Penumbra Imaging Collaborative Study (PICS)

Completed

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT00785161

Run by

Penumbra Inc.

People needed

289

Starts

2008-10-01

Expected to finish

2010-12-01

Last updated by the study team

2018-04-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients who signed informed consent and revascularized by the Penumbra™ System in accordance to the Instruction For Use are eligible for this study.

Where it is running

• Swedish Medical Center — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

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