[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carotid-artery-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carotid-artery-stenosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,41,63,93,121,146,173,200,222,247,272,294,308,328,360,417,441,467,489,517,545,571],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100645086","a-randomized-trial-of-carotid-artery-stenting-with-balloon-guide-catheter-100645086",false,"NCT07678164","A Randomized Trial of Carotid Artery Stenting With Balloon Guide Catheter","Balloon Guide Catheter-Assisted Carotid Artery Stenting With Multimodal Cerebral Protection: A Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged between 18 and 80 years (inclusive), with no gender restriction.\n2. Imaging diagnosis indicates symptomatic carotid artery stenosis (by NASCET method) ≥50% or asymptomatic carotid artery stenosis (by NASCET method) ≥70%.\n3. Suitable for carotid artery stenting.\n4. Good compliance, voluntarily signed the informed consent form, and able to follow up as required.\n\nExclusion Criteria:\n\n1. Severe tortuosity or calcification of the diseased vessel, preventing device delivery.\n2. Patients with ipsilateral external carotid artery occlusion or severe stenosis of the intracranial segment of the internal carotid artery.\n3. Patients with contralateral common carotid artery occlusion or severe stenosis or occlusion of the internal carotid artery.\n4. Patients with severe stenosis or occlusion of the vertebrobasilar artery (excluding non-dominant vertebral artery).\n5. Spontaneous intracranial hemorrhage, massive cerebral infarction, progressive stroke, or myocardial infarction within the past 3 months.\n6. Presence of substantial acute or subacute thrombus adjacent to the lesion.\n7. mRS \\> 3.\n8. Patients with a clear risk of cardioembolism, such as atrial fibrillation, or those with definite indications for anticoagulation.\n9. Chronic obstructive pulmonary disease requiring long-term continuous oxygen therapy.\n10. Patients with prior stent treatment in the ipsilateral head and neck vessels.\n11. Patients with end-stage renal failure requiring dialysis.\n12. Life expectancy less than 6 months.\n13. Patients unsuitable for magnetic resonance imaging (MRI) for any reason.\n14. Patients with absolute or relative contraindications to antiplatelet therapy.\n15. Inability to cooperate with the study due to dementia or mental disorder.","ALL","18 Years","80 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24],"NA","This prospective, multicenter, randomized controlled study enrolled patients undergoing carotid artery stenting (CAS) with cerebral embolic protection for carotid artery stenosis. They were randomly assigned to either a combination of proximal balloon occlusion, filter protection, intermediate catheter or filter protection alone. The study included 132 patients, and the primary endpoint was the number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure.",[27],"Carotid Artery Stenosis",[29],"balloon guide catheter","NOT_YET_RECRUITING","2026-06-25",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":33,"type":21},{"date":37,"type":21},"2027-06-30",{"name":39,"class":40},"Hebei General Hospital","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":50,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":4},"100628177","a-prospective-multicenter-single-arm-registry-of-enroute-nps-in-conjunction-with-carotid-wallstent-in-chinese-population-100628177","NCT07458243","A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population","ASCENT-C","Inclusion Criteria:\n\n* 1\\. Patients must meet one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: Stenosis must be \\>50% as determined by an angiogram (CTA\u002FMRA or catheter angiogram prior to the index procedure) and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and\u002For amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be stented.\n\nOR Asymptomatic: Stenosis must be ≥70% as determined by angiogram (CTA\u002FMRA or catheter angiogram prior to the index procedure) without any neurological symptoms within the prior 180 days.\n\n2\\. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and Carotid WALLSTENT Endoprosthesis (refer to IFU for requirements).\n\n3\\. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).\n\n4\\. Patient is ≥18 years of age. 5. Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board\u002FEthics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.\n\n6\\. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.\n\nExclusion Criteria:\n\n* 1\\. Patient has an alternative source of cerebral embolus, including but not limited to:\n\n  1. Patient has chronic atrial fibrillation.\n  2. Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.\n  3. Knowledge of any cardiac sources of emboli. (including but not limited to left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).\n  4. Recently (\\\u003C60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.\n  5. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA\u002FMRA ≤ 6 months prior to index procedure) greater in severity than the lesion to be treated, cerebral aneurysm \\> 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.\n\n     2\\. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or has had a recent (\\\u003C7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.\n\n     3\\. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.\n\n     4\\. Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure.\n\n     5\\. Patient has an intracranial tumor. 6. Patient has an evolving stroke. 7. Patient has neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke, including but not limited to: moderate to severe dementia, partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, or intracranial hemorrhage).\n\n     8\\. Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure.\n\n     9\\. Patient has an isolated hemisphere. 10. Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.\n\n     11\\. Myocardial Infarction within 72 hours prior to the intervention. 12. Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion.\n\n     13\\. Occlusion or \\[Thrombolysis In Myocardial Infarction Trial (TIMI 0)\\] \"string sign\" \\>1cm of the ipsilateral common or internal carotid artery.\n\n     14\\. An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) whether or not it is associated with an ulcerated target lesion.\n\n     15\\. Ostium of Common Carotid Artery (CCA) requires revascularization. 16. Patient has an open stoma in the neck. 17. Female patients who are pregnant or may become pregnant. 18. Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel (or other P2Y12 inhibitors) , statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine or ASA and clopidogrel or ASA and alternative P2Y12 inhibitor (e.g. ticagrelor \\[Brilinta\\], prasugrel \\[Effient\\]).\n\n     19\\. Patient has a life expectancy \\\u003C1 year (for symptomatic group regardless of surgical risk designation), or \\\u003C3 years (for asymptomatic HSR group), or \\\u003C 5 years (for asymptomatic SSR group) without contingencies related to other medical, surgical, or interventional procedures as per the Wallaert Score (for asymptomatic patients) and patients with primary, recurrent or metastatic malignancy who do not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.\n\n     20\\. Patient has an unresolved or uncorrected bleeding disorder, known bleeding diathesis or hypercoagulable state.",{"count":49,"type":21},60,"1 Month","OBSERVATIONAL","The study is a prospective, non-randomized, single-arm, multi-center registry to confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese population",[27],{"date":55,"type":34},"2026-06-29",{"date":57,"type":21},"2026-10-31",{"date":59,"type":21},"2027-09-30",{"name":61,"class":62},"Boston Scientific Corporation","INDUSTRY",{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":72,"studyType":51,"phases":4,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100637073","carotid-endatorectomy-and-general-anesthesia-assessment-and-evaluation-of-cerebral-ischemic-damage-with-clinical-laboratory-and-imaging-parameters-100637073","NCT07602400","CAROTID ENDATORECTOMY AND GENERAL ANESTHESIA: Assessment and Evaluation of Cerebral Ischemic Damage With Clinical, Laboratory and Imaging Parameters","CAROTID ENDATORECTOMY AND GENERAL ANESTHESIA: Assessment and Evaluation of Cerebral Ischemic Damage With Clinical, Laboratory and Imaging Parameters: a Single-center, Prospective, Randomized, Comparative Clinical Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ASA 1-4\n* For planned carotid endarterectomy\n* Absence of major established neurological deficits that would not allow neurological evaluation and performance of the MoCA test\n* Patient consent to participate in the study\n\nExclusion Criteria:\n\n* Age ≤ 18 years\n* Presence of major neurological deficits that will not allow neurological evaluation and performance of the MoCA test\n* Claustrophobia and inability to enter the MRI scanner\n* Cochlear implants\n* Intracranial vascular clips\n* Neurostimulation systems\n* Pacemaker incompatible for MRI\n* Small cell and non-small cell lung cancer\n* Neuroendocrine tumors\n* Melanoma\n* Seminoma\n* Teratoma\n* Malignant pheochromocytoma\n* CNS or NM diseases\n* Schizophrenia\n* Allergy or contraindication to any anesthetic factor\n* Patient refusal to participate in the study",{"count":71,"type":21},160,"3 Days","This study is aiming to provide us with information about the neuroprotective effect of two commonly used anesthetic drugs, during carotid endarterectomy. A day before sugery, a brain MRI will be performed as well as a cognitive function assessment test. The day of the surgery each patient will receive anesthesia either by using intravenous anesthetic drug or an inhalation agent and during the intraoperative period, the Anesthesiologist will draw a small amount of blood in three different times in order to measure brain biomarkers. A day after the surgery, a second brain MRI will be performed as well as a second cognitive function assessment test and their results will be compared to the preoperative ones. The study will focus on whether there is a higher incidence of microischemic brain lesions shown in imaging tests or whether cognitive function is impaired postoperative or whether brain biomarkers indicating brain damage are elevayed with any of these drugs and thus conclude which one shows or not a neuroprotective effect, with the condition that no change in the regular anesthesia management was made and no danger was imposed on the patient.",[27,75,76],"Endarterectomy, Carotid","Ischemic Cerebrovascular Accident",[78,79,80,81,82,83],"carotid endarterectomy","MRI brain","general anesthesia","neuroprotection","propofol","sevoflurane","2026-05-18",{"date":86,"type":34},"2026-05-22",{"date":88,"type":21},"2026-05-30",{"date":90,"type":21},"2027-12",{"name":92,"class":40},"University Hospital of Patras",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100621409","cas-for-stenosis-with-high-risk-features-for-cea-100621409","NCT07370246","CAS for Stenosis With High-risk Features for CEA","Evaluating the Safety and Efficacy of the Carotid Artery Stenting System for Stenosis With High-risk Features for CEA: a Prospective, Multicenter, Single-group Target-value Study in China","HeartCare CAS","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female;\n2. Pre-procedural carotid duplex ultrasound and\u002For computed tomography angiography confirmed stenosis of the common carotid artery, internal carotid artery, or carotid bifurcation, and are considered suitable for endovascular treatment;\n3. Intra-procedural digital subtraction angiography, using NASCET criteria, confirmed stenosis of ≥ 50% (symptomatic) or ≥ 80% (asymptomatic), and symptomatic is defined as the occurrence of one or more clinical events within 6 months prior to the procedure, including transient ischemic attack, amaurosis fugax, or minor\u002Fnon-disabling stroke attributable to the ipsilateral intracranial circulation;\n4. The vessel diameter of the target lesion is between 3.0 mm and 9.0 mm;\n5. Voluntary participation in this trial and provision of written informed consent.\n\nInclusion criteria for high-risk features for carotid endarterectomy:\n\nComorbidity factors:\n\n1. Age ≥ 75 years at the time of enrollment;\n2. Patients with congestive heart failure (New York Heart Association Class III\u002FIV);\n3. Patients with unstable angina pectoris;\n4. Patients with severe chronic obstructive pulmonary disease, defined as an FEV1 ≤ 50% of predicted, requirement for chronic oxygen therapy, or a resting PO₂ ≤ 60 mmHg;\n5. Patients with left ventricular ejection fraction ≤ 30%;\n6. Patients with recent myocardial infarction (within 2 to 6 weeks);\n7. Patients with coronary artery disease with ≥ 70% stenosis in two or more major vessels;\n8. Planned coronary artery bypass grafting or valve replacement surgery within 31 to 60 days following the procedure.\n\nAnatomical factors:\n\n1. Lesions located at or above the level of the second cervical vertebra (C2) or lesions that are surgically inaccessible below the clavicle;\n2. History of radical head and neck surgery or radiotherapy;\n3. Patients with limited cervical spine mobility;\n4. Patients with tracheostomy;\n5. History of vocal cord paralysis or laryngectomy;\n6. Patients with contralateral recurrent laryngeal nerve palsy;\n7. Patients with restenosis following previous carotid endarterectomy;\n8. Patients with severe stenosis or occlusion of the contralateral carotid artery;\n9. Severe tandem lesions that can be covered by a single stent.\n\nExclusion Criteria:\n\n1. Target lesions caused by carotid arteritis;\n2. Target lesions located at the origin of the common carotid artery;\n3. Target lesions with extensive calcification or excessive tortuosity that preclude stent delivery;\n4. Target lesions attributable to asymptomatic complete occlusion or the presence of a \"string sign\";\n5. Target lesions adjacent to significant acute or subacute thrombus, or arteriovenous malformation;\n6. History of major surgery (including intra-abdominal, intrathoracic, cardiac, or vascular procedures) within 30 days before the procedure, or any such surgery scheduled within 30 days after the procedure;\n7. History of intracranial hemorrhage or progressive stroke within 3 months before the procedure;\n8. History of an extensive hemispheric stroke within 2 weeks before the procedure;\n9. History of bradycardia (heart rate \\\u003C 40 bpm) before the procedure;\n10. History of paroxysmal atrial fibrillation within the past 6 months, or paroxysmal atrial fibrillation requiring long-term anticoagulation therapy;\n11. Patients with known or potential sources of thromboembolism (including previously known symptomatic patent foramen ovale, mechanical heart valves, or deep vein thrombosis treated within 6 months);\n12. Patients with a known intracranial aneurysm requiring surgical intervention that cannot be treated before the procedure;\n13. Patients with known coagulation disorders (APTT \\> 3 times the upper limit of normal) or abnormal bleeding disorders;\n14. Patients with known contraindications to heparin or antiplatelet agents;\n15. Patients with a platelet count \\\u003C 100×10\\^9\u002FL;\n16. Patients with known allergies to any components of the investigational product, contrast agents;\n17. Patients with known severe hepatic or renal insufficiency (ALT or AST \\> 5 times the upper limit of normal, or serum creatinine \\> 3 times the upper limit of normal);\n18. Patients with known uncontrolled severe hypertension (persistent systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg);\n19. Patients with a pre-procedure mRS score \\> 3;\n20. Patients with extensively metastatic malignancy;\n21. Patients concurrently enrolled in another drug or medical device clinical trial;\n22. Female patients who are currently pregnant or breastfeeding, or who plan to conceive within 1 year;\n23. Lesions inaccessible by endovascular approach (including severe tortuosity of aortic arch branches with no suitable access artery, or special aortic arch anatomy);\n24. According to the judgment of the investigator, patients with an expected survival of less than 12 months;\n25. According to the judgment of the investigator, other situations that are not suitable for enrollment.",{"count":102,"type":21},212,[24],"The purpose of this prospective, multicenter, single-group target-value study is to evaluate the safety and efficacy of the carotid artery stent system in patients with high-risk features for carotid endarterectomy. This trial is utilizing the carotid artery stent system provided by Shanghai HeartCare Medical Technology Co., Ltd. and will be conducted at approximately 10 interventional neurology centers in China.",[27,106],"Carotid Artery Stenting",[108,109],"Carotid artery stenosis","Carotid artery stent","RECRUITING","2026-04-13",{"date":113,"type":34},"2026-04-14",{"date":115,"type":34},"2026-03-06",{"date":117,"type":21},"2028-12-31",{"name":119,"class":40},"Beijing Tiantan Hospital",16,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100614261","cguardians-iii-ide-pivotal-trial-100614261","NCT07277296","CGUARDIANS III IDE Pivotal Trial","A Multicenter, Single-arm, Pivotal Study to Evaluate the Safety and Efficacy of the SwitchGuard™ Neuroprotection System (NPS) for Providing Cerebral Embolic Protection During Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach When Used in Conjunction With the CGuard™ Prime 80 Carotid Stent System","Inclusion Criteria:\n\n1. Patient is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.\n2. Patient is diagnosed with carotid artery disease treatable with a Carotid Artery Stent via a Transcarotid Artery Revascularization approach and is either symptomatic or asymptomatic, defined as:\n\n   Symptomatic carotid stenosis ≥ 50%. Symptomatic is defined as amaurosis fugax, transient ischemia attack (TIA) or stroke within the last 6 months ipsilateral to the side of the stenosis OR asymptomatic carotid stenosis ≥ 80%\n3. High Risk condition for CEA: at least one, as shown below:\n\nComorbid conditions:\n\nAge ≥ 70 (maximum 82 years) CCS angina class 3-4 or unstable angina Congestive Heart Failure (CHF) NYHA class III-IV Left ventricular ejection fraction (LVEF) ≤ 35% MI ≥ 72 hours and \\\u003C 6 weeks pre-procedure Multi-vessel CAD (≥ 2 vessels \\>70% stenosis) and history of angina Chronic Obstructive Pulmonary Disease (COPD) with FEV1\\\u003C50 Permanent contralateral cranial nerve injury\u002Fparalysis Restenosis from previous carotid endarterectomy (CEA) Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31-60 days after CAS Abdominal aortic aneurysm surgical repair or Endovascular repair is planned between 31 to 60 days after CAS\n\nAnatomic conditions:\n\nOcclusion of the contralateral CCA or ICA Prior radiation treatment to the neck or a radical neck dissection Severe bilateral ICA stenosis requiring treatment Target lesion at or above the level of the jaw (C2) or below the clavicle Severe tandem lesions Inability to extend the neck due to cervical disorders Laryngeal palsy or laryngectomy Prior head and neck surgery in the region of the carotid artery Tracheostomy or tracheostoma Spinal immobility of the neck\n\nExclusion Criteria:\n\n1. Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure\n2. Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure\n3. Vascular anatomy that would preclude safe sheath insertion or deliverability of stent\n4. Previously placed stent in the ipsilateral ICA or CCA\n5. Total occlusion or presence of a \"string sign\" of the ipsilateral ICA or CCA\n6. Presence of a filling defect of the target lesion\n7. Tandem lesions, which cannot be covered by a single CGuard Prime stent\n8. Stenosis of the innominate artery or proximal CCA requiring revascularization\n9. Open neck stoma\n10. History of bleeding diatheses or coagulopathy\n11. Hypercoagulable state\n12. Alternative source of cerebral embolus, including but not limited to:\n\nChronic atrial fibrillation Episode(s) of paroxysmal atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation requiring chronic anticoagulation Knowledge of cardiac sources of embolus (e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma) Recently (\\\u003C60 days) implanted heart valve (either surgically or endovascularly) as a known source of emboli as confirmed on echocardiogram, Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA\u002FMRA 6 months prior to index procedure) greater in severity than the lesion to be treated; cerebral aneurysm \\> 5mm; AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings Known sensitivity or allergy to nickel or titanium.","82 Years",{"count":130,"type":21},103,[24],"This is a prospective, multi-center, single-arm, pivotal study. The objective of this study is to evaluate the safety and efficacy of the SwitchGuard NPS in providing cerebral embolic protection during Transcarotid Artery Revascularization procedures using the CGuard Prime Carotid Stent System 80 in the treatment of carotid artery stenosis in patients at high risk for complications from CEA.",[27],[135,136],"Transcarotid Artery Revascularization","Carotid Endarterectomy","2025-12-10",{"date":139,"type":34},"2025-12-11",{"date":141,"type":21},"2026-01-01",{"date":143,"type":21},"2028-02-01",{"name":145,"class":62},"InspireMD",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100611998","balloon-guide-catheter-combined-with-filter-protection-for-carotid-artery-stenting-100611998","NCT07247864","Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting","A Comparative Study of Carotid Artery Stenosis Stenting With Balloon Guide Catheter Combined With Distal Filter Versus Distal Filter Alone-A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study","ANGEL-BEACON","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Diagnosis of extracranial carotid artery stenosis meeting one of the following criteria (measured by DSA or CTA using NASCET criteria):\n\n   Symptomatic: TIA or non-disabling stroke in the ipsilateral carotid distribution within the past 6 months, with stenosis ≥ 50%.\n\n   Asymptomatic: Stenosis ≥ 70%, with indication for interventional therapy.\n3. Pre-treatment Modified Rankin Scale (mRS) score of 0 to 1.\n4. Scheduled for carotid artery stenting (CAS) as determined by the clinical team.\n5. Signed informed consent provided by the patient or their legal representative.\n\nExclusion Criteria:\n\n1. Occlusion of the contralateral internal carotid artery (ICA).\n2. Severe stenosis of the contralateral common carotid artery (CCA) or internal carotid artery (ICA).\n3. Occlusion of the ipsilateral external carotid artery (ECA).\n4. Severe stenosis of the ipsilateral intracranial segment of the internal carotid artery.\n5. Severe stenosis of the vertebrobasilar artery system (excluding non-dominant vertebral artery).\n6. History of previous stenting in the head or neck vessels.\n7. Presence of other cerebrovascular diseases, such as intracranial aneurysms \\> 5 mm or vascular malformations.\n8. Stroke onset within the last 7 days.\n9. Pregnant or lactating women.\n10. Known allergy to contrast media or stent materials (e.g., Nitinol).\n11. Previous large cerebral infarction with sequelae that would interfere with the assessment of endpoint events.\n12. Absolute or relative contraindications to antiplatelet therapy.\n13. Clear risk of cardioembolism (e.g., atrial fibrillation, atrial flutter, intracardiac thrombus) or clear indication for anticoagulation therapy.\n14. Life expectancy of less than 1 year.\n15. Pre-existing neurological or psychiatric diseases that would confound neurological assessment (e.g., severe dementia).\n16. Severe renal insufficiency (Glomerular Filtration Rate \\[GFR\\] \\\u003C 30 ml\u002Fmin).\n17. Contraindications to Magnetic Resonance Imaging (MRI).",{"count":155,"type":21},296,[24],"This multicenter, randomized, controlled trial evaluates a combined embolic protection strategy during carotid artery stenting (CAS). Carotid artery stenosis is a major cause of stroke. While stenting is an effective treatment, the procedure itself carries a risk of dislodging plaque debris, which can travel to the brain and cause new strokes or silent brain infarctions.\n\nCurrently, a distal filter (protection device) is standardly used to catch debris. However, it may not capture all particles. This study investigates whether adding a Balloon Guide Catheter (BGC)-which temporarily stops blood flow and allows for aspiration-to the standard filter protection is more effective than using the filter alone.\n\nPatients with symptomatic (≥50% stenosis) or asymptomatic (≥70% stenosis) carotid artery stenosis who are scheduled for stenting will be randomly assigned to one of two groups:\n\n1. Combined Protection Group: Receiving CAS using a Balloon Guide Catheter combined with a distal filter.\n2. Standard Protection Group: Receiving CAS using a distal filter alone. The primary goal is to determine if the combined approach reduces the number of new ischemic lesions detected on brain MRI within 72 hours post-procedure. The study will also assess clinical stroke events over a 90-day follow-up period.",[27],[108,106,160,161,162],"Balloon Guide Catheter","Embolic Protection Device","New Ischemic Lesions","2025-12-09",{"date":165,"type":34},"2025-12-16",{"date":167,"type":34},"2025-12-03",{"date":169,"type":21},"2027-12-01",{"name":171,"class":40},"Beijing Anzhen Hospital",1,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":179,"maxAge":18,"enrollmentInfo":180,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":182,"conditions":183,"keywords":187,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":172},"100500789","prediction-of-cerebral-hyperperfusion-syndrome-after-carotid-revascularization-using-deep-learning-100500789","NCT05800821","Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning","Inclusion Criteria:\n\n1. Age between 30 and 80 years.\n2. Occlusive-stenotic lesion of the carotid arteries with indications for carotid revascularization.\n\nExclusion Criteria:\n\n1. Systemic vasculitis.\n2. Cerebral vessel aneurysms.\n3. Arteriovenous malformation of the brain.\n4. Primary brain tumor (including metastatic lesions).\n5. Epilepsy.\n6. History of traumatic brain injury.\n7. Demyelinating diseases of the central nervous system.\n8. History of neuroinfection.\n9. Atrial fibrillation.\n10. Frequent supraventricular or ventricular extrasystoles.\n11. Chronic heart failure with left ventricular ejection fraction less than 40%.\n12. Chronic kidney disease with estimated glomerular filtration rate less than 45 mL\u002Fmin\u002F1.73 m².\n13. Presence of an implanted cardioverter-defibrillator or pacemaker.\n14. Presence of contraindications to the medical use of iodine-containing radiographic contrast agents.\n15. Patient's unwillingness to continue participating in the study.\n16. Absence of a temporal acoustic window for transcranial Doppler ultrasonography.","30 Years",{"count":181,"type":21},500,"Cerebral hyperperfusion syndrome (CHS) was initially described as a clinical complication following carotid endarterectomy (CEA), but it may occur after both CEA and carotid artery stenting. It is characterised by throbbing ipsilateral frontotemporal or periorbital headache, and sometimes diffuse headache, eye and facial pain, vomiting, confusion, macular oedema, visual disturbances, focal motor seizures with frequent secondary generalisation, focal neurological deficits, and intracerebral or subarachnoid haemorrhage.\n\nKnowledge of CHS among physicians remains limited. Most studies report an incidence of 1-3% after carotid endarterectomy. CHS is most common in patients with increases of more than 100% in cerebral perfusion compared with baseline after carotid revascularization, and is rare in patients with perfusion increases of less than 100% compared with baseline.\n\nThe pathophysiological mechanism of CHS is only partially understood. The chronic low-flow state induced by severe carotid disease results in compensatory dilation of cerebral vessels distal to the stenosis, as part of the normal autoregulatory response to maintain adequate cerebral blood flow (CBF). In this chronically dilated state, the vessels lose their ability to autoregulate vascular resistance in response to changes in blood pressure. Dysautoregulation has been shown to be proportional to the duration and severity of chronic hypoperfusion. After revascularization and reperfusion, impaired cerebral autoregulation may contribute to a cascade of intracranial microcirculatory changes, with an inability to respond adequately to the augmentation of CBF following carotid recanalization.\n\nAlthough most patients present with mild symptoms and signs, progression to severe and life-threatening complications can occur if CHS is not recognised and treated promptly. Because CHS is diagnosed on the basis of several non-specific signs and symptoms, patients may be misdiagnosed as having one of the better-known causes of perioperative complications, such as thromboembolism.",[184,185,27,186],"Carotid Artery Diseases","Carotid Atherosclerosis","Cerebral Hyperperfusion Syndrome",[186,188,189,190],"Carotid Stenosis","Stroke","Deep Learning","2025-11-20",{"date":193,"type":34},"2025-11-25",{"date":195,"type":34},"2023-05-03",{"date":197,"type":21},"2030-05-03",{"name":199,"class":40},"State Institution \"Republican Scientific and Practical Center\" Cardiology, Belarus",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":172},"100587146","study-on-the-trans-carotid-artery-occlusion-shunt-system-100587146","NCT06924593","Study on the Trans-Carotid Artery Occlusion Shunt System","Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization During Endovascular Treatment","Inclusion Criteria:\n\n* Age \\> 18 years;\n* For patients diagnosed with carotid artery stenosis and planned to undergo transcarotid artery endovascular revascularization, one of the following conditions must be met:\n\n  1. Symptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \\> 50%, and the patient has a history of stroke (mild or non-disabling), transient ischemic attack (TIA), and\u002For amaurosis fugax within 180 days before the operation.\n  2. Asymptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \\> 70%, and the patient has not experienced any neurological symptoms within 180 days before the operation.\n* The modified Rankin Scale (mRs) score ≤ 2 before enrollment.\n* The patient must meet at least one of the following important anatomical or comorbid high-risk conditions in order to be included in the study:\n\nAnatomical high-risk:\n\nA. Contralateral carotid artery occlusion; B. Presence of tandem stenosis in the internal carotid artery with a stenosis degree \\> 70%; C. Carotid artery stenosis above the C2 vertebral body; D. Restenosis after previous ipsilateral carotid endarterectomy; E. Bilateral carotid artery stenosis requiring treatment (treatment of the contralateral vessel should be carried out at least 30 days after the operation); F. \"Difficult neck\" suitable for the transcarotid approach as evaluated by the researcher, including but not limited to: history of previous neck radiotherapy, history of previous radical neck lymph node dissection, neck stoma or limited cervical spine mobility.\n\nComorbid high-risk:\n\nG. The patient's age is ≥ 70 years old; H. The patient has coronary artery disease involving \\> 2 vessels and has a history of angina pectoris of any severity; I. The patient has a history of angina pectoris, with Canadian Cardiovascular Society (CCS) angina class 3 or 4, or unstable angina pectoris (defined as resting angina pectoris accompanied by electrocardiogram changes); J. The patient has congestive heart failure (CHF) - New York Heart Association (NYHA) functional class 3 or 4; K. The patient is known to have severe left ventricular dysfunction with a left ventricular ejection fraction (LVEF) \\\u003C 30%; L. The patient has experienced a myocardial infarction within 72 hours to 6 weeks before the operation; M. The patient has severe pulmonary disease (chronic obstructive pulmonary disease, COPD), with a forced expiratory volume in one second (FEV1) \\\u003C 50% (predicted value), or has been receiving long-term oxygen therapy, or has an arterial partial pressure of oxygen (PO2) ≤ 60 mmHg (room air) at rest; N. The patient has permanent contralateral cranial nerve injury; O. The patient has chronic renal insufficiency (serum creatinine \\> 2.5 mg\u002FdL).\n\n* The diameter of the common carotid artery on the target lesion side is \\> 6 mm;\n* The patient is able to understand the purpose of the trial, voluntarily participates in this study, signs the informed consent form, and is willing to complete the follow-up according to the requirements of the protocol.\n\nExclusion Criteria:\n\n* Anatomical exclusion criteria:\n\nThere are extensive atherosclerotic plaques in the proximal part of the common carotid artery on the target lesion side, making the safe operation of the surgery difficult; There are lesions in the access area of the common carotid artery on the target lesion side and its proximal part towards the heart; The distance from the superior border of the clavicle on the target lesion side to the bifurcation of the common carotid artery is less than 5 cm; A stent or graft has been implanted in the carotid artery on the target lesion side; There are acute or subacute thrombosis, arteriovenous malformations at the target lesion or adjacent areas; Severe calcification or tortuosity at the target lesion site makes it difficult to deliver the instruments to the designated location; The target carotid artery is completely occluded;\n\n* Known to have uncontrollable hypertension (systolic blood pressure continuously ≥ 180 mmHg or diastolic blood pressure continuously ≥ 110 mmHg);\n* Combined with symptomatic severe stenosis of other blood vessels (including intracranial and extracranial vessels);\n* The patient has experienced an ischemic stroke within 3 months, and the stroke affects the evaluation of the endpoints;\n* There has been spontaneous intracranial hemorrhage within 12 months;\n* Carotid artery stenosis not caused by atherosclerosis (such as dissection, fibromuscular dysplasia, etc.);\n* There are other heart diseases that may lead to embolism: such as left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, artificial aortic valve or artificial mitral valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm or left atrial myxoma, etc.;\n* Severe dementia or other nervous system diseases that may interfere with the evaluation of neurological function;\n* Advanced heart failure;\n* Chronic atrial fibrillation; Paroxysmal atrial fibrillation with an episode within 6 months or paroxysmal atrial fibrillation requiring long-term anticoagulant therapy;\n* Myocardial infarction occurred within 72 hours before the operation;\n* Coronary artery bypass grafting (CABG), endovascular stent surgery, cardiac valve surgery or vascular surgical procedures have been or will be performed within 30 days before and after the operation;\n* There is an active bleeding tendency or severe coagulation dysfunction; There has been gastrointestinal bleeding within 30 days before the operation, which will affect antiplatelet therapy;\n* Hemoglobin (Hgb) \\\u003C 8 gm\u002FdL, platelet count \\\u003C 90×10\\^9\u002FL or a history of heparin-induced thrombocytopenia;\n* Patients with abnormal liver and kidney function before the operation \\[Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 5 times the upper limit of the normal value; Serum creatinine (Cr) \\> 3.0mg\u002FdL (265.2μmol\u002FL) or end-stage renal disease receiving hemodialysis\\];\n* Patients known to be allergic to contrast agents, stent and delivery device materials (referring to nitinol, PTFE, nylon polymer materials); Patients known to have contraindications to anticoagulant and antiplatelet drugs;\n* Intracranial tumors or other malignant tumors;\n* Life expectancy is less than 1 year;\n* Women who plan to become pregnant, are pregnant or are breastfeeding;\n* Patients who are participating in other clinical trials at the same time and have not withdrawn from the trials;\n* Patients who are judged by the researcher as not suitable for participating in this clinical trial.",{"count":208,"type":21},162,[24],"The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization during Endovascular Treatment",[212,27,184],"Revascularization","2025-08-04",{"date":215,"type":34},"2025-08-07",{"date":217,"type":34},"2025-06-30",{"date":219,"type":21},"2025-12-31",{"name":221,"class":40},"Shenzhen Wecan Medical Technology Co.,Ltd",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100595787","phase-4-clinical-trial-of-pcsk9-inhibitor-and-statin-treatment-for-carotid-artery-stenosis-100595787","NCT07036991","Clinical Trial of PCSK9 Inhibitor and Statin Treatment for Carotid Artery Stenosis","A Randomized Clinical TRial on Inhibitor of PCSK9 and Statin Treatment for Carotid Artery Stenosis (TRIP-CAS)","TRIP-CAS","Inclusion Criteria:\n\nClinical inclusion criteria:\n\n1. Age ≥ 18 years.\n2. Asymptomatic mild-to-moderate carotid artery stenosis confirmed by CTA, MRA, ultrasound, or DSA, with no anticipated need for surgical intervention.\n3. Modified Rankin Scale (mRS) score ≤ 2\n4. Signed informed consent form obtained from the subject\n\nUltrasound Inclusion Criteria:\n\nCarotid ultrasound showing a plaque burden rate ≥30% at the most stenotic cross-sectional site of the carotid artery (common carotid artery or proximal C1 segment of the internal carotid artery).\n\nExclusion Criteria:\n\n1. Non-atherosclerotic carotid stenosis, including arterial dissection, Takayasu arteritis, radiation-induced vasculopathy, fibromuscular dysplasia, neurofibromatosis, suspected vasospasm, or recanalized vascular embolism.\n2. Known cardioembolic sources: mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus\u002Fvegetation, myocardial infarction within 3 months, dilated cardiomyopathy, chronic\u002Fparoxysmal atrial fibrillation. (Confound ASCVD outcome assessment.)\n3. History of cerebrovascular, coronary, or peripheral arterial endovascular intervention within 30 days before enrollment or anticipated surgery within the next 6 months.\n4. History of ischemic stroke, transient ischemic attack (TIA), or intracranial hemorrhage (parenchymal, subarachnoid, subdural, or epidural) before enrollment.\n5. Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation.\n6. History of thromboembolic diseases (pulmonary embolism, mesenteric embolism, lower limb arterial embolism) or coronary atherosclerotic heart disease.\n7. Severe neurological deficits impairing independent living; diagnosed dementia\u002Fpsychiatric disorders interfering with follow-up; or life expectancy \\\u003C3 years due to other conditions.\n8. Severe\u002Funstable comorbidities: Severe heart failure (NYHA Class III\u002FIV or LVEF \\\u003C30%), Renal failure (serum creatinine \\>264 μmol\u002FL or creatinine clearance \\\u003C0.6 mL\u002Fs), Severe hepatic dysfunction (ALT\u002FAST \\>3× upper limit of normal), CK \\>5× upper limit of normal, Active malignancy.\n9. Use of PCSK9 inhibitors or CETP inhibitors within 24 weeks before enrollment.\n10. The subjects have taken strong inhibitor drugs of cytochrome P-450 3A4 (including: adagrasib, atazanavir, ceritinib, clarithromycin, darunavir, idelalisib, indinavir, itraconazole, ketoconazole, levonorgestrel, lonafarnib, lopinavir, mifepristone, nefazodone, nelfinavir, nirmatrelvir\u002Fritonavir, Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets), mbitasvir\u002Fparitaprevir\u002Fritonavir and dasabuvir, posaconazole, co-formulations containing ritonavir and ritonavir itself, saquinavir, erythromycin, tucatinib, voriconazole) within one month before randomization, or may require such drugs during the study period.\n11. Pregnancy or lactation.\n12. Concurrent participation in another trial that may affect outcome assessment.\n13. Other situations that the investigator believes may cause significant harm to the subjects if they participate in this trial.\n14. Situations where the investigator believes there are other vascular lesions that may lead to short - term ischemic events and surgeries.",{"count":231,"type":21},406,[233],"PHASE4","A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial.",[27],[237,27],"CAS","2025-06-23",{"date":240,"type":34},"2025-06-25",{"date":242,"type":21},"2025-07-30",{"date":244,"type":21},"2027-03-01",{"name":246,"class":40},"Changhai Hospital",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":254,"targetDuration":256,"studyType":51,"phases":4,"briefSummary":257,"conditions":258,"keywords":261,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":172},"100595569","a-real-world-study-on-ultrasound-based-screening-and-integrated-therapeutic-strategies-for-patients-with-concomitant-coronary-and-cervicocephalic-artery-stenosis-100595569","NCT07034157","A Real-World Study on Ultrasound-Based Screening and Integrated Therapeutic Strategies for Patients With Concomitant Coronary and Cervicocephalic Artery Stenosis","ANGEL-UNIFY","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Patients with coronary artery disease scheduled to undergo elective percutaneous coronary intervention (PCI) on the following day.\n\nExclusion Criteria:\n\n1. The expected survival is less than 1 years;\n2. Simultaneously merge other serious diseases;",{"count":255,"type":21},1000,"1 Year","This prospective observational cohort study aims to investigate the prevalence and clinical significance of head and neck arterial stenosis in patients with coronary artery disease (CAD) undergoing or scheduled for percutaneous coronary intervention (PCI). Using Doppler ultrasound as the primary screening tool, the study will assess the degree of stenosis and evaluate the impact of different combined treatment strategies on patient outcomes. The research will provide real-world evidence to optimize integrated care approaches for patients with comorbid cardiovascular and cerebrovascular diseases.",[259,27,260],"Coronary Artery Disease","Cerebrovascular Disorders",[259,27,262,263],"Doppler Ultrasound","Combined Vascular Intervention","2025-06-15",{"date":266,"type":34},"2025-06-24",{"date":268,"type":34},"2025-06-09",{"date":270,"type":21},"2026-12-30",{"name":171,"class":40},{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":172},"100588037","prospective-trial-of-ivl-for-calcified-carotid-lesionscreate-trial-100588037","NCT06936176","Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)","A Prospective, Multicenter, Single-Arm Objective Performance Criteria Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Neurovascular Intravascular Shockwave Catheter and Intravascular Shockwave Therapy Device for Pretreatment of Calcified Lesions in the Extracranial Carotid Artery (CREATE Trial)）","CREATE","Inclusion Criteria:\n\n1. Age 18-80 years (inclusive), gender unrestricted.\n2. Extracranial carotid artery: Preoperative CT angiography (CTA) confirms symptomatic carotid stenosis ≥50% or asymptomatic carotid stenosis ≥70% with calcification (CTA measurement: calcification \\> 50% of circumference).\n\n   Note: (Extracranial carotid artery: Internal carotid artery or carotid bifurcation; Symptomatic refers to having had a non-disabling ischemic stroke or TIA within 6 months.)\n3. Intraoperative digital subtraction angiography (DSA) confirms carotid stenosis ≥50% (by NASCET criteria) or asymptomatic carotid stenosis ≥70% (by NASCET criteria).\n4. Participants with a pre-enrollment modified Rankin Scale (mRS) score ≤2.\n5. Participants planned for carotid artery stenting (CAS) who have failed conventional balloon dilation.\n6. Patients or their legal guardians understand the purpose of the trial, provide informed consent, and agree to follow-up.\n\nExclusion Criteria:\n\n1. Target lesion caused by non-atherosclerotic disease.\n2. Participants with complete occlusion of the target lesion or contralateral carotid artery.\n3. Participants with severe disability due to cerebral infarction.\n4. Participants with large acute or subacute thrombi near the target lesion, or with arteriovenous malformations or aneurysms.\n5. Participants with tortuous target lesion vessels that prevent stent placement.\n6. Participants with symptomatic severe stenosis in other cerebral vessels.\n7. Participants requiring concurrent or additional surgical interventions during the trial period.\n8. Participants with tandem severe stenosis or occlusion in vessels proximal or distal to the target lesion.\n9. Participants who have had a myocardial infarction or large cerebral infarction within 2 weeks prior to screening.\n10. Participants who have had intracranial hemorrhage within 3 months prior to screening.\n11. Participants with vulnerable or high-risk plaques (unstable, prone to rupture, and thrombosis leading to acute cardiovascular events or death) as judged by carotid ultrasound.\n12. Participants with uncontrolled hypertension (systolic blood pressure persistently ≥180 mmHg or diastolic blood pressure persistently ≥110 mmHg).\n13. Participants with known platelet count \\\u003C 90×10\\^9\u002FL, severe liver impairment (transaminases \\> 3 times the upper limit of normal), severe renal impairment (serum creatinine \\> 2.5 mg\u002FdL \\[221 µmol\u002FL\\]), or New York Heart Association Class IV heart failure.\n14. Participants with coagulopathy (INR ≥2.0) or contraindications to heparin or antiplatelet agents.\n15. Participants with active infections.\n16. Participants unable to use cerebral protection devices.\n17. Participants allergic to components of the investigational device or contrast agents (excluding rash).\n18. Participants with life expectancy less than 1 year.\n19. Pregnant or breastfeeding women.\n20. Participants currently enrolled in another drug or medical device clinical trial (before reaching the primary endpoint).\n21. Other situations where the investigator deems the participant unsuitable for the trial.",{"count":281,"type":21},204,[24],"* Clinical Trial Summary\n\n  * Trial Title:\\*\\* CREATE Trial: Safety and Efficacy of IVL for Carotid Calcified Lesions\n  * Sponsor:\\*\\* Shanghai Bluesail Boyuan Medical Technology Co., Ltd.\n  * Clinical Trial Leader:\\*\\* Beijing Anzhen Hospital\n  * Coordinating Investigator:\\*\\* Prof. Huo Xiaochuan\n* Study Purpose This trial assesses a new device-a single-use neurovascular intravascular shockwave catheter and therapy device-for treating calcified blockages in the carotid artery. It uses sound waves to break up calcium deposits, facilitating stent placement and blood flow restoration.\n* Eligibility\n\n  * Adults aged 18-80 with severe carotid artery narrowing (≥50% symptomatic or ≥70% asymptomatic) due to calcium buildup.\n  * Patients who failed standard balloon dilation.\n  * Exclusions include pregnancy, recent strokes\u002Fheart attacks, uncontrolled hypertension, or other high-risk conditions.\n* Study Design\n\n  * \\*\\*Type:\\*\\* Prospective, multicenter, single-arm trial.\n  * \\*\\*Sample Size:\\*\\* 204 patients across multiple hospitals.\n  * \\*\\*Duration:\\*\\* 1-month follow-up post-procedure.\n* Procedures\n\n  1. \\*\\*Pre-treatment:\\*\\* Imaging (CT angiography, ultrasound) to confirm eligibility.\n  2. \\*\\*Procedure:\\*\\* Shockwave catheter breaks up calcium, followed by stent placement.\n  3. \\*\\*Follow-up:\\*\\* Assessments at 7 days (or discharge) and 1 month post-procedure.\n* Benefits and Risks\n\n  * \\*\\*Benefits:\\*\\* Improved stent placement success, reduced risk of complications, minimally invasive with shorter recovery time.\n  * \\*\\*Risks:\\*\\* Bleeding, infection, vessel damage, stroke, heart attack, device malfunction. Risks are closely monitored with emergency protocols.\n* Patient Protections\n\n  * Ethics committee approval and strict safety guidelines.\n  * Voluntary participation with the option to withdraw anytime.\n  * Free treatment and compensation for trial-related injuries.\n* For Healthcare Providers\n\n  * \\*\\*Innovation:\\*\\* Adapts coronary lithotripsy technology for carotid use.\n  * \\*\\*Evidence:\\*\\* Supported by preclinical data and a pilot study (100% success rate in 5 patients).\n  * \\*\\*Endpoints:\\*\\* Primary: Stent success (residual stenosis \\\u003C30%) and 30-day major adverse events. Secondary: Device success rate, repeat procedures, long-term outcomes.\n* Contact Information\n\nFor questions, contact:\n\n\\*\\*Ms. Zhang Yanjiao\\*\\* Email: yanjiao.zhang@jwmsgrp.com",[27],"2025-05-13",{"date":287,"type":34},"2025-05-16",{"date":289,"type":34},"2025-05-12",{"date":291,"type":21},"2027-12-30",{"name":293,"class":62},"Shanghai Bluesail Boyuan Medical Technology Co., Ltd.",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":301,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":306,"leadSponsor":307,"locationsCount":172},"100588038","prospective-trial-of-ivl-for-calcified-carotid-lesionscreate-trialextended-follow-up-100588038","NCT06936189","Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)","A Prospective, Multicenter, Single-Arm Objective Performance Criteria Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Neurovascular Intravascular Shockwave Catheter and Intravascular Shockwave Therapy Device for Pretreatment of Calcified Lesions in the Extracranial Carotid Artery (CREATE Trial)） (Extended Follow-Up)","Inclusion criteria:\n\nAll patients participating in this extended follow-up period are sourced from the registered clinical trial.\n\nExclusion criteria:\n\nnone",{"count":281,"type":21},"Purpose: To assess the long-term safety and efficacy of the intravascular lithotripsy system for pre-treatment of calcified carotid artery stenosis.\n\nDesign: Prospective, multicenter, single-arm study with an extended follow-up period.\n\nSample Size: 204 participants (based on the final number of cases enrolled in the registration trial).\n\nEndpoints:\n\nPrimary: Surgical success rate (residual stenosis \\\u003C30% after stenting). Secondary: Target lesion re-narrowing rate, target lesion revascularization rate, MAE rate, ipsilateral stroke rate, and MACCE rate at 3 and 6 months postoperatively.\n\nFollow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively.\n\nInclusion criteria:\n\nAll patients participating in this extended follow-up period are sourced from the registered clinical trial.\n\nEthics and Consent: The trial will be conducted in accordance with the Helsinki Declaration and Chinese regulations. Informed consent will be obtained from all participants or their legal guardians.\n\nSponsor: Shanghai Lanfan Boyuan Medical Technology Co., Ltd. Principal Investigator: Professor Huo Xiaochuan, Beijing Anzhen Hospital.",[27],{"date":287,"type":34},{"date":289,"type":34},{"date":291,"type":21},{"name":293,"class":62},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":172},"100589839","study-on-the-trans-carotid-artery-occlusion-shunt-system-combined-with-introducer-sets-100589839","NCT06959628","Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets","Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets for Cerebral Protection During Carotid Angioplasty","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Patients with internal carotid artery stenosis, meeting at least one of the following conditions:\n* Asymptomatic carotid artery stenosis: Stenosis severity \\> 70%;\n* Symptomatic carotid artery stenosis: Stenosis severity \\> 50%, with one or more of the following symptoms occurring within 180 days prior to the procedure: transient ischemic attack (TIA), transient visual obscurations (TVO), or mild\u002Fnon-disabling stroke;\n* Common carotid artery diameter \\> 6 mm, and meets the required vascular diameter for carotid artery stenting;\n* The participant or their legal guardian is able to understand the purpose of the trial, voluntarily consent to participation, sign an informed consent form, and is willing to comply with follow-up requirements as outlined in the study protocol.\n\nExclusion Criteria:\n\n* Anatomical Exclusion Criteria:\n* Patients with extensive atherosclerotic plaques in the proximal common carotid artery, which hinder safe surgical manipulation;\n* Patients with lesions in the common carotid artery access area or its proximal segment;\n* Patients with the common carotid artery bifurcation located \\\u003C 5 cm from the clavicular margin;\n* Patients with tandem severe stenosis or occlusion at the target lesion site;\n* Patients who have previously received stent or graft implantation in the ipsilateral carotid artery;\n* Patients with bilateral carotid artery stenosis requiring intervention on both sides;\n* Patients with acute or subacute thrombosis, arteriovenous malformations, or other abnormal vascular structures in the target lesion or adjacent regions;\n* Patients with severe calcification or tortuosity at the target lesion site, making it difficult to deliver devices to the intended location;\n* Patients with concomitant severe symptomatic stenosis in other vascular territories, including intracranial or extracranial arteries;\n* Patients who have experienced an ischemic stroke within the past 3 months, which may impact endpoint evaluation;\n* Patients with a history of spontaneous intracranial hemorrhage within the past 12 months;\n* Patients diagnosed with carotid artery dissection;\n* Patients with carotid stenosis due to non-atherosclerotic causes;\n* Patients with other cardiovascular conditions that may predispose to embolism, including left ventricular aneurysm, cardiomyopathy, mechanical aortic or mitral valves, infective endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma;\n* Patients with central nervous system disorders, including cranial nerve impairment, which could confound endpoint evaluation (e.g., severe dementia, secondary epilepsy, etc.);\n* Patients with chronic atrial fibrillation;\n* Patients with paroxysmal atrial fibrillation episodes within the past 6 months or those requiring long-term anticoagulation therapy due to paroxysmal atrial fibrillation;\n* Patients who have had a myocardial infarction within the last 6 months;\n* Patients who have undergone or plan to undergo coronary artery bypass grafting (CABG), endovascular stenting procedures, or heart valve surgeries within 90 days prior to the procedure, which may interfere with endpoint evaluation;\n* Patients with active bleeding tendencies or significant coagulation disorders;\n* Patients with a history of gastrointestinal bleeding that could interfere with antiplatelet therapy;\n* Patients with preoperative liver or renal dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 5 times the upper limit of normal, or serum creatinine (Cr) \\> 3.0 mg\u002FdL (265.2 μmol\u002FL);\n* Patients with known hypersensitivity to contrast agents, anticoagulants, antiplatelet medications, or materials used in stent delivery systems (e.g., nitinol, PTFE, nylon-based polymers);\n* Patients with intracranial or other malignancies;\n* Patients with a life expectancy of less than 3 years;\n* Women who are planning pregnancy, pregnant, or breastfeeding;\n* Patients participating in another clinical trial or those who have not withdrawn or been excluded from a trial within the last 3 months of the screening period;\n* Other patients who, in the investigator's opinion, are deemed unsuitable for inclusion in the study",{"count":316,"type":21},15,[24],"The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty",[27,184],"2025-04-28",{"date":322,"type":34},"2025-05-06",{"date":324,"type":34},"2024-07-01",{"date":326,"type":21},"2025-06-01",{"name":221,"class":40},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":338,"conditions":339,"keywords":342,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":4},"100586605","study-on-pad-and-cas-based-on-omics-and-imaging-100586605","NCT06917547","Study on PAD and CAS Based on Omics and Imaging","Study on the Pathogenesis of PAD and CAS Based on Multi-omics Analysis and Multi-modal Imaging Technology","Inclusion Criteria:\n\n1. The study subjects are inpatients from the Department of Vascular Surgery at the Second Hospital of Shanxi Medical University.\n2. Males or females aged between 18 and 85 years.\n3. Diagnosed with Peripheral Artery Disease (PAD) or Carotid Artery Stenosis (CAS).\n4. Participants are conscious, fully informed about the study content, and have signed the informed consent form, agreeing to participate in this study.\n\nExclusion Criteria:\n\n1. Non-atherosclerotic stenosis (e.g., vasculitis or dissection).\n2. PAD patients who have previously undergone interventional treatments (e.g., balloon angioplasty or stent placement) and\u002For surgical procedures.\n3. Patients with heart failure classified as NYHA Class II-IV or those with a history of coronary artery disease.\n4. Patients with acute infections, tumors, severe arrhythmias, psychiatric disorders, or drug\u002Falcohol addiction.\n5. Significant liver dysfunction or a history of liver diseases, including: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding twice the upper limit of normal. History of cirrhosis, hepatic encephalopathy, esophageal varices, or portosystemic shunt.\n6. Significant renal dysfunction or a history of kidney diseases, including: Serum creatinine levels exceeding 1.5 times the upper limit of normal. History of dialysis or nephrotic syndrome.\n7. Pregnant women, those planning to become pregnant, or breastfeeding women.\n8. Participation in other clinical trials within the past 3 months.\n9. Refusal to sign the informed consent form or participate in this study.","85 Years",{"count":337,"type":21},100,"This study aims to investigate the pathogenesis of Peripheral Artery Disease (PAD) and Carotid Artery Stenosis (CAS) using a comprehensive multi-omics and multi-modal imaging approach. The study will enroll patients diagnosed with PAD or CAS and perform advanced imaging techniques, including NIR-II Imaging, DUS-based V-flow Imaging, and Laser Speckle Imaging, to assess vascular structure and function. Simultaneously, single-cell transcriptomics, metabolomics, lipidomics, and proteomics analyses will be conducted on patient samples to identify key molecular targets and pathways involved in disease progression. Machine learning algorithms will be employed to integrate imaging and multi-omics data, enabling the development of predictive models for more accurate disease diagnosis and stratification. The findings from this study are expected to provide novel insights into the molecular mechanisms underlying PAD and CAS and contribute to the development of personalized therapeutic strategies.",[340,27,341],"Peripheral Artery Disease","Artery Stenosis",[343,27,344,345,346,347,348,349,350],"Peripheral artery disease","NIR-II Imaging","V-flow Imaging","Laser Speckle Imaging","Single-cell transcriptomics","Proteomics","Lipidomics","Metabolomics","2025-03-31",{"date":353,"type":34},"2025-04-08",{"date":355,"type":21},"2025-04-01",{"date":357,"type":21},"2025-10-01",{"name":359,"class":40},"Yijie Ning",{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":371,"conditions":372,"keywords":377,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":172},"100557713","coated-or-chewable-aspirin-and-a-hybrid-strategy-to-mitigate-adverse-effects-of-air-pollution-in-stable-atherosclerotic-disease-100557713","NCT06541691","Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease","Coated or Chewable Aspirin in Patients with Established Atherosclerotic Disease and a Hybrid Strategy to Mitigate the Adverse Effects of Air Pollution: the COATED-AIR Randomized Clinical Trial","COATED-AIR","Inclusion Criteria:\n\n* Adult patients (≥18 years) with documented ASCVD defined as at least one of the following:\n\n  * Coronary artery disease (CAD):\n\n    1. Previous or recent documented type I myocardial infarction \\*(if not specified, will be assumed as type I)\n    2. History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)\n    3. History of obstructive CAD (\\>50% stenosis) documented by coronary computed tomography (CT) or conventional angiography\n  * Peripheral arterial disease (PAD):\n\n    1. Previous or recent acute ischemic limb event (\\>7 days prior)\n    2. History of previous endovascular\u002Fsurgical lower or upper extremities revascularization for an atherosclerotic cause\n    3. History of ulcer or lower extremities amputation due to ASCVD.\n  * Carotid arterial diseases:\n\n    1. History of previous endovascular\u002Fsurgical carotid artery revascularization for atherosclerotic causes\n    2. History of \\> 50% carotid artery stenosis based on documented imaging tests (Duplex US, CT angiography, magnetic resonance angiography, or conventional angiography)\n  * Ischemic stroke:\n\n    1. History of recent or previous documented ischemic stroke not due to atrial fibrillation, endocarditis, or systemic hypoperfusion\u002Fhypotension, being treated with low-dose aspirin\n* Inhabitant of Tehran province\n* Willing to participate and able to provide written informed consent\n\nExclusion Criteria:\n\n* Being within 72 days of acute\u002Funstable atherosclerotic cardiovascular events (acute myocardial infarction, acute limb event, and acute ischemic stroke), or within 72 hours of revascularization.\n* Patients receiving triple antithrombotic therapy\n* History of upper gastrointestinal bleeding within the past 30 days\n* History of intracranial hemorrhage within the past 30 days\n* End-stage kidney disease with estimated creatinine clearance \\\u003C 15 mL\u002Fmin, or undergoing hemodialysis or peritoneal dialysis\n* Known comorbidities associated with poor prognosis (e.g., metastatic cancer) in conjunction with an estimated life expectancy of less than one year according to the treating clinician\n* Any other conditions that make the participants unsuitable for recruitment or follow-up (e.g., illiteracy)\n* Not having aspirin as part of the planned durable treatment regimen\n* Inability to receive\u002Fread text messages\u002Fphone calls by personal mobile phone (or that of a caregiver who lives with the patient and is willing to relay messages)\n\n  * The full list of exclusion criteria is provided in the study protocol",{"count":369,"type":21},3000,[24],"Although both enteric-coated and plain formulations of aspirin are being used commonly, there are no high-quality comparisons between these formulations with respect to clinical efficacy outcomes in patients with atherosclerotic cardiovascular diseases (ASCVD). Air pollution is also a major contributor to the excess risk of cardiovascular events in many regions of the world. However, little is known about the effect of individual-level mitigation strategies against air pollution in reducing cardiovascular outcomes. The purpose of the first randomization is to compare the efficacy and safety of enteric-coated versus plain low-dose (81 mg) aspirin formulations in a double-blind fashion. The second randomization compares a multifaceted intervention including one-page educational flashcard, cell phone text messages alerting participants on polluted days, recommending them to stay indoors or wear KN-95 facemasks provided by the study team in case of necessary outdoor activity, and recommendation to consume citrus fruits on polluted days versus usual care. Both randomization are powered for clinical outcomes and the results will inform practice.",[373,259,374,375,376,27,185],"Atherosclerotic Cardiovascular Disease","Ischemic Heart Disease","Ischemic Stroke","Peripheral Arterial Disease",[378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406,407],"atherosclerosis","atherosclerotic cardiovascular disease","atherosclerotic arterial disease","atherosclerotic plaque","coronay artery disease","ischemic heart disease","atherosclerotic disease","ischemic stroke","peripheral arterial disease","carotid artery stenosis","carotid atherosclerosis","myocardial infarction","acute limb ischemia","bleeding","major bleeding","gastrointestinal bleeding","gastrointestinal ulcer","peptic ulcer disease","gastric ulcer","duodenal ulcer","dyspepsia","intracerebral hemorrhage","aspirin","acetylsalicylic acid","antithrombotic therapy","antithrombotic agents","antiplatelet agents","air pollution","cerebral hemorrhage","hemorrhage","2025-03-14",{"date":410,"type":34},"2025-03-19",{"date":412,"type":34},"2024-03-06",{"date":414,"type":21},"2027-03-30",{"name":416,"class":40},"Rajaie Cardiovascular Medical and Research Center",{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":16,"minAge":424,"maxAge":18,"enrollmentInfo":425,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":172},"100518520","revascularization-effect-on-csvd-burden-in-carotid-artery-stenosis-100518520","NCT06031610","Revascularization Effect on CSVD Burden in Carotid Artery Stenosis","RECAS","Inclusion Criteria:\n\n1. Patients aged ≥ 40 years.\n2. ≥ 50% stenosis in unilateral carotid artery.\n3. Sign informed consent.\n\nExclusion Criteria:\n\n1. Previous history of major head trauma and any intracranial surgery\n2. Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage, and other space occupying lesions\n3. Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement.\n4. Severe loss of vision, hearing, or communicative ability.","40 Years",{"count":255,"type":21},"RECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and undergoing revascularization therapy or standard medication treatment alone. The goal of this study is to validate whether CAS revascularization when compared to standard medication treatment alone, can effectively reduce the progression of Cerebral small vessel disease (CSVD) burden, as well as improve the severity of retinal pathologies and cognitive impairment. Therefore, Patients aged ≥ 40 years have more than 50% stenosis in unilateral carotid artery and sign informed consent will be recruited. In this study, patients will be asked to undergo Computed Tomography Angiography (CTA)\u002F Digital Subtraction Angiography (DSA), Computed Tomography Perfusion (CTP),multimodal Magnetic Resonance Imaging (MRI), Optical Coherence Tomography Angiography (OCTA) and neuropsychological testing. Estimated follow-up can be up to 10 years.",[27,428],"Cerebral Small Vessel Diseases",[27,428,212,430,431],"Carotid artery stenting","prospective cohort","2025-02-10",{"date":434,"type":34},"2025-02-12",{"date":436,"type":34},"2023-06-10",{"date":438,"type":21},"2034-05",{"name":440,"class":40},"Zhejiang Provincial People's Hospital",{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":449,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":450,"conditions":451,"keywords":456,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":466,"locationsCount":172},"100513636","detection-of-microplastics-and-nanoplastics-in-neurosurgery-patients-dt-mini-100513636","NCT05968053","Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)","Presence of Microplastics and Nanoplastics in Neurosurgery Patients","DT-MiNi","Inclusion Criteria:\n\n* Age 18-80 years\n* Any type of neurosurgery\n\nExclusion Criteria:\n\n·refusal of the patient to participate",{"count":181,"type":21},"Plastic particles are a ubiquitous pollutant in the living environment and food chain, so far, plenty of studies have reported the internal exposure of microplastics and nanoplastics in human tissues and enclosed body fluids.\n\nNeurosurgery is the only department that can open the skull. In addition to blood and cerebrospinal fluid, there are brain tissue and tumors in the presence of lesions. Whether any of these microplastics and nanoplastics are present remains a mystery. This prospective observational study will harvest biological samples of neurosurgery patients.\n\nThe objective of this research is to be able to detect microplastics and nanoplastics on blood and operation samples of neurosurgery patients.",[27,452,453,454,455],"Glioma","Intracranial Aneurysm","Intracranial Hemorrhages","Brain Tumor",[457,458,453,459,27],"microplastics","nanoplastics","brain tumor","2025-01-21",{"date":462,"type":34},"2025-01-23",{"date":464,"type":34},"2023-09-25",{"date":219,"type":21},{"name":119,"class":40},{"id":468,"slug":469,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":476,"conditions":477,"keywords":478,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":172},"100571589","gaos-triple-eversion-carotid-endarterectomy-100571589","NCT06722222","Gao's Triple Eversion Carotid Endarterectomy","A New Surgical Method for Treating Tandem Carotid Lesions: Gao's Triple Eversion Carotid Endarterectomy","Inclusion Criteria:\n\n* Meet the diagnostic criteria for TCL stenosis.\n* Above 70% asymptomatic CCA and ICA stenosis or \\> 50% symptomatic CAS confirmed by DSA or CTA before surgery\n\nExclusion Criteria:\n\n* Did not meet the diagnostic criteria for CAS\n* Asymptomatic CAS \\\u003C 50% (as confirmed by DSA or CTA before surgery)\n* With stenosis at the opening of the CCA.",{"count":475,"type":21},11,"Carotid endarterectomy (CEA), an important surgical approach for managing carotid plaque, has evolved over more than 70 years but still cannot be applied to all tandem carotid lesions (TCLs) because of the wide range of these lesions. Herein, the investigators introduce an innovative CEA, Gao's triple eversion CEA (GTE-CEA), for the treatment of TCLs.",[27],[387,479],"tandem carotid lesion","2024-12-09",{"date":482,"type":34},"2024-12-13",{"date":484,"type":34},"2021-09-17",{"date":486,"type":21},"2031-09-20",{"name":488,"class":40},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":499,"briefSummary":500,"conditions":501,"keywords":502,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":172},"100525594","innovative-application-of-pressure-gradient-measurement-in-internal-carotid-stenosis-in-patients-undergoing-cas-100525594","NCT06123767","Innovative Application of Pressure Gradient Measurement in Internal Carotid Stenosis in Patients Undergoing CAS","Evaluation of Diagnostic and Predictive Capabilities of Novel Application of Carotid Carotid Stenosis Pressure Gradient Measurement in Patients Undergoing Percutaneous Carotid Angioplasty and Stenting (CAS).","NOTICE-CAS","Inclusion Criteria:\n\n* Stenosis of the internal carotid artery in symptomatic patients: \\> 50%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation\n* Stenosis of the internal carotid artery in asymptomatic patients: \\>60%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation\n* Age of patients: \\> 18 years of age\n* Provided informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Inability to obtain informed consent to participate in the study.\n* Difficult anatomy of the aortic arch and the descending cephalic arteries (increased atherosclerotic lesions, acute angle of departure of the common carotid arteries, kinking of the internal carotid arteries).",{"count":498,"type":21},200,[24],"About 20% of stroke causes are atherosclerotic strokes caused by carotid artery stenosis.\n\nIn 2005, 92% of carotid artery interventions in the USA were performed in asymptomatic patients. It should be noted that screening in the general population for carotid artery disease is unwarranted, due to uncertain eligibility criteria for interventional treatment of asymptomatic patients. On the other hand, 10-15% of all patients with a first-ever stroke will experience an ischemic stroke as a result of previously untreated, asymptomatic, significant carotid artery stenosis.\n\nCarotid artery angioplasty with stent placement (CAS) has become the second method of revascularization. ed, however, there is a great deal of ambiguity in the application of these criteria, which stems from the ratio of the risk to the possible benefit to the patient of performing the procedure, as well as the cost-effectiveness for health care systems.\n\nOBJECTIVES The overall goal is (following the model of measuring fractional flow reserve - FFR) to try to establish a new parameter that could prove helpful in qualifying patients for percutaneous internal carotid artery angioplasty with stent implantation (CAS). Determining whether measuring the pressure gradient across the stenosis will determine which patients will benefit from the CAS procedure. In the absence of convincing evidence on the effects of CAS, especially for so-called asymptomatic patients, it is advisable to establish a parameter that would complement the eligibility criteria that, on the one hand, could prevent strokes in the population of patients with silent internal carotid artery stenosis and, on the other hand, avoid performing the procedure in the absence of benefit.\n\nPRIMARY ENDPOINTS:\n\n1. Assessment of cerebral perfusion by magnetic resonanse before and after CAS\n2. Assessment of cognitive symptoms using before and after CAS\n3. Assessment of neurological symptoms before and after CAS\n4. Assessment of otolaryngological symptoms before and after CAS\n\nSECONDARY ENDPOINTS:\n\nCreation of a non-invasive computed tomography protocol with pressure gradient assessment in patients with carotid artery stenosis.\n\nA final version of the algorithm based on a new diagnostic measurement (concentration gradient) ready to be used in the diagnosis of CAS-eligible patients with an implemented function for automatic classification of measurement results that will indicate the group of patients who will benefit from the CAS procedure.",[27,106,189],[503,504,505,27,506,507],"CAS (carotid artery stenting)","FFR (fractional flow reserve)","FFR-CT (Fractional Flow Reserve - Computed Tomography)","Functional assessment of the stenosis","Decision making algorithm","2024-03-05",{"date":510,"type":34},"2024-03-07",{"date":512,"type":21},"2024-04-01",{"date":514,"type":21},"2027-07-31",{"name":516,"class":40},"4th Military Clinical Hospital with Polyclinic, Poland",{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":525,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":172},"100487585","optimization-strategy-of-carotid-artery-stenosis-100487585","NCT05629000","Optimization Strategy of Carotid Artery Stenosis","Cohort of Optimized Assessment Strategy of Carotid Artery Stenosis","COAS-CAS","Inclusion Criteria:\n\n1. patients with severe stenosis (≥50%) or near-occlusion diagnosed by computed tomographic angiogram;\n2. patients received carotid endarterectomy at Peking Union Medical College Hospital\n\nExclusion Criteria:\n\n(1) Any contraindication to image examination; (3) refuse to sign the Informed consent.",true,{"count":255,"type":21},"The goal of this observational study is to learn about how to utilize multiple evaluation techniques in carotid artery stenosis patients for optimizing assessment of diagnosis and treatment strategy.\n\nThe main questions it aims to answer are:\n\n* Identify best strategy that use multi-modal MRI and CT to assess patients' cerebral lesions and perfusion.\n* Identify best strategy that use multi-modal MRI, PET-MRI ultrasound and CT to assess components and characters of patients' carotid plaques.\n\nParticipants will accept imaging examination before and after surgery. And doctors will collect basic characteristics, imaging results and biological samples of patients for analysis.",[27],[387,530,531,532,533,534,535],"Perfusion","plaque","MRI","CT","PET\u002FMRI","Ultrasound","2022-11-28",{"date":538,"type":34},"2022-11-29",{"date":540,"type":34},"2015-01-01",{"date":542,"type":21},"2026-12-31",{"name":544,"class":40},"Peking Union Medical College Hospital",{"id":546,"slug":547,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":335,"enrollmentInfo":552,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":553,"conditions":554,"keywords":558,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":569,"locationsCount":172},"100480730","change-of-hemodynamics-and-cerebral-functions-after-carotid-artery-revascularization-100480730","NCT05539781","Change of Hemodynamics and Cerebral Functions After Carotid Artery Revascularization","HALO","Inclusion Criteria:\n\nInformed consent signed Patients with \\>=70% symptomatic or \\>=80% asymptomatic internal carotid stenosis\n\nExclusion Criteria:\n\nIncapability to give informed consent Previous disabling stroke Contralateral carotid occlusion or \\>70% stenosis Systemic disease judged non compatible with the procedures or randomization Suspected or manifested pregnancy General contraindications to MRI or CT studies",{"count":498,"type":21},"The majority (\\>80%) of strokes are of ischemic etiology, of which ≈15% to 20% are attributable to atherosclerosis of the extracranial carotid arteries. The primary goal in carotid artery revascularization is to prevent stroke in patients with carotid artery stenosis. Treatment options including carotid endarterectomy (CEA) and carotid artery stenting (CAS). Hence, the investigators aim to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in terms of long-term prognostic endpoints. Also, CEA and CAS result in different postoperative geometric features of carotid arteries that entail relevant modifications of rheological parameters, that may be associated with the risk of local complications and carotid artery restenosis. Finally, long-term and sustained cognitive benefits after carotid artery revascularization need further research and evidence.",[184,27,555,556,557],"Cerebrovascular; Disorder, Arteriosclerotic","Cardiovascular Diseases","Nervous System Diseases",[78,559,560,561,562],"carotid stenting","computational fluid dynamic","cognitive function","medical therapy","2022-09-13",{"date":565,"type":34},"2022-09-14",{"date":567,"type":34},"2020-01-01",{"date":542,"type":21},{"name":570,"class":40},"Beijing Friendship Hospital",{"id":572,"slug":573,"hasResults":11,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":172},"100454293","acute-stroke-of-carotid-artery-bifurcation-origin-treated-with-use-of-the-micronet-covered-cguard-safeguard-stroke-100454293","NCT05195658","Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)","Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF The MicronEt-covered CGUARD STent Under TRansient FlOw Reversal LinKed With Thrombus REtrieval: SAFEGUARD-STROKE Study","Inclusion Criteria:\n\n* Consecutive patients with acute ischemic stroke with carotid artery bifurcation stenosis\u002Focclusion as culprit lesion.\n* Clinical picture of acute ischemic stroke, stroke-in-evolution, or crescendo TIAs.\n* Patient eligible for endovascular stroke therapy according to AHA\u002FASA stroke management and accepted for emergent stroke intervention by the local NeuroVascular Team Committee according to local standard of practice.\n* Signed informed consent form to participate in the study (obtained at the point of first feasibility; note that live-saving procedure track may be executed for performing intervention according to local regulations and routine practice in the center)\n* Consent to (routinely performed in this group of patients) follow-up visits that may include imaging as per routine practice in the study center and as clinically indicated.\n\nExclusion Criteria:\n\n* Known stroke cause other than the carotid bifurcation lesion\n* Lack of effective endovascular route needed for intervention\n* Any known contraindications to stroke endovascular management",{"count":579,"type":21},20,"Prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin undergoing endovascular treatment using the Micronet-covered CGUARD Stent to seal the culprit lesion under proximal cerebral protection (by transient flow reversal using balloon catheter such as the MoMa or FlowGate) with thrombus retrieval achieved through active aspiration ± stentriever use.\n\nA study involving clinical and cerebrovascular imaging data evaluation in consecutive patients with acute stroke of carotid artery bifurcation origin, presenting in the time-window and\u002For cerebral tissue window allowing guideline-indicated reperfusion by interventional management.\n\nA registry of consecutive patients with the study condition. An open-label study, without randomization - a single arm, single-center study in John Paul II Hospital in Krakow, Poland.",[27,582],"Acute Ischemic Stroke",[188,582,584,585,586,587],"Anesthesia","Imaging","Interventional Management","Thrombectomy","2022-02-23",{"date":590,"type":34},"2022-02-28",{"date":592,"type":34},"2022-01-30",{"date":594,"type":21},"2027-12-31",{"name":596,"class":40},"John Paul II Hospital, Krakow"]