Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT04072367
Status:
WITHDRAWN
Last Update Posted:
2023-04-27
First Post:
2019-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FIrst-Pass Reperfusion With the NeVa Stent-Retriever Trial
Sponsor:
Vesalio
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Open-Label, Multi-Center, Assessor-Blinded Study Designed to Compare the Safety, Performance and Efficacy of the NeVatm Stent Retriever Versus the Solitairetm Stent Retriever
Status:
WITHDRAWN
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was withdrawn due to a change in company strategy.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIRST
Brief Summary:
This study is designed to compare the safety, performance and efficacy of blood clot (thrombus) removal in subjects presenting with acute ischemic stroke with the NeVa versus the Solitaire stent retrievers.
Detailed Description:
A pivotal, randomized, open label, assessor-blinded, 90-day study designed to compare the safety, performance and efficacy of thrombus removal in subjects aged ≥ 18 years presenting with acute ischemic stroke with the NeVa versus the Solitaire stent retrievers.
A total of 414 eligible subjects will be randomized in a 1:1 ratio to one of two treatment groups:
* Active Treatment Group
* Control Device
A total of 414 eligible subjects will be randomized in a 1:1 ratio to one of two treatment groups:
* Active Treatment Group
* Control Device
Study Oversight
Has Oversight DMC:
True
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?: