Penumbra Imaging Collaborative Study (PICS)
Status: | Completed |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 4/17/2018 |
Start Date: | October 2008 |
End Date: | December 2010 |
Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System
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.
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.
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.
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