Active not recruitingNAINTERVENTIONAL

Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease

This study is looking into a new way to treat Peripheral Artery Disease (PAD), a condition where arteries in the legs become narrowed, reducing blood flow. Researchers are comparing two methods: a standard balloon treatment (angioplasty) and a new type of angioplasty that uses a balloon coated with a special medicine called sirolimus. The main goal is to find out if the medicine-coated balloon is more effective at keeping the arteries open and just as safe as the standard method for people with serious PAD affecting the arteries below the knee. This is a randomised study, meaning participants will be assigned to one treatment or the other at random.

At a glance

Status

Active not recruiting

Phase

Sponsor

Jena University Hospital

Enrolment target

230

Start

10 Feb 2022

Estimated completion

17 Nov 2028

Peripheral Artery Disease

What is this study about?

Peripheral Artery Disease (PAD) is a common condition where a build-up of fatty deposits in the arteries reduces blood flow to the legs and feet. For some people, PAD can become very serious, leading to chronic limb-threatening ischaemia (CLTI). This means the blood supply is so poor that it causes ongoing pain, sores, or even tissue damage that won't heal, often in the lower leg and foot.

One common treatment for PAD is angioplasty, where a tiny balloon is inflated inside the narrowed artery to widen it. This study is comparing a standard angioplasty balloon with a new kind of balloon that is coated with a medicine called sirolimus. The idea is that this medicine might help prevent the artery from narrowing again after the procedure. Researchers want to see if this special balloon is better at keeping the arteries in the lower leg open for longer and if it's just as safe as the standard balloon.

By taking part in this study, you would help doctors understand the best ways to treat severe PAD in the arteries below the knee. This could lead to better treatments for many people in the future who suffer from this condition. It's important to remember that this is a research study, and you'll be helping to advance medical knowledge.

Key takeaways

Compares two treatments for narrowed leg arteries.
One treatment uses a standard balloon, the other a medicine-coated balloon.
Aims to find out which is safer and more effective for severe PAD.
Involves a common procedure called angioplasty.
Participation will help improve future treatments for serious leg conditions.

Who may be eligible?

To be able to take part in this study, you would need to be at least 18 years old and have a confirmed diagnosis of severe Peripheral Artery Disease (PAD) in the arteries below your knee. This severe stage is often called chronic limb-threatening ischemia (CLTI), which means you might have ongoing foot pain at rest, or unhealing wounds or sores on your foot or leg that are caused by poor blood flow. If you have wounds, they must not be severely infected.

Your doctor would also check that the narrowed part of your artery is within a specific size range (between 2mm and 4mm wide) and that the blockage is at least 75% narrowed or completely blocked. For women who could become pregnant, you would need to have a negative pregnancy test shortly before the procedure and agree to use reliable birth control during the study. You should also be expected to live for at least another year, in your doctor's opinion, to properly follow the study’s progress. Importantly, you must be willing to attend all follow-up appointments and understand what the study involves before you agree to take part.

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 a severe leg artery blockage (CLTI) below the knee?
If you have wounds, are they not severely infected?
Are you willing and able to attend all follow-up appointments?
For women, are you able to use reliable birth control during the study if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a special procedure where a thin tube with a balloon on the end is guided into the narrowed artery in your leg. This will either be a standard balloon or a balloon coated with medicine, decided randomly, like flipping a coin. You will have regular check-ups and assessments afterwards to see how your leg is healing and if the treatment has worked. This will involve visits to the clinic over a period of time, though the exact number and frequency of visits aren't detailed here. The study aims to follow participants to see the long-term effects of the treatment. All specific details about follow-up appointments and what they involve would be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a treatment that could be more effective at keeping your leg arteries open and improving your condition. However, there's also the chance you might receive the standard treatment, and even with the new treatment, there's no guarantee of a better outcome. Risks are similar to those of any angioplasty procedure, such as bleeding, infection, or damage to the artery, though the study aims to ensure both treatments are safe. You are free to withdraw from the study at any time, for any reason, and this will not affect your future medical care.

Locations (19)

AKH Wien, Universitätsklinik für Innere Medizin II, Klinische Abteilung für Angiologie
Verified postcode
Vienna, Austria
Hanusch-Krankenhaus
Verified postcode
Vienna, Austria
University Hospital Tuebingen, Diagnostic and Interventional Radiology
Verified postcode
Tübingen, Germany
Universitätsklinikum Hamburg-Eppendorf, Universitäres Herz- und Gefäßzentrum Hamburg, Klinik und Poliklinik für Gefäßmedizin
Verified postcode
Hamburg, Germany
Heart and Diabetes Center North Rhine Westphalia, Clinic for General and Interventional Cardiology/Angiology
Verified postcode
Bad Oeynhausen, Germany
Universitäts-Herzzentrum Freiburg-Bad Krozingen; Clinic for Cardiology and Angiology II
Verified postcode
Bad Krozingen, Germany
Universitätsklinikum Brandenburg, Abteilung für Innere Medizin 1, Hochschulklinik für Angiologie
Verified postcode
Brandenburg, Germany
Sana Kliniken Oberfranken Coburg
Verified postcode
Coburg, Germany
DIAKO gGmbH, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie
Verified postcode
Flensburg, Germany
Universitätsklinikum Heidelberg, Medizinische Klinik III, Kardiologie, Angiologie und Pneumologie
Verified postcode
Heidelberg, Germany
Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie
Verified postcode
Jena, Germany
University Hospital Leipzig
Verified postcode
Leipzig, Germany

Common questions

What is Peripheral Artery Disease (PAD)?

PAD is a condition where arteries in the legs become narrowed due to fatty deposits, reducing blood flow to your muscles and feet.

What is angioplasty?

Angioplasty is a procedure where a small balloon is used to open up narrowed or blocked arteries, improving blood flow.

What's the difference between the two treatments in this study?

One treatment uses a standard balloon, and the other uses a balloon coated with a special medicine called sirolimus, which might help prevent the artery from narrowing again.

Will I know which treatment I get?

No, you will be randomly assigned to one treatment or the other, like drawing lots, and you won't know which you received until after the study is over.

What if I change my mind about taking part?

You can withdraw from the study at any time, for any reason, and your decision will not affect your medical care.