[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600153":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":96,"collaborators":25,"id":99,"slug":25,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":25,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":120,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Nanjing First Hospital, Nanjing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Super high-pressure balloon","EXPERIMENTAL","Patients underwent intravascular imaging -guided PCI were treated with super high-pressure balloon for lesion preparation.",[13],"Device: super high-pressure balloon",{"label":15,"type":10,"description":16,"interventionNames":17},"Intravascular lithotripsy (IVL)","Patients underwent intravascular imaging -guided PCI were treated with Intravascular lithotripsy (IVL) for lesion preparation.",[18],"Device: intravascular lithotripsy (IVL)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","super high-pressure balloon","preparation strategy for calcified lesions after unsatisfactory dilation",[9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"intravascular lithotripsy (IVL)",[15],[30],{"name":31,"affiliation":32,"role":33},"Fei Ye, MD","The First Affiliated Hospital with Nanjing Medical University","PRINCIPAL_INVESTIGATOR",[35,40],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","18951670287","+86","doctor_ye@126.com",{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},"Yi-fei Wang, MD","18852577798","happywangyf2018@163.com",[45,64,77],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Lianyungang First People's Hospital","RECRUITING","Lianyungang","Jiangsu","222000","China",{"type":53,"coordinates":54},"Point",[55,56],119.21556,34.59845,{"lat":56,"lon":55},[59,63],{"name":60,"role":36,"phone":61,"phoneExt":38,"email":62},"De-lu Yin, MD","18961326475","druseyin@163.com",{"name":60,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":65,"status":47,"city":66,"state":49,"zip":67,"country":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Nanjing First Hospital","Nanjing","210006",{"type":53,"coordinates":69},[70,71],118.77778,32.06167,{"lat":71,"lon":70},[74,75,76],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},{"name":31,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":78,"status":47,"city":79,"state":49,"zip":80,"country":51,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Yixing People's Hospital","Yixing","214200",{"type":53,"coordinates":82},[83,84],119.82016,31.36059,{"lat":84,"lon":83},[87,91,95],{"name":88,"role":36,"phone":89,"phoneExt":38,"email":90},"Liang Xu, MD","18861576565","xl97010222@163.com",{"name":92,"role":36,"phone":93,"phoneExt":38,"email":94},"Peng-fei Wei, MD","18761550965","weipengfei.1988@163.com",{"name":88,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Ye-fei","chief physician","100600153",false,"NCT07093788","Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions","Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)","Shape","Inclusion Criteria:\n\n* Age \\> 18 years and \\\u003C 80 years\n* Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).\n* Have an indication for drug-eluting stent (DES) implantation\n* Denovo coronary artery calcified lesions\n* Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and \\\u003C 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA) ≤ 4.0 mm²).\n* Reference vessel diameter of the target vessel between 2.5 mm - 4.5 mm\n* Maximum calcium arc within the lesion ≥ 270⁰ assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)\n* Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of \\\u003C 30% under maximal inflation pressure.\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure\n* Presented as severe contrast agent allergy\n* Intolerant to dual antiplatelet therapy (DAPT) and\u002For anticoagulation therapy\n* Presented as active phase of autoimmune disease\n* Calcified nodules or eccentric calcification lesions\n* Failure to reach the target lesion with guidewires or catheters\n* Complex coronary bifurcation lesions\n* Target vessel thrombosis or aneurysm within 10 mm of the target lesion","ALL","18 Years","80 Years",{"count":110,"type":111},78,"ESTIMATED","INTERVENTIONAL",[114],"NA","this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \\& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions",[117,118,119],"PCI","Coronary Arterial Disease (CAD)","Calcified Coronary Lesions",[22,121,122],"percutaneous coronary intervention","intravascular lithotripsy","2026-03-06",{"date":125,"type":126},"2026-03-10","ACTUAL",{"date":128,"type":126},"2025-09-01",{"date":130,"type":111},"2027-06-30",{"name":5,"class":6},3]