Clinical Trial

Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With (N)STEMI or Unstable Angina

Study acronym: POLARSTAR

Active, Not Recruiting

Record status

This record was last updated March 24, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Summary

The POLARSTAR study is an early safety and feasibility study to evaluate the performance and safety of the CryoTherapy System (CTS) for the treatment of coronary plaque lesions that are not obstructing blood flow but are at high-risk of rupture which would cause a major heart attack. The CTS is used to apply local freezing of the lesion using a balloon catheter, controlled by a console that regulates in- and outflow of a cooling agent into the catheter. The treatment is expected to stabilize the lesion, diminishing the risk of rupture. The study will enrol subjects with acute coronary disease who have suitable coronary lesions. Subjects will be followed for 1 year after the CTS treatment. Baseline identification of lesions will be done using Coronary CT-angiography (CCTA), which will be repeated at 3 and 9 months after procedure.

Protocol Amendment History 8 amendments

This ClinicalTrials.gov record has been amended 8 times since 2022-10-26; most recent amendment 2026-03-20.

Status change: Recruiting → Active, Not Recruiting 2026-03-20

Status change: Active, Not Recruiting → Recruiting 2023-02-15

Trial Details

NCT Number	NCT05600088
Lead Sponsor	Cryotherapeutics SA Collaborators: CoreAalst BV
Conditions	Coronary Artery Disease, Coronary Syndrome, Cryotherapy Effect, Myocardial Infarction, Myocardial Disease, Atherosclerosis, Coronary
Enrollment	30 participants
Start Date	2022-05-18
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-24