ICECAP Study
Research type
Research Study
Full title
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in patients with Stable Angina or ACS – A traditional feasibility study
IRAS ID
364136
Contact name
Ranil de Silva
Contact email
Sponsor organisation
CryoTherapeutics S.A.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
1 years, 10 months, 0 days
Research summary
The ICECAP Study concerns a multi-centre, prospective, single-arm, traditional feasibility clinical investigation, to evaluate the efficacy and safety of intracoronary cryotherapy using the CryoTherapy System (CTS) for stabilization of high-risk plaque in patients with Stable Angina or Acute Coronary Syndrome (ACS). The NIRS/OCT imaging in this study will be performed with the Spectrawave HypervueTM imaging system. Since this imaging device has obtained market approval in the USA but is in the process of obtaining EU CE mark approval, it will be considered a second investigational device in the ICECAP Study.
The sponsor hypothesizes that intracoronary cryotherapy of high-risk non-obstructive plaques stabilizes the lesions by reducing the lipid burden within the plaque. Objectives set out for this study are the following:
• To evaluate the effect of cryotherapy on the treated high-risk plaque.
• To establish the safety of the CryoTherapy System (CTS).
• To evaluate the device and procedure success rates.
The study will enrol 30 subjects, in up to 5 sites in Belgium and the UK. Subjects will be selected for screening upon presentation of a Coronary Artery Disease (CAD) (stable angina or Acute Coronary Syndrome), successfully treated for their culprit lesion, and with presence of at least one non-flow-limiting high-risk plaque identified by coronary CT angiography, with final eligibility confirmation by NIRS. All subjects enrolled in the study will be followed for 12 months and will undergo 5 follow-up visits.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
26/EE/0052
Date of REC Opinion
21 Apr 2026
REC opinion
Further Information Favourable Opinion