[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493454":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":41,"collaborators":26,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":26,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"Keimyung University Dongsan Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Simple crossover arm","EXPERIMENTAL","This arm will receive the main vessel stenting only (with proximal optimization technique).",[13],"Procedure: Simple Crossover",{"label":15,"type":16,"description":17,"interventionNames":18},"Side branch opening arm","ACTIVE_COMPARATOR","This arm will receive a side branch opening procedure after the main vessel stenting.",[19],"Procedure: Side branch opening",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Simple Crossover","Regardless of allocated arms, stent implantation in the MV (selected 1:1 according to the distal MV size) followed by systematic proximal optimization technique (POT, post-dilatation of the stent at the level of proximal MV with a balloon diameter sized 1:1 according to the proximal MV) or POT like procedure is strongly recommended.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Side branch opening","According to the latest European Bifurcation Club (EBC) consensus document, distal SB rewiring followed by kissing balloon inflation (eventually conducted with short non-compliant balloons) and repeat POT procedures are highly recommended. An additional stent will be allowed if major dissection or decreased TIMI flow of SB occurs during SB treatment.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Chang-Wook Nam, MD","CONTACT","82-53-258-7019","namcwcv@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Ki Hong Choi","82-2-3410-6653","cardiokh@gmail.com",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","NAM, Chang-Wook","Professor","100493454","simple-crossover-versus-side-branch-opening-in-patients-with-non-left-main-bifurcation-lesion-100493454",false,"NCT05705362","Simple Crossover Versus Side Branch Opening in Patients With Non-Left Main Bifurcation Lesion","Randomized Controlled Trial of Simple CROSSsover Versus Side Branch Opening on Clinical Outcomes in Patients With Non-Left Main BIfurcation LeSion (CROSS-COBIS)","CROSS-COBIS","Inclusion Criteria:\n\n* (1) Subject must be at least 19 years of age\n* (2) Patients with non-left main bifurcation lesion (SB diameter ≥2.3 mm)\n* (3) Target lesions amenable for 1-stenting with provisional SB approach by operators' decision\n* (4) Angiographically compromised SB (visual SB stenosis ≥50%) after provisional MV stenting\n\nExclusion Criteria:\n\n* (1) Target lesions requiring elective 2-stenting technique by operators' decision (Observation Group 1)\\*\n* (2) Patients who inevitably require SB intervention after MV stenting, as follows. (Observation Group 2)\\*\n\n  1. Reduced SB TIMI flow (≤2) after MV stenting\n  2. SB dissection after MV stenting (≥ Type C)\n* (3) Patients without SB compromise after MV stenting (visually SB stenosis \\\u003C50%) (Observation Group 3)\\*\n* (4) Cardiogenic shock (Killip class IV) at presentation\n* (5) Patients with significant valvular heart disease or severe left ventricular systolic dysfunction (ejection fraction \\\u003C35%)\n* (6) Pregnancy or breast feeding\n* (7) Non-cardiac co-morbid conditions are present with life expectancy \\\u003C1 year or that may result in protocol non-compliance (per site investigator's medical judgment)\n* (8) Unwillingness or inability to comply with the procedures described in this protocol","ALL","19 Years",{"count":56,"type":57},1000,"ESTIMATED","INTERVENTIONAL",[60],"NA","Hypothesis:\n\nSimple crossover strategy would be non-inferior to SB opening strategy in the risk of target lesion failure (TLF) in patients with angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion.\n\nA total of 1000 patients (500 per each group) with the angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion will be enrolled. Patients will be randomized to either the simple crossover strategy group or SB opening strategy group at the time of enrollment with 1:1 ratio. Stratified randomization according to participating center, clinical presentation (acute coronary syndrome or stable ischemic heart disease), and type of bifurcation lesions (true or non-true) will be performed.",[63],"Coronary Artery Disease",[65,66,67,68],"Percutaneous coronary intervention","Bifurcation","Treatment strategy","Side branch","NOT_YET_RECRUITING","2023-01-26",{"date":72,"type":73},"2023-01-30","ACTUAL",{"date":75,"type":57},"2023-03-01",{"date":77,"type":57},"2029-12-31",{"name":5,"class":6}]