Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT05800002
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2023-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IVUS-guided DES Implantation in Coronary Calcification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018084', 'term': 'Ultrasonography, Interventional'}, {'id': 'D002533', 'term': 'Cerebral Angiography'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D000792', 'term': 'Angiography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 864}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2033-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of target-vessel failure at 12 months', 'timeFrame': '12 months after indexed procedure', 'description': 'the composite of cardiovascular death, target-vessel myocardial infarction, and clinically driven target-vessel revascularization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Coronary calcified lesion is associated with a poor clinical outcome. Intravascular ultrasound (IVUS) provides anatomic information in detail about reference vessel dimensions and lesion characteristics including severity of diameter stenosis, lesion length, and morphology. Both randomized and observational studies have reported the clinical benefits of IVUS guidance for patients with chronic total occlusion (CTO), long lesions, acute coronary syndrome (ACS) with complex bifurcation lesions. Our previous ULTIMATE trial has demonstrated that IVUS-guided drug-eluting stent (DES) implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance. However, the benefit of IVUS guidance in coronary severe calcification still remains unknown in the modern DES era.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Silent ischemia, stable or unstable angina, non-ST-segment elevation myocardial infarction \\> 48 hours, or ST-segment elevation myocardial infarction \\> 7 days;\n2. De novo coronary lesion eligible for drug-eluting stent implantation;\n3. Target lesion with severe calcification;\n\nExclusion Criteria:\n\n1. Age less than 18-year-old;\n2. Comorbidity with a life expectancy \\<12 months;\n3. Intolerant of antithrombotic therapy;\n4. Significant anemia, thrombocytopenia, or leucopenia;\n5. History of major hemorrhage (intracranial, gastrointestinal, and so on);\n6. Chronic total occlusion lesion not recanalized;\n7. Scheduled major surgery in the next 12 months;\n8. Left ventricular ejection fraction \\< 25%;\n9. Uremia dependent on dialysis treatment;\n10. Previous drug-eluting stent implantation in target vessel;'}, 'identificationModule': {'nctId': 'NCT05800002', 'acronym': 'ULTIMATE IV', 'briefTitle': 'IVUS-guided DES Implantation in Coronary Calcification', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Intravascular Ultrasound Versus Angiography Guided Drug-eluting Stent Implantation for Patients With Coronary Severe Calcification: a Prospective, Multicenter, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KY20230310-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravascular ultrasound guidance', 'interventionNames': ['Procedure: Intravascular ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Angiography guidance', 'interventionNames': ['Procedure: Angiography']}], 'interventions': [{'name': 'Intravascular ultrasound', 'type': 'PROCEDURE', 'description': 'Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on intravascular ultrasound.', 'armGroupLabels': ['Intravascular ultrasound guidance']}, {'name': 'Angiography', 'type': 'PROCEDURE', 'description': 'Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on angiography.', 'armGroupLabels': ['Angiography guidance']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaoliang Chen, MD', 'role': 'CONTACT', 'email': 'chmengx@126.com', 'phone': '13605157029'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Jun-Jie Zhang, MD', 'role': 'CONTACT', 'email': 'jameszll@163.com', 'phone': '025-52271350'}], 'overallOfficials': [{'name': 'Shao-Liang Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice chief', 'investigatorFullName': 'Junjie Zhang', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}