Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-26 @ 10:29 PM
Study NCT ID:
NCT06380868
Status:
RECRUITING
Last Update Posted:
2025-03-14
First Post:
2024-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], '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.'}, 'primaryPurpose': 'TREATMENT', '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1332}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of target vessel failure (TVF)', 'timeFrame': 'At one-year since interventions', 'description': 'TVF is defined as a composite of cardiac death, target-vessel myocardial infraction, or clinically driven target vessel revascularization'}], 'secondaryOutcomes': [{'measure': 'Rate of target vessel failure without procedure-related MI', 'timeFrame': 'At one-year since interventions', 'description': 'Procedural-related myocardial infarction (PMI) would be excluded from the calculation of TVF'}, {'measure': 'Rate of cardiac death', 'timeFrame': 'At one-year since interventions', 'description': 'Any death without clear reasons'}, {'measure': 'Rate of all-cause death', 'timeFrame': 'At one-year since interventions', 'description': 'Any death occurs within one-year follow-up'}, {'measure': 'Rate of procedure-related myocardial infarction (PMI)', 'timeFrame': 'Within 48 h since coronary intervention', 'description': '48 hours after coronary intervention'}, {'measure': 'Rate of spontaneous myocardial infarction (SMI)', 'timeFrame': 'Within one-year follow-up', 'description': 'MI happens between 48 h and one-year since coronary intervention'}, {'measure': 'Rate of clinically-driven revascularization', 'timeFrame': 'At one-year since coronary artery intervention', 'description': '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.'}, {'measure': 'Rate of stent thrombosis', 'timeFrame': 'At one-year since coronary artery intervention', 'description': 'Definite or probable stent thrombosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '39914556', 'type': 'DERIVED', 'citation': 'Gao XF, Kan J, Wu HY, Chen J, Chen X, Wen SY, Gong YT, Tong Q, Luo J, Shao YB, Gill BUA, Malik FTN, Santoso T, Daggubati R, Rodriguez AE, Francesco L, Rahman A, Sheiban I, Kedev S, Munawar M, Kwan TW, Wang Y, Ye F, Zhang JJ, Shou XL, Chen SL; IVI-DIABETES investigators. Intravascular imaging-guided versus angiography-guided percutaneous coronary intervention in patients with diabetes mellitus: Rationale and design of an international, multicenter, randomized IVI-DIABETES trial. Am Heart J. 2025 May;283:81-88. doi: 10.1016/j.ahj.2025.01.017. Epub 2025 Feb 4.'}]}, '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.\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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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) \\<0.80)\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 \\< 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) \\< 20 ml/min/1.73m2\n7. Platelet count \\< 100,000 mm3\n8. Contraindication to study medications or metal\n9. Women of childbearing potential\n10. Life expectancy \\< 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.)'}, 'identificationModule': {'nctId': 'NCT06380868', 'acronym': 'IVI-DIABETES', 'briefTitle': 'IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial', 'orgStudyIdInfo': {'id': 'Nanjing-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravascular imaging-guided PCI group', 'description': 'For patients in this group, intravascular imaging will be encouraged to performed prior-to and post-coronary intervention using new generation drug-eluting stents', 'interventionNames': ['Procedure: Intravascular imaging-guided PCI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Angiography-guided PCI group', 'description': '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.', 'interventionNames': ['Procedure: Angiography-guided PCI group']}], 'interventions': [{'name': 'Intravascular imaging-guided PCI', 'type': 'PROCEDURE', 'description': 'Intravascular imaging including intravascular ultrasound or optical coherence tomography.', 'armGroupLabels': ['Intravascular imaging-guided PCI group']}, {'name': 'Angiography-guided PCI group', 'type': 'PROCEDURE', 'description': 'Deployment of a drug-eluting stent under angiography.', 'armGroupLabels': ['Angiography-guided PCI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuli M Zhao, MD', 'role': 'CONTACT', 'email': 'shuliz@126.com', 'phone': '+86-25-52271003'}, {'name': 'Ling F Lin, MD', 'role': 'CONTACT', 'email': 'linling@126.com', 'phone': '+86-25-52271--9'}, {'name': 'Jun-Jie M Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fei M Ye, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ling F Lin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yue F Gu, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wenying F Zhou, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jing F Kan, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jinque F Luo, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zhen M Ge, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiaobo M Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiaofei M Gao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiangquan M Kong, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Minghui F Li, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juan F Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Linlin F Zhu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Shao-Liang C Chen, MD', 'role': 'CONTACT', 'email': 'chmengx@126.com', 'phone': '13605157029'}, {'name': 'Xiling Shou, MD', 'role': 'CONTACT', 'email': 'chmengx@hotmail.com', 'phone': '+8618966700335'}], 'overallOfficials': [{'name': 'Jing Kan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nanjing First Hospital, Nanjing Medical University, and Shan'Xi Provincial People's Hospital, China"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Shanxi Provincial People's Hospital", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shaoliang Chen, MD', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}