[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carotid-occlusion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carotid-occlusion":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100299571","endovascular-revascularization-for-chronic-carotid-artery-occlusion-trial-100299571",false,"NCT03179774","Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial","Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial (ERCAO Trial) Part 1: Prospective Clinical Registry Study Part 2: Prospective Randomized Control Trial Study","ERCAO","Part 1: Clinical registry study\n\nInclusion criteria for clinical registry study\n\n* Patient age 20 years or older\n* Abnormal cerebral perfusion by CTP or MRI\n* No medical history of stroke or transient ischemic attack (TIA) ipsilateral to the carotid occlusion within 90 days of randomization\n* Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.\n\nExclusion Criteria for clinical registry study\n\n* Patient has acute stroke within 90 days,\n* Intolerance or allergic reaction to a study medication without a suitable management alternative.\n* Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure.\n* GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy\n* Bleeding diathesis\n* Intracranial hemorrhage within the past 12 months.\n* Platelet count \\\u003C100,000\u002Fμl or history of heparin-induced thrombocytopenia.\n* Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area \\\u003C 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired patent foramen ovale (PFO) with prior paradoxical embolism.\n* Any major surgery, major trauma, revascularization procedure within the past 1 month.\n* Acute coronary syndrome within the past 1 month or acute coronary syndrome (ACS) that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization).\n* Inability to understand and cooperate with study procedures or provide informed consent.\n* Patients with \\\u003C 5 years life expectancy\n* Concomitant vascular conditions precluding endovascular revascularization procedure;\n* Previous ipsilateral carotid artery stenting\n* Intracranial aneurysm or arteriovenous malformation;\n* Educational level lower than elementary school;\n* Aphasia or right-sided hemiparesis\n* Marked depression.\n* Severe dementia.\n\nPart 2: Randomized control study\n\nInclusion Criteria for randomized control study\n\n* Patient age 20 years or older\n* Abnormal cerebral perfusion by CTP or MRI\n* No medical history of stroke or TIA ipsilateral to the carotid occlusion within 90 days of randomization\n* Patients must have a modified Rankin Scale (mRS) ≤2 at the time of informed consent.\n* Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.\n* Randomization will apply to only 1 carotid artery occlusion for patients with bilateral carotid occlusion. Intervention of the contralateral stenosis, should it exists, may be done in according to clinical indications at least 30 days prior to randomization.\n\nExclusion Criteria randomized control study\n\n* Patient has acute stroke within 90 days,\n* Prior major ipsilateral stroke in the past with moderate disability (mRS ≥ 3) that is likely to confound study outcomes.\n* Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke.\n* Patient has significant renal insufficiency with estimated glomerular filtration rate (eGFR) \\\u003C30 ml\u002Fmin (at screening). and would not receive renal replacement therapy if contrast agent related nephropathy occurs\n* Intolerance or allergic reaction to a study medication without a suitable management alternative.\n* Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure.\n* GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy\n* Bleeding diathesis\n* Intracranial hemorrhage within the past 12 months.\n* Platelet count \\\u003C100,000\u002Fμl or history of heparin-induced thrombocytopenia.\n* Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area \\\u003C 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired PFO with prior paradoxical embolism.\n* Major (non-carotid) surgery\u002Fprocedures planned within 3 months after enrollment.\n* Any major surgery, major trauma, revascularization procedure within the past 1 month.\n* Acute coronary syndrome within the past 1 month or ACS that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization).\n* Coronary artery disease with two or more proximal or major diseased coronary arteries with ≥ 70% stenosis that have not, or cannot, be revascularized.\n* Inability to understand and cooperate with study procedures or provide informed consent.\n* Patients with \\\u003C 5 years life expectancy\n* Concomitant vascular conditions precluding endovascular revascularization procedure;\n* Previous ipsilateral carotid artery stenting\n* Intracranial aneurysm or arteriovenous malformation;\n* Educational level lower than elementary school;\n* Aphasia or right-sided hemiparesis\n* Marked depression.\n* Severe dementia.","ALL","20 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","Revascularization for carotid artery occlusion (CAO) remained controversial, there is no prospective randomized control trial (RCT) regarding carotid artery stenting (CAS) in CAO patients. The investigators conduct a prospective study composed of clinical registry arm and RCT arm. The main purpose of the study is investigate neurocognitive function at 3 months and thereafter up to 12 months.",[27],"Carotid Occlusion","RECRUITING","2025-07-23",{"date":31,"type":32},"2025-07-28","ACTUAL",{"date":34,"type":32},"2017-05-17",{"date":36,"type":21},"2025-12",{"name":38,"class":39},"National Taiwan University Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":40},"100555361","phase-3-carotid-artery-stenting-during-endovascular-treatment-of-acute-stroke-100555361","NCT06511089","Carotid Artery Stenting During Endovascular Treatment of Acute Stroke","Carotid Artery Stenting During Endovascular Treatment of Acute Ischemic Stroke: A Randomized Multicenter Clinical Trial in Patients With Acute Ischemic Stroke and Carotid Artery Stenosis Undergoing Endovascular Treatment","CASES","Inclusion Criteria:\n\n1. Acute ischemic stroke due to proximal intracranial occlusion in the anterior circulation (intracranial ICA, M1, proximal M2) on the CT angiography\n2. Stenosis \\>50% according to the NASCET criteria16 or initial occlusion of the ipsilateral cervical carotid artery of presumed atherosclerotic origin on baseline CT angiography\n3. Eligible for EVT according to the guidelines: EVT within 6 hours of onset or EVT between 6-24 hours after onset based on perfusion CT imaging selection (conform current guidelines)\n4. Baseline National Institute of Health Stroke Scale (NIHSS) score ≥2\n5. Age \\>18 years\n6. Written informed consent (deferred consent)\n\nExclusion Criteria:\n\n1. Any intracranial hemorrhage\n2. Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus, carotid web)\n3. Any exclusion criterion for EVT according to the guidelines\n4. Pre stroke disability (defined as a modified Rankin Scale score \\>2)\n5. Recent gastro-intestinal or urinary tract hemorrhage (\\\u003C6 weeks)\n6. Recent severe head trauma (\\\u003C6 weeks)\n7. Recent infarction on baseline brain CT in the same vascular territory (\\\u003C6 weeks)\n8. Known allergy to aspirin and\u002For clopidogrel\n9. Pregnancy","18 Years",{"count":51,"type":21},600,[53],"PHASE3","Rationale: Approximately 20% of the patients with acute ischemic stroke due to an intracranial large vessel occlusion (LVO) has a high-grade stenosis in the ipsilateral cervical carotid artery. It is uncertain whether immediate carotid artery stenting (CAS) of a cervical carotid artery stenosis during endovascular thrombectomy (EVT) is beneficial. Immediate CAS could improve cerebral perfusion and prevent recurrent ischemic stroke but could also increase the chance of intracranial hemorrhagic complications due to hyperperfusion syndrome or to the required antiplatelet treatment to prevent stent occlusion. Moreover, some patients end up with a severe disabling stroke after EVT. In these patients carotid revascularization by carotid endarterectomy (CEA) or CAS would usually not be performed but these patients would be treated by medical management only.\n\nObjective: to assess the safety and efficacy of immediate cervical CAS during EVT in patients with acute ischemic stroke due to LVO with a high-grade stenosis \\>50% or occlusion of the ipsilateral cervical carotid artery.\n\nStudy design: prospective randomized open label controlled trial comparing immediate CAS during EVT versus EVT with deferred treatment of the cervical carotid artery lesion (deferred CAS\u002FCEA or medical management alone). Outcome assessment will be blinded for treatment allocation.",[56,57,58,59,27],"Stroke, Acute","Stroke, Ischemic","Carotid Stenosis","Carotid Atherosclerosis","2024-07-15",{"date":62,"type":32},"2024-07-19",{"date":64,"type":32},"2022-11-15",{"date":66,"type":21},"2026-11-15",{"name":68,"class":39},"University Medical Center Groningen"]