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.
The POLARSTAR study is an early feasibility study to evaluate the safety and performance of the CryoTherapy System (CTS) medical device, consisting of a console and a balloon catheter. The CTS is designed to deliver local cryo-energy to vulnerable plaque lesions in the coronary arteries, aiming to stabilize the plaque to reduce the risk of rupture and subsequent cardiac events. The study will enrol up to 10 subjects with NSTEMI or unstable angina, who underwent successful Percutaneous Coronary Intervention (PCI) of their culprit coronary lesion, and who were identified to have presence of at least 1 non-culprit suitable plaque lesion at high-risk of rupture. After providing informed consent the subjects will undergo a Coronary CT-angiography (CCTA) to confirm suitability of the coronary plaque lesion. A single high-risk plaque lesion will be treated by the investigators, with Intra-vascular Ultrasound (IVUS) imaging prior to and after CTS treatment. Subjects will be followed clinically for up to one year after the CTS treatment, and will have follow-up CCTA assessments at 3 and 9 months post-procedure. Primary endpoint will be Major cardiac events rate at 3 months post procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
30
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
Israeli-Georgian Research Clinic Helsicore
Tbilisi, Georgia
RECRUITINGTbilisi Heart Center
Tbilisi, Georgia
RECRUITINGHospital of Lithuanian University of health sciences Kauno Klinikos
Kaunas, Lithuania
RECRUITINGKlaipèda University Hospital
Klaipèda, Lithuania
RECRUITINGVilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
RECRUITINGSafety: Rate of Cryotherapy related adverse events
Any cryotherapy procedure related complication defined as coronary artery dissection (angiographic dissection ≥ NHLBI type B), acute vessel closure, life threatening arrythmia, need for bailout stenting, or any Major Adverse Cardia Event (MACE) defined as cardiac death, CTS-treated vessel myocardial infarction, CTS-treated lesion revascularization, rehospitalization for unstable or progressive angina adjudicated to the CTS-treated lesion
Time frame: 90 days post-procedure
Safety: Rate of Cryotherapy related events
Any cryotherapy procedure related complication defined as coronary artery dissection (angiographic dissection ≥ NHLBI type B), acute vessel closure, life threatening arrythmia, need for bailout stenting, or any MACE defined as cardiac death, CTS-treated vessel myocardial infarction, CTS-treated lesion revascularization, rehospitalization for unstable or progressive angina adjudicated to the CTS-treated lesion
Time frame: 1 year post-procedure
Device success
Number of lesions successfully treated without device deficiency
Time frame: end of CTS treatment
CTS procedure success
Number of lesions successfully treated to obtain Thrombolysis in Myocardial Infarction (TIMI) 3 flow
Time frame: end of CTS treatment
Imaging: CCTA assessed Minimum lumen area (MLA)
Change in MLA (mm²) compared to baseline
Time frame: 90 days post-procedure
Imaging: CCTA assessed Minimum lumen area (MLA)
Change in MLA (mm²) compared to baseline
Time frame: 9 months post-procedure
Imaging: CCTA assessed area stenosis
Change in area stenosis % compared to baseline
Time frame: 3 months post-procedure
Imaging: CCTA assessed area stenosis
Change in area stenosis % compared to baseline
Time frame: 9 months post-procedure
Imaging: CCTA assessed lesion plaque burden
Change in lesion plaque burden % from baseline
Time frame: 3 months post-procedure
Imaging: CCTA assessed lesion plaque burden
Change in lesion plaque burden from baseline
Time frame: 9 months post-procedure
Imaging: CCTA assessed Total plaque volume
Change in total plaque volume (mm³) from baseline
Time frame: 3 months post-procedure
Imaging: CCTA assessed Total plaque volume
Change in total plaque volume(mm³) from baseline
Time frame: 9 months post-procedure
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