CryoTherapeutics Treats First Patient in ICECAP Trial Evaluating Localized Cryotherapy for Vulnerable Coronary Plaques
核心洞察
CryoTherapeutics (搜索) has treated the first patient in its ICECAP clinical trial, evaluating localized cryotherapy to stabilize high-risk coronary plaques before they cause myocardial infarction (搜索).
The first enrolled patient had stable angina (搜索) and was identified with a non-obstructive high-risk coronary plaque using coronary CT imaging and AI-enabled plaque characterization tools.
The ICECAP study employs a multimodal imaging strategy combining NIRS and DeepOCT to confirm plaque morphology and guide cryotherapy delivery at temperatures of -10 to -20°C.
CryoTherapeutics (搜索), a medical device company based in Liège, Belgium, announced today the successful treatment of the first patient in its ICECAP clinical trial, marking a significant step in evaluating whether localized cryotherapy can stabilize vulnerable coronary plaques before they lead to myocardial infarction (搜索).
The first patient, who presented with stable angina (搜索), was identified during ICECAP screening as having a non-obstructive high-risk coronary plaque. Such plaques, while not significantly restricting blood flow, are increasingly recognized as a major cause of heart attacks due to their potential to rupture unexpectedly.
"Treating the first patient in ICECAP is an important milestone for CryoTherapeutics (搜索) and the clinical development of our technology," said Dr. John Yianni, CEO of CryoTherapeutics. "We are excited to work with our clinical and technology partners to generate the evidence needed to evaluate localized cryotherapy and advance the field."
A Multimodal Imaging Approach to Plaque Identification
The ICECAP study is designed to evaluate both the efficacy and safety of localized cryotherapy applied to non-obstructive, high-risk coronary plaques. The trial employs a sophisticated multimodal imaging strategy that combines non-invasive and invasive technologies to identify and characterize vulnerable plaques.
Patients are initially screened using coronary CT imaging and AI-enabled plaque characterization tools to detect high-risk plaque features. During the interventional procedure, intravascular imaging modalities—including near-infrared spectroscopy (NIRS) and optical coherence tomography (DeepOCT)—are used to further confirm high-risk plaque morphology and guide treatment delivery. Follow-up imaging will assess the biological response to cryotherapy over time, with the study also evaluating changes in fibroatheroma cap thickness.
Cryotherapy Mechanism and Trial Design
CryoTherapeutics (搜索)' investigational catheter-based system delivers localized cooling at temperatures ranging from -10 to -20°C to non-obstructive plaques identified through advanced imaging. The technology explores cryothermal processes that address vulnerable plaque pathophysiology without the need for permanent implants.
"We are in a new phase of the detection and treatment of high-risk plaques," said Dr. Carlos Collet, MD, PhD, Director of Cardiovascular Imaging, Physiology, and Translational Therapeutics at the Cardiovascular Research Foundation (CRF). "In the ICECAP study, we are combining state-of-the-art plaque assessment with a novel therapy to stabilize vulnerable plaques."
Multidisciplinary Collaboration
ICECAP brings together a multidisciplinary ecosystem of clinical, imaging, and data science collaborators. In addition to CRF, the study includes HeartFlow (搜索) and Medis Medical Imaging (搜索) as partners, contributing expertise spanning intravascular imaging, coronary CT analysis, quantitative image analysis, AI-assisted plaque assessment, and cardiovascular clinical research. Together, these collaborators aim to advance a next-generation approach to identifying and treating vulnerable plaque.
Patient recruitment is currently active and will expand to up to five centers across Belgium and the United Kingdom in the coming months. CryoTherapeutics (搜索)' cryotherapy system remains an investigational device, not approved or cleared for commercial use in any jurisdiction, and is limited to use in approved clinical studies.