Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable An… (NCT06939374) | Clinical Trial Compass
RecruitingNot Applicable
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Belgium, United Kingdom30 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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.
✓. 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
Exclusion criteria
✕. Visible distal embolization/no-reflow following culprit lesions PCI.
What they're measuring
1
Primary efficacy endpoint
Timeframe: At 9 months post-CTS procedure compared to baseline.