Pilot Study on the Effect of Intracoronary Cryotherapy on Stabilization of Vulnerable Plaque at Risk of Rupture (ICEBERG)

This is an interventional treatment trial for Acute Coronary Syndrome Read More

Inclusion Criteria:

• Men or women at least 18 years old.

• Acute cardiac pain/angina consistent with acute coronary syndrome eligible for coronary angiography meeting one of the following criteria:

  1. 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 Percutaneous Coronary Intervention (PCI) within 72 hours from diagnosis
  2. Stabilized ST-segment elevation myocardial infarction (STEMI) with at least one value above the 99th percentile of the upper reference limit requiring PCI within < 12 hours from symptoms onset.
  3. Unstable angina with new or worsening angina symptoms over the last 2 weeks requiring PCI within 72 hours.
• Patient must have one, two or three-vessel disease in native coronary arteries.
• PCI of the culprit lesion on all patients.

• At least one lesion meeting the criteria below:

  1. Located in a non-culprit vessel, or proximal to the culprit lesion if located in the culprit vessel with at least 10 mm distance from the culprit lesion.
  2. Lesion stenosis ≤ 70% of the reference vessel diameter by visual assessment on coronary angiogram.
  3. Plaque-level maxLCBI4mm ≥ 325 by NIRS (Near-Infrared Spectroscopy).
  4. Plaque burden ≥ 65% by IVUS (IntraVascular UltraSound).
  5. Not intended for revascularization based on angiographic criteria and negative physiology assessment (FFR>0.80 or iFR/RFR>0.89).
  6. Lesion-level balloon to artery ratio > 1.0.
  7. Lesion length ≤ 20 mm.
  8. Investigator considers that lesions are accessible.
  9. If more than two suitable lesions available, investigator will select two lesions for randomization.
• Subject able to consent and has a signed and dated the informed consent form.

Exclusion Criteria:

• Unstable patients (cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, refractory ventricular arrhythmias, and IABP).
• Patients with ongoing ST-segment elevation myocardial infarction.
• Patients that had a procedural complication during the PCI procedure, such as coronary dissection, perforation or a complication that would necessitate immediate and/or unplanned surgical revascularization.
• History of Coronary Artery Bypass Graft (CABG) or planned CABG within 12 months after the index procedure.
• Known ejection fraction < 30%.
• Known severe valvular heart disease.
• Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
• Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months.
• Participation in any investigational study that has not yet reached its primary endpoint.
• Women who are pregnant or lactating, or NOT surgically sterile (tubal ligation or hysterectomy) or NOT postmenopausal for at least 6 months or women with childbearing potential without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device).

Angiographic exclusion criteria:

• Visible distal embolization/no-reflow following culprit PCI.
• Left main coronary artery disease (visual diameter stenosis > 50%).
• Stent thrombosis/restenosis as a culprit lesion.
• Index lesion involving a bifurcation.
• Angiographic evidence of severe calcification and/or marked tortuosity of the index vessel and/or lesion.