Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-28 @ 12:50 PM
Study NCT ID:
NCT00785161
Status:
COMPLETED
Last Update Posted:
2018-04-12
First Post:
2008-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Penumbra Imaging Collaborative Study (PICS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 289}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2008-11-03', 'studyFirstSubmitQcDate': '2008-11-04', 'lastUpdatePostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System.', 'timeFrame': 'Admission'}, {'measure': '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.', 'timeFrame': 'Post-Procedure'}, {'measure': 'The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure.', 'timeFrame': '90-Days Post-Procedure'}], 'secondaryOutcomes': [{'measure': 'Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge.', 'timeFrame': 'Admission and Discharge'}, {'measure': 'Incidence of intracranial hemorrhage.', 'timeFrame': '24-Hours Post-Procedure'}, {'measure': 'Incidence of device-related serious adverse events.', 'timeFrame': 'During the Procedure'}, {'measure': 'All cause mortality at 90 days post-procedure.', 'timeFrame': '90-Days Post-Procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Penumbra System', 'Mechanical Thrombectomy', 'Ischemic Stroke', 'Intervention', 'Neurovascular', 'Thrombus', 'Imaging', 'Ischemic Penumbra', 'Functional Outcome'], 'conditions': ['Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.penumbrainc.com', 'label': 'Penumbra Website'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A stroke cohort who were revacularized by the Penumbra System', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who signed informed consent and revascularized by the Penumbra™ System in accordance to the Instruction For Use are eligible for this study.'}, 'identificationModule': {'nctId': 'NCT00785161', 'acronym': 'PICS', 'briefTitle': 'Penumbra Imaging Collaborative Study (PICS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Penumbra Inc.'}, 'officialTitle': 'Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System', 'orgStudyIdInfo': {'id': 'CLP 1953.A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Penumbra System', 'type': 'DEVICE', 'description': 'Mechanical Thrombectomy in acute stroke'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}], 'overallOfficials': [{'name': 'Siu Po Sit, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Penumbra Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penumbra Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}