Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT02312856
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2014-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction
Sponsor:
Pulsar Vascular
Organization:
Study Overview
Official Title:
Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and
Status:
COMPLETED
Status Verified Date:
2019-04
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:
ANSWER
Brief Summary:
This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.
Detailed Description:
Primary Endpoints:
* Safety: Death or stroke in downstream territory to 180-days post-procedure
* Technical Success: Device placement success and ability to retain coils at the time of the index procedure
* Rate of aneurysm occlusion at Day zero (0) and 180 days
Additional Evaluations to 180-days and at 365-day follow up:
* Rate of aneurysm occlusion at 365 days
* Device movement or migration
* Stenosis
* Rate of incidence of new neurological deficits
* Complication rate (neurological and non-neurological)
* Safety: Death or stroke in downstream territory to 180-days post-procedure
* Technical Success: Device placement success and ability to retain coils at the time of the index procedure
* Rate of aneurysm occlusion at Day zero (0) and 180 days
Additional Evaluations to 180-days and at 365-day follow up:
* Rate of aneurysm occlusion at 365 days
* Device movement or migration
* Stenosis
* Rate of incidence of new neurological deficits
* Complication rate (neurological and non-neurological)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: