Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT05101005
Status:
UNKNOWN
Last Update Posted:
2021-10-29
First Post:
2021-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion failure', 'timeFrame': '12 months follow-up', 'description': 'A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Procedural success', 'timeFrame': 'During the hospital stay, up to 7 days after PCI', 'description': "Consisting of device success ( after successful delivery of the study balloon, the visual residual stenosis of the target lesion is less than 50%, TIMI level 3 blood flow ) , Lesion success (defined as the proportion of the target lesions in which the final stenosis is \\<20% after treatment with any other adjunctive therapy ) , Clinical success ( Defined as no major adverse cardiac events caused by ischemia during the subject's hospitalization)."}, {'measure': 'Target lesion failure', 'timeFrame': '1 month, 6months follow-up', 'description': 'A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization'}, {'measure': 'Patient-oriented composite endpoint', 'timeFrame': '1 month, 6months,12 months follow-up', 'description': 'A composite of all-cause mortality, myocardial infarction, and any revascularization'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Drug-coated Balloon']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75\\~4.0mm).', 'detailedDescription': 'Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years and ≤80 years, regardless of gender;\n2. De novo lesion in a native coronary artery;\n3. Stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia;\n4. Reference vessel diameter is 2.75mm-4.0mm with diameter stenosis ≥70% or ≥50% (with evidence of ischemia) and TIMI flow ≥1;\n5. The subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting);\n6. The subject who can understand the purpose of the trial, voluntarily participate in and sign an informed consent form, and is willing to accept clinical follow-up.\n\nExclusion Criteria:\n\n1. Reference vessel diameter \\<2.75 mm or \\>4.0 mm;\n2. In stent restenosis;\n3. Left main lesion, chronic complete occlusion lesion;\n4. Ostial lesion ≤2mm from the LM, or bifurcation lesion with branch vessel diameter≥2.5mm;\n5. There is a large scale of thrombus in the target vessel, and the thrombus grade \\>3 after thrombolysis or aspiration;\n6. Severe heart failure (NYHA IV);\n7. Severe renal failure (GFR\\<30ml/min) or undergoing hemodialysis treatment;\n8. Severe liver failure (bilirubin is over 2 times the upper limit of normal, or alanine aminotransferase is over 3 times the upper limit of normal);\n9. Patients with vein graft restenosis after bypass or severe heart valve disease;\n10. Pregnant or breastfeeding female patients;\n11. The life expectancy of the patient is less than 12 months;\n12. The subject cannot be treated with anticoagulation because of bleeding tendency, history of active peptic ulcer, stroke in the 6 months before surgery, anti-platelet agents or anticoagulant treatment contraindications;\n13. Anemia (women's hemoglobin \\<117g/L, or men's hemoglobin \\<134g/L), or thrombocytopenia detected before the intervention within 6 months (\\<100×10⁹/L);\n14. Planned to perform non-cardiac surgery within 12 months after index procedure;\n15. The subject who participated in other clinical trials of drugs or instruments and did not reach time of primary endpoint;\n16. Heart transplant patients;\n17. Allergic to aspirin, clopidogrel, heparin, contrast agents, or paclitaxel;\n18. The investigator judged that the patient had poor compliance and could not complete the study as required."}, 'identificationModule': {'nctId': 'NCT05101005', 'briefTitle': 'Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lepu Medical Technology (Beijing) Co., Ltd.'}, 'officialTitle': 'A Prospective, Multi-center, Randomized Trial Comparing the Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions', 'orgStudyIdInfo': {'id': 'SJDCB-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug-coated balloon', 'description': 'Drug-coated balloon is used to treat coronary artery stenosis lesions and improve myocardial blood flow.', 'interventionNames': ['Device: Drug-Coated Balloon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sirolimus-Eluting Stent', 'description': 'Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions.', 'interventionNames': ['Device: Sirolimus-Eluting Stent']}], 'interventions': [{'name': 'Drug-Coated Balloon', 'type': 'DEVICE', 'description': 'Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions.', 'armGroupLabels': ['Drug-coated balloon']}, {'name': 'Sirolimus-Eluting Stent', 'type': 'DEVICE', 'description': 'Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions.', 'armGroupLabels': ['Sirolimus-Eluting Stent']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yansong Li', 'role': 'CONTACT', 'email': 'liyansong021@126.com', 'phone': '8618221277176'}], 'overallOfficials': [{'name': 'Yansong Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Songjiang Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lepu Medical Technology (Beijing) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}