POLARSTAR – Early Feasibility and safety study (FIH Pilot)
Clinicaltrials.gov identifier: NCT05600088.
The objectives of the study are to:
- Establish the safety of the CTS system for coronary cryotherapy
- Evaluate the effect of cryotherapy on the morphology and composition of the treated high-risk plaque lesion
- Evaluate the device and procedure success rates
Design: prospective, single arm, early safety and feasibility study.
Population: the study aims to enrol up to 10 patients with Non-ST-elevated myocardial infarction (NSTEMI) or Unstable angina, with at least 1 high-risk plaque lesion in a non-culprit vessel.
Study Sites: 2 sites in Tbilisi, Georgia.
Study Status: the study is currently enrolling patients.
Study Results: the primary endpoint results are expected in Q3 of 2023.