Penumbra Imaging Collaborative Study (PICS)

Penumbra

Status: Completed

Conditions: Stroke

Treatments: Device: Penumbra System

Study type: Observational

Funder types: Industry

Identifiers

NCT00785161

CLP 1953.A

Details and patient eligibility

About

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.

Enrollment: 289 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.