[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559730":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":29,"studyPopulation":29,"armGroups":77,"interventions":89,"overallOfficials":97,"centralContacts":102,"locations":112,"responsibleParty":131,"collaborators":29,"id":133,"slug":29,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":134,"sex":140,"minAge":141,"maxAge":29,"enrollmentInfo":142,"targetDuration":29,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":115,"whyStopped":29,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"First Affiliated Hospital Xi'an Jiaotong University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR)","The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups.","12 months",[14,17,21,24,27,30,33,35,38,40],{"measure":15,"description":16,"timeFrame":12},"Hierarchical composite of target vessel failure","Hierarchical composite of cardiac death, target vessel MI, or clinically driven target vessel revascularization after randomization analyzed by win ratio method.",{"measure":18,"description":19,"timeFrame":20},"30-day cardiorenal endpoint","A composite of contrast-associated acute kidney injury (CA-AKI), requiring specific treatment for acute renal failure, persistent decline in eGFR, MI, or all-cause death.","30 days",{"measure":22,"description":23,"timeFrame":12},"Target vessel failure excluding periprocedural MI","The difference will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.",{"measure":25,"description":26,"timeFrame":12},"Cardiac death","Death that could not be attributed to a noncardiac etiology is considered cardiac death.",{"measure":28,"description":29,"timeFrame":12},"Target vessel MI",null,{"measure":31,"description":32,"timeFrame":12},"Clinically driven target vessel revascularization","Any clinically driven repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.",{"measure":34,"description":29,"timeFrame":12},"Spontaneous MI",{"measure":36,"description":37,"timeFrame":12},"Target lesion failure","A composite of cardiac death, target vessel related MI, or clinically driven target lesion revascularization.",{"measure":39,"description":29,"timeFrame":12},"Clinically driven target lesion revascularization",{"measure":41,"description":42,"timeFrame":12},"Major adverse cardiovascular event","A composite of cardiac death, MI, definite stent thrombosis (ST), or clinically driven TVR",[44,47,50,53,56,58,61,65,67],{"measure":45,"description":46,"timeFrame":12},"Renal outcomes","A composite of requiring specific treatment for acute renal failure (continuous renal replacement therapy, or dialysis), chronic dialysis (peritoneal dialysis, or hemodialysis), persistent decline in eGFR, or renal death.",{"measure":48,"description":49,"timeFrame":12},"Annual change in eGFR from baseline","total slope",{"measure":51,"description":52,"timeFrame":12},"Clinically relevant bleeding","Bleeding Academic Research Consortium Definition for Bleeding types 2，3 or 5",{"measure":54,"description":55,"timeFrame":12},"Major bleeding","Bleeding Academic Research Consortium Definition for Bleeding types 3 or 5",{"measure":57,"description":29,"timeFrame":12},"All-cause death",{"measure":59,"description":60,"timeFrame":12},"Definite or probable stent thrombus (ST)","ST was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC).",{"measure":62,"description":63,"timeFrame":64},"Procedure time","From first wire insertion to guide catheter removal.","during PCI",{"measure":66,"description":63,"timeFrame":64},"Radiation exposure",{"measure":68,"description":63,"timeFrame":64},"Total amount of contrast use",{"allocation":70,"interventionModel":71,"interventionModelDescription":29,"primaryPurpose":72,"observationalModel":29,"timePerspective":29,"maskingInfo":73},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":74,"maskingDescription":29,"whoMasked":75},"SINGLE",[76],"OUTCOMES_ASSESSOR",[78,84],{"label":79,"type":80,"description":81,"interventionNames":82},"IVUS-guidance PCI","EXPERIMENTAL","In the IVUS-guidance group, the optimal stent deployment criteria for non-left main lesion will include the following: : (1) the minimal lumen area (MLA) in the stented segment \\> 5.0 mm\\^2 or \\> 90% of the MLA at the distal reference segments, (2) plaque burden 5 mm proximal or distal to the stent edge is \\\u003C 55%, and (3) absence of medial dissection over 3 mm in length. In the setting of a two-stent approach for distal left main bifurcation lesions, the optimal stent deployment criteria are an absolute minimal stent area (MSA) greater than 8 mm\\^2 for the left main, greater than 7 mm\\^2 for carina, greater than 6 mm\\^2 for the ostial or proximal left anterior descending artery, and greater than 5 mm\\^2 for the ostial or proximal left circumflex artery. For left main lesion treated with single-stent technique, the criteria are greater than 7mm\\^2 for distal and greater than 8mm\\^2 for proximal. Further treatment will be required if the criteria are not met.",[83],"Procedure: Percutaneous coronary intervention",{"label":85,"type":86,"description":87,"interventionNames":88},"Angiography-guidance PCI","ACTIVE_COMPARATOR","Angiographic success is defined as thrombolysis in myocardial infarction (TIMI) flow grade 3, and residual stenosis \\\u003C 20%.",[83],[90],{"type":91,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"PROCEDURE","Percutaneous coronary intervention","PCI with DES implantation",[85,79],[96],"PCI",[98],{"name":99,"affiliation":100,"role":101},"Ning Guo","The First Affiliated of Xi'an Jiaotong University","PRINCIPAL_INVESTIGATOR",[103,108],{"name":104,"role":105,"phone":106,"phoneExt":29,"email":107},"Ning Guo, PhD,MD","CONTACT","+86 13991229101","nguomd@mail.xjtu.edu.cn",{"name":109,"role":105,"phone":110,"phoneExt":29,"email":111},"Xin Huang, PhD,MD","+86 13571961135","hearthx@126.com",[113],{"facility":114,"status":115,"city":116,"state":117,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":126,"contacts":127},"The First Affiliated Hopital of Xi'an Jiaotong University","RECRUITING","Xi'an","Shaanxi","710061","China","CN",{"type":122,"coordinates":123},"Point",[124,125],108.92861,34.25833,{"lat":125,"lon":124},[128,129,130],{"name":104,"role":105,"phone":106,"phoneExt":29,"email":107},{"name":109,"role":105,"phone":110,"phoneExt":29,"email":111},{"name":104,"role":101,"phone":29,"phoneExt":29,"email":29},{"type":132,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100559730",false,"NCT06567938","Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease","Intravascular Ultrasound-Guided or Angiography-Guided Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease: The IVUS-CKD Trial","IVUS-CKD","Inclusion Criteria:\n\n* CKD patients with eGFR\\\u003C60 mL\u002Fmin\u002F1.73 m\\^2\n* De novo coronary lesion suitable for second-generation metallic drug-eluting stent placement and IVUS imaging\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Onset of STEMI within 24 hours or emergent angiography\n* Pregnant or childbearing women\n* Co-morbidity with an estimated life expectancy of \\\u003C 1 year\n* LVEF ≤ 30%\n* Cardiogenic shock or hemodynamic instability\n* Severe hepatic dysfunction, defined as ALT or AST more than 5 times the ULN\n* PCI within the previous 12 months\n* Target lesion of stent thrombosis or in-stent restenosis\n* Any planned non-cardiac surgery within 12 months\n* Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk\n* Current enrolment in other clinical trials\n* Contraindication to anti-platelet agents\n* History of intracranial or gastrointestinal bleeding requiring transfusion or surgical intervention for control (excluding hemorrhoid)\n* Chronic total occlusion lesion with unsuccessful guidewire crossing\n* Current intake of nephrotoxic medications (e.g., nonsteroidal anti-inflammatory drugs except acetylsalicylic acid, phenylbutazone, aminoglycosides, amphotericin B, polymyxin, platinum complexes)\n* Immune-related kidney disease or on hormone therapy (e.g. lupus nephritis, IgA nephropathy)\n* Planned exposure to contrast within 72 h after the procedure, intravascular administration of contrast within the previous 5 days\n* Intake of anticoagulants\n* Hemoglobin \\\u003C60 g\u002FL\n* Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial\n* Patients allergic to metals or contrast","ALL","18 Years",{"count":143,"type":144},1528,"ESTIMATED","INTERVENTIONAL",[147],"NA","The IVUS-CKD study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (IVUS)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (CKD) patients with respect to target vessel failure (TVF) at 12 months after randomization.",[150,151],"Coronary Artery Disease","Chronic Kidney Diseases",[150,153,154,155,156],"Chronic Kidney Disease","Percutaneous Coronary Intervention","Intravascular Ultrasound","Randomized Trial","2024-08-21",{"date":159,"type":160},"2024-08-23","ACTUAL",{"date":162,"type":160},"2024-07-25",{"date":164,"type":144},"2027-12",{"name":5,"class":6},1]