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

Primary Purpose

Coronary Artery Disease, Coronary Syndrome, Cryotherapy Effect

Status
Recruiting
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
CryoTherapy System (CTS)
Sponsored by
Cryotherapeutics SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 (NSTEMI) 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 Investigator considers that lesions are accessible. If more than two suitable lesions available, investigator will select the most appropriate lesion for cryotherapy treatment. Subject is able to provide consent and has signed and dated the informed consent form. Exclusion Criteria: 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). Angiographic exclusion criteria: 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. Thrombotic lesions Ostial lesions

Sites / Locations

  • Israeli-Georgian Research Clinic HelsicoreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CTS Treatment Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Device success
Number of lesions successfully treated without device deficiency
CTS procedure success
Number of lesions successfully treated to obtain Thrombolysis in Myocardial Infarction (TIMI) 3 flow
Imaging: CCTA assessed Minimum lumen area (MLA)
Change in MLA (mm²) compared to baseline
Imaging: CCTA assessed Minimum lumen area (MLA)
Change in MLA (mm²) compared to baseline
Imaging: CCTA assessed area stenosis
Change in area stenosis % compared to baseline
Imaging: CCTA assessed area stenosis
Change in area stenosis % compared to baseline
Imaging: CCTA assessed lesion plaque burden
Change in lesion plaque burden % from baseline
Imaging: CCTA assessed lesion plaque burden
Change in lesion plaque burden from baseline
Imaging: CCTA assessed Total plaque volume
Change in total plaque volume (mm³) from baseline
Imaging: CCTA assessed Total plaque volume
Change in total plaque volume(mm³) from baseline

Full Information

First Posted
October 26, 2022
Last Updated
February 15, 2023
Sponsor
Cryotherapeutics SA
Collaborators
CoreAalst BV
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1. Study Identification

Unique Protocol Identification Number
NCT05600088
Brief Title
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With NSTEMI or Unstable Angina
Acronym
POLARSTAR
Official Title
Clinical Investigation of Intracoronary Cryotherapy Using the CryoTherapy System (CTS) for High-risk Plaque in Patients With Non-ST-segment Elevation Myocardial Infarction (NSTEMI) or Unstable Angina
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cryotherapeutics SA
Collaborators
CoreAalst BV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The POLARSTAR study is an early 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Syndrome, Cryotherapy Effect, Myocardial Infarction, Myocardial Disease, Atherosclerosis, Coronary

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
up to 10 subjects with NSTEMI or unstable angina undergoing cryotherapy treatment of coronary vulnerable plaque lesions
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CTS Treatment Arm
Arm Type
Experimental
Arm Description
active cryotherapy of a single suitable high-risk coronary plaque lesion with CTS device
Intervention Type
Device
Intervention Name(s)
CryoTherapy System (CTS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety: Rate of Cryotherapy related adverse events
Description
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
Secondary Outcome Measure Information:
Title
Safety: Rate of Cryotherapy related events
Description
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
Title
Device success
Description
Number of lesions successfully treated without device deficiency
Time Frame
end of CTS treatment
Title
CTS procedure success
Description
Number of lesions successfully treated to obtain Thrombolysis in Myocardial Infarction (TIMI) 3 flow
Time Frame
end of CTS treatment
Title
Imaging: CCTA assessed Minimum lumen area (MLA)
Description
Change in MLA (mm²) compared to baseline
Time Frame
90 days post-procedure
Title
Imaging: CCTA assessed Minimum lumen area (MLA)
Description
Change in MLA (mm²) compared to baseline
Time Frame
9 months post-procedure
Title
Imaging: CCTA assessed area stenosis
Description
Change in area stenosis % compared to baseline
Time Frame
3 months post-procedure
Title
Imaging: CCTA assessed area stenosis
Description
Change in area stenosis % compared to baseline
Time Frame
9 months post-procedure
Title
Imaging: CCTA assessed lesion plaque burden
Description
Change in lesion plaque burden % from baseline
Time Frame
3 months post-procedure
Title
Imaging: CCTA assessed lesion plaque burden
Description
Change in lesion plaque burden from baseline
Time Frame
9 months post-procedure
Title
Imaging: CCTA assessed Total plaque volume
Description
Change in total plaque volume (mm³) from baseline
Time Frame
3 months post-procedure
Title
Imaging: CCTA assessed Total plaque volume
Description
Change in total plaque volume(mm³) from baseline
Time Frame
9 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 (NSTEMI) 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 Investigator considers that lesions are accessible. If more than two suitable lesions available, investigator will select the most appropriate lesion for cryotherapy treatment. Subject is able to provide consent and has signed and dated the informed consent form. Exclusion Criteria: 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). Angiographic exclusion criteria: 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. Thrombotic lesions Ostial lesions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danny Detiege, RN
Phone
+32467024773
Email
ddetiege@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irakli Gogorishvili, MD
Organizational Affiliation
Israeli_Georgian research Clinic Helsicore, Tbilisi, Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Israeli-Georgian Research Clinic Helsicore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irakli Gogorishvili, MD
Phone
+995 32 243 33 43
Email
gogorishvili@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With NSTEMI or Unstable Angina

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