[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dongguan TT Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100563598","efficacy-and-safety-of-sirolimus-coated-spiral-balloon-for-coronary-bifurcation-lesions-100563598",false,"NCT06618248","Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation Lesions","A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Sirolimus-coated Spiral Balloon Catheter for the Treatment of Coronary Bifurcation Lesions","Inclusion Criteria:\n\n* Patients aged between 18 and 85 years, regardless of gender.\n* Patients must voluntarily participate in the study and sign an informed consent form.\n* Patients must demonstrate sufficient adherence to the study protocol and agree to follow-up visits at 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) post-procedure, with angiography required at 9 months (±30 days).\n* Patients must have evidence of myocardial ischemia.\n* Angiographically confirmed primary coronary bifurcation lesions (Medina classification non-0, 0, 1) with branch stenosis ≥70% (estimated visually).\n* Patients suitable for PCI where the branch lesion is not expected to require stenting; stenting is planned for the main vessel, with DCB used on the branch. It is recommended to treat the branch with DCB first, followed by main vessel stenting.\n* Residual stenosis ≤50% after pre-treatment of the branch lesion, TIMI 3 flow, with no dissection or only A or B grade dissection. C grade dissections should be carefully considered by the investigator before deciding, and are generally not included.\n* The diameter of the branch vessel must be between 2.0 mm and 4.0 mm, with a lesion length ≤40 mm.\n\nExclusion Criteria:\n\n* Patients with bleeding disorders or active gastrointestinal ulcers, those who have had a stroke within the past 6 months, or those who are expected to be intolerant to dual antiplatelet therapy post-intervention.\n* Patients with severe renal insufficiency (creatinine level \\> 3.0 mg\u002FdL or 265.2 µmol\u002FL) and\u002For end-stage renal disease requiring dialysis.\n* Patients in cardiogenic shock.\n* Patients who have experienced a myocardial infarction within the week prior to enrollment.\n* Patients with severe congestive heart failure or NYHA class IV severe heart failure.\n* Patients with severe valvular heart disease.\n* Patients who have undergone heart transplantation.\n* Patients with a life expectancy of less than 1 year.\n* Patients currently participating in other drug or device clinical trials that have not yet reached the primary endpoint.\n* Patients with contraindications to taking aspirin and\u002For clopidogrel and\u002For ticagrelor.\n* Patients known to be allergic to paclitaxel, rapamycin, contrast agents, etc.\n* Pregnant or breastfeeding women, those with plans to conceive within the year, or those unwilling to use effective contraception.\n* Target vessels that are completely occluded, severely calcified, have \\>45° angulation, or are non-protected left main lesions.\n* Non-target lesions that cannot be treated prior to or fail to be treated successfully before addressing the target lesion.\n* Target lesions in branch vessels that are in-stent restenosis.\n* Other patients deemed unsuitable for inclusion by the investigator.","ALL","18 Years","85 Years",{"count":20,"type":21},280,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a multicenter, prospective randomized controlled study to evaluate the safety and effectiveness of Sirolimus-coated spiral balloon (SuperFlow®) versus Paclitaxel-coated balloon (Bingo™) in the treatment of coronary bifurcation lesions.",[27],"Coronary Bifurcation Lesion","RECRUITING","2024-09-28",{"date":31,"type":32},"2024-10-01","ACTUAL",{"date":34,"type":32},"2023-12-20",{"date":36,"type":21},"2027-03",{"name":38,"class":39},"Dongguan TT Medical","INDUSTRY",""]