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 Q2 of 2024.