ICECAP Study of Cryotherapy for Nonobstructive High-Risk Plaques to Begin Enrollment

November 21, 2025—CryoTherapeutics announced a three-way collaboration with SpectraWave and the Cardiovascular Research Foundation (CRF) to initiate the ICECAP clinical study, which will evaluate localized cryotherapy for nonobstructive high-risk coronary plaques using a multimodality intravascular imaging strategy.

The study is planned for up to five centers in Belgium and the United Kingdom. Enrollment is expected to begin in Q1 2026, advised the company.

CryoTherapeutics company stated that the ICECAP trial pairs a cryotherapy approach with next-generation near-infrared spectroscopy (NIRS) and optical coherence tomography (OCT) to characterize plaque morphology at baseline and 9 months.

SpectraWave will provide its HyperVue system, which integrates DeepOCT imaging and NIRS to assess cap thickness and lipidic burden as markers of plaque instability.

According to the company, the study aims to clarify the biological effects of localized cryotherapy on vulnerable plaques—particularly changes in fibrous-cap thickness and lipidic burden. The investigators reported that the study protocol integrates artificial intelligence to standardize high-risk plaque detection and quantify longitudinal change. The study builds on safety findings and early signals of plaque stabilization from the POLARSTAR study.

ICECAP will be conducted with Carlos Collet, MD, CRF’s Director of Cardiovascular Imaging, Physiology, and Translational Therapeutic at CRF, will serve as scientific lead investigator with CRF acting as the core lab.

“This study will allow us to integrate for the first time AI-detection of high-risk plaques with a novel treatment approach without the use of a permanent implant to modify the course of high-risk atherosclerosis,” commented Dr. Collet in the CryoTherapeutics press release.