RecruitingNAINTERVENTIONAL

Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study

This study, called ICECAP, is investigating a new treatment called 'intracoronary cryotherapy' (freezing) for people with coronary artery disease. This condition involves fatty build-ups, called plaques, in the heart's arteries. Some plaques are 'vulnerable,' meaning they are more likely to break off and cause a heart attack or other serious problems. The study aims to see if freezing these vulnerable plaques can make them more stable and less dangerous. Researchers will treat 25 patients with this cryotherapy after they've already had a blockage treated. They will use special imaging to check the plaques before and after treatment, and follow patients for 12 months to see if the treatment works and is safe. This is a first step to see if this new approach could help prevent future heart issues.

At a glance

Status

Recruiting

Phase

Sponsor

Cryotherapeutics SA

Enrolment target

Start

01 Mar 2025

Estimated completion

30 Jun 2027

Coronary Arterial Disease (CAD)Plaque Vulnerable Plaque Cryotherapy Cryotherapy Effect Coronary Balloon Atherosclerosis Coronary Artery With Angina Pectoris

What is this study about?

Heart disease, also known as coronary artery disease, happens when the arteries that supply blood to your heart become narrowed or blocked by fatty deposits called plaques. Sometimes, these plaques can be "vulnerable" or "high-risk." This means they are more likely to break open, leading to blood clots that can cause a heart attack or stroke. Currently, doctors treat blockages, but there's ongoing research into how to deal with these vulnerable plaques that haven't caused a major problem yet but could in the future.

This study, called ICECAP, is exploring a new technique called "intracoronary cryotherapy." 'Intracoronary' means inside the heart's arteries, and 'cryotherapy' means using very cold temperatures, like controlled freezing. The idea is that applying cold to these vulnerable plaques might make them stronger and less likely to break apart.

Researchers want to see if this freezing treatment can reduce the amount of plaque and make these areas more stable. They will use advanced imaging techniques during the procedure and again nine months later to see if the plaques have changed. This is a 'feasibility study,' which means it's a small, early investigation to see if this new treatment is safe enough and shows enough promise to be studied in larger groups of people in the future.

Key takeaways

The ICECAP study is testing a new 'freezing' treatment (cryotherapy) for vulnerable plaques in heart arteries.
It aims to see if freezing these plaques can make them more stable and reduce future heart problems.
Only 25 patients will take part, making it a small, early-stage study.
Participants must have recently had a heart blockage treated and have another high-risk plaque.
Special scans will be used to monitor the plaques before and after the treatment.
Patients will be followed for 12 months to assess safety and effectiveness.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with either stable angina (chest pain that doesn't change much over time) or acute coronary syndrome (a sudden type of heart problem like a heart attack or unstable angina). Crucially, you must have recently had a significant blockage in one of your heart arteries successfully treated. You also need to have at least one other fatty plaque in a different heart artery that hasn't caused a severe blockage yet, but which doctors consider "high-risk" or "vulnerable" based on special scans.

You would not be able to join the study if you are in a very unstable health condition, for example, if you need medication to support your blood pressure or breathing. There are also specific criteria about the size and type of the high-risk plaque your doctor has identified. The medical team will check all your health details and scans to see if you meet all the requirements for this study.

Quick self-check

Are you at least 18 years old?
Have you recently had a heart blockage treated successfully?
Do you have another 'high-risk' fatty plaque in a different heart artery?
Are you generally stable and not needing intensive medical support?
Are you able to attend follow-up visits for about 12 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have medical tests, including special scans of your heart, to confirm you meet all the study requirements. Within eight weeks of being confirmed eligible, you would undergo a planned procedure where the cryotherapy treatment is performed on your high-risk plaque. This involves using a tiny device to apply cold to the plaque inside your artery. During this procedure, and again nine months later, doctors will use special imaging called NIRS and OCT to take detailed pictures of the treated plaque.

After the procedure, you'll have follow-up clinic visits at 1, 3, 6, 9, and 12 months. These visits are to check on your general health and how you're feeling. You'll be part of the study for a total of about 12 months from when you have the cryotherapy procedure.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new treatment that could stabilise vulnerable plaques in your heart, possibly reducing your risk of future heart problems. However, because this is a new treatment being studied, there are also potential risks, including those associated with any heart catheterisation procedure (like bleeding, infection, or damage to blood vessels), and specific risks related to the cryotherapy itself, which the doctors will discuss with you. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

AZORG Aalst
Aalst, Belgium· Recruiting
St Bartholomew's Hospital
London, United Kingdom· Not yet recruiting
Royal Brompton Hospital
London, United Kingdom· Not yet recruiting

Common questions

What is a 'vulnerable plaque'?

A vulnerable plaque is a fatty build-up in a heart artery that hasn’t caused a major blockage but is considered high-risk because it could break open and cause a heart attack or stroke.

What is cryotherapy?

Cryotherapy involves using very cold temperatures to treat specific areas. In this study, it's used inside a heart artery to potentially stabilise a vulnerable plaque.

Will I receive new medication in this study?

This study focuses on a procedure (cryotherapy), not new medications. Your current medications for heart disease would continue as usual.

How long will I be in the study?

You will be followed for 12 months after the cryotherapy procedure, with a number of clinic visits during that time.

Is this treatment available to everyone?

No, this is an investigational treatment being tested in a small study. It's not yet available for general use outside of clinical trials.

How to find out more

Danny Detiege, RN

dde@cryotherapeutics.com +32 467 02 47 73 Official trial record

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