[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545358":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":51,"studyPopulation":38,"armGroups":52,"interventions":65,"overallOfficials":74,"centralContacts":79,"locations":89,"responsibleParty":141,"collaborators":144,"id":148,"slug":38,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":149,"sex":155,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":38,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":38,"overallStatus":92,"whyStopped":38,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Nanjing First Hospital, Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of target vessel failure (TVF)","TVF is defined as a composite of cardiac death, target-vessel myocardial infraction, or clinically driven target vessel revascularization","At one-year since interventions",[14,17,20,23,27,31,35],{"measure":15,"description":16,"timeFrame":12},"Rate of target vessel failure without procedure-related MI","Procedural-related myocardial infarction (PMI) would be excluded from the calculation of TVF",{"measure":18,"description":19,"timeFrame":12},"Rate of cardiac death","Any death without clear reasons",{"measure":21,"description":22,"timeFrame":12},"Rate of all-cause death","Any death occurs within one-year follow-up",{"measure":24,"description":25,"timeFrame":26},"Rate of procedure-related myocardial infarction (PMI)","48 hours after coronary intervention","Within 48 h since coronary intervention",{"measure":28,"description":29,"timeFrame":30},"Rate of spontaneous myocardial infarction (SMI)","MI happens between 48 h and one-year since coronary intervention","Within one-year follow-up",{"measure":32,"description":33,"timeFrame":34},"Rate of clinically-driven revascularization","Target vessel revascularization was defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, which included upstream and downstream branches and the target lesion itself.","At one-year since coronary artery intervention",{"measure":36,"description":37,"timeFrame":34},"Rate of stent thrombosis","Definite or probable stent thrombosis",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","Patients will undergo 1:1 randomization to either intravascular imaging (including intravascular ultrasound or optical coherence tomography)-guided DES implantation which will be the treatment group or Angio-guided DES implantation which will be the control group, stratified by research sites.","TREATMENT",{"masking":45,"maskingDescription":46,"whoMasked":47},"TRIPLE","Randomization will be performed in the catheter laboratory by an invasive nurse. Staff in the catheter laboratory will be not blinded to the treatment allocation.",[48,49,50],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","The current study hypothesizes that IVI-guided PCI will be superior with respect to target vessel failure (TVF), including cardiac death, target-vessel myocardial infarction (TVMI), or clinically-driven TVR when compared with angiography-guided PCI in patients with diabetes mellitus.",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"Intravascular imaging-guided PCI group","EXPERIMENTAL","For patients in this group, intravascular imaging will be encouraged to performed prior-to and post-coronary intervention using new generation drug-eluting stents",[58],"Procedure: Intravascular imaging-guided PCI",{"label":60,"type":61,"description":62,"interventionNames":63},"Angiography-guided PCI group","ACTIVE_COMPARATOR","For patients in this group, implantation of a new generation drug-eluting stent will be guided by angiography only. Unless coronary artery lesion is complex or ambiguous, intravascular imaging is not allowed to be used. If intravascular imaging is used because of the reason mentioned above, post-stenting assessment is absolutely not allowed.",[64],"Procedure: Angiography-guided PCI group",[66,71],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":38},"PROCEDURE","Intravascular imaging-guided PCI","Intravascular imaging including intravascular ultrasound or optical coherence tomography.",[54],{"type":67,"name":60,"description":72,"armGroupLabels":73,"otherNames":38},"Deployment of a drug-eluting stent under angiography.",[60],[75],{"name":76,"affiliation":77,"role":78},"Jing Kan, MD","Nanjing First Hospital, Nanjing Medical University, and Shan'Xi Provincial People's Hospital, China","PRINCIPAL_INVESTIGATOR",[80,85],{"name":81,"role":82,"phone":83,"phoneExt":38,"email":84},"Shao-Liang C Chen, MD","CONTACT","13605157029","chmengx@126.com",{"name":86,"role":82,"phone":87,"phoneExt":38,"email":88},"Xiling Shou, MD","+8618966700335","chmengx@hotmail.com",[90],{"facility":91,"status":92,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"Nanjing First Hospital","RECRUITING","Nanjing","Jiangsu","210006","China","CN",{"type":99,"coordinates":100},"Point",[101,102],118.77778,32.06167,{"lat":102,"lon":101},[105,109,113,115,118,119,121,123,125,127,129,131,133,135,137,139],{"name":106,"role":82,"phone":107,"phoneExt":38,"email":108},"Shuli M Zhao, MD","+86-25-52271003","shuliz@126.com",{"name":110,"role":82,"phone":111,"phoneExt":38,"email":112},"Ling F Lin, MD","+86-25-52271--9","linling@126.com",{"name":114,"role":78,"phone":38,"phoneExt":38,"email":38},"Jun-Jie M Zhang, PhD",{"name":116,"role":117,"phone":38,"phoneExt":38,"email":38},"Fei M Ye, MD","SUB_INVESTIGATOR",{"name":110,"role":117,"phone":38,"phoneExt":38,"email":38},{"name":120,"role":117,"phone":38,"phoneExt":38,"email":38},"Yue F Gu, PhD",{"name":122,"role":117,"phone":38,"phoneExt":38,"email":38},"Wenying F Zhou, PhD",{"name":124,"role":78,"phone":38,"phoneExt":38,"email":38},"Jing F Kan, MBBS",{"name":126,"role":117,"phone":38,"phoneExt":38,"email":38},"Jinque F Luo, PhD",{"name":128,"role":78,"phone":38,"phoneExt":38,"email":38},"Zhen M Ge, MD",{"name":130,"role":78,"phone":38,"phoneExt":38,"email":38},"Xiaobo M Li, MD",{"name":132,"role":78,"phone":38,"phoneExt":38,"email":38},"Xiaofei M Gao, MD",{"name":134,"role":117,"phone":38,"phoneExt":38,"email":38},"Xiangquan M Kong, MD",{"name":136,"role":117,"phone":38,"phoneExt":38,"email":38},"Minghui F Li, PhD",{"name":138,"role":78,"phone":38,"phoneExt":38,"email":38},"Juan F Zhang, MD",{"name":140,"role":78,"phone":38,"phoneExt":38,"email":38},"Linlin F Zhu, MD",{"type":78,"investigatorFullName":142,"investigatorTitle":143,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Shaoliang Chen, MD","Professor",[145],{"name":146,"class":147},"Shanxi Provincial People's Hospital","OTHER_GOV","100545358",false,"NCT06380868","IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus","Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial","IVI-DIABETES","Inclusion Criteria:\n\n1. Age between 18 \\~ 80 years old,\n2. Confirmed diabetes mellitus\n3. Indications for undergoing percutaneous coronary intervention using a drug-eluting stent (Invasive or quantitative fractional flow reserve (QFR or FFR) \\\u003C0.80)\n4. Silent angina, stable angina, unstable angina, or Non-ST-elevation myocardial infarction\n\nExclusion Criteria:\n\n1. Cardiogenic shock\n2. Previous coronary artery bypass graft (CABG)\n3. Left ventricular ejection fraction \\\u003C 30%\n4. Requiring oral anticoagulation medications\n5. Any planned surgery within 12 months\n6. Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) \\\u003C 20 ml\u002Fmin\u002F1.73m2\n7. Platelet count \\\u003C 100,000 mm3\n8. Contraindication to study medications or metal\n9. Women of childbearing potential\n10. Life expectancy \\\u003C 1 year\n11. Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)","ALL","18 Years","80 Years",{"count":159,"type":160},1332,"ESTIMATED","INTERVENTIONAL",[163],"NA","Intravascular ultrasound (IVUS) serves as a beneficial instrument during percutaneous coronary intervention (PCI) procedures, affording insight into lesion characteristics and stent implantation. The ULTIMATE trial recently evidenced that IVUS-guided Drug-Eluting Stent (DES) implantation notably ameliorated clinical outcomes in all-comers, especially in patients who underwent an optimal procedure defined by IVUS, as opposed to angiography guidance, resonating with findings from the IVUS-XPL study, OCTOBER trial, and RENOVATE COMPLEX PCI trial, further confirmed by more recent IVUS-ACS trial.\n\nOptical coherence tomography (OCT) has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI.\n\nRegrettably, a dearth of prospective, randomized, multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus. However, several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus, which served as the foundation for the design of this trial.",[166],"Diabetes","2026-05-15",{"date":169,"type":170},"2026-05-19","ACTUAL",{"date":172,"type":170},"2024-07-17",{"date":174,"type":160},"2027-07-20",{"name":5,"class":6},1]