Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-18 @ 12:42 AM
Study NCT ID:
NCT03910166
Status:
COMPLETED
Last Update Posted:
2024-08-01
First Post:
2019-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AcoArt VI / Vertebral Artery Ostium Stenosis in China
Sponsor:
Acotec Scientific Co., Ltd
Organization:
Study Overview
Official Title:
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of Vertebral Artery Ostium Stenosis
Status:
COMPLETED
Status Verified Date:
2024-01
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 purpose of this study is to determine whether DEB is not inferior to common bare metal stent using under in long-term vessel patency and inhibiting restenosis in Vertebral Artery Ostium Stenosis
Detailed Description:
Vertebral Artery Origin Stenting is an established alternative to open surgical bypass for the treatment of Vertebral Artery Ostium Stenosis .
DEBs are designed to promote arterial patency by reducing neointimal proliferation.
DEBs are designed to promote arterial patency by reducing neointimal proliferation.
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?: