Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT04562194
Status:
RECRUITING
Last Update Posted:
2024-12-24
First Post:
2020-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NeVa ONE Registry Study
Sponsor:
Vesalio
Organization:
Study Overview
Official Title:
NEVA ONE One-Pass Reperfusion With the NeVa Stent-Retriever EMEA Registry
Status:
RECRUITING
Status Verified Date:
2024-12
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:
A prospective, open label study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.
Detailed Description:
This is a prospective, open label, multi-center registry designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 600 subjects will be enrolled at up 30 sites.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: