Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penumbra System | Device | Mechanical Thrombectomy in acute stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System. | Admission | |
| 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 | |
| The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure. | 90-Days Post-Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge. | Admission and Discharge | |
| Incidence of intracranial hemorrhage. | 24-Hours Post-Procedure |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
A stroke cohort who were revacularized by the Penumbra System
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Siu Po Sit, PhD | Penumbra Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Medical Center | Englewood | Colorado | 80113 | United States |
Not provided
| Label | URL |
|---|---|
| Penumbra Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Incidence of device-related serious adverse events. | During the Procedure |
| All cause mortality at 90 days post-procedure. | 90-Days Post-Procedure |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |