[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605459":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":28,"locations":11,"responsibleParty":34,"collaborators":11,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":11,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":11,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":11},{"fullName":5,"class":6},"Xuzhou Third People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BRS group","EXPERIMENTAL",null,[13],"Device: bioresorbable scaffold",{"label":15,"type":10,"description":11,"interventionNames":16},"DCB group",[17],"Device: drug-coated balloon",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","bioresorbable scaffold","75 subjects with de novo large vessel coronary lesions who met the inclusion\u002Fexclusion criteria were enrolled; subjects were assigned to the treatment group of BRS.",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"drug-coated balloon","75 subjects with de novo large vessel coronary lesions who met the inclusion\u002Fexclusion criteria were enrolled; subjects were assigned to the treatment group of DCB.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"yaojun zhang, Ph.D.","CONTACT","0516-85786383","mts0207@163.com",{"type":35,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100605459","the-safety-and-efficacy-of-new-generation-brs-vs-dcb-for-de-novo-large-coronary-artery-lesions-a-prospective-rct-100605459",false,"NCT07162792","The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT","The Safety and Efficacy of New-Generation Bioabsorbable Scaffolds Versus Drug-Coated Balloons in the Treatment of De Novo Lesions in Large Coronary Arteries: A Prospective Randomized Controlled Study","Inclusion Criteria:\n\n* \\- Radiography inclusion criteria\n\n  1. angiographically confirmed de novo coronary artery lesion;\n  2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);\n  3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment);\n  4. either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels;\n  5. successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria\n\n  \u003C!-- -->\n\n  1. subjects at the age between ≥18 and ≤80 years old;\n  2. patients with symptoms or evidence of myocardial ischaemia;\n  3. subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation.\n\nExclusion Criteria:\n\n* 1\\. in-stent lesions; 2. For the left main disease, chronic total occlusive lesions; 3. bifurcation lesion (reference vessel diameter of side branch vessels \\> 2.0 mm); 4. Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation; 5. Previous use of any brand of drug-coated balloon in the target vessel. General inclusion criteria\n\n  1. Any patient with myocardial infarction within one month;\n  2. Patients with severe congestive heart failure (NYHA Level III severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 40%;\n  3. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;\n  4. Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;\n  5. Patients with severe renal failure(eGFR\\\u003C30ml\u002Fminute) or such medical history, failure to comply with angiography conditions;\n  6. Subjects who are intolerance or allergic to heparin, contrast agent, polyethylene oxide and polylactic acid - glycolic acid polymer;\n  7. Patients who plans to accept selective operation within 1 year;\n  8. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;\n  9. Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.","ALL","18 Years","80 Years",{"count":47,"type":48},150,"ESTIMATED","INTERVENTIONAL",[51],"NA","This study plans to enroll 150 patients who are candidates for \"intervention without implantation\" therapy and they will be randomly assigned in a 1:1 ratio to either the new-generation Firesorb scaffold group (BRS group, N=75) or the drug-coated balloon group (DCB group, N=75). All enrolled patients will undergo angiographic follow-up at 1 year post-procedure, and serial follow-up (via telephone or outpatient visit) will be performed at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure. The primary study endpoint was percentage diameter stenosis at 1 year post-procedure.",[54,55],"Coronary Artery Disease(CAD)","de Novo Coronary Lesions",[25,57,21],"percutaneous coronary intervention","NOT_YET_RECRUITING","2025-09-01",{"date":61,"type":62},"2025-09-09","ACTUAL",{"date":64,"type":48},"2025-10-23",{"date":66,"type":48},"2028-12-30",{"name":5,"class":6}]