Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT00334061
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2006-06-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Safety and Effectiveness of the Penumbra System
Sponsor:
Penumbra Inc.
Organization:
Study Overview
Official Title:
Evaluation of the Penumbra™ Stroke System in the Revascularization of Patients With Acute Ischemic Stroke Secondary to Intracranial Large Vessel Occlusive Disease
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical evaluation is a prospective, single-arm, multi-center trial.
The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.
The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.
Detailed Description:
Purpose:
The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease. Up to 125 evaluable patients will be enrolled in the study.
The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease. Up to 125 evaluable patients will be enrolled in the study.
Study Oversight
Has Oversight DMC:
True
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?: