[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647570":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IVUS-Guided Approach","ACTIVE_COMPARATOR","Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.",[13],"Procedure: IVUS-Guided LM PCI",{"label":15,"type":16,"description":17,"interventionNames":18},"\"Trained Eye\" (Angiography-Guided) Approach","EXPERIMENTAL","Stent sizing and procedural optimization guided by angiographic visual assessment and operator experience, with only IVUS assessment after intervention.",[19],"Procedure: \"Trained Eye\" (Angiography-Guided) LM PCI",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","IVUS-Guided LM PCI","Coronary stent - single manufacturer and model (\"Calypso\", R-Vascular, Russia) used in all patients, to minimize variability related to stent design (strut thickness, cell design, expansion limits).\n\nProcedure steps:\n\n* Baseline IVUS pullback - assessment of proximal and distal reference segments and lesion length\n* Stent selection based on IVUS data\n* Stent implantation\n* Mandatory optimization: kissing balloon dilation; proximal optimization\n* Final IVUS pullback to confirm result",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"\"Trained Eye\" (Angiography-Guided) LM PCI","Coronary stent - single manufacturer and model (\"Calypso\", R-Vascular, Russia) used in all patients, to minimize variability related to stent design (strut thickness, cell design, expansion limits).\n\nProcedure steps:\n\n* Anatomical assessment based on visual angiographic evaluation\n* Stent and balloon selection at operator discretion\n* Stent implantation\n* Mandatory optimization (same steps: kissing balloon dilation, proximal optimization)\n* Final IVUS pullback performed only afterward, solely to assess planimetric result (not used to guide the procedure itself)",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Aleksei A. Prokhorikhin, PhD","CONTACT","+79137178040","aa.prohorihin@gmail.com",[38],{"facility":5,"status":39,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Saint Petersburg","Russia","RU",{"type":44,"coordinates":45},"Point",[46,47],30.31413,59.93863,{"lat":47,"lon":46},[50,54],{"name":51,"role":34,"phone":52,"phoneExt":26,"email":53},"Alexandra O. Conradi, M.D., Ph.D.","+79219931159","konradi@almazovcentre.ru",{"name":55,"role":34,"phone":35,"phoneExt":26,"email":36},"Aleksei A. Prokhorikhin, M.D., Ph.D.",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Conrady Alexandra","Deputy Director for Science","100647570","expert-ivus-eye-vs-ivus-guided-left-main-bifurcation-pci-100647570",false,"NCT07711106","\"Expert IVUS-Eye\" vs. IVUS-guided Left Main Bifurcation PCI","\"IVUS-Trained Eye\" vs. Intravascular Ultrasound in Left Main Bifurcation Stenting: A Prospective Randomized Trial","EYE-IVUS LM","Inclusion Criteria:\n\n* De novo lesion in an unprotected left main coronary artery, indicated for bifurcational stenting (provisional or 2-stent)\n* Patient referred for elective or delayed (non-emergency) stenting\n* Technical feasibility of performing IVUS\n* Signed informed consent\n\nExclusion Criteria:\n\n* ST-elevation myocardial infarction (STEMI) within the preceding 72 hours\n* Cardiogenic shock\n* Isolated (non-bifurcation) left main lesion\n* Prior PCI in the target segment\n* Diameter of one of the left main main branches \\\u003C 2 mm\n* Occlusion in the proximal segment of one of the main left main branches without the possibility of simultaneous recanalization\n* History of coronary artery bypass grafting (CABG)\n* Severe comorbidity with expected life expectancy \\\u003C 1 year\n* Participation in another interventional study\n* Patient is a woman who is pregnant or nursing;\n* Female patient of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause);\n* IVUS is strictly required for pre-PCI lesion severity assessment\n* Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 6 months in stable patients and 1 year in ACS patients;\n* Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants.","ALL","18 Years",{"count":71,"type":72},50,"ESTIMATED","INTERVENTIONAL",[75],"NA","This is a prospective, randomized, controlled trial comparing two strategies for optimizing stent implantation during bifurcation stenting of the left main coronary artery (LM): an intravascular ultrasound (IVUS)-guided approach versus a \"IVUS-trained eye\" approach based on angiographic assessment and operator experience. All patients receive the same stent brand and procedure steps to minimize variability. The primary objective is to compare the planimetric stent appearance between two strategies.",[78,79,80,81],"Coronary Artery Disease (CAD)","Chronic Coronary Syndrome","Left Main Coronary Artery Disease","Coronary Bifurcation Lesion",[83,84,85,86,87,88,89],"Intravascular ultrasound","Percutaneous coronary intervention","Left main","Bifurcation","IVUS-trained eye","Stent optimization","Minimal stent area","2026-07-14",{"date":92,"type":93},"2026-07-17","ACTUAL",{"date":95,"type":93},"2026-07-01",{"date":97,"type":72},"2027-12-31",{"name":5,"class":6},1]