Atherosclerosis is a progressive inflammatory disease of the large and medium sized arteries, which is characterized by the formation of plaques in the vessel wall. The morphology and composition of the plaque play a major role in its stability during the development of the disease. The CTS system allows to deliver coronary cryotherapy intended for stabilization of vulnerable plaque with non-significant stenosis. Vulnerable plaque at high risk of rupture will be assessed by NIRS-IVUS imaging modality in patients with Acute Coronary Syndrome (ACS). The ICEBERG study is an early feasibility single arm study enrolling a maximum of 45 patients. After enrolment of the first 5 patients in the First-in-Man safety cohort, the trial will enroll and randomize 40 eligible lesions in the randomized cohort of which 20 will be treated with cryotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Coronary cryotherapy is delivered locally on eligible lesions randomized to the treatment using the CTS System.
Rigshospitalet
Copenhagen, Denmark
Zealand University Hospital
Roskilde, Denmark
Skåne University Hospital
Lund, Sweden
Cryotherapy procedure related complication
Any cryotherapy procedure related complication defined as coronary artery dissection, acute vessel closure, ischemia, arrythmia, need for bailout stenting, or any Major Adverse Cardiac Events (MACE) adjudicated to the index lesion
Time frame: 90 days
Optical Coherence Tomography (OCT)-assessed fibrous cap thickness
Change in Optical Coherence Tomography (OCT)-assessed fibrous cap thickness from index lesion.
Time frame: 90 days
Cryotherapy related complication
Any cryotherapy related complication defined as coronary artery dissection, acute vessel closure, ischemia, arrythmia, need for bailout stenting, or any MACE defined as cardiac death, myocardial infarction, revascularization, rehospitalization for unstable or progressive angina adjudicated to the index lesion.
Time frame: 9 months
Device success
Device success defined as ability to successfully track and treat the lesion.
Time frame: Baseline
Cryotherapy/lesion procedure success
Cryotherapy/lesion procedure success defined as TIMI 3 flow, percent diameter stenosis equivalent to or lower than pre-procedure.
Time frame: Baseline
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