[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643898":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":63,"collaborators":27,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":27,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":90,"whyStopped":27,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intra-arterial Thrombolysis plus Best Medical Management","EXPERIMENTAL","Participants receive intra-arterial thrombolysis (IAT) via microcatheter plus best medical management (BMM). For small thrombus, microcatheter is positioned adjacent to or within the thrombus. For larger burden, microcatheter is advanced through the occluded segment with staged administration from distal to proximal portions (one-third of total dose per segment). Agent: alteplase 0.225 mg\u002Fkg (max 22.5 mg) or tenecteplase 0.0625 mg\u002Fkg (max 6.25 mg), administered over 15-30 min, consistent with any prior IV thrombolysis. Procedure ends at meTICI ≥ 2b or when risks outweigh benefits. BMM includes antiplatelet, anticoagulation (if indicated), statins, BP\u002Fglycemic control, and rehabilitation.",[13,14,15],"Drug: rt-PA; Recombinant Tissue Plasminogen Activator","Procedure: Intra-arterial Thrombolysis","Drug: Best Medical Management",{"label":17,"type":18,"description":19,"interventionNames":20},"Best Medical Management Alone","ACTIVE_COMPARATOR","Participants receive best medical management alone per local guidelines, including antiplatelet therapy, anticoagulation (if indicated), statins, blood pressure and glycemic control, and rehabilitation. No endovascular intervention is permitted.",[15],[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","rt-PA; Recombinant Tissue Plasminogen Activator","Administered intra-arterially via microcatheter. Agent options: alteplase (rt-PA) at 0.225 mg\u002Fkg (maximum 22.5 mg) or tenecteplase (TNK) at 0.0625 mg\u002Fkg (maximum 6.25 mg), infused over 15-30 minutes. The choice of agent should be consistent with any prior intravenous thrombolysis.",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"PROCEDURE","Intra-arterial Thrombolysis","Microcatheter is navigated to the occluded medium vessel. For small thrombus burden, positioned adjacent to or within the thrombus. For larger burden, advanced through occluded segment with staged administration distal-to-proximal (one-third per segment). Procedure ends at meTICI ≥ 2b or when risks outweigh benefits.",[9],{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Best Medical Management","Best medical management per local guidelines, including antiplatelet therapy, anticoagulation (if indicated), statins, blood pressure and glycemic control, and rehabilitation.",[17,9],[38],{"name":39,"affiliation":5,"role":40},"Sheng Liu, Professor","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Xinglong Liu, Doctor","CONTACT","+8618262638087","plear_new@163.com",[48],{"facility":49,"status":27,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"the First Affiliated Hospital with Nanjing Medical University","Nanjing","Jiangsu","210000","China","CN",{"type":56,"coordinates":57},"Point",[58,59],118.77778,32.06167,{"lat":59,"lon":58},[62],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},{"type":64,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100643898","phase-3-intra-arterial-thrombolysis-for-acute-ischemic-stroke-with-medium-vessel-occlusion-100643898",false,"NCT07668323","Intra-arterial Thrombolysis For Acute Ischemic Stroke With Medium Vessel Occlusion","Intra-arterial Thrombolysis for Acute Ischemic Stroke With Medium Vessel Occlusion： A Multicenter Prospective Randomized Controlled Clinical Trial","IAT-MEVO","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Time from symptom onset or last known well to randomization within 24 hours.\n* Clinical diagnosis of acute ischemic stroke confirmed by CTA or MRA as being caused by isolated acute medium vessel occlusion, including distal M2\u002FM3 segments of the middle cerebral artery, A2\u002FA3 segments of the anterior cerebral artery, or P1\u002FP2\u002FP3 segments of the posterior cerebral artery. Isolated occlusion is defined as a single symptomatic vessel occlusion; patients with multiple vessel occlusions or uncertain culprit vessel are excluded.\n* Baseline NIHSS score ≥ 6, or 3-5 with disabling deficits (e.g., motor weakness, aphasia, visual field defects), and NIHSS score ≤ 25 at the time of randomization.\n* For patients presenting beyond 6 hours from symptom onset: perfusion imaging criteria require Tmax \\> 6s volume ≥ 10 cc, and core infarct volume (defined as rCBF \\\u003C 30%) less than 50% of the Tmax \\> 6s volume.\n* Patient or legally authorized representative is able to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Clinical Exclusion Criteria:\n* Pre-stroke modified Rankin Scale (mRS) score \\> 2.\n* Presence of contraindications to intravenous thrombolysis.\n* Known allergy to heparin, contrast media, anesthetics, or other definite contraindications to endovascular treatment.\n* Comorbid severe diseases that may affect outcome assessment, including but not limited to malignancy, severe heart failure, or renal failure, with expected life expectancy \\\u003C 6 months.\n* Uncontrolled hypertension refractory to medical therapy (systolic blood pressure \\> 220 mmHg or diastolic blood pressure \\> 120 mmHg).\n* Baseline blood glucose \\\u003C 2.8 mmol\u002FL (50 mg\u002FdL) or \\> 22.2 mmol\u002FL (400 mg\u002FdL).\n* Known bleeding diathesis, including but not limited to: platelet count \\\u003C 100 × 10⁹\u002FL; heparin treatment within 48 hours with APTT ≥ 35 seconds; oral warfarin with INR \\> 3. Note: Patients without a history or suspicion of coagulation disorders do not require laboratory testing for coagulation parameters prior to enrollment.\n* Stroke onset with seizure or seizure occurring during the course of stroke, precluding accurate determination of baseline NIHSS score.\n* Female patients who are pregnant, lactating, or have a positive pregnancy test at hospital admission.\n* Currently participating in another investigational drug or device study that may interfere with the results of this study.\n* Other conditions judged by the investigator to be unsuitable for participation or posing significant risk to the patient.\n* Imaging Exclusion Criteria:\n* Intracranial hemorrhage confirmed by baseline head CT or MRI, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, or subdural\u002Fepidural hemorrhage.\n* Presence of midline shift or cerebral herniation, or other ventricular mass effect with midline shift.\n* Anticipated inability to complete endovascular treatment due to vascular tortuosity, severe vessel wall calcification, or other anatomical challenges.\n* Aortic dissection.\n* Multiple vessel occlusions confirmed by CTA or MRA with inability to identify the symptomatic culprit vessel, such as bilateral middle cerebral artery occlusion or concurrent middle cerebral artery and basilar artery occlusion.\n* Suspected or confirmed non-acute occlusion of the symptomatic culprit vessel.","ALL","18 Years","80 Years",{"count":77,"type":78},306,"ESTIMATED","INTERVENTIONAL",[81],"PHASE3","Study purpose:\n\nA multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) phase III trial is planned to evaluate the efficacy and safety of intra-arterial thrombolysis (IAT) in patients with acute ischemic stroke caused by medium vessel occlusion (MeVO), compared with best medical management alone.\n\nEligible participants (aged 18-80 years, baseline NIHSS score 6-25 or 3-5 with disabling deficits, confirmed MeVO within 24 hours of symptom onset) will be randomly assigned 1:1 to the intra-arterial thrombolysis plus best medical management group or the best medical management alone group.\n\nPrimary endpoint: proportion of patients with favorable functional outcome (modified Rankin Scale score 0-2) at 90±7 days post-randomization.\n\nSecondary endpoints:\n\n1. Recanalization rate (meTICI ≥ 2b) at 24±12 hours post-randomization;\n2. Early neurological improvement (NIHSS score change from baseline) at 7±1 days or discharge;\n3. Overall distribution of mRS scores at 90±7 days (shift analysis);\n4. Excellent functional outcome (mRS score 0-1) at 90±7 days;\n5. Health-related quality of life (EQ-5D-5L) at 90±7 days;\n6. Functional independence (Barthel Index score 95-100) at 90±7 days;\n7. Symptomatic intracranial hemorrhage (sICH) per Heidelberg criteria within 48 hours;\n8. Early neurological deterioration (NIHSS increase ≥ 4 points or any single item increase ≥ 2 points) within 7 days;\n9. Any intracranial hemorrhage within 48 hours;\n10. Procedure-related complications;\n11. All-cause mortality within 90±7 days.",[84,85],"Medium Vessel Occlusion","Ischemic Stroke, Acute",[87,88,89],"medium vessel occlusion","acute ischemic stroke","intra-arterial thrombolysis","NOT_YET_RECRUITING","2026-06-22",{"date":93,"type":94},"2026-06-25","ACTUAL",{"date":96,"type":78},"2026-07-01",{"date":98,"type":78},"2029-08-31",{"name":5,"class":6},1]