At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Intracoronary Cryotherapy (device)
- How long the study runs
- Study runs about 27 months (dates as stated)
- About the drug or intervention
- Intracoronary Cryotherapy — device: Intracoronary cryotherapy for stabilization of High-risk coronary plaque
- Patient visit burden
- Not specified by the sponsor
In plain English
This feasibility study is looking at whether freezing treatment (cryotherapy) can help stabilise risky patches of fatty build-up (called vulnerable plaque) in the heart arteries of people with coronary artery disease. It involves people who have chest pain (stable angina) or a heart attack (acute coronary syndrome) and who also have at least one risky plaque that has not yet caused symptoms. The freezing is delivered using a special coronary balloon during a heart procedure.
Who can take part
- Adults aged 18 or over
- Have chest pain or a heart attack (such as NSTEMI, unstable angina, or STEMI) and are due to have a coronary angiogram (a scan of the heart arteries)
- Have had a successful procedure (PCI, meaning a balloon or stent treatment) to open the artery that caused the problem, or are being treated with medicine instead
- Have at least one high-risk plaque in a different artery to the one that caused the problem, seen on a heart scan (CCTA, a type of CT scan)
- The risky plaque must be 20 mm or shorter, cause a 30–70% narrowing, and the artery must be between 2.50 mm and 3.75 mm wide
- Able to give informed consent by signing the form
Who may not be able to
- Are unstable, for example in cardiac shock, needing strong blood pressure medicines, breathing support, or having serious heart rhythm problems
- Are currently having a STEMI heart attack or had a complication during their heart procedure
- Have had heart bypass surgery (CABG) or are planning it within 12 months
- Have a weak heart pump (ejection fraction under 30%), severe heart valve disease, or severe kidney problems
- Have another serious illness giving a life expectancy under 12 months
- Are already taking part in another clinical trial that has not finished its main stage
- Have severe disease in the leg arteries that would block access through the groin artery
- Are pregnant, breastfeeding, or could become pregnant without effective contraception
- The risky plaque is in certain awkward places, such as at a branch point, at the very start of an artery, is heavily calcified, very twisted, or contains a blood clot, or there is disease in the left main heart artery
What taking part involves
- • Freezing treatment (cryotherapy) delivered to the risky plaque using a coronary balloon
- • Heart scans and tests, including a CT scan of the heart arteries (CCTA) and coronary angiogram, to check the plaque
Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and exactly what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 30
- Started
- 2025-03-01
- Last checked
- 2025-04
Plain English Summary
What is this study?
- • Testing a new treatment for coronary arterial disease (cad)
- • NA - 30 participants
- • ICECAP is a multi-centre, prospective, single-arm, interventional, traditional feasibility clinical investigation to evaluate the efficacy and safety of intra-coronary cryotherapy on vulnerable or high-risk plaque (HRP), using the CryoTherapy System (CTS)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with coronary arterial disease (cad)
Where?
- • London - St Bartholomew's Hospital
- • London - Royal Brompton Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
ICECAP is a multi-centre, prospective, single-arm, interventional, traditional feasibility clinical investigation to evaluate the efficacy and safety of intra-coronary cryotherapy on vulnerable or high-risk plaque (HRP), using the CryoTherapy System (CTS). The study aims to enroll 25 patients with symptomatic coronary artery disease, successfully treated for their culprit lesion and with presence of at least one HRP lesion in another vessel. Eligible patients will undergo cryotherapy during a planned procedure. Near-infrared spectrometry (NIRS and Optical Coherence Tomography imaging will be used during baseline procedure, and during a 9 months follow visit. The primary endpoint is reduction of plaque burden measured as 30% reduction in maxLCBI4mm as measured by NIRS at 9 months post procedure.
More detail
ICECAP is a multi-centre, prospective, single-arm, interventional, traditional feasibility clinical investigation to evaluate the efficacy and safety of intra-coronary cryotherapy on vulnerable or high-risk plaque (HRP), using the CryoTherapy System (CTS). The study aims to enroll 25 patients with stable angina or Acute Coronary Syndrome (ACS). Patients who have undergone successful treatment of their culprit lesion, and in whom presence of at least one non-flow-limiting HRP lesion in another vessel is identified (confirmed by Coronary Computed Tomography Angiography - CCTA), are eligible for the study. Eligible patients will undergo cryotherapy using the CTS during a planned procedure within maximum 8 weeks after eligibility has been confirmed. Near-infrared spectrometry (NIRS) and Optical Coherence Tomography (OCT) imaging will be used during baseline procedure, and during a 9 months angiographic follow visit. Clinical follow-up visits will be done at 1, 3, 6, 9 and 12 months post-procedure. The primary endpoint is reduction of plaque burden, defined as 30% reduction in maxLCBI4mm measured by NIRS at 9 months post procedure. Secondary efficacy endpoints include: changes in fibrous cap thickness assessed by OCT at 9 months post-procedure, changes in Plaque volume and plaque composition at 9 months post-procedure. Safety endpoints include procedural success rates, any cryotherapy related complication or any Major Adverse Cardiac Event (MACE) at 3 and 12 months post procedure. The enrolment period is expected to last 9 months, and all subjects will be followed for 12 months after the CTS procedure.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Unstable angina
- ✓4\) Subject has at least one high-risk plaque meeting the criteria below:
- ✓Located in a non-culprit vessel,
- ✓High-risk plaque lesion on CCTA and at least one of the following features:
- ✓Presence of low-attenuation plaque (HU\<50) and/or
Who cannot take part
- ✗1\) Subject is hemodynamically unstable (cardiogenic shock, hypotension needing inotropes, hypoxia needing...
- ✗9\) Subject is currently participating in another clinical investigation that has not yet reached its primary endpoint.
- ✗10\) Subject has severe peripheral vascular disease impeding femoral artery access.
- ✗Angiographic exclusion criteria:
- ✗Visible distal embolization/no-reflow following culprit lesions PCI.
See the full criteria
Where Is This Study? (2 UK sites)
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
Royal Brompton Hospital
London SW3 6NP, United Kingdom
How to Get in Touch
Danny Detiege, RN
Sponsor contactCONTACT
Elisa Rossetti, MSc, Biomedical engineering
Sponsor contactCONTACT
