Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449274
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-04-10
Brief Title:
RESTORE Imaging an OCT-IVUS Imaging Substudy of RESTORE Trial
Sponsor:
Harbin Medical University
Organization:
Harbin Medical University
Study Overview
Official Title:
Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque an OCT-IVUS Imaging Substudy RESTORE Imaging
Status:
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 objective of this imaging substudy of RESTORE 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 plaque stabilization in patients with acute coronary syndrome
Detailed Description:
The present study is an integrated imaging substudy of randomized controlled and intervention trial of preventive drug-coated balloon angioplasty in vulnerable atherosclerotic plaque RESTORE The RESTORE Imaging trial will equally enroll from the DCB arm and GDMT arm to at least 180 consecutive individuals to validate the superiority of drug-coated balloon DCB treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy GDMT in enlarge luminal dimensions
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