Ignite Creation Date:
2024-05-06 @ 4:02 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04857580
Status:
WITHDRAWN
Last Update Posted:
2023-02-17
First Post:
2021-04-13
Brief Title:
Pilot Study on the Effect of Intracoronary Cryotherapy on Stabilization of Vulnerable Plaque at Risk of Rupture
Sponsor:
Cryotherapeutics SA
Organization:
Cryotherapeutics SA
Study Overview
Official Title:
Intracoronary Cryotherapy Effect for staBilization of vulnErable Plaque at Risk of Rupture as Assessed by imaGing
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No subjects enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICEBERG
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None