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.
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.
Located in a non-culprit vessel,
1) Subject is hemodynamically unstable (cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, refractory ventricular arrhythmias, and IABP).
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.
Single group
Intracoronary Cryotherapy
DeviceIntracoronary cryotherapy for stabilization of High-risk coronary plaque
Primary efficacy endpoint
Reduction of in maxLCBI4mm in the lesion measured by NIRS
co-primary safety endpoint
Rate of Cryotherapy procedure related complications or MACE
Change in Fibrous Cap Thickness
Change in OCT-derived fibrous cap thickness
Change in Minimal Lumen Area (MLA)
Change in minimum lumen area (MLA) by OCT
Prevalence of Thin Cap Fibrous Atheroma
Prevalence of thin cap fibroatheroma (minimum fibrous cap thickness \< 65 µm with lipid arc \> 90°) by OCT.
Prevalence of lipid Arc >90°
Prevalence of lipid arc greater than 90° by OCT.
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Cryotherapeutics SA
Lead sponsor
CoreAalst BV
Collaborator
