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.
Primary Outcome Measures:
- Revascularization of the occluded target vessel (revascularization is defined by a Thrombolysis in Myocardial Infarction [TIMI] score of II or III following use of the Penumbra System)
- Incidence of device-related and procedure-related serious adverse events
Secondary Outcome Measures:
- The proportion of patients who have either a 4-point improvement on the National Institutes of Health Stroke Scale (NIHSS) at discharge or a modified Rankin Scale (mRS) score of ≤ 2 at 30 days after treatment
- The proportion of patients with a modified Rankin Scale (mRS) score of ≤ 2 at 90 days post treatment
- All cause mortality
- Incidence of symptomatic hemorrhage
Enrollment: |
125 |
Study Start Date: |
June 2006 |
Study Completion Date: |
September 2007 |
Primary Completion Date: |
June 2007 (Final data collection date for primary outcome measure) |
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.