Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT06104033
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2023-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
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': 'D054855', 'term': 'Drug-Eluting Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2023-10-23', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The reclassification rate of the treatment strategy', 'timeFrame': 'At the time of procedure', 'description': 'The reclassification rate according to the change in treatment approach from the default strategy of using only drug-eluting stents (DES-only) to the hybrid strategy of using both drug-coated balloons and drug-eluting stents in the treatment of multivessel coronary artery disease.'}], 'secondaryOutcomes': [{'measure': 'Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy', 'timeFrame': 'At the time of procedure', 'description': 'Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy'}, {'measure': 'Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy', 'timeFrame': 'At the time of procedure', 'description': 'Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy'}, {'measure': 'Cardiovascular death', 'timeFrame': '1 year', 'description': 'Cardiovascular death'}, {'measure': 'All-cause death', 'timeFrame': '1 year', 'description': 'All-cause death'}, {'measure': 'Non-fatal myocardial infarction (MI)', 'timeFrame': '1 year', 'description': 'Non-fatal myocardial infarction (MI)'}, {'measure': 'Target vessel MI excluding periprocedural MI', 'timeFrame': '1 year', 'description': 'Target vessel MI excluding periprocedural MI'}, {'measure': 'Target vessel MI including periprocedural MI', 'timeFrame': '1 year', 'description': 'Target vessel MI including periprocedural MI'}, {'measure': 'Clinically indicated target lesion revascularization', 'timeFrame': '1 year', 'description': 'Clinically indicated target lesion revascularization'}, {'measure': 'Clinically indicated target vessel revascularization', 'timeFrame': '1 year', 'description': 'Clinically indicated target vessel revascularization'}, {'measure': 'Any revascularization', 'timeFrame': '1 year', 'description': 'Any revascularization'}, {'measure': 'Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition', 'timeFrame': '1 year', 'description': 'Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition'}, {'measure': 'Cardiovascular death or target vessel MI', 'timeFrame': '1 year', 'description': 'Cardiovascular death or target vessel MI'}, {'measure': 'All-cause death or non-fatal MI', 'timeFrame': '1 year', 'description': 'All-cause death or non-fatal MI'}, {'measure': 'Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization', 'timeFrame': '1 year', 'description': 'Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization'}, {'measure': 'Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization', 'timeFrame': '1 year', 'description': 'Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization'}, {'measure': 'Cardiovascular death, target vessel MI, or vessel or stent thrombosis', 'timeFrame': '1 year', 'description': 'Cardiovascular death, target vessel MI, or vessel or stent thrombosis'}, {'measure': 'All-cause death, non-fatal MI, or clinically indicated target vessel revascularization', 'timeFrame': '1 year', 'description': 'All-cause death, non-fatal MI, or clinically indicated target vessel revascularization'}, {'measure': 'Major bleeding events (BARC type 2, 3, or 5)', 'timeFrame': '1 year', 'description': 'Major bleeding events (BARC type 2, 3, or 5)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'Multivessel coronary artery disease', 'Percutaneous coronary intervention', 'Drug-coated balloon', 'Drug-eluting stent'], 'conditions': ['Coronary Artery Disease', 'Multi Vessel Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, multicenter, open-label, observational study to investigate the impact of using drug-coated balloons (DCBs) in the treatment of coronary artery lesions in patients with multivessel coronary artery disease (MVD), as opposed to the default strategy of using only drug-eluting stents (DES). The investigators aim to assess changes in clinical practice towards a hybrid treatment strategy (DES and DCB) and its effects on clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with multivessel coronary artery disease who undergo coronary intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 19 or older\n2. Multivessel coronary artery disease patients requiring coronary intervention\n\n * Stenosis of 2 or more major coronary arteries or major coronary artery branches (Vessel size ≥2.5mm) with diameter stenosis ≥50% or fractional flow reserve ≤0.80 requiring repeat revascularization\n * Having stenotic lesions requiring revascularization with a vessel size of 2.5mm to 3.0mm\n3. Capable of understanding the risks and benefits of participating in the study and providing informed consent\n\nExclusion Criteria:\n\n1. Incapable of voluntarily providing informed consent\n2. Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents\n3. Cardiogenic shock or cardiac arrest patients\n4. Patients with severe left ventricular systolic dysfunction (ejection fraction \\<30%)\n5. Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention\n6. Patients with severe valvular heart disease requiring open heart surgery\n7. Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT06104033', 'acronym': 'DCB-MVD', 'briefTitle': 'Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease', 'orgStudyIdInfo': {'id': '2306-138-1440'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hybrid strategy', 'description': 'The patient undergoes percutaneous coronary intervention with drug-coated balloons and drug-eluting stents or drug-coated balloons only in the coronary artery lesion.', 'interventionNames': ['Device: drug-coated balloon', 'Device: drug-eluting stent']}, {'label': 'DES only', 'description': 'The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion.', 'interventionNames': ['Device: drug-eluting stent']}], 'interventions': [{'name': 'drug-coated balloon', 'type': 'DEVICE', 'description': 'For the procedure, the drug-coated balloon (Agent®, Boston Scientific, USA) that can be used for both de-novo coronary lesions and in-stent restenosis lesions is used.', 'armGroupLabels': ['Hybrid strategy']}, {'name': 'drug-eluting stent', 'type': 'DEVICE', 'description': 'When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.', 'armGroupLabels': ['DES only', 'Hybrid strategy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bon-Kwon Koo, MD, PhD', 'role': 'CONTACT', 'email': 'bkkoo@snu.ac.kr', 'phone': '+82-2-2072-2062'}], 'facility': 'Bon-Kwon Koo', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Bon-Kwon Koo, MD, PhD', 'role': 'CONTACT', 'email': 'bkkoo@snu.ac.kr', 'phone': '+82-2-2072-2062'}], 'overallOfficials': [{'name': 'Bon-Kwon Koo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': '+82-2-2072-2062'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bon-Kwon Koo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': "St Vincent's Hospital", 'class': 'OTHER'}, {'name': 'Uijeongbu St. Mary Hospital', 'class': 'OTHER'}, {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, {'name': 'Inje University Ilsan Paik Hospital', 'class': 'OTHER'}, {'name': 'Daegu Catholic University Medical Center', 'class': 'OTHER'}, {'name': 'Sejong General Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}, {'name': 'Yeungnam University Hospital', 'class': 'OTHER'}, {'name': 'Wonju Severance Christian Hospital', 'class': 'OTHER'}, {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, {'name': 'Ewha Womans University Mokdong Hospital', 'class': 'OTHER'}, {'name': 'Inje University', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': 'Chung-Ang University Gwangmyeong Hospital', 'class': 'OTHER'}, {'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, {'name': 'Ulsan Medical Center', 'class': 'OTHER'}, {'name': 'Hanyang University Seoul Hospital', 'class': 'OTHER'}, {'name': 'Jeju National University Hospital', 'class': 'OTHER'}, {'name': 'KangWon National University Hospital', 'class': 'OTHER'}, {'name': 'Uijeongbu Eulji Medical Center, Eulji University', 'class': 'UNKNOWN'}, {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, {'name': 'Gyeongsang National University Hospital', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Chosun University Hospital', 'class': 'OTHER'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, {'name': 'Kyung Hee University Hospital at Gangdong', 'class': 'OTHER'}, {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bon-Kwon Koo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}