Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study

Other illness

• Left main coronary artery disease (visual diameter stenosis \> 50%).
• Stent thrombosis/restenosis as a culprit lesion.

Lab values

• 1\) Subject is hemodynamically unstable (cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, refractory ventricular arrhythmias, and IABP).
  • 2\) Subject has ongoing ST-segment elevation myocardial infarction. 3) Subject had a procedural complication during the ACS PCI procedure. 4) Subject has history of Coronary Artery Bypass Graft (CABG) or planned CABG within 12 months after the index procedure.
  • 5\) Subject has known reduced Left Ventricular Ejection Fraction \< 30%. 6) Subject has known severe valvular heart disease. 7) Subject has known severe renal insufficiency (eGFR \<30 ml/min/1.72 m2). 8) Subject has any life-threatening conditions or medical comorbidity resulting in life expectancy \< 12 months.
  • 9\) Subject is currently participating in another clinical investigation that has not yet reached its primary endpoint.
  • 10\) Subject has severe peripheral vascular disease impeding femoral artery access.
  • 11\) 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:

Other

• Visible distal embolization/no-reflow following culprit lesions PCI.
• 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.

• 1\) Subject is at least 18 years old. 2) Subject has acute cardiac pain/angina consistent with stable angina or 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
  • ST-segment elevation myocardial infarction (STEMI) 3) Successful PCI (defined as diameter stenosis less than 30% and TIMI 3 flow on final angiography without procedural complication) of the culprit lesion.
  • NOTE: subjects with unstable angina, for whom the culprit lesion as assessed by investigator does not require PCI currently or within the next 6 months (subject treated with optimal medical treatment) can be enrolled in the study.
  • 4\) 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 NHPR\>0.89).
• Reference vessel diameter (RVD) \< 3.75 mm and \> 2.50 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.
  • 5\) maxLCBI4mm in the lesion \> 324.7 6) Subject is able to provide consent and has signed and dated the informed consent form.