Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 3:28 PM
Study NCT ID:
NCT00810095
Status:
COMPLETED
Last Update Posted:
2012-07-26
First Post:
2008-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010243', 'term': 'Paralysis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tmccarthy@mindframeinc.com', 'phone': '949-204-0806', 'title': 'Dr. Thomas J. McCarthy', 'organization': 'MindFrame, Inc .'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All adverse events up to and including the 90-day follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group', 'description': 'All participants treated with the Test System', 'otherNumAtRisk': 40, 'otherNumAffected': 12, 'seriousNumAtRisk': 40, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malignant infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'All participants treated with the Test System'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately postprocedure', 'description': 'TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures:\n\nTIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with the Test System'}, {'type': 'PRIMARY', 'title': 'Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'All participants treated with the Test System'}], 'classes': [{'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately postprocedure', 'description': 'TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty:\n\nTIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage of participants who achieved (TIMI/TICI grade 2/3 flow), with or without the use of adjuvant therapy, in all treatable vessels as confirmed by the final post treatment angiogram.'}, {'type': 'PRIMARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'All participants treated with the Test System'}], 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days postprocedure', 'description': "Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage of participants achieving a Modified Rankin Scale score of 0-2 at 90 days postprocedure.'}, {'type': 'SECONDARY', 'title': 'Number of Device-related Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'All participants treated with the Test System'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment to 90 days postprocedure', 'description': 'Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis of all participants treated with the 1st generation MindFrame System of neurothrombotic stent retrievers.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MindFrame System Treatment Group', 'description': 'All participants with acute ischemic stroke who were treated with the 1st generation MindFrame System of neurothrombotic stent retrievers. The first generation MindFrame System was a self-expanding nitinol stent retriever mounted on a hypotube delivery wire and delivered to the occlusion site via a 0.027 inch microcatheter. Eligible patients were aged 18-80 years, had a baseline NIHSS score of 6-30, had a thrombotic occlusion of the ICA, MCA (M1 or M2) or basilar arteries, and could be treated within 6 hours of stroke onset.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group', 'description': 'All participants treated with the Test System'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'spread': '13.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Mean Baseline National Institutes of Health Stroke Scale (NIHSS) score', 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '4.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The NIH stroke scale (abbreviated NIHSS)is a scale developed by National Institutes of Health that communicates several different neurological deficits upon a single axis, represented by a score from 0 to 42 with "0" being no deficits and "42" being death.', 'unitOfMeasure': 'NIHSS units', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Median Baseline NIHSS score', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'description': 'The NIH stroke scale (abbreviated NIHSS)is a scale developed by National Institutes of Health that communicates several different neurological deficits upon a single axis, represented by a score from 0 to 42 with "0" being no deficits and "42" being death.', 'unitOfMeasure': 'NIHSS units', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-19', 'studyFirstSubmitDate': '2008-12-15', 'resultsFirstSubmitDate': '2012-03-21', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-19', 'studyFirstPostDateStruct': {'date': '2008-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.', 'timeFrame': 'Immediately postprocedure', 'description': 'TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures:\n\nTIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow'}, {'measure': 'Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.', 'timeFrame': 'Immediately postprocedure', 'description': 'TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty:\n\nTIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow'}, {'measure': 'Clinical Success', 'timeFrame': '90 days postprocedure', 'description': "Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent."}], 'secondaryOutcomes': [{'measure': 'Number of Device-related Serious Adverse Events', 'timeFrame': 'Treatment to 90 days postprocedure', 'description': 'Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cerebral Infarction', 'Stroke', 'Vascular Diseases', 'Central Nervous System Diseases', 'Penumbra', 'Functional Outcome', 'Aphasia', 'Hemiplegia', 'Left sided weakness', 'Right Sided weakness'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The primary study objective is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients experiencing an ischemic stroke.', 'detailedDescription': 'The objective of PRIISM is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients with acute ischemic stroke. Safety will be assessed by the device-related serious event rate as it compares to other similar therapies. The events include but are not limited to symptomatic hemorrhage, vessel dissection, embolization and overall morbidity and mortality. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. NIHSS 6 to 30 within 6 hours of symptom onset\n2. Pre-stroke Modified Rankin Score ≤ 2\n3. Large Vessel Occlusion\n4. Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation.\n5. Patients must meet at least one of the following criteria:\n\n * Eligible for Intravenous rt-PA\n * Eligible for Intra-arterial rt-PA - IA rt-PA initiated within 6 hours of symptom onset\n * Patient presents within 6 hours of symptom onset\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Glucose \\<50mg/dL\n3. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR\\>3.0\n4. Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal.\n5. Patient has baseline platelets \\< 30,000\n6. Evidence of rapidly improving neurological signs of stroke at time of enrollment\n7. Coma\n8. Pre-existing neurological or psychiatric disease that could confound the study results\n9. Known severe allergy to contrast media or nitinol\n10. Patient has severe sustained hypertension\n11. CT/MRI scan reveals significant mass effect with midline shift\n12. Patient's angiogram shows an arterial stenosis \\>50% proximal to the embolus.\n13. Patient's anticipated life expectancy is less than 3 months\n14. Participation in another clinical investigation that could confound the evaluation of the study device"}, 'identificationModule': {'nctId': 'NCT00810095', 'acronym': 'PRIISM', 'briefTitle': 'Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'MindFrame, Inc.'}, 'officialTitle': 'A Feasibility Trial to Evaluate the MindFrame System in the Recanalization of Occluded Vessels in Patients Experiencing an Ischemic Stroke', 'orgStudyIdInfo': {'id': 'EU-PRIISM-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'interventionNames': ['Device: MindFrame System']}], 'interventions': [{'name': 'MindFrame System', 'type': 'DEVICE', 'otherNames': ['IRIIS System', 'Clot', 'Thrombus', 'Mechanical Thrombectomy', 'Ischemic Stroke', 'Intervention', 'Neurovascular'], 'description': 'Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Martin Bendszus, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MindFrame, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}