Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT03366818
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2017-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Stent Retriever, VERSI System for AIS
Sponsor:
Kobe City General Hospital
Organization:
Study Overview
Official Title:
Efficacy and Safety of VERSI System for Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2019-10
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:
To confirm efficacy and safety of VERSI system for acute ischemic stroke
Detailed Description:
Efficacy; TICI 2a or more recanalization upto 3 pass of study device Safety; symptomatic intracranial hemorrhage within 24 hours of procedure
Study Oversight
Has Oversight DMC:
False
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?: