Actively Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Led by Cryotherapeutics SA · Updated on 2026-04-06
30
Participants Needed
3
Research Sites
121 weeks
Total Duration
On this page
Sponsors
C
Cryotherapeutics SA
Lead Sponsor
C
CoreAalst BV
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Acute cardiac pain or angina consistent with stable angina or acute coronary syndrome eligible for coronary angiography
- Non-ST-segment elevation myocardial infarction with elevated cardiac enzymes requiring PCI within 72 hours
- Unstable angina
- ST-segment elevation myocardial infarction
- Successful PCI of the culprit lesion with less than 30% diameter stenosis and TIMI 3 flow without complications
- Presence of at least one high-risk plaque in a non-culprit vessel confirmed by imaging with specific features
- Lesion length 20 mm or less
- Diameter stenosis between 30% and 70% or negative physiology assessment
- Reference vessel diameter between 2.5 mm and less than 3.75 mm
- Lesions accessible for treatment as considered by investigator
- If more than two lesions are suitable, investigator selects the most appropriate for cryotherapy
- maxLCBI4mm in the lesion greater than 324.7
- Able to provide informed consent and sign consent form
You will not qualify if you...
- Hemodynamically unstable conditions such as cardiogenic shock or severe arrhythmias
- Ongoing ST-segment elevation myocardial infarction
- Procedural complications during ACS PCI procedure
- History of coronary artery bypass graft or planned CABG within 12 months
- Left ventricular ejection fraction less than 30%
- Severe valvular heart disease
- Severe renal insufficiency (eGFR less than 30 ml/min/1.72 m2)
- Life-threatening conditions or comorbidities with life expectancy less than 12 months
- Participation in another clinical trial not yet completed
- Severe peripheral vascular disease preventing femoral artery access
- Pregnancy, lactation, or lack of surgical sterilization or effective contraception in females with childbearing potential
- Visible distal embolization or no-reflow after culprit lesion PCI
- Left main coronary artery disease with stenosis over 50%
- Stent thrombosis or restenosis as culprit lesion
- Lesions involving a bifurcation with side branches over 2.0 mm
- Severe calcification or marked vessel tortuosity at lesion site
- Thrombotic lesions
- Ostial lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
AZORG Aalst
Aalst, Belgium, 9300
Actively Recruiting
2
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Not Yet Recruiting
3
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Not Yet Recruiting
Research Team
D
Danny Detiege, RN
CONTACT
E
Elisa Rossetti, MSc, Biomedical engineering
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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