Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-28 @ 2:16 PM
Study NCT ID:
NCT04391803
Status:
SUSPENDED
Last Update Posted:
2025-06-06
First Post:
2020-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
Sponsor:
Medtronic Neurovascular Clinical Affairs
Organization:
Study Overview
Official Title:
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
Status:
SUSPENDED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor-initiated suspension to halt enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELEVATE
Brief Summary:
The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.
Detailed Description:
The ELEVATE study is a prospective, multi-center, single-arm trial of the Pipeline™ Shield Device for the treatment of adults with acutely ruptured intracranial aneurysms. The primary objective of the ELEVATE study is to assess the safety and effectiveness of treatment with the Pipeline™ Shield Device of acutely ruptured intracranial aneurysms that are not amenable for clipping and coiling.
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?:
None
Is an FDA AA801 Violation?: