[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"medium-vessel-occlusion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:medium-vessel-occlusion":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,73,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":21,"type":22},306,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Medium Vessel Occlusion","Ischemic Stroke, Acute",[31,32,33],"medium vessel occlusion","acute ischemic stroke","intra-arterial thrombolysis","NOT_YET_RECRUITING","2026-06-22",{"date":37,"type":38},"2026-06-25","ACTUAL",{"date":40,"type":22},"2026-07-01",{"date":42,"type":22},"2029-08-31",{"name":44,"class":45},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100620466","phase-3-intra-arterial-tenecteplase-for-acute-medium-vessel-occlusion-stroke-100620466","NCT07357987","Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke","Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke: the ANGEL-MeVO-TNK Randomized Clinical Trial","ANGEL-MeVO-TNK","Inclusion Criteria:\n\nClinical Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Pre-stroke mRS 0-1;\n3. Within 24 h from symptom onset;\n4. Baseline National Institutes of Health Stroke Scale (NIHSS) score \\>5 or baseline NIHSS 3-5 with disabling deficit (e.g., loss of hand function, aphasia, hemianopia);\n5. Informed consent obtained from patients or their legal representatives.\n\nImaging Inclusion Criteria:\n\n1. Baseline CTA\u002FMRA\u002FDSA diagnosed isolated MeVO, referring to the M2\u002FM3 segment of the MCA, the A1\u002FA2\u002FA3 segment of the ACA, the P1\u002FP2\u002FP3 segment of the PCA;\n2. NCCT or MRI DWI imaging showing that the territory of the ischemic infarct volume is less than 50% of the estimated territory supplied by the occluded artery.\n\nExclusion Criteria:\n\n1. Acute intracranial hemorrhage;\n2. ASPECT ≤5;\n3. MeVO secondary to spontaneous fragmentation and distal migration of thrombus from an acute large vessel occlusion, or occurring after intravenous thrombolysis (IVT), intra-arterial thrombolysis, or endovascular thrombectomy;\n4. Contraindication to TNK;\n5. Known severe allergy to contrast agents (excluding mild rash-type allergic reactions);\n6. Use of heparin or novel oral anticoagulants within the previous 48 hours with an INR ≥ 1.7;\n7. A history of major bleeding within the past 6 months or the presence of conditions such as active gastrointestinal ulcer, aortic dissection, platelet count \\\u003C 100 × 10⁹\u002FL, etc.;\n8. Radiologically confirmed vascular malformations, arterial dissection, intracranial aneurysm (diameter≥3 mm), tumors (except small meningiomas), cerebral vasculitis, cerebral amyloid angiopathy, or other major non-ischemic intracranial diseases (e.g., multiple sclerosis);\n9. Acute renal failure, current dialysis, or estimated glomerular filtration rate (eGFR)\\\u003C30ml\u002Fmin\u002F1.72m2, and\u002For serum creatinine\\>220mmol\u002FL (2.5mg\u002Fdl);\n10. History of severe liver disease, or aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) and\u002For glutamyl transferase (GGT) ≥3×upper limit of normal value (ULN) and\u002For total bilirubin (TBIL) ≥2×ULN;\n11. Severe non-cardiovascular comorbidity with an expected life expectancy of less than 3 months (e.g., malignant tumors);\n12. Known pregnancy or breastfeeding, or a positive pregnancy test prior to randomization;\n13. Current participation in another drug or device clinical trial;\n14. Any other condition deemed by the investigator to make the patient unsuitable for participation in the study or to pose a significant risk to the patient (e.g., inability to understand and\u002For comply with study procedures and\u002For follow-up due to psychiatric illness, cognitive impairment, or emotional disorders).",{"count":56,"type":22},488,[25],"The ANGEL-MeVO-TNK is a multicentered, prospective, randomized, open label, blinded endpoint (PROBE) phase III trial. A total of 488 AIS patients (age ≥18 years) with acute MeVO-AIS (occlusion of the M2\u002FM3, the A1\u002FA2\u002FA3, the P1\u002FP2\u002FP3, and with baseline NIHSS score \\>5 or disabling stroke with NIHSS score 3-5 \\[such as neurological deficits in motor strength, language, vision, etc\\]), will be enrolled. Patients fulfilling all the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into the IA TNK group or the control group after offering informed content.\n\n* The IA TNK group：1) If the patient has not received IVT, IA TNK will be administered as a slow, continuous infusion for super-selective contact thrombolysis in a stepwise manner: an initial dose of 0.0625 mg\u002Fkg with a duration of 15 minutes. A repeat angiographic assessment will then be performed; if recanalization is not achieved, an additional dose of 0.0625 mg\u002Fkg will be administered over a further 15 minutes (maximum dose 12.5 mg) .\n\n  2\\) If the patient has received IVT, intra-arterial TNK will be administered as a slow infusion for super-selective contact thrombolysis at a dose of 0.0625 mg\u002Fkg (maximum dose 6.25 mg) with a duration of 15 minutes.\n* The control group will be given standard medical management.\n\nThe study consists of four visits including the day of randomization, 48±12 hours after randomization, and 90±7 days after randomization. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program.\n\nThe primary outcome is the modified Rankin Scale (mRS) score of 0 to 1 at 90±7 days after onset. The primary safety outcome is the incidence of sICH within 48±12 hours after randomization (ECASS III).",[60,28,61,62],"Ischemic Stroke","Tenecteplase","Endovascular Treatment","RECRUITING","2026-04-26",{"date":66,"type":38},"2026-04-30",{"date":68,"type":38},"2026-01-22",{"date":70,"type":22},"2027-12-31",{"name":72,"class":45},"Beijing Tiantan Hospital",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":93,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100607166","intra-arterial-thrombolysis-for-acute-ischemic-stroke-with-medium-vessel-occlusion-100607166","NCT07185022","Intra-arterial Thrombolysis for Acute Ischemic Stroke With Medium Vessel Occlusion","a Multicenter Prospective Randomized Controlled Trial of Intra-artErial thrombolysiS for aCUte Ischemic strokE With Medium Vessel Occlusion (RESCUE MeVO)","RESCUE MeVO","Inclusion Criteria:\n\n* Age \\> 18 years\n* Primary medium vessel occlusion (MeVO) or severe stenosis (≥70%) was detected on CTA, MRA, or DSA, involving arterial segments including M2-M3 of the middle cerebral artery (MCA), A1-A2 of the anterior cerebral artery (ACA), P1-P2 of the posterior cerebral artery (PCA), and the anterior inferior cerebellar artery (AICA), posterior inferior cerebellar artery (PICA), and superior cerebellar artery (SCA)\n* The clinical symptoms were consistent with MeVO, with a NIHSS score 5 - 25, or an NIHSS score of 3-4 in the presence of disabling neurological deficits (e.g., hemianopia, aphasia, or motor dysfunction)\n* Intra-arterial thrombolysis was administered within the following time windows:\n\n  1. Acute ischemic stroke within 24 hours of symptom onset or last known well, including stroke with known onset, wake-up stroke and stroke with unknown onset, with no obvious hypodensity on CT and good collateral circulation on CTA;\n  2. Acute ischemic stroke within 24-72 hours of onset, meeting at least one of the following imaging criteria: a.CT or MR perfusion imaging demonstrating target mismatch, defined as an ischemic core volume \\\u003C30 mL, a mismatch ratio ≥1.2, and a mismatch volume ≥10 mL.; b.MRI demonstrating DWI-FLAIR mismatch, defined as the presence of acute ischemic lesions on diffusion-weighted imaging (DWI) with no corresponding hyperintense signal on FLAIR, or with FLAIR hyperintense lesions occupying less than one-third of the DWI lesion volume.\n* Signed informed consent obtained\n\nExclusion Criteria:\n\n* Pre-stroke mRS ≥ 2\n* Secondary MeVO or severe stenosis caused by endovascular therapy\n* Neuroimaging demonstrated intracranial hemorrhage, subarachnoid hemorrhage, or other hemorrhagic disorders\n* Non-contrast CT demonstrating a clearly hypodense lesion corresponding to the vascular territory\n* Platelet count \\\u003C100 × 10⁹\u002FL, known bleeding tendency or coagulation factor deficiency, or oral anticoagulant therapy with an international normalized ratio (INR) \\>3.0\n* Persistent and uncontrolled hypertension, defined as systolic blood pressure \\>185 mmHg or diastolic blood pressure \\>110 mmHg\n* History of intracranial hemorrhage within the past 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage, or subdural hemorrhage\n* Presence of arteriovenous malformations or brain tumors with mass effect\n* Gastrointestinal or urinary tract bleeding, or major surgery within the past 3 months\n* Chronic dialysis or severe renal impairment, defined as a glomerular filtration rate (GFR) \\\u003C30 mL\u002Fmin or serum creatinine \\>220 μmol\u002FL (2.5 mg\u002FdL)\n* Patients with known allergy to thrombolytic agents or their excipients\n* Patients with known allergy to iodinated contrast agents or other established contraindications\n* Pregnant or current breastfeeding\n* Presence of severe systemic comorbidities with a life expectancy of less than 3 months\n* Deemed unsuitable for participation by the investigator for any reason",{"count":82,"type":22},282,[84],"NA","Acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) or severe stenosis poses a significant clinical challenge. Recent large randomized controlled trials, DISTAL and ESCAPE-MeVO, demonstrated no significant benefit of endovascular therapy in patients with MeVO. Although intra-arterial thrombolysis has shown promise in clinical experience, robust evidence supporting its efficacy in MeVO or severe stenosis-related AIS is still absent. To fill this gap, the RESCUE MeVO trial has been designed as a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study to evaluate the efficacy and safety of intra-arterial thrombolysis in patients with AIS caused by MeVO or severe stenosis.",[87,88,89,90,91,60,92,28],"Stroke","Cerebrovascular Disorders","Brain Diseases","Nervous System Diseases","Vascular Diseases","Infarction",[94,95,87,96,97],"Ischemic stroke","Medium vessel occlusion","Intra-arterial thrombolysis","Severe stenosis","2026-04-13",{"date":100,"type":38},"2026-04-16",{"date":102,"type":38},"2026-01-06",{"date":104,"type":22},"2030-05-01",{"name":106,"class":45},"The Second Hospital of Anhui Medical University",6,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":46},"100616226","phase-2-intra-arterial-recombinant-human-tenecteplase-tissue-type-plasminogen-activator-rhtnk-tpa-thrombolysis-for-acute-medium-vessel-occlusion-100616226","NCT07302854","Intra-arterial Recombinant Human Tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) Thrombolysis for Acute Medium Vessel Occlusion","Intra-arterial Recombinant Human Tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) Thrombolysis for Acute Medium Vessel Occlusion -- A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Trial","MeVO-TNK Ⅱ","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Pre-stroke mRS score 0-1\n3. Baseline NIHSS ≥4 or symptoms deemed clearly disabling by treating physician (e.g., hemianopia, aphasia, or motor dysfunction)\n4. Isolated medium distal vessel occlusion (i.e., an occlusion of the co-\u002Fnon-dominant M2, the M3\u002FM4 segment of the MCA, the A1\u002FA2\u002FA3 segment of the ACA or the P1\u002FP2\u002FP3 segment of the PCA) confirmed by CT angiography (CTA) or MR angiography (MRA)\n5. Acute ischemic stroke within 24 hours of symptom onset, including wake-up stroke or unwitnessed stroke; The onset time of symptoms was defined as the last time of normal performance.\n6. Acute ischemic stroke within 6-24 hours of onset, meeting at least one of the following imaging criteria:\n\n   1. Evidence of a hypoperfusion-ischemic core mismatch on CT or MRI perfusion, defined as an ischemic core volume \\\u003C50mL, hypoperfused tissue volume to ischemic core volume ratio ≥1.2, and mismatch volume ≥10 mL\n   2. Evidence of a diffusion-hyperintensity mismatch, defined as absence of hyperintensity on fluidattenuated inversion recovery (FLAIR) imaging within ≥ 90% of the area of the diffusion weighted imaging (DWI) lesion)\n7. The participant or legally authorized representative is capable of providing informed consent\n\nExclusion Criteria:\n\n1. Evidence of intracranial hemorrhage\n2. Any active bleeding (gastrointestinal, urinary, hemorrhagic retinopathy, etc.) or parenchymal organ surgery or biopsy within 30 days before stroke; Severe head trauma or stroke within the past 3 months\n3. Persistent and uncontrolled hypertension, defined as systolic blood pressure \\>185 mmHg or diastolic blood pressure \\>110 mmHg\n4. Inherited or acquired hemorrhagic tendancy; deficiency of anticoagulant factors; or on oral anticoagulant with an INR\\> 1.7\n5. Blood glucose \\\u003C2.8 mmol\u002FL (50 mg\u002Fdl) or \\> 22.2mmol\u002FL (400 mg\u002Fdl), platelets count \\\u003C100\\*109\u002FL, or hemoglobin \\\u003C70g\u002FL\n6. Severe hepatic insufficiency, chronic hemodialysis and severe renal insufficiency (or recent blood tests suggesting a glomerular filtration rate \\\u003C30 ml\u002Fmin or blood creatinine\\> 200 mmol\u002FL (2.5 mg\u002Fdl)\n7. Women who are pregnant or breastfeeding\n8. Allergy to rhTNK-tPA or radiocontrast agent\n9. Participation in other clinical trials\n10. Expected survival time less than 6 months (e.g., due to malignancy, severe cardiopulmonary disease, etc.)\n11. Other conditions deemed by the investigator to make the patient unsuitable for participation or pose significant risks (e.g., inability to understand and\u002For comply with study procedures and\u002For follow-up due to mental illness, cognitive or emotional disorders)",{"count":117,"type":22},382,[119,25],"PHASE2","Medium vessel occlusion (MeVO) accounts for 20-45% of acute ischemic stroke (AIS). Although patients with MeVO often present with relatively low NIHSS scores, up to one-third remain functionally dependent at follow-up despite receiving standard medical therapy, including intravenous thrombolysis. Recent randomized trials (DISTAL, ESCAPE-MeVO, DISCOUNT) have not demonstrated clinical benefit of endovascular treatment (EVT) for MeVO and have suggested higher risks of symptomatic intracranial hemorrhage and mortality, underscoring the need for safer and more targeted reperfusion strategies.\n\nIntra-arterial thrombolysis (IAT) enables localized, high-concentration thrombolytic delivery with minimal mechanical manipulation, which may be advantageous for medium and distal vessels. Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA), a genetically engineered third-generation thrombolytic agent, has shown favorable pharmacologic properties and clinical safety in AIS, including in intra-arterial use following EVT. However, prospective evidence supporting its direct therapeutic role in MeVO-related AIS remains lacking.\n\nThis multicenter, prospective, open-label randomized controlled trial with blinded endpoint assessment is designed to evaluate the efficacy and safety of intra-arterial rhTNK-tPA thrombolysis in improving functional outcome in MeVO within 24 hours of symptom onset.",[122,28],"Acute Ischemic Stroke",[122,31,96,61],"2026-01-19",{"date":126,"type":38},"2026-01-21",{"date":128,"type":38},"2025-12-30",{"date":130,"type":22},"2028-12",{"name":132,"class":45},"Xiang Luo"]