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

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.