Penumbra Imaging Collaborative Study (PICS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Device: Penumbra System |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System |
- 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 ]
- 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 ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
-
Device: Penumbra System
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
A stroke cohort who were revacularized by the Penumbra System
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Penumbra Inc. |
| ClinicalTrials.gov Identifier: | NCT00785161 History of Changes |
| Other Study ID Numbers: | CLP 1953.A |
| Study First Received: | November 3, 2008 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Penumbra Inc.:
|
Penumbra System Mechanical Thrombectomy Ischemic Stroke Intervention Neurovascular |
Thrombus Imaging Ischemic Penumbra Functional Outcome |
Additional relevant MeSH terms:
|
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013