NCT04857580

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

Intracoronary Cryotherapy Effect for staBilization of vulnErable Plaque at Risk of Rupture as Assessed by imaGing

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cryotherapeutics SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	CTS Device	Coronary cryotherapy is delivered locally on eligible lesions randomized to the treatment using the CTS System.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2021-04-23
• Last updated: 2023-02-17

Locations

3 sites across 2 countries: Denmark, Sweden