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.
• 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:
⁃ 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.