NCT06939374 Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
| NCT ID | NCT06939374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cryotherapeutics SA |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-03-01 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility 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.
Contact & Investigator
Carlos Collet, MD
STUDY CHAIR
Cardiovascular Research Foundation, New York, USA
Frequently Asked Questions
Who can join the NCT06939374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06939374 currently recruiting?
Yes, NCT06939374 is actively recruiting participants. Contact the research team at dde@cryotherapeutics.com for enrollment information.
Where is the NCT06939374 trial being conducted?
This trial is being conducted at Aalst, Belgium, London, United Kingdom, London, United Kingdom.
Who is sponsoring the NCT06939374 clinical trial?
NCT06939374 is sponsored by Cryotherapeutics SA. The principal investigator is Carlos Collet, MD at Cardiovascular Research Foundation, New York, USA. The trial plans to enroll 30 participants.