Ignite Creation Date:
2024-05-06 @ 8:22 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02729740
Status:
COMPLETED
Last Update Posted:
2021-03-01
First Post:
2016-03-15
Brief Title:
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
Sponsor:
Penumbra Inc
Organization:
Penumbra Inc
Study Overview
Official Title:
SMART - A Prospective Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL System
Status:
COMPLETED
Status Verified Date:
2021-02
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:
SMART
Brief Summary:
The primary objective of this study is to gather post market data on the Penumbra SMART COIL System Smart System in the treatment of intracranial aneurysms and other malformations
Detailed Description:
This is a prospective multi-center registry of patients treated in accordance with the cleared indications for the Smart System Smart Penumbra Coil 400TM PC 400 and Penumbra Occlusion Device POD Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up Approximately 1000 patients with intracranial aneurysms or other malformations treated by the Smart System at up to 100 centers will be enrolled It is anticipated patient enrollment will take 3 years All patients are to be assessed in accordance with the standard of care at each participating hospital through one year follow-up
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