protocolSection identificationModule nctId: NCT06380868, orgStudyIdInfo id: Nanjing-2, briefTitle: IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus, acronym: IVI-DIABETES, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-06-10, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-07-20, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, collaborators name: Shanxi Provincial People's Hospital, descriptionModule briefSummary: 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.Optical coherence tomography (OCT) has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI.Regrettably, 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., conditionsModule conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: 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., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1332, type: ESTIMATED, armsInterventionsModule interventions name: Intravascular imaging-guided PCI, interventions name: Angiography-guided PCI group, outcomesModule primaryOutcomes measure: Rate of target vessel failure (TVF), secondaryOutcomes measure: Rate of target vessel failure without procedure-related MI, secondaryOutcomes measure: Rate of cardiac death, secondaryOutcomes measure: Rate of all-cause death, secondaryOutcomes measure: Rate of procedure-related myocardial infarction (PMI), secondaryOutcomes measure: Rate of spontaneous myocardial infarction (SMI), secondaryOutcomes measure: Rate of clinically-driven revascularization, secondaryOutcomes measure: Rate of stent thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing First Hospital, city: Nanjing, state: Jiangsu, zip: 210006, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False