[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bioresorbable-scaffold\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bioresorbable-scaffold":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"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":21,"type":22},2256,"ESTIMATED","INTERVENTIONAL",[25],"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",[28,29,30,31],"Drug Coated Balloon","Bioresorbable Scaffold","Percutaneous Coronary Intervention (PCI)","Acute Coronary Syndrome (ACS)",[33,34,35,36,37,38,39,40],"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","RECRUITING","2026-04-27",{"date":44,"type":45},"2026-04-30","ACTUAL",{"date":47,"type":45},"2026-04-24",{"date":49,"type":22},"2032-03",{"name":51,"class":52},"Ceric Sàrl","INDUSTRY"]