[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639049":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":26,"responsibleParty":41,"collaborators":26,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":26,"eligibilityCriteria":48,"healthyVolunteers":45,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":26,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":26},{"fullName":5,"class":6},"JW Medical Systems Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"experimental group","EXPERIMENTAL","Biolimus-Coated Coronary Balloon Dilatation Catheter",[13],"Device: Biolimus-Coated Coronary Artery Balloon Dilatation Catheter",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Xinyue Drug-Coated Stent System",[19],"Device: Xinyue Drug-Coated Stent System",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Biolimus-Coated Coronary Artery Balloon Dilatation Catheter","A total of 774 subjects meeting the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Biolimus-Coated Coronary Artery Balloon Dilatation Catheter.",[9],null,{"type":22,"name":17,"description":28,"armGroupLabels":29,"otherNames":26},"A total of 774 eligible subjects who met the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Excrossal™ Xinyue Drug-Coated Stent System.",[15],[31],{"name":32,"affiliation":33,"role":34},"Bin Liu","Second Hospital of Jilin University","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Wang Yang Project Manager","CONTACT","13366024088","yang.wang@jwmsgrp.com",{"type":42,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100639049","a-prospective-multicenter-randomized-controlled-clinical-study-on-the-safety-and-efficacy-of-biolimus-drug-coated-balloon-dcb-versus-drug-eluting-stent-des-in-the-treatment-of-de-novo-coronary-artery-lesions-100639049",false,"NCT07582250","A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Efficacy of Biolimus Drug-Coated Balloon (DCB) Versus Drug-Eluting Stent (DES) in the Treatment of De Novo Coronary Artery Lesions","General Inclusion Criteria:\n\n1. Patients aged ≥ 18 years and ≤ 80 years;\n2. Patients with stable angina, unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia with objective evidence;\n3. Patients without contraindications to coronary revascularization (PCI or CABG);\n4. Patients who can understand the study purpose, voluntarily participate in the trial, sign the informed consent form, and are willing to complete follow-up as required by the protocol.\n\nAngiographic Inclusion Criteria:\n\n1. The target lesions are de novo native coronary artery lesions, located in 1 or 2 different coronary arteries; the number of target lesions in each coronary artery shall not exceed 1 (for two-vessel disease, a maximum of 2 target lesions are permitted).\n2. All target lesions shall meet the following requirements:\n\n   ① The reference vessel diameter is between 2.25 mm and 4.0 mm, and the lesion length ≤ 30 mm;\n\n   ② The visual estimated stenosis degree before procedure ≥ 70%, or ≥ 50% with documented ischemic evidence;\n\n   ③ Successful pre-dilation: defined as no NHLBI type C or higher dissection; TIMI flow grade 3; residual stenosis ≤ 30%.\n3. Each target lesion is only allowed to be treated with one investigational device or control device (except for bailout stent implantation).\n4. If the patient has non-target lesions requiring concurrent intervention, such non-target lesions shall be successfully treated prior to the treatment of target lesions.","ALL","18 Years","80 Years",{"count":53,"type":54},1548,"ESTIMATED","INTERVENTIONAL",[57],"NA","To compare the safety and efficacy of Biolimus drug-coated balloon (DCB) versus drug-eluting stent (DES) in the treatment of de novo coronary artery lesions.",[60],"Patients With de Novo Coronary Artery Lesions","NOT_YET_RECRUITING","2026-05-06",{"date":64,"type":65},"2026-05-12","ACTUAL",{"date":67,"type":54},"2026-06",{"date":69,"type":54},"2030-12",{"name":5,"class":6}]