Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-04 @ 7:02 PM
Study NCT ID:
NCT03554850
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2018-05-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trevo® Retriever Registry (China)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fei.qin@stryker.com', 'phone': '+8613524821775', 'title': 'Fei Qin', 'organization': 'Stryker Neurovascular'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'If the subjects completed their 90-day visit, the subjects were considered as alive at Day 90. If the subjects did not come for their Day 90 visit and died, the date of death was used to compare with the upper window of their Day 90 (90 + 14 days post procedure). If the subjects died after the upper window of their Day 90, the subjects were considered as alive at their Day 90. Otherwise, the subjects were counted as deaths before Day 90.', 'description': 'The Adverse Events will be monitored/accessed without regard to the specific Adverse Event Term.', 'eventGroups': [{'id': 'EG000', 'title': 'Overall Summary of All AEs and SAEs', 'description': 'All SAEs through Day 90 will be summarized by number of events, number of subjects with events and the percentages of subjects with events by the type of SAEs and by their relatedness.\n\nAll AEs during procedure will be summarized by number of events, number of subjects with events and the percentages of the subjects with events by the type of AEs and by their relatedness.', 'otherNumAtRisk': 201, 'deathsNumAtRisk': 201, 'otherNumAffected': 5, 'seriousNumAtRisk': 201, 'deathsNumAffected': 11, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2.49'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Effectiveness Outcome', 'description': 'post-procedural eTICI score (≥2b)'}], 'classes': [{'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the end of the neuro-thrombectomy procedure (Day 1)', 'description': 'The primary endpoint is measured using the modified TICI scale at the end of procedure.Success of primary endpoint was defined as a modified TICI score of 2b or better at the end of procedure. Primary endpoint will be analyzed by percentages, frequencies and the 95% confidence interval of the percentage of success. The 95% confidence interval will be calculated using ClopperPearson exact method.\n\nNote: Modified TICI score has 6 grades: 0(No Perfusion), 1(Penetration with Minimal Perfusion), 2(Partial Perfusion), 2a(Partial filling with \\<50% of the entire vascular territory is visualized), 2b(Partial filling with ≥50% of the entire vascular territory is visualized), 3(Complete Perfusion). Higher scores mean a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Trevo Retriever was used as the primary device in all subjects.'}, {'type': 'SECONDARY', 'title': 'Day 90 mRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 90 mRS Data', 'description': 'good clinical outcomes defined as mRS of 0-2.'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 90', 'description': 'good clinical outcomes defined as mRS of 0-2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Day 90 Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 90 Mortality', 'description': 'If the subjects had completed their 90-day visit, the subjects will be considered as alive at Day 90. If the subjects did not come for their Day 90 visit and died, the date of death will be used to compare with the upper window of their Day 90 (90 + 14 days post procedure). If the subjects died after the upper window of their Day 90, the subjects will be considered as alive at their Day 90. Otherwise, the subjects will be counted as death before Day 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 90', 'description': 'If the subjects had completed their 90-day visit, the subjects will be considered as alive at Day 90. If the subjects did not come for their Day 90 visit and died, the date of death will be used to compare with the upper window of their Day 90 (90 + 14 days post procedure). If the subjects died after the upper window of their Day 90, the subjects will be considered as alive at their Day 90. Otherwise, the subjects will be counted as death before Day 90.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neurological Deterioration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurological Deterioration', 'description': 'Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Study Device and Procedure Related SAE Through Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rate of Study Device and Procedure Related SAE Through Day 90.', 'description': 'Rate of study device and procedure related serious adverse events (SAE) through Day 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 90', 'description': 'Rate of study device and procedure related serious adverse events (SAE) through Day 90.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm-Trevo® Retriever', 'description': 'All subjects who meet the inclusion/exclusion criteria and where Trevo Retriever is used as the initial mechanical thrombectomy device to remove thrombus from the neurovasculature in the setting of acute ischemic stroke.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}], 'preAssignmentDetails': 'Enrollment occurs when the Trevo Retriever is deployed as the first mechanical neuro-thrombectomy device used to remove the thrombus. A Screening and Enrollment Log will be maintained by each site to document basic information such as date screened and reason for screen failures for subjects who fail to meet the study eligibility criteria. In order to avoid bias, every effort should be made to include all Trevo cases performed over a given duration of time in the registry.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subject Demographics and Baseline Characteristics', 'description': "Subjects' demographic characteristics will be summarized using descriptive statistic methods.- Continuous variables will be summarized by mean±SD, median, minimum and maximum. Categorical variables will be summarized by percentages and frequencies."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '111', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age will be summarized by percentages and frequencies.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'description': 'Age will be summarized by mean±SD, median, minimum and maximum.', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '142', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '201', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-27', 'size': 633568, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-15T02:39', 'hasProtocol': True}, {'date': '2018-08-15', 'size': 523581, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-15T02:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2018-05-23', 'resultsFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-15', 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure', 'timeFrame': 'At the end of the neuro-thrombectomy procedure (Day 1)', 'description': 'The primary endpoint is measured using the modified TICI scale at the end of procedure.Success of primary endpoint was defined as a modified TICI score of 2b or better at the end of procedure. Primary endpoint will be analyzed by percentages, frequencies and the 95% confidence interval of the percentage of success. The 95% confidence interval will be calculated using ClopperPearson exact method.\n\nNote: Modified TICI score has 6 grades: 0(No Perfusion), 1(Penetration with Minimal Perfusion), 2(Partial Perfusion), 2a(Partial filling with \\<50% of the entire vascular territory is visualized), 2b(Partial filling with ≥50% of the entire vascular territory is visualized), 3(Complete Perfusion). Higher scores mean a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Day 90 mRS', 'timeFrame': 'Day 90', 'description': 'good clinical outcomes defined as mRS of 0-2.'}, {'measure': 'Day 90 Mortality', 'timeFrame': 'Day 90', 'description': 'If the subjects had completed their 90-day visit, the subjects will be considered as alive at Day 90. If the subjects did not come for their Day 90 visit and died, the date of death will be used to compare with the upper window of their Day 90 (90 + 14 days post procedure). If the subjects died after the upper window of their Day 90, the subjects will be considered as alive at their Day 90. Otherwise, the subjects will be counted as death before Day 90.'}, {'measure': 'Neurological Deterioration', 'timeFrame': '24 hours', 'description': 'Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure.'}, {'measure': 'Rate of Study Device and Procedure Related SAE Through Day 90', 'timeFrame': 'Day 90', 'description': 'Rate of study device and procedure related serious adverse events (SAE) through Day 90.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Real World Data in China']}, 'descriptionModule': {'briefSummary': 'Trevo® Retriever Registry (China) is to assess real world performance of the FDA cleared Trevo Retriever intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke in China.', 'detailedDescription': 'Trevo Registry (China) is a prospective, open-label, multi-center study, and it is the first Stryker China trial. This trial assesses real world performance of the Trevo® Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in subjects experiencing ischemic stroke. Total of 200 subjects among up to 15 sites in China local will participate in this trial. The primary endpoint is revascularization status assessment at the end of the procedure using the modified TICI score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Populations met the inclusion/exclusion criteria above', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18\n2. Subjects experiencing acute ischemic stroke due to a large vessel occlusion who are eligible and suitable for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus\n3. Trevo Retriever is planned to be the primary mechanical neuro-thrombectomy device to remove the thrombus\n4. Subject or subject's legally authorized Representative (LAR) has signed the study Informed Consent Form\n5. Subject willing to comply with the protocol follow-up requirements\n\nExclusion Criteria:\n\n1. mRS \\>2\n2. Any known coagulopathy\n3. Anticipated life expectancy less than 3 months\n4. Known absolute contraindications to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, radiographic contrast agents, etc.)\n5. Preexisting neurological or psychiatric disease that would prevent complete the study required evaluations\n6. The subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point."}, 'identificationModule': {'nctId': 'NCT03554850', 'briefTitle': 'Trevo® Retriever Registry (China)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Neurovascular'}, 'officialTitle': 'Trevo® Retriever Registry (China)', 'orgStudyIdInfo': {'id': 'CDM10001400'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Trevo® Retriever', 'type': 'DEVICE', 'description': 'Stent retriever procedure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing TianTan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '101300', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The Hospital of Shunyi District Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '511518', 'city': 'Qingyuan', 'state': 'Guangdong', 'country': 'China', 'facility': "Qingyuan City People's Hospital", 'geoPoint': {'lat': 23.7, 'lon': 113.03333}}, {'zip': '050051', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The Third Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '457001', 'city': 'Puyang', 'state': 'Henan', 'country': 'China', 'facility': 'Puyang Oilfield General Hospital', 'geoPoint': {'lat': 35.75641, 'lon': 115.04363}}, {'zip': '276003', 'city': 'Linyi', 'state': 'Shandong', 'country': 'China', 'facility': "Linyi People's Hospital", 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'zip': '266042', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'Qingdao Central Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '310016', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Wenzhou Central Hospital', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'ZhongRong Miao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Neurovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}