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| Sponsor: | Penumbra Inc. |
|---|---|
| Information provided by: | Penumbra Inc. |
| ClinicalTrials.gov Identifier: | NCT00785161 |
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 IV |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System |
| 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) |
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:
Contacts and Locations| Contact: Siu Po Sit, PhD | 510-748-3200 ext 221 | siupo.sit@penumbrainc.com |
| Contact: Gina Orsot, BS | 510-748-3200 ext 256 | gina.orsot@penumbrainc.com |
| United States, Colorado | |
| Swedish Medical Center | Recruiting |
| Englewood, Colorado, United States, 80113 | |
| Contact: Carol Greenwald, MD 303-806-7418 | |
| Principal Investigator: Don Frei, MD | |
| Study Director: | Siu Po Sit, PhD | Penumbra Inc. |
More Information
| Responsible Party: | Penumbra, Inc ( Siu Po Sit, PhD ) |
| Study ID Numbers: | CLP 1953.A |
| Study First Received: | November 3, 2008 |
| Last Updated: | August 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00785161 History of Changes |
| Health Authority: | United States: Institutional Review Board; Japan: Institutional Review Board |
|
Penumbra System Mechanical Thrombectomy Ischemic Stroke Intervention Neurovascular |
Thrombus Imaging Ischemic Penumbra Functional Outcome |
|
Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Brain Diseases Cerebrovascular Disorders |