[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100383313":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":30,"responsibleParty":48,"collaborators":50,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":19,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"John Paul II Hospital, Krakow","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Carotid Artery Stenting","EXPERIMENTAL","Consecutive male and female patients older than 18 year with symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.",[13],"Device: Carotid Artery Stenting",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Carotid artery stenting according to local clinical experience and ESC\u002FESVS guidelines using exclusively CGuard™, MicroNet covered stent under proximal or distal intraprocedural cerebral protection according to \"tailored CAS\" algorithm.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Piotr Musialek, MD, PhD","Jagiellonian University","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","+48126142287","p.musialek@szpitaljp2.krakow.pl",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Department of Cardiac and Vascular Diseases, The John Paul II Hospital","RECRUITING","Krakow","Maloplska","31-202","Poland","PL",{"type":40,"coordinates":41},"Point",[42,43],19.93658,50.06143,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":28,"phoneExt":19,"email":29},"Piotr Musialek, Prof",{"type":49,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[51],{"name":23,"class":6},"100383313","micronet-covered-stent-system-for-stroke-prevention-in-all-comer-carotid-revascularization-100383313",false,"NCT04271033","MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization","Long-term Outcomes of MicroNet-covered Stent Routine Use for Stroke Prevention in Symptomatic and Increased-risk Asymptomatic Carotid Stenosis Patients Requiring Revascularization by Neurovascular Team Decision: PARADIGM-EXTEND","PARADIGM-EXT","General Inclusion Criteria:\n\n* Patient \\> 18 years old qualified by NeuroVascular Team for carotid revascularization according to local standards of care\n* Signed informed consent\n* Agreement (routin un this group of patients) to clinical and ultrasonographis follow up.\n\nAngiographic Inclusion Criteria:\n\n* De-novo atherosclerotic lesions or neo-atherosclerosis\n* Symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis ≥50% assessed in angiography with NASCET method or\n* Asymptomatic patients with index artery stenosis ≥70-80% assessed in angiography with NASCET method\n\nGeneral Exclusion Criteria:\n\n* Lack of NeuroVascular Team agreement on carotid revascularization indication\n* Lack of signed informed consent\n* Estimated life expectancy less than 1 year\n* Chronic renal failure with serum creatinine level \\> 3.0 mg\u002FdL\n* Myocardial Infarction within 72 hours prior to index procedure.\n* Pregnant women\n* Diagnosed coagulopathies\n* History of contrast media allergy, not reacting to pharmacotherapy\n\nAngiographic Exclusion Criteria:\n\n* Index lesion occlusion\n* Common carotid artery stent protruding to aortic arch\n* Anatomical conditions restricting stent implantation\n* Significant common carotid artery stenosis proximal to index lesion (unless treated)","ALL","18 Years",{"count":63,"type":64},550,"ESTIMATED","INTERVENTIONAL",[67],"NA","All-comer study of unselected patients suitable for carotid artery revascularization to evaluate the feasibility, efficacy and safety of first line endovascular revasculariztion using MicroNet covered stent (CGuard™) in the treatment of consecutive symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.",[70],"Carotid Artery Diseases",[72],"Stenting","2022-03-14",{"date":75,"type":76},"2022-03-29","ACTUAL",{"date":78,"type":76},"2015-09-01",{"date":80,"type":64},"2026-06",{"name":5,"class":6},1]