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

NCT05600088 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

CryoTherapy System (CTS)

local cryotherapy of coronary high-risk plaque lesions using the CTS consisting of a semi-compliant balloon and a console controlling the temperature of cryotherapy

Sponsors & Collaborators

  • CoreAalst BV

    collaborator INDUSTRY

  • Cryotherapeutics SA

    lead INDUSTRY

Principal Investigators

  • Irakli Gogorishvili, MD · Israeli_Georgian research Clinic Helsicore, Tbilisi, Georgia

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2026-06-30
Completion
2026-07-31

Countries

  • Georgia
  • Lithuania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05600088 on ClinicalTrials.gov