Condition: Coronary Arterial Disease (CAD) · Plaque · Vulnerable Plaque · Sponsor: Cryotherapeutics SA
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.
This description comes directly from the study's public registry record.
Danny Detiege, RN · +32 467 02 47 73 · dde@cryotherapeutics.com
Elisa Rossetti, MSc, Biomedical engineering · +3242644773 · ero@cryotherapeutics.com
Always discuss trial participation with your own doctor first.
| AZORG Aalst | Aalst, Belgium | Recruiting |
| St Bartholomew's Hospital | London, United Kingdom | Not Yet Recruiting |
| Royal Brompton Hospital | London, United Kingdom | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06939374