Penumbra Imaging Collaborative Study (PICS)

Penumbra Inc.289 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

289

Conditions

Stroke

Interventions

Penumbra SystemDEVICE

Mechanical Thrombectomy in acute stroke

Eligibility

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.