Penumbra Imaging Collaborative Study (PICS)
This study has been completed.
Information provided by (Responsible Party):
First received: November 3, 2008
Last updated: April 30, 2015
Last verified: April 2015
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.
Device: Penumbra System
||Observational Model: Cohort
Time Perspective: Prospective
||Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System
Primary Outcome Measures:
- Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System. [ Time Frame: Admission ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Post-Procedure ] [ Designated as safety issue: No ]
- The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure. [ Time Frame: 90-Days Post-Procedure ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge. [ Time Frame: Admission and Discharge ] [ Designated as safety issue: No ]
- Incidence of intracranial hemorrhage. [ Time Frame: 24-Hours Post-Procedure ] [ Designated as safety issue: No ]
- Incidence of device-related serious adverse events. [ Time Frame: During the Procedure ] [ Designated as safety issue: No ]
- All cause mortality at 90 days post-procedure. [ Time Frame: 90-Days Post-Procedure ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
A stroke cohort who were revacularized by the Penumbra System
- 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00785161
|Swedish Medical Center
|Englewood, Colorado, United States, 80113 |
||Siu Po Sit, PhD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 3, 2008
||April 30, 2015
||United States: Institutional Review Board
Keywords provided by Penumbra Inc.:
ClinicalTrials.gov processed this record on October 06, 2015