[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579286":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":40,"centralContacts":45,"locations":28,"responsibleParty":55,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":28,"enrollmentInfo":71,"targetDuration":28,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":85,"whyStopped":28,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":28},{"fullName":5,"class":6},"Ceric Sàrl","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Stepwise Provisional Stent Strategy","ACTIVE_COMPARATOR","Coronary guide wires are passed into both the main vessel (MV) and side branch (SB). Stenting of the MV is undertaken with a wire jailed in the SB to preserve SB flow and access. Stent diameter is chosen according to the diameter of the distal MV. Following stent deployment, the stent portion in the proximal MV is dilated with a short non-compliant balloon (POT technique) to achieve full expansion and apposition.\n\nFinally, after POT technique, SB is rewired and a kissing balloon inflation (KBI) is undertaken to address any plaque or carina shift and to open stent struts. Thus, non-compliant balloons sized to the diameter of the distal MV and SB are sequentially inflated at high pressure, and then simultaneously at low pressure.\n\nFurther SB treatment is required only if \\\u003CTIMI 3 flow, significant stenosis \\>70% or significant dissection. Thus, a side vessel stent implantation followed with KBI are mandatory.",[13,14],"Procedure: Percutaneous Coronary Angioplasty","Device: Stepwise Provisional Stent Strategy",{"label":16,"type":17,"description":18,"interventionNames":19},"Drug Coated Balloon Strategy","EXPERIMENTAL","Coronary guide wires are passed into both the main vessel (MV) and side branch (SB). If residual stenosis remains \\>30%, or TIMI flow\\\u003C3, or dissection propagation, the stenting of the MV is mandatory.\n\nOtherwise, a paclitaxel-drug coated balloon (DCB) is inflated in the prepared SB for 60 seconds at nominal pressure.\n\nIf residual stenosis remains \\>50%, or TIMI flow\\\u003C3, or dissection propagation, the operator will decide between prolonged balloon dilatation (1-2 minutes) or stent implantation, in the SB.\n\nAfter SB treatment, MV is treated with a DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds. If result is unacceptable, MV stenting followed with kissing balloon inflation and DCB or stent implantation into SB, are mandatory.\n\nThe procedure is complete when the MV has residual stenosis \\\u003C30%, has TIMI 3 flow and has no dissection propagation ; when the SB has residual stenosis \\\u003C50%, has TIMI 3 flow and has no dissection propagation.",[13,20,21],"Device: Drug Coated Balloon Strategy","Device: Cross-Over Stepwise Provisional Stent Strategy",[23,29,33,36],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Percutaneous Coronary Angioplasty","A Percutaneous Coronary Intervention is used in both arms, with the drug Zotarolimus for stenting strategy and Paclitaxel for balloon strategy.\n\nCoronary guide wires are passed into both the distal main vessel (distal MV) and side branch (SB) and predilation of MV on a 1:1 basis is required.\n\nThe device component dilates the vessel lumen by Percutaneous Transluminal Coronary Angioplasty (PTCA), while the drug is intended to reduce the proliferative response associated with restenosis.",[16,9],null,{"type":30,"name":9,"description":31,"armGroupLabels":32,"otherNames":28},"DEVICE","In the stepwise provisional stent strategy, stenting of the MV is undertaken with a wire jailed in the SB. Then, non-compliant balloons sized to the diameter of the distal MV and SB are sequentially inflated at high pressure, and then simultaneously at low pressure (kissing balloon inflation ; KBI).",[9],{"type":30,"name":16,"description":34,"armGroupLabels":35,"otherNames":28},"In the drug coated balloon (DCB) strategy, SB is prepared with a balloon at a 1:1 diameter, followed with a 1:1 sized DCB inflation for 60 seconds at nominal pressure. Then, MV is re-evaluated and treated with DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds.",[16],{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":28},"Cross-Over Stepwise Provisional Stent Strategy","Following Drug Coated Balloon treatment in the Main vessel (MV) in the Drug Coated Balloon Arm, if the result is unacceptable in the MV, with either TIMI\\>3 flow and\u002For dissection propagation, MV stenting is mandatory followed with Kissing Balloon Inflation (KBI), where non-compliant balloons sized to the diameter of the distal main and side branch are sequentially inflated at high pressure, and then simultaneously at low pressure. If the cross-over stent implantation in the MV is used, a further SB treatment with either DCB or stent implantation is used, according to operator preference.",[16],[41],{"name":42,"affiliation":43,"role":44},"David HILDICK-SMITH, Prof., MD","Brighton & Sussex University NHS Hospitals Trust - Royal Sussex County Hospital - Eastern Road - Brighton, East Sussex - BN25BE, United Kingdom","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"Basile GRAVEZ, PhD","CONTACT","+33 (0)789452048","bgravez@cerc-europe.org",{"name":52,"role":48,"phone":53,"phoneExt":28,"email":54},"Laure MORSIANI, PhD","+33 (0)176739236","lmorsiani@cerc-europe.org",{"type":56,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[58],{"name":59,"class":60},"European Cardiovascular Research Center","NETWORK","100579286","the-european-bifurcation-club-randomized-trial-of-stepwise-provisional-stenting-versus-drug-coated-balloon-therapy-for-non-left-main-true-coronary-bifurcations-100579286",false,"NCT06822322","The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations","The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations - EBC DCB Study","EBC DCB","Inclusion Criteria:\n\n* True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1\u002F1\u002F1, 1\u002F0\u002F1, 0\u002F1\u002F1)\n* Bifurcation lesion responsible for an acute or chronic coronary syndrome with at least one of the following:\n\n  * ≥70% angiographic MV and SB diameter stenosis\n  * Positive non-invasive testing for ischaemia\n  * Positive coronary physiology for ischaemia\n* Significant SB as described by diameter stenosis ≥50% and all of the following:\n\n  * SB length ≥73mm\n  * SB diameter ≥2.5mm\n  * Absence of another SB emerging distally from the MV\n  * Non-dominant circumflex artery, if SB is a diagonal branch.\n\nExclusion criteria\n\n* Patients \\\u003C18 years old\n* STEMI \\\u003C48 hours\n* Cardiogenic shock\n* Chronic total occlusion involving target bifurcation vessels\n* In-stent restenosis\n* Patient life expectancy \\\u003C12 months\n* \\>2 other coronary lesions (target or non-target) planned for treatment\n* SYNTAX score \\>32\n* Platelet count ≤50x109\u002Fmm3\n* Left ventricular ejection fraction ≤20%\n* Participation in another investigational drug or device study\n* Patient unable to give informed consent","ALL","18 Years",{"count":72,"type":73},750,"ESTIMATED","INTERVENTIONAL",[76],"NA","Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.",[79,80],"Coronary Artery Disease (non-left Main)","Coronary Bifurcation Lesion",[82,83,84],"non-left coronary bifurcation","drug coated balloon","drug eluted stent","NOT_YET_RECRUITING","2025-02-13",{"date":88,"type":89},"2025-02-14","ACTUAL",{"date":91,"type":73},"2025-05",{"date":93,"type":73},"2035-08",{"name":5,"class":6}]