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

Sponsor: Cryotherapeutics SA

NCT ID: NCT06939374

View on ClinicalTrials.gov ↗

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.

Coronary Arterial Disease (CAD)PlaqueVulnerable PlaqueCryotherapyCryotherapy EffectCoronary BalloonAtherosclerosis Coronary Artery With Angina Pectoris

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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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

angiogram or negativeeGFR

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
Inclusion Criteria: * 1\) Subject is at least 18 years old. 2) Subject has acute cardiac pain/angina consistent with stable angina or acute coronary syndrome eligible for coronary angiography meeting one of the following criteria: 1. Non-ST-segment elevation myocardial infarction (NSTEMI) with rise/fall of cardiac enzymes (troponin I or T) with at least one value above the 99th percentile of the upper reference limit requiring PCI within 72 hours from diagnosis 2. Unstable angina 3. ST-segment elevation myocardial infarction (STEMI) 3) Successful PCI (defined as diameter stenosis less than 30% and TIMI 3 flow on final angiography without procedural complication) of the culprit lesion. NOTE: subjects with unstable angina, for whom the culprit lesion as assessed by investigator does not require PCI currently or within the next 6 months (subject treated with optimal medical treatment) can be enrolled in the study. 4\) Subject has at least one high-risk plaque meeting the criteria below: 1. Located in a non-culprit vessel, 2. High-risk plaque lesion on CCTA and at least one of the following features: 1. Presence of low-attenuation plaque (HU\<50) and/or 2. Positive remodelling (remodelling index \>1.1) and/or 3. Napkin ring sign and/or 4. Plaque burden ≥70% 3. Lesion length ≤ 20 mm. 4. Diameter stenosis on invasive angiography between 30% and 70% on coronary angiogram or negative physiology assessment (FFR\>0.80 or NHPR\>0.89). 5. Reference vessel diameter (RVD) \< 3.75 mm and \> 2.50 mm in diameter 6. Investigator considers that lesions are accessible. 7. If more than two suitable lesions available, investigator will select the most appropriate lesion for cryotherapy treatment. 5\) maxLCBI4mm in the lesion \> 324.7 6) Subject is able to provide consent and has signed and dated the informed consent form. Exclusion Criteria: * 1\) Subject is hemodynamically unstable (cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, refractory ventricular arrhythmias, and IABP). 2\) Subject has ongoing ST-segment elevation myocardial infarction. 3) Subject had a procedural complication during the ACS PCI procedure. 4) Subject has history of Coronary Artery Bypass Graft (CABG) or planned CABG within 12 months after the index procedure. 5\) Subject has known reduced Left Ventricular Ejection Fraction \< 30%. 6) Subject has known severe valvular heart disease. 7) Subject has known severe renal insufficiency (eGFR \<30 ml/min/1.72 m2). 8) Subject has any life-threatening conditions or medical comorbidity resulting in life expectancy \< 12 months. 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. 11\) Subject is pregnant or lactating, or NOT surgically sterile (tubal ligation or hysterectomy) or NOT postmenopausal for at least 6 months or is a female with childbearing potential without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device). Angiographic exclusion criteria: 1. Visible distal embolization/no-reflow following culprit lesions PCI. 2. Left main coronary artery disease (visual diameter stenosis \> 50%). 3. Stent thrombosis/restenosis as a culprit lesion. 4. CTS lesion involving a bifurcation (defined as lesions involving side branches \>2.0 mm). 5. Angiographic or CCTA evidence of severe calcification and/or marked tortuosity of the index vessel and/or lesion. 6. Thrombotic lesions. 7. Ostial lesions.

Where Is This Study? (2 UK sites)

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Dan Jones, MDPrincipal Investigator

Royal Brompton Hospital

London SW3 6NP, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Ranil de Silva, MDPrincipal Investigator

How to Get in Touch

Danny Detiege, RN

Sponsor contact

CONTACT

+32 467 02 47 73 dde@cryotherapeutics.com

Elisa Rossetti, MSc, Biomedical engineering

Sponsor contact

CONTACT

+3242644773 ero@cryotherapeutics.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-04