Active not recruitingNAINTERVENTIONAL

SELUTION4SFA Trial

This research study, called SELUTION4SFA, is investigating a new treatment for a common problem called Peripheral Arterial Disease (PAD), which causes poor circulation, mainly in the legs. Specifically, it's looking at blockages in the main arteries of the upper leg (superficial femoral artery) and just behind the knee (proximal popliteal artery). The study compares a new device called SELUTION SLR™ 018 DEB, which is a special balloon that delivers medicine, with the usual balloon treatment (plain angioplasty) that doesn't deliver medicine. The main goal is to find out if the new treatment is both safe and more effective at keeping these arteries open. This information will help doctors decide on the best ways to treat PAD in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

M.A. Med Alliance S.A.

Enrolment target

300

Start

01 Dec 2022

Estimated completion

01 Dec 2030

Peripheral Arterial Disease Superficial Femoral Artery Stenosis

What is this study about?

Imagine the pipes that carry water around your house, sometimes they get blocked or narrowed, right? It's a bit similar with your body's blood vessels. Peripheral Arterial Disease (PAD) happens when the arteries in your legs, which carry blood from your heart, get narrowed or blocked. This can cause pain, especially when you walk, and in more serious cases, can lead to sores or other problems.

Doctors often treat these blockages by pushing them open with a small balloon, a procedure called angioplasty. This study is testing a new type of balloon called the SELUTION SLR™ 018 DEB. This special balloon does the same job of opening the artery, but it also delivers a medicine to the artery wall that helps prevent it from narrowing again. The study wants to see if this new balloon treatment works better and is safer than the standard balloon treatment without medicine.

By comparing these two treatments, researchers hope to find out if the SELUTION SLR™ 018 DEB could offer a better long-term solution for people with PAD, helping them to walk more easily and improve their quality of life. Knowing which treatment is more effective allows doctors to provide the best possible care.

Key takeaways

Tests a new 'drug-eluting balloon' for leg artery blockages.
Compares it to standard balloon treatment.
Aims to find out if the new treatment is safer and more effective.
For people with poor circulation (PAD) in their upper leg arteries.
Involves a single treatment and follow-up checks.
Participation helps improve future care for PAD patients.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with Peripheral Arterial Disease (PAD) and are experiencing symptoms like pain when walking. You need to be well enough to live for at least another year, in your doctor's opinion, and be able to walk without a walking frame. Participants must also be willing to follow all the study instructions and attend follow-up appointments.

For the treatment itself, the blockages or narrow areas in your leg arteries must be in specific locations (the main artery in your thigh or just behind your knee) and be of a certain size and type. The arteries leading to this area must also be healthy. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective contraception for 12 months after the treatment.

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) causing pain in your legs?
Can you walk without a walking frame?
Are you able and willing to attend follow-up appointments?
If you are a woman of childbearing potential, are you willing to use effective contraception for 12 months after the procedure?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either the new SELUTION SLR™ 018 DEB treatment or the standard balloon treatment. This is like flipping a coin, so neither you nor your doctor can choose which one you get. You'll undergo the procedure, and then attend follow-up appointments over time to see how well the treatment worked and how you are doing. For a small number of participants, there might be additional blood tests to understand how the medicine in the special balloon acts in the body. The total duration of your participation will involve the treatment day and subsequent follow-up visits, which will be explained in detail.

Potential risks and benefits

Taking part in a study means you might receive a new treatment that could be more effective than standard care, or you might help researchers learn more about your condition. However, there's no guarantee the treatment will work for you, and like any medical procedure, there are potential risks, such as bruising, bleeding, infection, or damage to the artery. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (38)

Arkansas Heart Hospital
Verified postcode
Little Rock, United States
Mission Cardiovascular Research Institute
Verified postcode
Fremont, United States
St. Helena Hospital
Verified postcode
St. Helena, United States
ClinRé
Verified postcode
Thornton, United States
Vascular Care Group
Verified postcode
Darien, United States
Manatee Memorial Hospital
Verified postcode
Bradenton, United States
The Cardiac and Vascular Institute Research Foundation
Verified postcode
Gainesville, United States
Memorial Healthcare System
Verified postcode
Hollywood, United States
First Coast Cardiovascular Institute
Verified postcode
Jacksonville, United States
Palm Vascular Centers
Verified postcode
Miami Beach, United States
Guardian Research Organization, LLC
Verified postcode
Winter Park, United States
Emory University Hospital
Verified postcode
Atlanta, United States

Common questions

What is Peripheral Arterial Disease (PAD)?

PAD is a condition where narrowed arteries reduce blood flow to your limbs, most commonly your legs, causing pain, especially when walking.

What is a 'drug-eluting balloon'?

It's a special type of balloon used during angioplasty that not only opens up a blocked artery but also delivers medicine to the artery wall to help keep it from narrowing again.

Will I know which treatment I'm getting?

Everyone in the main part of the study (except the doctors carrying out the actual procedure) won't know which treatment you are assigned to. This helps make the study fair and unbiased.

What does 'randomised' mean?

It means you'll be put into one of the treatment groups by chance, like drawing numbers from a hat. This helps ensure the study results are reliable.

How long will I be followed after the treatment?

The study will track your progress for a certain period after your treatment. The exact schedule of follow-up visits will be fully explained to you before you agree to participate.