CryoTherapeutics Launches ICECAP Trial Combining Cryotherapy with AI-Powered Imaging to Target High-Risk Coronary Plaques
Key Insights
CryoTherapeutics (search) has partnered with SpectraWAVE (search) and the Cardiovascular Research Foundation to launch the ICECAP clinical study, targeting non-obstructive high-risk coronary plaques with localized cryotherapy.
The trial will use a multimodal imaging approach combining Near-Infrared Spectroscopy and next-generation Optical Coherence Tomography with AI-assisted analysis to assess plaque stabilization effects.
Patient recruitment is expected to begin in Q1 2026 across up to five centers in Belgium and the United Kingdom, building on encouraging safety results from the previous POLARSTAR Study.
CryoTherapeutics (search) has announced a groundbreaking three-way collaboration with SpectraWAVE (search) and the Cardiovascular Research Foundation (CRF) to launch the ICECAP clinical study, marking a first-of-its-kind approach to treating non-obstructive high-risk coronary plaques. The Belgian medical device company's innovative cryotherapy technology targets vulnerable plaques that, despite being angiographically non-obstructive, can rupture without warning and are major drivers of myocardial infarction—the leading cause of death worldwide.
Novel Therapeutic Approach Addresses Critical Unmet Need
The ICECAP study builds on encouraging results from CryoTherapeutics (search)' previous POLARSTAR Study, which demonstrated a strong safety profile and early indications of plaque stabilization. The company's catheter-based cryotherapy system is designed to stabilize high-risk plaques by temporarily cooling them to temperatures between -10°C to -20°C, aiming to reduce inflammation and increase fibrous-cap thickness to lower rupture risk.
"This will be an important step in the development of our unique treatment approach to stabilize these high-risk plaques, preventing major adverse events," said Danny Detiège, VP Clinical Affairs of CryoTherapeutics (search).
Unlike traditional interventions such as stents or drug-coated balloons, this approach avoids implanting foreign materials or relying on long-term medical therapy, offering a potentially transformative treatment paradigm for vulnerable plaque management.
Advanced Imaging Technology Integration
The collaboration leverages SpectraWAVE (search)'s HyperVue Imaging System, which integrates next-generation comprehensive DeepOCT and Near-Infrared Spectroscopy (NIRS) technologies. This multimodal imaging approach will provide unique insights into lesion assessment and the biological effects of localized cryotherapy over time.
The study will employ a comprehensive imaging strategy combining NIRS and next-generation Optical Coherence Tomography (OCT) imaging at the time of the procedure and at nine-month follow-up, in addition to Coronary CT Angiography (CCTA). DeepOCT enables measurement of fibrous-cap thickness, while NIRS characterizes lipidic burden—together identifying non-obstructive high-risk plaques and supporting efficacy readouts.
"By leveraging the unique capability of our HyperVue imaging technology—from visualization of cap-thickness to quantification of lipid burden—alongside CryoTherapeutics (search)' treatment modality, we aim to deepen our understanding of non-obstructive high-risk plaque behavior," said Eman Namati, PhD, CEO of SpectraWAVE (search).
AI-Assisted Analysis and Clinical Leadership
ICECAP will incorporate AI-assisted analysis to standardize the detection of high-risk plaque features and measure change over time, representing a significant advancement in precision cardiovascular medicine. The Cardiovascular Research Foundation, a globally recognized leader in cardiovascular innovation, will serve as the Core Lab for the study.
Dr. Carlos Collet, MD, PhD, Director of Cardiovascular Imaging, Physiology, and Translational Therapeutics at CRF, will lead the trial's scientific activities. "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," said Dr. Collet.
Clinical Timeline and Study Design
The ICECAP Study is planned across up to five centers in Belgium and the United Kingdom, with patient recruitment expected to begin in Q1 2026. The study design positions the trial to generate definitive evidence of safety and biological effect in this underserved patient population.
"This dual-innovation setup underscores the scientific ambition and cutting-edge nature of this project," said Dr. John Yianni, CEO of CryoTherapeutics (search). "Clinical centers involved in the study have expressed strong enthusiasm for participating in a truly first-of-its-kind trial."
The collaboration reflects a shared commitment to innovation in cardiovascular medicine, with the potential to impact millions of patients through advances in both detection and treatment of non-obstructive high-risk plaques. The companies plan to share progress from ICECAP at major scientific meetings as data mature.