Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-01 @ 8:41 PM
Study NCT ID:
NCT05024292
Status:
RECRUITING
Last Update Posted:
2023-07-12
First Post:
2021-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'thrombus retrieved from the occluded artery. Serum collected from the vein at different time points.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-10', 'studyFirstSubmitDate': '2021-08-22', 'studyFirstSubmitQcDate': '2021-08-22', 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional independence', 'timeFrame': '3 month', 'description': 'mRS 0-2'}], 'secondaryOutcomes': [{'measure': 'excellent functional independence', 'timeFrame': '3 month', 'description': 'mRS 0-1'}, {'measure': 'early therapeutic response', 'timeFrame': 'on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5', 'description': 'defined as a decrease in the NIHSS score of ≥10 from baseline or an NIHSS score of 0 or 1'}, {'measure': 'Mortality', 'timeFrame': '3 month', 'description': 'Mortality of 3 month after stoke onset'}, {'measure': 'hemorrhagic transformation', 'timeFrame': '24 hours after treatment', 'description': 'according to European Cooperative Acute Stroke Study II criteria'}, {'measure': 'Symptomatic intracerebral hemorrhage (sICH)', 'timeFrame': '24 hours after treatment', 'description': 'an increase of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS) according to Heidelberg Bleeding Classification'}, {'measure': 'malignant infarction', 'timeFrame': '24 hours after treatment', 'description': 'defined as infarct lesions with significant space-occupying mass effect with over 1/2 affected middle cerebral artery territory with imaging signs of herniation and/or and clinical signs of herniation requiring decompressive hemicraniectomy and/or leading to death due to direct implications of stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute ischemic stroke', 'thrombectomy', 'thrombolysis', 'outcome'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT.', 'detailedDescription': 'For acute ischemic stroke (AIS) patients with large vessel occlusion in the anterior circulation receieved successful reperfusion, in situ ischemic postconditioning (ISIPC) was performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were treated according to national guidelines for treatment of AIS, including intravenous thrombolysis, if indicated. Thrombectomy were performed according to standard techniques. The method of endovascular therapy was selected at the discretion of treating physicians and could include stent retriever and/or catheter aspiration.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (age ≥ 18 to 95 years) patients with an occlusion of the internal carotid artery or M1 or M2 segment of the middle cerebral artery,;\n2. Patients with a score of at least 6 on the National Institutes of Health Stroke Scale (NIHSS) at admission and a score of 0 or 1 on the modified Rankin scale before the onset of stroke;\n3. Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value;\n4. Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital\n5. The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt\n\nExclusion Criteria:\n\n1. Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion;\n2. Patients underwent rescue angioplasty or stenting after thrombectomy'}, 'identificationModule': {'nctId': 'NCT05024292', 'acronym': 'ORANGE', 'briefTitle': 'Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"}, 'officialTitle': 'Oriental Research Alliance of Acute Ischemic Stroke Given Endovascular Treatment: Technique Feasibility, Safety and Neuroprotective Effects of in Situ Ischemic Postconditioning in Patients Underwent Successful Endovascular Thrombectomy', 'orgStudyIdInfo': {'id': '2021MT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'rapid local ischemic postconditioning (RL-IPostC) group', 'description': 'RL-IPostC is performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.', 'interventionNames': ['Procedure: rapid local ischemic postconditioning (RL-IPostC)']}, {'label': 'control group', 'description': 'no intervention was provided after successful reperfusion'}], 'interventions': [{'name': 'rapid local ischemic postconditioning (RL-IPostC)', 'type': 'PROCEDURE', 'description': 'with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation', 'armGroupLabels': ['rapid local ischemic postconditioning (RL-IPostC) group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhangzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenhuo Chen, MD', 'role': 'CONTACT', 'email': 'doctorwwenhuo@126.com', 'phone': '+86-596-2082950'}], 'facility': 'Zhangzhou Municipal Hospital of Fujian Province', 'geoPoint': {'lat': 24.51333, 'lon': 117.65556}}, {'zip': '200233', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiangshan Deng, PhD', 'role': 'CONTACT', 'email': 'johnson120@126.com', 'phone': '02164369181'}], 'facility': "Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yueqi Zhu, PhD', 'role': 'CONTACT', 'email': 'zhuyueqi@hotmail.com', 'phone': '+86-21-18930177565'}], 'overallOfficials': [{'name': 'Yueqi Zhu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhangzhou Municipal Hospital of Fujian Province', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated dean of the radiology', 'investigatorFullName': 'Yueqi Zhu', 'investigatorAffiliation': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"}}}}