Coronary Arterial Disease (CAD)ICECAPNCT06939374
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
A study testing Intracoronary Cryotherapy in people with Coronary Arterial Disease (CAD) and Plaque, run by Cryotherapeutics SA at 3 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Plaque, Vulnerable Plaque
- What is being tested?
- Intracoronary Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Mar 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
- Unstable angina
- 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:
Show all 18Show fewer
- 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
- Positive remodelling (remodelling index >1.1) and/or
- Napkin ring sign and/or
- Plaque burden ≥70%
- Lesion length ≤ 20 mm.
- Diameter stenosis on invasive angiography between 30% and 70% on coronary angiogram or negative physiology assessment (FFR>0.80 or NHPR>0.89).
- Reference vessel diameter (RVD) < 3.75 mm and > 2.50 mm in diameter
- Investigator considers that lesions are accessible.
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- Angiographic exclusion criteria:
- Visible distal embolization/no-reflow following culprit lesions PCI.
- Left main coronary artery disease (visual diameter stenosis > 50%).
- Stent thrombosis/restenosis as a culprit lesion.
- CTS lesion involving a bifurcation (defined as lesions involving side branches >2.0 mm).
- Angiographic or CCTA evidence of severe calcification and/or marked tortuosity of the index vessel and/or lesion.
- Thrombotic lesions.
- Ostial lesions.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
St Bartholomew's Hospital
London, EC1A 7BE
Dan Jones, MD, +44 20 7377 7000, dan.jones8@nhs.net
Dan Jones, MD
- Not yet recruiting
Royal Brompton Hospital
London, SW3 6NP
Ranil de Silva, MD, +44 20 7352 8121, ranil.desilva@nhs.net
Ranil de Silva, MD
Belgium1 site, 1 recruiting
- Recruiting
AZORG Aalst
Aalst, 9300
Adriaan Wilgenhof, MD, +32 53 72 49 96, adriaan.wilgenhof@azorg.be
Hilde Delacroix, RN, +32 53724168, hilde.deacroix@azorg.be
About this study
Official title: Clinical Investigation of the Efficacy and Safety of Intracoronary Cryotherapy Using the CryoTherapy System (CTS) for High-risk Plaque in Patients With Stable Angina or Acute Coronary Syndrome.
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.
Read the detailed description
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.
- Conditions
- Coronary Arterial Disease (CAD), Plaque, Vulnerable Plaque, Cryotherapy, Cryotherapy Effect, Coronary Balloon
- Being tested
- Intracoronary Cryotherapy
- Keywords
- Medical device, traditional feasibility, Single Group, Device Feasibility, Multi-Center, Prospective, Interventional
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary CryotherapyDevice
Intracoronary cryotherapy for stabilization of High-risk coronary plaque
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Subjects with coronary HRP lesions treated with intracoronary cryotherapy using the CTS device Receives: Device: Intracoronary Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint
Reduction of in maxLCBI4mm in the lesion measured by NIRS
Measured: At 9 months post-CTS procedure compared to baseline.
co-primary safety endpoint
Rate of Cryotherapy procedure related complications or MACE
Measured: at 30 days post procedure
Secondary outcomes (15)
Change in Fibrous Cap Thickness
Change in OCT-derived fibrous cap thickness
Measured: At 9 months post-CTS procedure compared to baseline
Change in Minimal Lumen Area (MLA)
Change in minimum lumen area (MLA) by OCT
Measured: At 9 months post-CTS procedure compared to baseline.
Prevalence of Thin Cap Fibrous Atheroma
Prevalence of thin cap fibroatheroma (minimum fibrous cap thickness < 65 µm with lipid arc > 90°) by OCT.
Measured: At 9 months post-CTS procedure compared to baseline.
Prevalence of lipid Arc >90°
Prevalence of lipid arc greater than 90° by OCT.
Measured: At 9 months post-CTS procedure compared to baseline.
Prevalence of lipid Arc >180°
Prevalence of lipid arc greater than 180° by OCT.
Measured: At 9 months post-CTS procedure compared to baseline.
Prevalence of lipid Arc >270°
Prevalence of lipid arc greater than 270° by OCT.
Measured: At 9 months post-CTS procedure compared to baseline.
Total angle of macrophage
Total angle of macrophage within the treated segment by OCT.
Measured: At 9 months post-CTS procedure compared to baseline.
Maximum angle of macrophage
Maximum angle of macrophage within the treated segment by OCT.
Measured: At 9 months post-CTS procedure compared to baseline.
Total angle of lipidic plaque
Total angle of lipidic plaque within the treated segment by OCT.
Measured: At 9 months post-CTS procedure compared to baseline.
Maximum angle of lipidic plaque
Maximum angle of lipidic plaque within the treated segment by OCT.
Measured: At 9 months post-CTS procedure compared to baseline.
Total angle of calcification
Total angle of calcification within the treated segment by OCT.
Measured: At 9 months post-CTS procedure compared to baseline.
Maximum angle of calcification
Maximum angle of calcification within the treated segment by OCT.
Measured: At 9 months post-CTS procedure compared to baseline.
Total Plaque volume
Total Plaque volume within the treated lesion segment assessed by CCTA
Measured: At 12 months post-CTS procedure compared to baseline.
Calcified Plaque volume
Calcified Plaque volume within the treated lesion segment assessed by CCTA
Measured: At 12 months post-CTS procedure compared to baseline.
Area stenosis
Area stenosis within the treated lesion segment assessed by CCTA
Measured: At 12 months post-CTS procedure compared to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Multi-Center, Interventional, Device Feasibility
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cryotherapeutics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CoreAalst BV
- Responsible party
- Sponsor
- Investigators
- Carlos Collet, MD, Study chair, Cardiovascular Research Foundation, New York, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939374
- Sponsor's protocol ID
- CT-CP-P01_0104
- Acronym
- ICECAP
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Efficacy and Safety of Intracoronary Cryotherapy Using the CryoTherapy System (CTS) for High-risk Plaque in Patients With Stable Angina or Acute Coronary Syndrome.
- ClinicalTrials.gov ID
- NCT06939374
- Acronym / sponsor ID
- ICECAP / CT-CP-P01_0104
- Conditions
- Coronary Arterial Disease (CAD), Plaque, Vulnerable Plaque, Cryotherapy, Cryotherapy Effect, Coronary Balloon
- Keywords
- Medical device, traditional feasibility, Single Group, Device Feasibility, Multi-Center, Prospective, Interventional
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cryotherapeutics SAIndustry (pharma, biotech, devices)
- Collaborators
- CoreAalst BV
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Multi-Center, Interventional, Device Feasibility
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Intracoronary CryotherapySubjects with coronary HRP lesions treated with intracoronary cryotherapy using the CTS device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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.
- Located in a non-culprit vessel,
- High-risk plaque lesion on CCTA and at least one of the following features:
- Lesion length ≤ 20 mm.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracoronary CryotherapyIntracoronary cryotherapy for stabilization of High-risk coronary plaque | Device | Treatment arm |
Primary outcome
Primary efficacy endpoint
Time frame: At 9 months post-CTS procedure compared to baseline.
Reduction of in maxLCBI4mm in the lesion measured by NIRS
co-primary safety endpoint
Time frame: at 30 days post procedure
Rate of Cryotherapy procedure related complications or MACE
15 secondary outcomes
Change in Fibrous Cap Thickness
Time frame: At 9 months post-CTS procedure compared to baseline
Change in Minimal Lumen Area (MLA)
Time frame: At 9 months post-CTS procedure compared to baseline.
Prevalence of Thin Cap Fibrous Atheroma
Time frame: At 9 months post-CTS procedure compared to baseline.
Prevalence of lipid Arc >90°
Time frame: At 9 months post-CTS procedure compared to baseline.
Prevalence of lipid Arc >180°
Time frame: At 9 months post-CTS procedure compared to baseline.
Prevalence of lipid Arc >270°
Time frame: At 9 months post-CTS procedure compared to baseline.
Total angle of macrophage
Time frame: At 9 months post-CTS procedure compared to baseline.
Maximum angle of macrophage
Time frame: At 9 months post-CTS procedure compared to baseline.
Total angle of lipidic plaque
Time frame: At 9 months post-CTS procedure compared to baseline.
Maximum angle of lipidic plaque
Time frame: At 9 months post-CTS procedure compared to baseline.
Total angle of calcification
Time frame: At 9 months post-CTS procedure compared to baseline.
Maximum angle of calcification
Time frame: At 9 months post-CTS procedure compared to baseline.
Total Plaque volume
Time frame: At 12 months post-CTS procedure compared to baseline.
Calcified Plaque volume
Time frame: At 12 months post-CTS procedure compared to baseline.
Area stenosis
Time frame: At 12 months post-CTS procedure compared to baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Arterial Disease (CAD)
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Collet, MD study chair
Cardiovascular Research Foundation, New York, USA
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracoronary Cryotherapy in people with Coronary Arterial Disease (CAD) and Plaque, run by Cryotherapeutics SA at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danny Detiege, RN (+32 467 02 47 73, dde@cryotherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint (time frame: At 9 months post-CTS procedure compared to baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.