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

Prior treatment

• 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 illness

• 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 severe valvular heart disease.
• Subject has any life-threatening conditions or medical comorbidity resulting in life expectancy \< 12 months.
• Left main coronary artery disease (visual diameter stenosis \> 50%).
• Stent thrombosis/restenosis as a culprit lesion.

Lab values

• Subject has known reduced Left Ventricular Ejection Fraction \< 30%.
• Subject has known severe renal insufficiency (eGFR \<30 ml/min/1.72 m2).

Other

• Subject is currently participating in another clinical investigation that has not yet reached its primary endpoint.
• 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

• 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
  • 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.