Ignite Creation Date:
2024-05-06 @ 2:00 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04187573
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2019-11-27
Brief Title:
Coil Assisted Flow Diversion Safety and Performance Study
Sponsor:
Cerus Endovascular Ltd
Organization:
Cerus Endovascular Ltd
Study Overview
Official Title:
Coil Assisted Flow Diversion A Prospective Single Arm Multi-center Study to Assess the Safety and Performance of Neqstent in Adjunctive Therapy CAFI Study
Status:
COMPLETED
Status Verified Date:
2024-10
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:
CAFI
Brief Summary:
Cerus Endovascular is sponsoring a prospective single arm multi-center study to document the safety and performance of Neqstent in adjunctive therapy
The purpose of the study is to document safety and performance of the Neqstent in adjunctive therapy in treatment for patients with intracranial aneurysms IA
The purpose of the study is to document safety and performance of the Neqstent in adjunctive therapy in treatment for patients with intracranial aneurysms IA
Detailed Description:
Neqstent is designed as an adjunctive therapy for patients with unruptured and failed bifurcation aneurysm embolizations Neqstent can be positioned at the neck of the aneurysm with or without existing coils and other embolization products Embolization coils should be added to fill the dome of the aneurysm after placement of Neqstent
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?:
None