Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416813
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-02
Brief Title:
Preventive Intervention Value of DCB in Vulnerable Coronary Atherosclerotic Plaques
Sponsor:
Yong He
Organization:
West China Hospital
Study Overview
Official Title:
Preventive Intervention Value of Drug-Coated Balloons in Vulnerable Coronary Atherosclerotic Plaques
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The PASSIVATE-CAP study is an investigator-initiated prospective randomized multicenter open-label superiority trial focusing on acute coronary syndrome ACS patients with nonflow-limiting vulnerable plaques in nonculprit vessels In this study eligible patients were randomized at a 11 ratio into two groups patients who received guideline-directed medical therapy GDMT and patients who received GDMT combined with a drug-coated balloon DCB In this study the use of PCSK9 inhibitors was limited to inclisiran The primary endpoint was the minimal lumen area of the target lesion 1 year after randomization The secondary endpoints encompass a range of factors including the proportion of patients with vulnerable plaques in the target vessel fibrous cap thickness lipid core arc of the target lesion minimal lumen area of the target vessel and extent of LDL-C reduction in patients treated with inclisiran
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?:
False
Is an FDA AA801 Violation?:
None