Active not recruitingOBSERVATIONAL

SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries

This research study, called the SIGNATURE Study, is looking into better ways to treat a common problem where arteries in the legs become narrowed or blocked, a condition known as Peripheral Arterial Disease (PAD). Specifically, it's comparing two types of balloons used to open these blocked arteries: the Legflow DCB, which is a drug-coated balloon, and a standard balloon angioplasty (POBA). The main goal is to see if the drug-coated balloon is more effective and safer at keeping the arteries open and improving blood flow for patients who have symptoms like leg pain when walking. Participants will be randomly assigned to receive one of these two treatments.

At a glance

Status

Active not recruiting

Sponsor

Cardionovum GmbH

Enrolment target

150

Start

08 Jun 2022

Estimated completion

01 Jan 2028

Peripheral Arterial Disease Superficial Femoral Artery Stenosis Angiopathy, Peripheral

What is this study about?

This study is for people who have Peripheral Arterial Disease (PAD), which means the blood vessels in their legs are narrowed or blocked. This can cause pain, cramping, or tiredness in the legs, especially when walking, because not enough blood is getting to the muscles. The study is particularly focused on blockages in the main artery that runs down the thigh (called the superficial femoral artery) and just above the knee (the popliteal artery).

Doctors often use a procedure called angioplasty to open these blocked arteries. This involves inserting a tiny balloon into the artery and inflating it to push the blockage aside. This study is comparing a new type of balloon, called a drug-coated balloon (Lefglow DCB), with the standard balloon (POBA). The drug-coated balloon releases medicine directly into the artery wall to help prevent it from narrowing again after the procedure.

The main purpose of the SIGNATURE Study is to see if the drug-coated balloon is better than the standard balloon. 'Better' means it's safer, has fewer side effects, and is more effective at keeping the artery open for longer, helping to improve blood flow and reduce leg symptoms. Participants in the study will be randomly assigned to receive either the drug-coated balloon or the standard balloon, allowing doctors to fairly compare the results of both treatments.

Key takeaways

This study compares two balloon treatments for blocked leg arteries.
It aims to see if a drug-coated balloon (Lefglow DCB) is better than a standard balloon.
The study is for people with Peripheral Arterial Disease in their upper leg.
Participants are randomly assigned to one of the two treatments.
Regular follow-up appointments are part of the study.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with Peripheral Arterial Disease (PAD) causing symptoms like leg pain when walking or even at rest. The blockages in your leg arteries must be in specific locations in your thigh and around your knee, and they should be between 4mm and 7mm wide, and no longer than 15cm. If you've had a balloon treatment before, there are specific timeframes you need to meet before you can be considered.

You would not be able to join if you have a severe, sudden lack of blood flow to your leg (acute limb ischemia). Also, if you've had any recent treatment on the affected leg artery within the last 3 months, or if you've had a previous angioplasty with a standard balloon within the last 3 months for that leg, you wouldn't be eligible. The medical team will check for healthy blood flow before and after the blocked section of your artery to make sure the treatment can be effective.

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 leg pain or discomfort from blocked arteries?
Has it been more than 3 months since any previous balloon treatment on your affected leg artery?
Is the blocked artery in your upper leg or around your knee?
Do you have good blood flow into and out of the blocked section of your artery?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first have some tests to confirm you meet all the requirements. Then, you'll be randomly assigned to receive either the coated balloon or the standard balloon treatment. The procedure itself is similar to a standard angioplasty, where a thin tube is inserted into your artery, and the balloon is used to open the blockage. After the procedure, you'll have scheduled follow-up visits with the study team. These visits will involve check-ups and tests to see how your artery is healing and how your symptoms are improving. The exact number and timing of these visits will be explained by the study team, but they are crucial for monitoring your progress and for the study to gather all necessary information.

Potential risks and benefits

Participating in this study might offer you access to a new treatment approach that could potentially be more effective than standard care for your blocked leg arteries. However, all medical procedures carry risks, including bleeding, infection, and potential damage to the artery. Being part of a study means you'll undergo careful monitoring, which can be beneficial. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Coris Medicina Vascular
Verified postcode
Florianópolis, Brazil
Hospital Universitario da Universidade Federal de Santa Cataria
Verified postcode
Florianópolis, Brazil
Sankt Gertrauden-Krankenhaus Berlin
Verified postcode
Berlin, Germany
Kreiskrankenhaus Alsfeld
Verified postcode
Alsfeld, Germany
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
Verified postcode
Hamburg, Germany
Universitätsklinikum Heidelberg
Verified postcode
Heidelberg, Germany
SRH Klinikum Karlsbad-Langenseinbach GmbH
Verified postcode
Karlsruhe, Germany
St. Franziskus-Hospital GmbH
Verified postcode
Münster, Germany
GRN-Klinik Weinheim
Verified postcode
Weinheim, Germany
Inselspital, Universitätsspital Bern
Verified postcode
Bern, Switzerland
Hôpital de la Providence
Verified postcode
Neuchâtel, Switzerland

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.

What is a 'drug-coated balloon'?

It's a special balloon used during angioplasty that has medicine on its surface. When it's inflated in the artery, it releases this medicine to help keep the artery from narrowing again.

What's the difference between this study and standard treatment?

This study is comparing a new type of balloon treatment (drug-coated) with the standard balloon treatment to see if the new one works better and is safer.

Will I know which treatment I'm getting?

Because this is a randomised study, you will be assigned to either the drug-coated balloon or the standard balloon by chance, and you might not know which one you're receiving at the time of treatment, and neither will your doctor.

How long will I be involved in the study?

The study involves initial treatment followed by regular check-ups over a period of time. The exact duration will be explained by the study team.