[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657092":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":31,"interventions":43,"overallOfficials":24,"centralContacts":53,"locations":59,"responsibleParty":76,"collaborators":24,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":24,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":24,"enrollmentInfo":87,"targetDuration":24,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":62,"whyStopped":24,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"BrosMed Medical Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Minimum stent area (MSA) at the site of maximum calcification immediately after stent implantation","IVUS-measured results obtained after stent implantation and prior to balloon post-dilation","procedure day (0 day)",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Procedural success","Defined as successful stent implantation, residual stenosis ≤20%, absence of severe complications such as severe dissection, perforation, acute occlusion, no-reflow, and intraprocedural death, and TIMI 3 flow in the target vessel.",{"measure":18,"description":19,"timeFrame":12},"Strategy success","Defined as successful stent implantation, residual stenosis ≤20%, absence of severe complications such as severe dissection, perforation, acute occlusion, no-reflow, and intraprocedural death, and no need for alternative calcium modification devices (e.g., bailout rotational atherectomy, excimer laser coronary atherectomy, shockwave balloon).",{"measure":21,"description":22,"timeFrame":23},"Major adverse cardiac events (MACE)","Defined as a composite endpoint consisting of all-cause death, unplanned urgent target vessel revascularization, unplanned cardiac surgery, or spontaneous myocardial infarction.","the hospitalization period and 30-day after procedure",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"Test group","EXPERIMENTAL","In the test group, the lesion is prepared using a high-pressure cutting balloon prior to DES implantation.",[37],"Device: High pressure cutting balloon",{"label":39,"type":34,"description":40,"interventionNames":41},"Control group","In the control group, the lesion is prepared using a non-cutting balloon prior to DES implantation.",[42],"Device: Non-cutting balloon",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":24},"DEVICE","High pressure cutting balloon","Lesion preparation is carried out using the cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.",[33],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":24},"Non-cutting balloon","Lesion preparation is carried out using the non-cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.",[39],[54],{"name":55,"role":56,"phone":57,"phoneExt":24,"email":58},"Ning Guo, Professor","CONTACT","85323473","hearthx@126.com",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"The First Affiliated Hospital of Xi'an Jiaotong University","RECRUITING","Xi'an","Shaanxi","710061","China","CN",{"type":69,"coordinates":70},"Point",[71,72],108.92861,34.25833,{"lat":72,"lon":71},[75],{"name":55,"role":56,"phone":57,"phoneExt":24,"email":58},{"type":77,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100657092","post-marketing-clinical-study-of-high-pressure-cutting-balloon-100657092",false,"NCT07835178","Post-Marketing Clinical Study of High-Pressure Cutting Balloon","A Clinical Study of the High-Pressure Cutting Balloon for Interventional Treatment of Calcified Coronary Lesions","Inclusion Criteria:\n\n* Age ≥18 years;\n* Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation;\n* Moderate-to-severe calcified lesions on coronary angiography;\n* Target lesion is a de novo lesion in a native vessel that has not received any prior interventional treatment;\n* Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion;\n* In patients with multiple lesions, only one lesion will be selected as the target lesion in this study. If target and non-target lesions are treated during the same procedure, the target and non-target lesions must be located in different vessel branches; furthermore, the non-target lesion must be treated first, and the target lesion may be treated only after successful revascularization of the non-target lesion without severe angiographic complications;\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year;\n* Cardiogenic shock or hemodynamic instability;\n* Left main coronary artery disease;\n* Chronic total occlusion;\n* Bifurcation lesions planned for a \"two-stent strategy\";\n* Active bleeding;\n* Known history of allergy to contrast media or metals;\n* Patients with a bleeding tendency, contraindications to antiplatelet or anticoagulant therapy, or inability to receive anticoagulation therapy;\n* New-onset stroke\u002Ftransient ischemic attack within 6 months;\n* Pregnant or lactating women;\n* Left ventricular ejection fraction \\\u003C25%, or NYHA functional class IV, or Killip class ≥2;\n* Non-target vessel revascularization within 30 days before randomization with complications.","ALL","18 Years",{"count":88,"type":89},280,"ESTIMATED","INTERVENTIONAL",[92],"NA","This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation. Subjects will be randomized in a 1:1 ratio to the experimental group (n=140) or the control group (n=140). The primary endpoint is the MSA measured by IVUS immediately after the procedure, with the purpose of verifying the safety and efficacy of the high-pressure cutting balloon in optimizing stent implantation outcomes.",[95,96],"Coronary Artery Disease","Calcification",[98,99],"Coronary artery disease","calcification lesion","2026-09-17",{"date":102,"type":103},"2026-09-22","ACTUAL",{"date":105,"type":89},"2026-09",{"date":107,"type":89},"2028-12",{"name":5,"class":6},1]