Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-01-07 @ 1:53 AM
Study NCT ID:
NCT00334061
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2006-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Safety and Effectiveness of the Penumbra System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'siupo.sit@penumbrainc.com', 'phone': '510 748 3200', 'title': 'Siu Po Sit, PhD Study Coordinator', 'phoneExt': '221', 'organization': 'Penumbra Inc'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Penumbra System', 'otherNumAtRisk': 125, 'otherNumAffected': 125, 'seriousNumAtRisk': 125, 'seriousNumAffected': 65}], 'otherEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrolyte Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Pulmonary Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Vascular Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Dysfunction/Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepato-Biliary Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening Symptoms of Qualifying Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphasia-Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Embolization of Previously Uninvolved Vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GERD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cerebral Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 14}], 'organSystem': 'Nervous system disorders'}, {'term': 'Intracerebral Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'Nervous system disorders'}, {'term': 'Respiratory Dysfunction/Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Worsening Symptoms of Qualifying Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 9}], 'organSystem': 'Nervous system disorders'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'General disorders'}, {'term': 'Other Pulmonary Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Cardiac Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Cardiac disorders'}, {'term': 'Access Site Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Peripheral Vascular Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Vascular disorders'}, {'term': 'Renal Dysfunction/Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Stroke in New Territory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Revascularization of the Occluded Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Penumbra System'}], 'classes': [{'categories': [{'measurements': [{'value': '81.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-Month Post-Procedure', 'description': 'Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System.\n\nTIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Device-related and Procedure-related Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Penumbra System'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-Month Post-Procedure', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All adverse events were summarized by showing the number and percent of patients who reported the event. Events were also reported by relationship to the procedure or device. Causality of adverse events was adjudicated by a Clinical Events Committee. The denominator for the analyses was all enrolled patients.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Penumbra System'}], 'classes': [{'categories': [{'measurements': [{'value': '41.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge or 30-Days Post-Procedure', 'description': 'NIHSS is a 42 point scale to describe the neurological status of the patients:\n\n0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Penumbra System'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90-Day', 'description': 'The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Penumbra System'}], 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90-Days Post-Treatment', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Symptomatic Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Penumbra System'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24-Hour Post-Procedure', 'description': 'All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Penumbra System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'June 2006', 'groupId': 'FG000', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'November 2007', 'groupId': 'FG000', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From June 19, 2006 to June 5, 2007 a total of 856 patients were screened of which 125 patients were enrolled at 24 centers in Europe and the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Penumbra System'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '13.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2006-06-02', 'resultsFirstSubmitDate': '2008-11-20', 'studyFirstSubmitQcDate': '2006-06-02', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-01-09', 'studyFirstPostDateStruct': {'date': '2006-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Revascularization of the Occluded Target Vessel', 'timeFrame': '3-Month Post-Procedure', 'description': 'Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System.\n\nTIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.'}, {'measure': 'Percentage of Participants With Device-related and Procedure-related Serious Adverse Events', 'timeFrame': '3-Month Post-Procedure'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment', 'timeFrame': 'Discharge or 30-Days Post-Procedure', 'description': 'NIHSS is a 42 point scale to describe the neurological status of the patients:\n\n0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.'}, {'measure': 'Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment', 'timeFrame': '90-Day', 'description': 'The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.'}, {'measure': 'Percentage of Participants With All Cause Mortality', 'timeFrame': '90-Days Post-Treatment'}, {'measure': 'Percentage of Participants With Symptomatic Hemorrhage', 'timeFrame': '24-Hour Post-Procedure', 'description': 'All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Penumbra', 'Ischemic', 'Stroke', 'Intervention', 'Neurovascular', 'Thrombus', 'Embolectomy', 'Ischemic stroke'], 'conditions': ['Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.penumbrainc.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This clinical evaluation is a prospective, single-arm, multi-center trial.\n\nThe purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.', 'detailedDescription': 'Purpose:\n\nThe purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease. Up to 125 evaluable patients will be enrolled in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical signs consistent with acute ischemic stroke\n* 18 to 79 years of age\n* Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score \\> 8\n* TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System\n* Signed informed consent\n* Present within 8 hours of stroke symptom onset; ineligible or refractory to intravenous tissue plasminogen activator (t-PA) therapy if presenting within 3 hours of symptom onset.\n\nExclusion Criteria:\n\n* Evidence of rapidly improving neurological signs of stroke at time of enrollment\n* NIHSS \\> 30 or coma\n* Females who are pregnant\n* Vessel tortuosity too difficult to allow endovascular access\n* Known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an International Normalized Ratio (INR) \\> 3.0\n* Partial thromboplastin time (PTT) greater than 2 times the lab normal\n* Admission platelets \\< 30,000\n* Pre-existing neurological or psychiatric disease that could confound the study results\n* Known severe allergy to contrast media\n* Uncontrolled hypertension\n* Computed tomography (CT) evidence of significant mass effect with a midline shift\n* CT reveals evidence of large hypodensity region \\> 1/3 of the middle cerebral artery territory\n* CT reveals evidence of intracranial hemorrhage\n* CT reveals significant mass effect with midline shift\n* Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal\n* Angiographic evidence of preexisting arterial injury\n* Life expectancy of less than 90 days\n* Participation in another clinical investigation that could confound the evaluation of the study device.'}, 'identificationModule': {'nctId': 'NCT00334061', 'briefTitle': 'Study to Assess the Safety and Effectiveness of the Penumbra System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Penumbra Inc.'}, 'officialTitle': 'Evaluation of the Penumbra™ Stroke System in the Revascularization of Patients With Acute Ischemic Stroke Secondary to Intracranial Large Vessel Occlusive Disease', 'orgStudyIdInfo': {'id': 'CLP 0676'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Penumbra System', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penumbra Inc.', 'class': 'INDUSTRY'}}}}