Stroke
Conditions
Keywords
Penumbra System, Mechanical Thrombectomy, Ischemic Stroke, Intervention, Neurovascular, Thrombus, Imaging, Ischemic Penumbra, Functional Outcome
Brief summary
The primary aim of this study are to gather data on the real world experience of the Penumbra System and to determine if there is a correlate between the imaging-defined size of the ischemic penumbra at admission and patient outcome in patients already treated by the System. This will be accomplished by the collection of all available admission imaging data along with patient clinical and functional outcome results at 90-day follow-up to determine if a positive association exists between these variables. A secondary aim is to collect and summarize the 90-day functional outcome data for the purpose of sample size estimation for a potential randomized concurrent controlled trial. This will be accomplished by collecting the data on 90-day modified Rankin Scores (mRS) and all cause mortality.
Interventions
DEVICEPenumbra System
Mechanical Thrombectomy in acute stroke
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients who signed informed consent and revascularized by the Penumbra™ System in accordance to the Instruction For Use are eligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with successful revascularization of the occluded target vessel as defined by a TIMI score of 2 or 3 following use of the Penumbra System. | Post-Procedure |
| Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System. | Admission |
| The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure. | 90-Days Post-Procedure |
Secondary
| Measure | Time frame |
|---|---|
| Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge. | Admission and Discharge |
| All cause mortality at 90 days post-procedure. | 90-Days Post-Procedure |
| Incidence of intracranial hemorrhage. | 24-Hours Post-Procedure |
| Incidence of device-related serious adverse events. | During the Procedure |
Countries
United States
Outcome results
None listed