Penumbra Imaging Collaborative Study (PICS)

Completed

• Conditions: Stroke

• Registration Number: NCT00785161
• Lead Sponsor: Penumbra Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Incidence of intracranial hemorrhage.	24-Hours Post-Procedure
Incidence of device-related serious adverse events.	During the Procedure
All cause mortality at 90 days post-procedure.	90-Days Post-Procedure
Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge.	Admission and Discharge

Trial Locations

Locations (1)

Swedish Medical Center; 🇺🇸 Englewood, Colorado, United States