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

  • STATUS
    Recruiting
  • participants needed
    45
  • sponsor
    Cryotherapeutics SA
Updated on 8 February 2023
atherosclerosis
stenosis
acute coronary syndrome

Summary

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.

Details
Condition Acute Coronary Syndrome
Treatment CTS Device
Clinical Study IdentifierNCT04857580
SponsorCryotherapeutics SA
Last Modified on8 February 2023

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