5 years).

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, and this will not affect your future medical care.