Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-05 @ 6:09 PM
Study NCT ID:
NCT03383666
Status:
TERMINATED
Last Update Posted:
2023-06-06
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
Sponsor:
Pulsar Vascular
Organization:
Study Overview
Official Title:
A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No safety issues; change in innovation strategy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAPA
Brief Summary:
This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.
Detailed Description:
The objective of this study is to evaluate the safety and effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device in conjunction with coil embolization in the endovascular treatment of unruptured wide-neck intracranial aneurysms.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: