Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620458
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-04-28
Brief Title:
A Retrospective Study on the Factors of Drug-coated Balloon Restenosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Retrospective Study on the Factors of Drug-coated Balloon Restenosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RE-DCB
Brief Summary:
The purpose of this study is to analyze potential factors post paclitaxel drug-coated balloon angioplasty in patients with Denovo large vessels disease It includes imaging endpoints and clinical event endpoints Over 5000 patients are expected to be enrolled
Detailed Description:
This study is a retrospective analysis that retrospectively reviewed over approximately 5000 patients with de novo-large-vessel disease who underwent paclitaxel drug-coated balloon angioplasty The study endpoints include cardiovascular adverse events at 1 year cardiovascular death cardiovascular events and coronary angiographic outcomes primarily late lumen loss restenosis rate It primarily focuses on differences in baseline characteristics lesion features intracavitary imaging characteristicsIncluding OCT IVUS hemodynamic parameterand procedural approaches among patients Over 5000 patients are expected to be enrolled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None