Ignite Creation Date:
2024-05-06 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03383666
Status:
TERMINATED
Last Update Posted:
2023-06-06
First Post:
2017-12-12
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:
Pulsar Vascular
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:
None
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?:
None