Ignite Creation Date:
2024-05-06 @ 2:47 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02122133
Status:
TERMINATED
Last Update Posted:
2019-04-12
First Post:
2014-04-21
Brief Title:
CARE A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
Sponsor:
Penumbra Inc
Organization:
Penumbra Inc
Study Overview
Official Title:
CARE A Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision to focus on other studies No safety concern
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE
Brief Summary:
The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400 System PC 400 or conventional coils per their respective indications for useThis is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the PC 400 or conventional coils Data for each patient are collected acutelyUp to 90 patients treated with the PC 400 or conventional coils 21 at up to 15 centers in the USA will be enrolled
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None