[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carotid-artery-stenting\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carotid-artery-stenting":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100621409","cas-for-stenosis-with-high-risk-features-for-cea-100621409",false,"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.","ALL","18 Years",{"count":20,"type":21},212,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28],"Carotid Artery Stenosis","Carotid Artery Stenting",[30,31],"Carotid artery stenosis","Carotid artery stent","RECRUITING","2026-04-13",{"date":35,"type":36},"2026-04-14","ACTUAL",{"date":38,"type":36},"2026-03-06",{"date":40,"type":21},"2028-12-31",{"name":42,"class":43},"Beijing Tiantan Hospital","OTHER",16,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100605762","high-coverage-carotid-stenting-vs-medical-management-alone-to-prevent-embolism-from-symptomatic-non-stenotic-carotid-disease-sync-100605762","NCT07166731","High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)","High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC) - CARESTAR","CARESTAR","Inclusion Criteria:\n\n* Patients diagnosed with acute ischemic stroke or acute retinal artery ischemia within the last two weeks related to symptomatic non-stenotic carotid disease (SyNC) and high-risk carotid plaque features\n\n  * Ipsilateral acute ischemic stroke must be determined by acute ischemic infarct on DWI or CT OR\n  * by neurological symptoms indicating ipsilateral cortical deficits consistent with ischemia in the territory of the internal carotid artery and after exclusion of a significant microangiopathy\n  * Acute retinal artery ischemia must be determined by ophthalmologic examination\n* Patients with no other identifiable cause of stroke, evaluated using standard echocardiographic examinations to exclude cardiogenic or aortogenic sources of embolism\n* Symptomatic non-stenotic carotid disease defined as one or more plaques in the ipsilateral internal carotid artery causing 10-49% luminal narrowing AND\n* Presence of high-risk plaque features which must be determined through visual inspection on CTA or MRI (Ultrasound findings alone are insufficient; features must be confirmed by CTA or MRI to meet the criteria):\n\n  * Identification of at least two of the following characteristics Plaque thickness ≥ 3mm Irregular plaque surface Ulceration \\\u003C50% plaque calcification Lipid-rich necrotic core\n  * and\u002For identification of at least one of the following characteristics Intraplaque haemorrhage\n* Presence of carotid web characterized as shelf-like\u002Flinear, smooth filling defects\n* Plaque assessment including evaluation of the presence of high-risk features by routine imaging (CTA, MRI) confirmed by an independent CoreLab\n* Signed Informed Consent Form\n* Patient ≥ 18 years\n* mRS ≤ 3 at time of randomisation\n* Dual antiplatelet therapy (DAPT) according to standard of care before endovascular treatment\n\nExclusion Criteria:\n\n* Patients with acute complete occlusion of the carotid artery in an emergency setting\n* Incidence of acute infarcts in other vascular (i.e., not ipsilateral carotid) territories\n* Patients in whom the stroke was likely caused by one of the following diseases:\n* Small vessel disease\n\n  * Large vessel atherosclerotic disease ≥ 50%\n  * Cardioembolism\n  * Other known disease e.g. vasculitis\n* Predominantly calcified Plaques (≥50% calcified plaque components on CT-Angio)\n* Patients presenting with intraluminal carotid thrombus (e.g. characterized by 'donut sign' on CTA)\n* Patients with highly tortuous vessels (\\>90°) which may prevent access or safe insertion of the stent\n* Patients with post-CEA re-stenosis or post-CAS re-stenosis\n* Patients with blood coagulation disorders\n* Patients in whom access to the carotid lesion is impossible or associated with an increased risk of procedural complications\n* Patients with lesions in the ostium of the common carotid artery\n* Patients with known hypersensitivity to nickel-titanium\n* Patients who are allergic to heparin\n* Any known conditions that affect life expectancy to less than 12 months\n* Any known conditions associated with an increased risk of endovascular treatment\n* Patients not able to visit the outpatient clinic for annual follow-up",{"count":54,"type":21},536,"OBSERVATIONAL","Goal is to analyse the clinical safety and efficacy of the CARESTO® heal Stent within standard clinical routine for the treatment of patients with symptomatic non-stenotic carotid disease (SyNC) and with high-risk plaque features for stroke recurrence compared to medical treatment alone with respect to the mid- and long-term clinical outcomes.",[58,59,28,60,61,62],"Carotid Artery Disease","Symptomatic Carotid Artery Stenosis","Carotid Plaque Imaging","Embolic Stroke of Undetermined Source","Carotid Artery Thrombosis",[64,65,66,67,68,69],"SyNC","Carotid artery disease","carotid artery stenting","symptomatic non-stenotic carotid artery disease","carotid artery stenosis","symptomatic carotid artery stenosis","2026-03-03",{"date":72,"type":36},"2026-03-04",{"date":74,"type":36},"2026-03-01",{"date":76,"type":21},"2032-06",{"name":78,"class":79},"Acandis GmbH","INDUSTRY",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":80},"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":90,"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.",[27,28,94],"Stroke",[96,97,98,27,99,100],"CAS (carotid artery stenting)","FFR (fractional flow reserve)","FFR-CT (Fractional Flow Reserve - Computed Tomography)","Functional assessment of the stenosis","Decision making algorithm","NOT_YET_RECRUITING","2024-03-05",{"date":104,"type":36},"2024-03-07",{"date":106,"type":21},"2024-04-01",{"date":108,"type":21},"2027-07-31",{"name":110,"class":43},"4th Military Clinical Hospital with Polyclinic, Poland"]