Viewing Study NCT01465841



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Last Modification Date: 2024-10-26 @ 10:43 AM
Study NCT ID: NCT01465841
Status: COMPLETED
Last Update Posted: 2020-07-07
First Post: 2011-10-28

Brief Title: Study of the Penumbra Coil 400 System to Treat Aneurysm
Sponsor: Penumbra Inc
Organization: Penumbra Inc

Study Overview

Official Title: ACE An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System
Status: COMPLETED
Status Verified Date: 2020-06
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: ACE
Brief Summary: This is a prospective multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System The primary objective is to gather post market data on the Penumbra Coil 400 PC 400 System in the acute treatment of intracranial and peripheral aneurysms Approximately 2000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled Data for each patient are collected up to discharge or 3 days post-procedure whichever occurs sooner Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital
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
Secondary IDs
Secondary ID Type Domain Link
CLP 4492 OTHER Penumbra Inc None