[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437231":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":30,"responsibleParty":45,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":32,"whyStopped":10,"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},"Simultaneous cardiac surgery and carotid stenting",null,"Patients with Heart Team and NeuroVascular Team recommendation to perform simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) including proximal or distal neuroembolic protection and cardiac surgery (CABG or surgical valve replacement \u002F repair procedure)",[13],"Procedure: Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement \u002F repair procedure)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement \u002F repair procedure)","The registry enrolls patients qualified for treatment with the methods evaluated in the registry, using routinely applicable procedures and devices.\n\nIn cardiac surgery - surgical treatment systems for advanced ischemic heart disease and\u002For valvular disease (including - mechanical\u002Fbiologic heart valves - regulatory approved for routine use and typically used at the Facility.\n\nIn the simultaneous treatment of stroke-threatening carotid artery atherosclerosis - temporary neuroprotection systems (proximal, distal, according to medical indications and local experience) - regulatory approved for routine use and typically used at the center (for over 20 years).\n\nCGuard anti-embolic mesh stent system - a self-expanding nitinol carotid stent wrapped in MicroNet, which prevents fragments of atherosclerotic plaque from entering the lumen of the carotid artery - approved for routine use and typically used at the Center (over 5 years).",[9],[21],{"name":22,"affiliation":23,"role":24},"Piotr Musialek, MD, DPhil","Department of Cardiac and Vascular Diseases, John Paul II Hospital","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","+48126142287","pmusialek@szpitaljp2.krakow.pl",[31],{"facility":23,"status":32,"city":33,"state":10,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Krakow","31-202","Poland","PL",{"type":38,"coordinates":39},"Point",[40,41],19.93658,50.06143,{"lat":41,"lon":40},[44],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":46,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100437231","simultaneous-cardiac-surgery-and-micronet-covered-stent-carotid-revascularization-in-high-perioperative-stroke-risk-patients-100437231",false,"NCT04973579","Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients","SIMultaneous Urgent Cardiac Surgery and Endovascular Stroke Prevention Using the Micronet-covered CGUARD Stent in Hemodynamically Compromised Patients at Increased Peri-operative Stroke Risk: SIM-GUARD Study","SIM-GUARD","Inclusion Criteria:\n\n* Patients eligible for concomitant carotid artery stenting in conjunction with cardiac surgery based on Heart Team and NeuroVascular Team reccomendation and according to local standards of practice.\n* Signed informed consent form\n* Consent to (routinely performed in this group of patients) follow-up visits and tests performed (routinely) during long-term follow-up\n* De novo atherosclerotic lesions or neo-atherosclerosis.\n* Symptomatic patients (with a history of ipsilateral transient cerebral ischemia, stroke or amaurosis fugax within the past 6 months) with carotid artery stenosis ≥50% as assessed by NASCET angiography or\n* Asymptomatic patients with carotid artery stenosis ≥70-80% as assessed by angiography (NASCET method).\n* Coronary angiography-confirmed multivessel disease or left main stem stenosis with the symptoms of unstable angina or non-ST-segment elevation myocardial infarction.\n* Severe symptomatic valvular disease detected by echocardiography.\n\nExclusion Criteria:\n\n* Expected survival time \\\u003C1 year (e.g., cancer).\n* Renal failure with GFR \\\u003C 20 ml\u002Fmin\u002F1.73 m2 as calculated by the CKD-EPI formula\n* Women who are pregnant (pregnancy test).\n* Coagulopathies.\n* History of hypersensitivity to a contrast agent that does not respond to pharmacotherapy.\n* Total carotid artery occlusion.\n* Stent in the carotid artery that protrudes into the aortic arch.\n* Anatomic variants that preclude stent implantation.\n* Significant stenosis of the common carotid artery proximal to the target lesion.\n* Mobile atherosclerotic plaques in the aortic arch.\n* Anatomy of the coronary arteries unsuitable for bypass grafting.\n* Lack of available vascular material for grafting.\n* Porcelain aorta.","ALL","18 Years",{"count":58,"type":59},50,"ESTIMATED","OBSERVATIONAL","Prospective, single-center, clinical registry of patients with symptomatic\u002Fcritical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and\u002For severe valvular heart disease undergoing endovascular treatment of carotid atherosclerosis using a mesh stent in combination with cardiac surgery (coronary artery bypass grafting (CABG) and\u002For valve surgery). A study involving clinical data evaluation of truly simultaneous treatment outcomes in patients deemed to require carotid revascularization at the time of surgical cardiac intervention (single-stage, simultaneous treatment). An open-label study, without randomization - a single arm study.\n\nAcademic Registry - scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University and John Paul II Hospital.",[63,64,65,66,67],"Carotid Stenosis","Coronary Artery Disease","Valvular Heart Disease","Myocardial Infarction","Pulmonary Edema With Heart Failure",[63,69,70,71,72],"Coronary Artery Disease, Valvular Disease","Heart Failure, Pulmonary Edema","Single Anesthesia","Simultaneous Procedure","2021-07-13",{"date":75,"type":76},"2021-07-22","ACTUAL",{"date":78,"type":76},"2021-05-01",{"date":80,"type":59},"2027-05-01",{"name":5,"class":6},1]