Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:12 PM
Study NCT ID:
NCT01539603
Status:
COMPLETED
Last Update Posted:
2015-06-12
First Post:
2012-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Drug Eluting Balloon and Drug Eluting Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}], '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'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}, '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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2012-02-21', 'studyFirstSubmitQcDate': '2012-02-24', 'lastUpdatePostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'in-segment late loss', 'timeFrame': '9 month', 'description': 'angiographic in-segment late loss measure by QCA program'}], 'secondaryOutcomes': [{'measure': 'stent thrombosis', 'timeFrame': '9 month', 'description': 'any stent thrombosis'}, {'measure': 'angiographic and procedure success', 'timeFrame': '9 month', 'description': 'Angiographic success denotes that residual diameter stenosis is less than 10% without complication such as coronarhy dissection or thrombosis.\n\nProcedural success means that adequate DEB+BMS or DES delivery to the target lesion without geographic miss.'}, {'measure': 'MACE', 'timeFrame': '9 month', 'description': 'death, MI and TVF'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['drug eluting balloon', 'bare metal stent', 'drug eluting stent', 'coronary artery disease'], 'conditions': ['Coronary Artery Disease', 'Stable Angina', 'Unstable Angina', 'NSTEMI']}, 'referencesModule': {'references': [{'pmid': '28480650', 'type': 'DERIVED', 'citation': 'Chae IH, Yoon CH, Park JJ, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ. Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial. J Korean Med Sci. 2017 Jun;32(6):933-941. doi: 10.3346/jkms.2017.32.6.933.'}, {'pmid': '23394404', 'type': 'DERIVED', 'citation': 'Park SD, Yoon CH, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ, Chae IH. Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial. Trials. 2013 Feb 8;14:38. doi: 10.1186/1745-6215-14-38.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon first and then bare metal stent compared with drug-eluting stent for treatment of de novo lesions (DEB first).', 'detailedDescription': 'A recent trial to test premount bare metal stent on drug-eluting balloon failed to demonstrate non-inferiority and safety compared to drug-eluting stent alone for treatment of coronary artery stenosis.\n\nWe think that inappropriate drug delivery to diseased vessel due to stent strut might affect the efficacy of drug-eluting balloon. Therefore, we design a clinical study with a different protocol, that is, drug-eluting balloon first and then bare metal stent implantation in comparison to drug-eluting stent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* De novo lesion\n* 2.5mm =\\< Reference diameter =\\< 4mm\n* Lesion length =\\< 28mm\n* Type A, B1/B2 lesion\n\nExclusion Criteria:\n\n* ST-segment elevation MI\n* Reference diameter \\< 2.5mm or \\> 4mm\n* Bifurcation lesion\n* Type C lesion\n* history of AMI or stroke within 1 year F. chronic renal disease (Cr \\> 2mg/dL)'}, 'identificationModule': {'nctId': 'NCT01539603', 'acronym': 'DEBfirst', 'briefTitle': 'Comparison of Drug Eluting Balloon and Drug Eluting Stent', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Comparison of Drug-Eluting Balloon First and Then Bare Metal Stent With Drug-eluting Stent for Treatment of de Novo Lesions (DEB First): A Randomized Controlled Single Center Clinical Trial', 'orgStudyIdInfo': {'id': 'E-1104/061-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DEB-BMS', 'description': 'Drug eluting balloon + Bare metal stent', 'interventionNames': ['Device: Drug eluting balloon + Bare metal stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Drug eluting stent', 'description': 'conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent)', 'interventionNames': ['Device: drug eluting stent (Zotarolimus-eluting stent)']}], 'interventions': [{'name': 'Drug eluting balloon + Bare metal stent', 'type': 'DEVICE', 'otherNames': ['Sequent Please (B.Braun, drug eluting balloon)', 'Coroflex Blue (B.Braun, bare metal stent)'], 'description': 'PCI using Sequent Please and then Coroflex Blue', 'armGroupLabels': ['DEB-BMS']}, {'name': 'drug eluting stent (Zotarolimus-eluting stent)', 'type': 'DEVICE', 'otherNames': ['Endeavor integrity', 'Zotarolimus-eluting stent'], 'description': 'conventional PCI using Endeavor Integrity', 'armGroupLabels': ['Drug eluting stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National Universtiy Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'overallOfficials': [{'name': 'In-Ho Chae, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Chang-Hwan Yoon', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}