[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Acandis GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":173},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,82,107,132,153],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100636098","stenting-of-symptomatic-cerebral-sinus-stenosis-with-the-lasercut-self-expanding-silance-stent-100636098",false,"NCT07561268","Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent","SONIC","Inclusion Criteria:\n\n* Diagnosis of idiopathic intracranial hypertension (IIH) according to the Modified Dandy Criteria.\n* Cerebrospinal fluid (CSF) lumbar puncture opening pressure \\> 25 cm H₂O.\n* Presence of lateral venous sinus stenosis confirmed by venous magnetic resonance angiography (MRA) or venous computed tomography angiography (CTA).\n* Presence of clinical symptoms consistent with IIH, including headaches, visual field loss, papilledema or pulsatile tinnitus.\n* Venous pressure gradient across the stenosis \\> 3 mmHg under general anaesthesia, \\> 4 mmHg under local anaesthesia.\n* Temporal Bone CT done for Patients suffering from Pulsatile Tinnitus\n* Written informed consent obtained prior to any study-related procedures.","ALL","18 Years",{"count":19,"type":20},99,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of this clinical investigation is to evaluate and demonstrate the clinical benefit, performance, and safety of the SILANCE Stent, which is specifically designed for the treatment of patients with symptomatic sinus stenoses associated with IIH.",[26],"Idiopathic Intracranial Hypertension (IIH)",[28,29,30,31,32,33],"Symptomatic venous sinus stenosis","IIH","Sinus stenosis","Lateral Sinus Stenosis","Sinus Stenting","Idiopathic intracranial hypertension","NOT_YET_RECRUITING","2026-04-28",{"date":37,"type":38},"2026-05-01","ACTUAL",{"date":40,"type":20},"2026-09",{"date":42,"type":20},"2029-10",{"name":44,"class":45},"Acandis GmbH","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"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":55,"type":20},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.",[59,60,61,62,63,64],"Carotid Artery Disease","Symptomatic Carotid Artery Stenosis","Carotid Artery Stenting","Carotid Plaque Imaging","Embolic Stroke of Undetermined Source","Carotid Artery Thrombosis",[66,67,68,69,70,71],"SyNC","Carotid artery disease","carotid artery stenting","symptomatic non-stenotic carotid artery disease","carotid artery stenosis","symptomatic carotid artery stenosis","RECRUITING","2026-03-03",{"date":75,"type":38},"2026-03-04",{"date":77,"type":38},"2026-03-01",{"date":79,"type":20},"2032-06",{"name":44,"class":45},1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":81},"100571951","sirex-stent-for-the-treatment-of-symptomatic-lateral-venous-sinus-stenosis-100571951","NCT06726928","SiREX-Stent for the Treatment of SymptOmatic Lateral VEnous Sinus Stenosis","RESOLVE","Inclusion Criteria:\n\n* • Patient ≥ 18 years old\n\n  * Disabling pulsatile tinnitus lasting for more than three months\n  * Venous type: pulsatile tinnitus is interrupted by ipsilateral jugular vein compression\n  * Lateral sinus stenosis visible on venous MRA or venous angio CT\n  * Exclusion of other cause (excepted dehiscence of the lateral sinus related to the stenosis) of PT on MRI and on the temporal bone CT\n  * Stenosis located on a dominant or codominant lateral sinus\n  * Stenosis associated with a venous gradient of at least 3 mm Hg under general anesthesia (GA) in the absence of sinus dehiscence, or 2 mm Hg under GA if there is sinus dehiscence in a mastoid cell\n  * Patients asking for the treatment of her\u002Fhis pulsatile tinnitus\n  * Patients accepting to receive the SiREX® Stent (instead of a carotid stent)\n  * Written informed consent\n\nExclusion Criteria:\n\n* Non-pulsatile tinnitus or pulsatile tinnitus unrelated to lateral sinus stenosis\n* Stenosis with gradient \\\u003C 2 mm Hg in the absence of associated lateral sinus dehiscence\n* Any contraindication for treatment according to Instructions for Use:\n\n  * Patients in whom the size of the venous vessel section to be treated does not lie within the range indicated for the stent.\n  * Patients for whom angiography shows that the anatomic morphology is not suitable for endovascular treatment due to severe vessel tortuosity or stenosis.Patients who were not pre-treated with antiplatelet agents prior to the procedure.\n  * Patients in whom treatment with antiplatelet agents and\u002For anticoagulants is contraindicated.\n  * Patients with an acute subarachnoid haemorrhage.\n  * Patients with an active bacterial infection.\n  * Patients who are hypersensitive to nickel-titanium.\n* Pregnant or breastfeeding woman\n* Subject is participating in another clinical study\n* Patients with a life-threatening event in the last 6 months\n* Patients with a life expectancy under 12 months\n* Known, severe comorbidities, which will likely influence carrying out of the follow-up visits (cancer, alcohol\u002Fdrug abuse or dementia)",{"count":90,"type":20},78,[23],"The purpose of the study is to assess the efficacy, safety and the clinical benefit of the SiREX stent for the treatment of disabling pulsatile tinnitus due to stenosis of lateral sinus.\n\nThe study will enrol patients suffering from pulsatile tinnitus related to a lateral sinus stenosis lasting more than three months, and who want to be treated with lateral sinus stenting",[94,95],"Treatment of Symptomatic Lateral Sinus Stenosis","Treatment of Pulsatile Tinnitus Due tu Sinus Stenosis",[97,98],"Pulsatile Tinnitus","Sinus vein stenosis","2025-08-27",{"date":101,"type":38},"2025-09-04",{"date":103,"type":20},"2025-09",{"date":105,"type":20},"2029-01",{"name":44,"class":45},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100481011","derivo-2heal-study-clinical-safety-and-efficacy-of-the-derivo-2heal-embolisation-device-100481011","NCT05543447","DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device","DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device for Intracranial Aneurysms","REheal","Inclusion Criteria:\n\n* Patient to be treated with DERIVO® 2heal® Embolisation Device due to intracranial aneurysm according to IFU\n* Age \\> 18 years\n* Signed Informed Consent Form\n* Patient scheduled to be treated for only one target aneurysm except multiple aneurysms located in the same target zone to be treated with one DERIVO® 2heal® Embolisation Device\n* Effective use of antiplatelet medication confirmed by applicable testing method according to local standard\n\nExclusion Criteria:\n\n* Previously treated aneurysms with flow diverter, stent or WEB device\n* Treatment as preparation for the flow-diversion treatment does not lead to exclusion of the patient\n* Patient with a ruptured aneurysm in the acute phase of bleeding\n* Pre-treatment disability (mRS \\> 2)\n* Aneurysms related to pre-existing arteriosclerotic vascular disease in the target vessel\n* Contraindication against treatment with anti-platelet medication\n* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study\n* Participating in another study",{"count":116,"type":20},158,"To analyse the clinical safety and efficacy of the DERIVO® 2heal® Embolisation Device in the standard clinical routine of flow diversion treatment with respect to the mid- and long-term clinical and angiographic outcomes.",[119,120],"Intracranial Aneurysm","Flow Diverter",[122,123,124],"Aneurysm","DERIVO","DERIVO 2 Heal",{"date":101,"type":38},{"date":127,"type":38},"2022-12-15",{"date":129,"type":20},"2026-12",{"name":44,"class":45},17,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":81},"100588402","post-market-product-surveillance-of-intracranial-aneurysms-treated-with-commercial-registered-acandis-devices-in-france-100588402","NCT06940934","Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE","ANCRAGE: Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE","ANCRAGE PMS","Inclusion Criteria:\n\n* The subject has an intracranial aneurysm that can be treated with one of the Acandis device indicated for the treatment of intracranial aneurysms.\n* The subject is 18 years of age or older.\n* The subject is willing to comply with scheduled visits and examinations, per institution standard of care.\n\nExclusion Criteria:\n\n* The subject has provided tacit opposition to data collection.\n* Any IFU warning will be considered for exclusion in the cohort.",{"count":141,"type":20},100,"The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks associated with the use of the commercial device(s) and to ensure the long-term safety and performance of Acandis Device(s) after its placing on the French market. On top of this, these cohorts will generate data for getting the renewal of the device's reimbursement on the French market.",[144],"Intracranial Aneurysms","2025-04-16",{"date":147,"type":38},"2025-04-23",{"date":149,"type":38},"2021-12-01",{"date":151,"type":20},"2027-04",{"name":44,"class":45},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":131},"100465804","rescue-stenting-with-credo-heal-for-recanalisation-after-unsuccessful-thrombectomy-rechrut-100465804","NCT05345483","REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)","RECHRUT","Inclusion Criteria:\n\n* Patients, treated with CREDO® heal according to IFU\n* Over 18 years old\n* With acute persistent vascular occlusion due to high grade intracranial artery stenosis in the anterior or posterior circulation for which alternative therapy concepts are not considered or fail\n* With suspected underlying stenosis of the occluded artery, which is suitable for PTA and stenting according to the treating physician's assessment and\u002For persistent occlusion after failed recanalization by mechanical thrombectomy of the target region\n* With small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10, DWI lesion \\\u003C 70 ml)\n* With symptoms onset less than 24 hours before start of the procedure\n* Treated with study device following at least one futile mechanical recanalization attempt with a stent retriever, direct aspiration or combination of both\n* With pre-stroke disability mRS 0-2\n\nExclusion Criteria:\n\n* Any contraindication according to IFU and patients:\n* With atherosclerotic (probable according to clinical, anamnestic or laboratory chemical testing) vessel constrictions (high-grade intracranial stenoses \\> 70 %) with significant circulatory disturbance (haemodynamic infarct pattern and signs of restricted collaterals) and recurrent symptoms in spite of medical therapy\n* With contraindication against treatment with anti-platelet medication\n* Participating in another trial",{"count":161,"type":20},153,"Goal of the study is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable CREDO® heal Stent.",[164],"Rescue Stenting","2024-12-04",{"date":167,"type":38},"2024-12-05",{"date":169,"type":38},"2023-01-25",{"date":171,"type":20},"2027-01",{"name":44,"class":45},""]