Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365502
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-10
Brief Title:
Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque RESTORE Trial
Sponsor:
Harbin Medical University
Organization:
Harbin Medical University
Study Overview
Official Title:
A Multicenter Prospective Open-label Controlled Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque RESTORE Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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 objective of this multicenter prospective open-label controlled randomized trial is to demonstrate the superiority of drug-coated balloon DCB treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy GDMT in improving clinical cardiovascular outcomes in patients with acute coronary syndrome
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