An observational study in Stroke, sponsored by Penumbra Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2018-04-12.
Sponsored by Penumbra Inc. · Observational
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.
Penumbra Inc. is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A stroke cohort who were revacularized by the Penumbra System
Inclusion Criteria:
Mechanical Thrombectomy in acute stroke
Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System.
Time frame: 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.
Time frame: Post-Procedure
The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure.
Time frame: 90-Days Post-Procedure
Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge.
Time frame: Admission and Discharge
Incidence of intracranial hemorrhage.
Time frame: 24-Hours Post-Procedure
Incidence of device-related serious adverse events.
Time frame: During the Procedure
All cause mortality at 90 days post-procedure.
Time frame: 90-Days Post-Procedure
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Penumbra Inc.