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

NCT05600088 | Active Not Recruiting DMC

• 1 other identifier: CT-CD-P03-1
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 5

Brief 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

Coronary Artery Disease; Coronary Syndrome; Cryotherapy Effect; Myocardial Infarction; Myocardial Disease; Atherosclerosis, Coronary

Outcome Measures

Primary Outcomes (1)

• Safety: 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

  90 days post-procedure

Secondary Outcomes (11)

• Safety: Rate of Cryotherapy related events

  1 year post-procedure

• Device success

  end of CTS treatment

• CTS procedure success

  end of CTS treatment

• Imaging: CCTA assessed Minimum lumen area (MLA)

  90 days post-procedure

• Imaging: CCTA assessed Minimum lumen area (MLA)

  9 months post-procedure

Study Arms (1)

CTS Treatment Arm

EXPERIMENTAL

active cryotherapy of a single suitable high-risk coronary plaque lesion with CTS device

Device: CryoTherapy System (CTS)

Interventions

CryoTherapy System (CTS) DEVICE

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

CTS Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years old.
• Subject has acute cardiac pain/angina consistent with acute coronary syndrome eligible for coronary angiography meeting one of the following criteria:
• (Non-)ST-segment elevation myocardial infarction ((N)STEMI) with rise/fall of cardiac enzymes (troponin I or T) with at least one value above the 99th percentile of the upper reference limit requiring PCI within 72 hours from diagnosis
• Unstable angina
• Successful PCI (defined as diameter stenosis less than 30% and TIMI 3 flow on final angiography without procedural complication) of the culprit lesion.
• Subject has at least one high-risk plaque meeting the criteria below:
• Located in a non-culprit vessel,
• High-risk plaque lesion on CCTA and at least one of the following features:
• Presence of low-attenuation plaque (HU\<50) and/or
• Positive remodelling (remodelling index \>1.1) and/or
• Napkin ring sign and/or
• Plaque burden ≥70%
• Lesion length ≤ 20 mm.
• Diameter stenosis on invasive angiography between 30% and 70% on coronary angiogram or negative physiology assessment (FFR\>0.80 or non-hyperemic pressure ratios (NHPR) \>0.89).
• Reference vessel diameter (RVD) \< 3.75 mm and \> 2.00 mm in diameter

You may not qualify if:

• Subject is hemodynamically unstable (cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, refractory ventricular arrhythmias, and IABP).
• Subject has ongoing ST-segment elevation myocardial infarction.
• Subject had a procedural complication during the Acute coronary syndrome (ACS) PCI procedure.
• Subject has history of Coronary Artery Bypass Graft (CABG) or planned CABG within 12 months after the index procedure.
• Subject has known reduced Left Ventricular Ejection Fraction \< 30%.
• Subject has known severe valvular heart disease.
• Subject has known severe renal insufficiency (eGFR \<30 ml/min/1.72 m2).
• Subject has any life-threatening conditions or medical comorbidity resulting in life expectancy \< 12 months.
• Subject is currently participating in another clinical investigation that has not yet reached its primary endpoint.
• Subject is pregnant or lactating, or NOT surgically sterile (tubal ligation or hysterectomy) or NOT postmenopausal for at least 6 months or is a female with childbearing potential without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device).
• Visible distal embolization/no-reflow following culprit lesions PCI.
• Left main coronary artery disease (visual diameter stenosis \> 50%).
• Stent thrombosis/restenosis as a culprit lesion.
• CTS lesion involving a bifurcation (defined as lesions involving side branches \>2.0 mm).
• Angiographic or CCTA evidence of severe calcification and/or marked tortuosity of the index vessel and/or lesion.

Sponsors & Collaborators

• Cryotherapeutics SA: lead
• CoreAalst BV: collaborator

Study Sites (5)

Israeli-Georgian Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

Tbilisi Heart Center

Tbilisi, 0186, Georgia

Location

Hospital of Lithuanian University of health sciences Kauno Klinikos

Kaunas, LT-50161, Lithuania

Location

Klaipèda University Hospital

Klaipèda, LT-92288, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, LT-08661, Lithuania

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Unstable; Myocardial Infarction; Cardiomyopathies

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Irakli Gogorishvili, MD

  Israeli_Georgian research Clinic Helsicore, Tbilisi, Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: up to 10 subjects with NSTEMI or unstable angina undergoing cryotherapy treatment of coronary vulnerable plaque lesions. Once This safety cohort has been enrolled, additional 20 subjects will be enrolled to further confirm feasibility and safety of the device.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: May 18, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GE (2); LI (3)