[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595896":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":44,"responsibleParty":61,"collaborators":34,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":34,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":47,"whyStopped":34,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Ceric Sàrl","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DCB treatment (Mozec SEB)","EXPERIMENTAL","Mozec SEB is used during the angioplasty (V2) for patients randomized in the DCB arm with bail-out BRS. If the operator considers the results as insufficient, the MeRes100 is also used in the patient.",[13],"Procedure: Angioplasty with DCB (bail-out BRS)",{"label":15,"type":16,"description":17,"interventionNames":18},"BRS treatment (MeRes100)","ACTIVE_COMPARATOR","MeRes100 is used during the angioplasty (V2) for patients randomized in the BRS arm.",[13,19],"Procedure: Angioplasty with BRS",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Angioplasty with DCB (bail-out BRS)","Angioplasty starts with lesion preparation in both arms with a PTCA balloon catheter.\n\nThe lesion is treated with the Mozec SEB through femoral or brachial artery. The DCB should be delivered to the target lesion within 120 seconds of insertion into the guide catheter. Under fluoroscopic visualization, the DCB is inflated at least 30 seconds (single inflation). If the results are insufficient, multiple inflation is permitted. If despite appropriate delivery and inflation of the DCB, the results remain insufficient bail-out BRS should be performed.\n\nBail-out BRS is performed through femoral or brachial artery. After correct positioning, the BRS is deployed slowly, i.e. 10 seconds\u002Fatm up to 4 atm, then 5 seconds\u002Fatm up to nominal pressure or higher until desired expansion is obtained. After desired expansion obtained, pressure is maintained for 30 seconds before balloon deflation. After BRS implantation, Optical Coherence Tomography (OCT) is performed, if available.",[15,9],[27],"DCB arm with bail-out BRS",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Angioplasty with BRS","Bail-out BRS is performed through femoral or brachial artery. BRS implantation is guided by OCT, if available. After correct positioning, the BRS is deployed slowly, i.e. 10 seconds\u002Fatm up to 4 atm, then 5 seconds\u002Fatm up to nominal pressure or higher until desired expansion is obtained. After desired expansion obtained, pressure is maintained for 30 seconds before balloon deflation. After BRS implantation, OCT is performed, if available.",[15],[33],"BRS arm",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"DAVIDE CAPODANNO, Professor","CONTACT","+39-3393238566","dcapodanno@unict.it",{"name":42,"role":38,"phone":34,"phoneExt":34,"email":43},"CERC France","LeaveNothingBehind@cerc-europe.org",[45],{"facility":46,"status":47,"city":48,"state":34,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Põhja-Eesti Regionaalhaigla","RECRUITING","Tallinn","13419","Estonia","EE",{"type":53,"coordinates":54},"Point",[55,56],24.75353,59.43696,{"lat":56,"lon":55},[59],{"name":60,"role":38,"phone":34,"phoneExt":34,"email":34},"Peep Laanmets",{"type":62,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100595896","leave-nothing-behind-study-which-compares-dcb-with-bail-out-brs-versus-brs-strategy-alone-100595896",false,"NCT07038408","Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone","Multi-center, Open-label, Prospective, Randomized Study to Show Long-term Efficacy of DCB Treatment With Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in a Relatively Young PCI Population.","LNB","Inclusion Criteria:\n\n* Patients aged ≥ 18 years ≤ 68 years\n* Single vessel or multivessel disease with low to moderate complex de-novo native coronary artery lesions up to 30 mm length and reference vessel diameter 2.75-4.0 mm\n* Maximum of 3 target lesions\n* Maximal cumulative lesion length of all treated lesions 80 mm\n* Signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* ST-segment Elevation Myocardial Infarction (STEMI) treatment at index or in the previous 48 hours\n* Severe calcified lesions\n* Bifurcations lesions with planned 2 device strategy\n* Left-Main (LM) disease ≥ 50% diameter stenosis\n* More than 3 target lesions\n* Renal insufficiency with Glomerular Filtration Rate (GFR) \\\u003C 45 ml\u002Fmin\n* Life expectancy less than 1 year\n* Known hypersensitivity or allergy to aspirin or P2Y12 receptor inhibitors\n* Incapable of providing written informed consent\n* Pregnant or breastfeeding women\n* Under judicial protection, tutorship, or curatorship\n* Participation in another trial","ALL","18 Years","68 Years",{"count":75,"type":76},2256,"ESTIMATED","INTERVENTIONAL",[79],"NA","The goal of this study is to investigate the equivalence in early and long-term efficacy between the two \"Leave nothing behind strategies\" (Drug-Coated Baloon \\[DCB\\] strategy with bail-out BioResorbable Scaffold \\[BRS\\] versus BRS strategy) of de-novo native coronary artery lesions in a relatively young Percutaneous Coronary Intervention (PCI) population, to be more specific, Patients with Chronic Coronary Syndromes (CCS) and Acute Coronary Syndrome (ACS) (Non-ST-segment Elevation Myocardial Infarction \\[NSTEMI\\] and Unstable angina) between 18-68 years of age scheduled for PCI. The main questions aim to answer are:\n\nDCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 12 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has noninferior angiographic in-segment net gain at 13 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 60 months compared to BRS strategy?\n\nParticipants will be followed at:\n\n1. st FU visit - 1 month (in hospital)\n2. nd FU visit - 6 months (telephone)\n3. rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint\n4. th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy\n5. th FU visit - 730 days±30 days (telephone call) - 2Y\n6. th FU visit - 1095 days±30 days (telephone call) - 3Y\n7. th FU visit - 1460 days±30 days (telephone call) - 4Y\n8. th FU visit- 1825 days±30 days (telephone call) - 5Y",[82,83,84,85],"Drug Coated Balloon","Bioresorbable Scaffold","Percutaneous Coronary Intervention (PCI)","Acute Coronary Syndrome (ACS)",[87,88,89,90,91,92,93,94],"MULTI-CENTER","OPEN-LABEL","PROSPECTIVE","RANDOMIZED STUDY","LONG-TERM EFFICACY OF DCB TREATMENT WITH BAIL-OUT BRS","BRS TREATMENT","DE-NOVO NATIVE CORONARY ARTERY LESIONS","YOUNG PCI POPULATION","2026-04-27",{"date":97,"type":98},"2026-04-30","ACTUAL",{"date":100,"type":98},"2026-04-24",{"date":102,"type":76},"2032-03",{"name":5,"class":6},1]