Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:47 PM
Study NCT ID:
NCT07323368
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advancing Reperfusion Therapy for Ischemic Stroke: Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 568}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-08', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The proportion of successful recanalization', 'timeFrame': 'immediately after the intervention', 'description': 'The proportion of successful recanalization(eTICI 2b50-3) following EVT'}, {'measure': 'The proportion of improvement on reperfusion at 24 hours after randomization', 'timeFrame': '24 hours', 'description': 'Improvement on reperfusion is defined as \\>90% reduction in Tmax \\> 6s lesion volume'}, {'measure': 'The proportion of complete recanalization at 24 hours after randomization', 'timeFrame': '24 hours', 'description': 'Complete recanalization is defined as an Arterial Occlusion Lesion scale \\[AOL\\] score of 3 (scale range, 0 \\[no recanalization\\] to 3 \\[complete recanalization\\]).'}], 'primaryOutcomes': [{'measure': 'The proportion of patients who have a score of 0 or 1 on the modified Rankin Scale (mRS) at 90 days', 'timeFrame': '90 days', 'description': 'The proportion of patients with an mRS score ≤ 1 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.'}], 'secondaryOutcomes': [{'measure': 'Ordinal distribution of modified Rankin Scale (mRS) at 90 days', 'timeFrame': '90 days', 'description': 'Ordinal distribution of mRS at 90 days (shift analysis). The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.'}, {'measure': 'The proportion of patients with an modified Rankin Scale (mRS) score of 0-2 at 90 days', 'timeFrame': '90 days', 'description': 'The proportion of patients with an mRS score of 0-2 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.'}, {'measure': 'The rate of early neurological improvement at 24 hours', 'timeFrame': '24 hours', 'description': 'The rate of early neurological improvement at 24 hours after randomization (defined as a National Institute of Health Stroke Scale \\[NIHSS\\] score ≤1 or ≥4 points compared with the baseline)'}, {'measure': 'The proportion of patients with an modified Rankin Scale (mRS) score of 5-6 at 90 days', 'timeFrame': '90 days', 'description': 'The proportion of patients with an mRS score of 0-2 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.'}, {'measure': 'The median value of EuroQol 5-Dimension (EQ-5D) index', 'timeFrame': '90 days and 1 year', 'description': 'EuroQol 5-Dimension (EQ-5D) index at 90 days and 1 year. The EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) is a standardized instrument for the measurement of health status. The domains mobility, self-care, everyday activity, pain or physical discomfort, and fear or depression are assessed on a five-point scale, with 1 indicating no problem in this domain and 3 indicating extreme problems. The visual analogue scale ranges from 0 to 100, with 0 indicating the worst health imaginable and 100 the best health imaginable.'}, {'measure': 'Ordinal distribution of modified Rankin Scale (mRS) at 1 year', 'timeFrame': '1 year', 'description': 'Ordinal distribution of modified Rankin Scale (mRS) at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.'}, {'measure': 'The proportion of symptomatic intracranial hemorrhage', 'timeFrame': '24 hours', 'description': 'Symptomatic intracranial hemorrhage within 24 hours (as defined by Heidelberg criteria)'}, {'measure': 'The proportion of all-cause mortality', 'timeFrame': '90 days and 1 year', 'description': 'All-cause mortality at 90 days and 1 year'}, {'measure': 'The proportion of systematic bleeding', 'timeFrame': '90 days', 'description': 'Moderate or severe systemic bleeding is defined according to the criteria established in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial'}, {'measure': 'The proportion of serious adverse events (SAEs)', 'timeFrame': '90 days', 'description': 'serious adverse events within 90 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ischemic stroke', 'medium vessel occlusions', 'endovascular treatment', 'perfusion imaging'], 'conditions': ['Stroke Ischemic', 'Medium Vessel Occlusions']}, 'descriptionModule': {'briefSummary': 'The investigators initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of perfusion-guided endovascular treatment (EVT) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 24 hours from symptom onset.', 'detailedDescription': 'Adult acute ischemic stroke patients due to primary medium vessel occlusions (non-dominant proximal M2 or mid-distal M2/M3 segments of the middle cerebral artery, A1/A2/A3 segments of the anterior cerebral artery, and P1/P2/P3 segments of the posterior cerebral artery) confirmed by CTA/MRA and responsible for the signs and symptoms of acute ischemic stroke with baseline National Institutes of Health Stroke Scale (NIHSS) ≥8 will be enrolled in this trial. The investigators use perfusion imaging to select subjects and the enrolled patients have target mismatch profile on CTP or MRI+PWI (ischemic core volume \\<70mL, mismatch ratio\\>1.2, mismatch volume \\>10mL). The eligible patients will be randomly assigned to receive endovascular treatment (EVT) +best medical treatment or best medical treatment within 24 hours after the time that the patient was last known to be well (including after stroke on awakening and unwitnessed stroke). The primary outcome is the proportion of patients with an mRS score ≤ 1 at 90 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥18 years old;\n* Acute ischemic stroke symptom onset within 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";\n* Primary medium vessel occlusions confirmed by CTA/MRA, including non-dominant proximal M2 or mid-distal M2/M3 segments of the middle cerebral artery (MCA), A1/A2/A3 segments of the anterior cerebral artery (ACA), and P1/P2/P3 segments of the posterior cerebral artery (PCA) and responsible for the signs and symptoms of acute ischemic stroke;\n* Pre-stroke modified Rankin scale (mRS) score ≤1;\n* Baseline National Institutes of Health Stroke Scale (NIHSS) ≥8;\n* Neuroimaging criteria: Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume \\<70 mL, mismatch rate \\>1.2, mismatch volume \\>10 mL);\n* Written informed consent from patients or their legally authorized representatives.\n\nExclusion Criteria:\n\n* Any evidence of intracranial hemorrhage on qualifying imaging;\n* Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys and unable to complete CTP/PWI;\n* Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the arterial access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after EVT;\n* Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma);\n* Clinical diagnosis of cerebral vasculitis;\n* Evidence of vessel recanalization prior to randomisation;\n* Severe comorbidities, which will likely prevent improvement or follow-up;\n* Any terminal illness such that the patient would not be expected to survive more than 1 year;\n* Hypodensity in \\>1/3 MCA territory on non-contrast CT or significant hypodensity outside the current perfusion lesion suggesting distal clot migration (secondary MeVO);\n* Multiple arterial occlusion;\n* Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of the trial;\n* Unlikely to adhere to the trial protocol or follow-up;\n* Participation in other interventional clinical trials within the previous 3 months.'}, 'identificationModule': {'nctId': 'NCT07323368', 'acronym': 'ARTS-PIVOT', 'briefTitle': 'Advancing Reperfusion Therapy for Ischemic Stroke: Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy (PIVOT)', 'orgStudyIdInfo': {'id': 'SQ2024QB01857'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endovascular treatment (EVT) +Best medical treatment', 'description': 'The treating physician should attempt to perform EVT with the goal to restore blood flow to the affected vascular territory immediately after randomisation. EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team. All decisions regarding the performance of EVT are made by the treating physician, based on his/her own judgement, and using local standards for endovascular treatment technique and devices and/or medications used for EVT. All other treatments (especially after-care and best medical treatment) will not differ between the intervention and control group.', 'interventionNames': ['Procedure: Endovascular treatment']}, {'type': 'OTHER', 'label': 'Best medical treatment (BMT)', 'description': 'Administration of BMT should be done according to routine clinical practice and current guidelines.', 'interventionNames': ['Drug: Best medical treatment (BMT)']}], 'interventions': [{'name': 'Endovascular treatment', 'type': 'PROCEDURE', 'description': 'EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.', 'armGroupLabels': ['Endovascular treatment (EVT) +Best medical treatment']}, {'name': 'Best medical treatment (BMT)', 'type': 'DRUG', 'description': 'Administration of BMT should be done according to routine clinical practice and current international guidelines. Administration of BMT must not be delayed by randomisation and should be done independently from participation in this trial.', 'armGroupLabels': ['Best medical treatment (BMT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunyun Xiong, professor', 'role': 'CONTACT', 'email': 'xiongyunyun@bjtth.org', 'phone': '86-10-59978350'}], 'facility': 'Beijing tiantan hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunmiao Duan', 'role': 'CONTACT', 'email': 'miao3252003@163.com', 'phone': '010-60283006'}], 'facility': "Beijing Daxing District People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Longzhou', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanxin Wang', 'role': 'CONTACT', 'email': 'bdaczfg@163.COM', 'phone': '0311-82981231'}], 'facility': "Xingtang County People's Hospital", 'geoPoint': {'lat': 38.43814, 'lon': 114.54953}}, {'city': 'Luoyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yajun Yang', 'role': 'CONTACT', 'email': 'sqyyj7119@163.com', 'phone': '0379-82888808'}], 'facility': 'Luoyang Yiluo Hospital', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'city': 'Panlong', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianxin Xu', 'role': 'CONTACT', 'email': '249957242@qq.com', 'phone': '0396-7068021'}], 'facility': "People's Hospital of Queshan", 'geoPoint': {'lat': 32.80222, 'lon': 114.01917}}, {'city': 'Changle', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruiguang Liu', 'role': 'CONTACT', 'email': 'lrgys@126.com', 'phone': '0536-6222822'}], 'facility': "Changle People's Hospital", 'geoPoint': {'lat': 36.70583, 'lon': 118.8275}}], 'centralContacts': [{'name': 'Yunyun Xiong, professor', 'role': 'CONTACT', 'email': 'xiongyunyun@bjtth.org', 'phone': '86-10-59978350'}], 'overallOfficials': [{'name': 'Yunyun Xiong, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yunyun Xiong', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}