Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
Study NCT ID:
NCT04380350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-25
First Post:
2020-05-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trenza Embolization Device for Intrasaccular Aneurysm Treatment
Sponsor:
Stryker Neurovascular
Organization:
Study Overview
Official Title:
Trenza Embolization Device for Intrasaccular Aneurysm Treatment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
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 Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.
Detailed Description:
Prospective, multi-center, single-arm, post-market follow-up study conducted in Europe for the treatment of patients with saccular intracranial aneurysms.
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?:
False
Is an FDA AA801 Violation?: