RecruitingOBSERVATIONAL

REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia

This study, called RESCUE, is looking into a new dissolving device for people with a serious leg circulation problem called chronic limb-threatening ischemia (CLTI). This condition means the blood flow to the lower leg is very poor, which can cause pain, wounds, or even lead to needing an amputation. The study is for people who have hardened arteries in the lower part of their leg, below the knee. The device, called an Esprit BTK scaffold, is designed to keep these arteries open and releases a medicine to stop them from narrowing again. What's special about it is that it dissolves over time, unlike permanent metal stents. Researchers want to see how well these dissolving scaffolds work in everyday medical care across Europe.

At a glance

Status

Recruiting

Sponsor

Cardiovascular and Interventional Radiological Society of Europe

Enrolment target

400

Start

31 Aug 2026

Estimated completion

01 Dec 2032

Chronic Limb Threatening Ischemia Chronic Limb-Threatening Ischemia

What is this study about?

RESCUE is an important study happening across Europe that’s looking for better ways to treat a serious condition called chronic limb-threatening ischemia, or CLTI. If you have CLTI, it means the blood flow to your lower leg and foot is very poor. This can cause severe pain, open sores that don't heal, or even put your limb at risk. Often, this is because the arteries in your legs have become very hard and blocked.

This study is focusing on people with particularly hardened arteries below the knee. Doctors will be using a special type of medical device called an Esprit BTK scaffold. This isn't a permanent metal tube like some stents. Instead, it's designed to give temporary support to the artery to keep it open. It also slowly releases a medicine that helps stop the artery from becoming narrow again after treatment, which is a common problem.

The unique thing about this scaffold is that it's made from a material that gradually dissolves and is absorbed by your body over time. This means there's nothing left permanently inside your artery. The study aims to understand how well these dissolving scaffolds work in a real-world medical setting and if they can offer a good long-term solution for people facing severe artery problems in their legs. Doctors hope this approach might lead to fewer complications compared to permanent devices.

Key takeaways

The study explores a dissolving device for severe leg circulation problems.
The device (scaffold) helps keep leg arteries open and releases medicine.
It naturally dissolves in the body, unlike permanent metal stents.
Aims to improve blood flow and reduce artery re-narrowing in the lower leg.
It's a Europe-wide study to see how well it works in real-life care.

Who may be eligible?

To be considered for this study, you would need to have severe chronic limb-threatening ischemia (CLTI), which your doctor will be able to confirm. The treatment involves using the Esprit BTK dissolving scaffold in the arteries below your knee. For this to be suitable, imaging tests like X-rays or special CT scans must show that these arteries are hardened or 'calcified'. Crucially, you must also be able and willing to fully understand the study and agree to take part.

There are several reasons why you might not be able to join the study. For example, if you are a child, pregnant, breastfeeding, or unable to give your consent freely. If the main artery supplying blood to your leg (the 'inflow' vessel) is very narrow, or if you don't have enough healthy smaller blood vessels in your lower leg, you might not be suitable. Also, if you've had a procedure on the same part of your leg within the last month, or if doctors are planning to amputate your leg above the ankle, this study would not be right for you. Finally, if you are already taking part in another specific study called ORACLE, you cannot join RESCUE.

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.

Do you have a severe blood circulation problem in your leg (CLTI)?
Have imaging tests shown hardened arteries below your knee?
Are you able to understand the study and agree to take part?
Have you not had a procedure on the same part of your leg in the last month?
Is your doctor planning to try and save your leg, rather than amputate it above the ankle?

Answer every question to see your result.

What does participation involve?

If you join the RESCUE study, you will receive the Esprit BTK dissolving scaffold as part of your treatment for chronic limb-threatening ischemia. The treatment itself involves a standard procedure to place the scaffold in your leg artery. After the procedure, you will have regular check-ups and assessments with the study team. These check-ups will involve doctors monitoring your progress and how well the scaffold is working. This may include follow-up appointments, physical examinations, and possibly further imaging tests. The study will follow you for a total duration to see the long-term effects of the dissolving scaffold. Your medical team will explain the full schedule of visits and what each involves.

Potential risks and benefits

Taking part in this study means you would be among the first to receive this new dissolving scaffold as part of your treatment, which could potentially offer a way to keep your leg arteries open without a permanent implant. It might lead to better blood flow and help with your symptoms. However, like any medical procedure, there are potential risks, such as bleeding, infection, or the possibility that the scaffold might not work as expected or the artery could still narrow again. You will be closely monitored, and your well-being is the top priority. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Hull University Teaching Hospitals NHS Trust
Verified postcode
Hull, United Kingdom· Recruiting

Common questions

What is chronic limb-threatening ischemia (CLTI)?

CLTI is a serious condition where there isn't enough blood flowing to your leg and foot, often due to blocked arteries. This can cause severe pain, open wounds, or put the limb at risk.

What is an Esprit BTK Everolimus Eluting Resorbable Scaffold?

It's a special medical tube that helps keep a narrowed artery open. It also releases medicine to prevent the artery from closing up again, and it dissolves naturally in your body over time.

Why use a dissolving scaffold instead of a permanent metal one?

Dissolving scaffolds provide temporary support, then disappear. This might reduce long-term risks associated with permanent metal stents, like blockages later on, and allow the artery to return to a more natural state.

Where in the leg is this treatment used?

This study specifically focuses on arteries in the lower leg, below the knee, in an area called the infrapopliteal arteries.

What if I decide I don't want to be in the study anymore?

You are free to leave the study at any time, for any reason. Your decision will not affect the quality of your medical care.

How to find out more

Claire Poulet, PhD

oracue@cirse.org +41 79 385 16 78 Official trial record

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