Penumbra Imaging Collaborative Study (PICS) "PICS"

Completed

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Thrombus Dissolution/Mechanical Thrombectomy (Penumbra System)Procedure/Surgery
    Intervention Desc: Designed to either break up and remove the thrombus by aspiration or to mechanically remove the occlusive thrombus.
  • Penumbra System Device
    Intervention Desc: Mechanical Thrombectomy in acute stroke

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

A stroke cohort who were revacularized by the Penumbra System

Patient Involvement

Patients who have revascularization using the Penumbra system after admission. Patients will have NIHSS at admission and discharge, TIMI after use of Penumbra System, and mRS 90 days post procedure.

Outcomes

Type Measure Time Frame Safety Issue
Primary 1. Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System. 2. 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. 3. The proportion of patients with a modified Rankin Score (mRS) of ?2 at 90 days post-procedure.
Secondary 1. Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge. 2. Incidence of intracranial hemorrhage. 3. Incidence of device-related serious adverse events. 4. All cause mortality at 90 days post-procedure.
Primary Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System. Admission No
Primary 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 No
Primary The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure. 90-Days Post-Procedure No
Secondary Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge. Admission and Discharge No
Secondary Incidence of intracranial hemorrhage. 24-Hours Post-Procedure No
Secondary Incidence of device-related serious adverse events. During the Procedure No
Secondary All cause mortality at 90 days post-procedure. 90-Days Post-Procedure No

Sponsors