RecruitingOBSERVATIONAL

ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia

The ORACLE study is a European trial for people who have a serious condition called Chronic Limb-Threatening Ischemia (CLTI). This is where blood flow to the legs and feet is severely reduced, which can cause pain, sores, and even put the limb at risk. The study is investigating a special procedure called orbital atherectomy (OA). This treatment uses a small, spinning device to carefully remove hard, calcium deposits from inside the leg arteries. The idea is that by clearing these blockages, other treatments, such as balloons or stents, will work more effectively to improve blood flow. The study aims to follow 250 people across Europe to see how well this orbital atherectomy device works in a real-world setting, particularly for those with very hardened arteries in their legs.

At a glance

Status

Recruiting

Sponsor

Cardiovascular and Interventional Radiological Society of Europe

Enrolment target

250

Start

31 Aug 2026

Estimated completion

01 Dec 2031

Chronic Limb Threatening Ischemia Chronic Limb-Threatening Ischemia

What is this study about?

This study, called ORACLE, is designed for people who have a severe problem with blood flow to their legs and feet. This condition is known as Chronic Limb-Threatening Ischemia, or CLTI. It means that the arteries (blood vessels) in the legs are very narrowed or blocked, often due to a build-up of hard material called calcium. This can cause severe pain, make wounds slow to heal, and put the leg at risk.

The main aim of the ORACLE study is to look at a specific treatment called orbital atherectomy (OA). This is a medical procedure where a special tool with a tiny, spinning head is carefully guided into the affected artery. Its job is to gently grind away and remove the hard calcium deposits that are blocking the blood flow. By clearing these blockages, the artery becomes more open, which can then help other treatments, like balloons (to push the artery open) or stents (small mesh tubes to keep it open), work much better.

This study will follow 250 people across Europe who are undergoing this procedure. Researchers want to understand how well orbital atherectomy works in real-life situations, especially for people whose leg arteries are very hardened with calcium. By gathering this information, doctors can learn more about how to best treat patients with CLTI and improve their outcomes.

Key takeaways

The ORACLE study is for people with severe leg circulation problems (CLTI).
It's looking at how well a procedure called orbital atherectomy works.
This procedure uses a spinning tool to clear hardened arteries in the legs.
The study aims to improve treatment options for people with very calcified arteries.
It is observing a treatment already used by doctors, not testing a new drug.

Who may be eligible?

To be considered for this study, you would generally need to have a serious form of reduced blood flow in your leg that is putting the limb at risk. This means you would likely be experiencing severe pain even at rest, or have non-healing sores or wounds on your foot or leg due to poor circulation. The doctors would need to see hardened, calcium deposits in the arteries of your upper or lower leg, which would be confirmed by scans like X-rays (fluoroscopy) or CT scans.

You would also need to be receiving the specific orbital atherectomy treatment as part of your care. Importantly, you must be able to understand the study and agree to take part freely. The study is open to adults aged 18 and over.

There are also some reasons why you might not be able to join. For example, if your leg has other serious blood flow issues that can't be fixed, or if you've recently had another procedure on the same part of your leg. You also wouldn't be able to take part if you are planning to have an amputation above the ankle on the affected leg, or if you are already involved in another specific study called 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 severe blood flow problems in your leg, causing pain or unhealed sores?
Has your doctor confirmed you have hardened, calcium blockages in your leg arteries?
Are you scheduled to have the orbital atherectomy procedure on your leg?
Are you 18 years old or older and able to give your consent?
Have you *not* had another procedure on the same part of your leg in the last 4 weeks?
Are you *not* planning to have an amputation above the ankle on the affected leg?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the ORACLE study, you would receive the orbital atherectomy procedure as planned by your doctor for your leg condition. The study would involve your medical information being collected before, during, and after this procedure, to see how well it worked for you. This might include details about your leg pain, wound healing, and any other treatments you receive for your leg condition. The study follows people over a period of time to track their progress. You wouldn't be asked to take any experimental medication, as the study is observing a procedure already in use. The specific number of follow-up visits or the total duration isn't detailed here, but generally, studies like this involve regular check-ups for several months or even a couple of years to monitor your health and the success of the treatment. You would be informed of the exact schedule before you agree to participate.

Potential risks and benefits

Taking part in a study like ORACLE means you are contributing valuable information that could help others with similar conditions in the future. The orbital atherectomy procedure is already a treatment used in practice, so you would be receiving care that your doctor believes is best for you. As with any medical procedure, there are potential risks, such as bleeding, infection, damage to the artery, or other complications. Your doctor will discuss all potential risks with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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 legs and feet. This can cause severe pain, wounds that won't heal, and in serious cases, can put your leg at risk.

What is orbital atherectomy?

It's a procedure that uses a tiny, spinning tool to gently remove hard, calcium blockages from inside your leg arteries, helping to improve blood flow.

Is orbital atherectomy a new, experimental treatment?

No, orbital atherectomy is a treatment already used by doctors. This study is observing how well it works in a real-world setting for people with severe blockages.

Will I get special treatment if I join this study?

You will receive the standard medical care your doctor recommends, including the orbital atherectomy procedure. The study primarily involves collecting information about your health and the treatment's results.

Who is running this study?

The study is being carried out across Europe and is looking at a device made by Abbott, a medical technology company.

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.