Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-06 @ 7:34 PM
Study NCT ID:
NCT01752894
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2012-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DETErmination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents(EES) Versus Biolimus A9-eluting Stents(BES)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 776}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2012-12-14', 'studyFirstSubmitQcDate': '2012-12-14', 'lastUpdatePostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of neointimal coverage at 3 month-OCT after stent implantation', 'timeFrame': 'at 3 month-OCT after stent implantation'}], 'secondaryOutcomes': [{'measure': 'The occurrence of the composite of cardiac death, MI, definite or probable stent thrombosis, and TIMI-defined major bleeding for 12 months', 'timeFrame': '12 months after PCI'}, {'measure': 'percentage of malposition strut at 3 month-OCT after stent implantation', 'timeFrame': '3 months after PCI'}, {'measure': 'The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke.', 'timeFrame': '12 months after PCI'}, {'measure': 'Target vessel revascularization', 'timeFrame': '12 months after PCI'}, {'measure': 'TIMI-defined major bleeding for 12 months', 'timeFrame': '12 months after PCI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '41044734', 'type': 'DERIVED', 'citation': 'Jin IT, Kim Y, Heo SJ, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim JS, Cho DK, Ko YG, Choi D, Hong MK, Kim BK. Comparison of Short-term and Standard Duration Dual Antiplatelet Therapy in Elderly Patients: A Pooled Analysis of Five Korean Randomized Clinical Trials. Korean Circ J. 2025 Jul 14. doi: 10.4070/kcj.2025.0093. Online ahead of print.'}, {'pmid': '30562088', 'type': 'DERIVED', 'citation': 'Lee SY, Ahn CM, Yoon HJ, Hur SH, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Early Follow-Up Optical Coherence Tomographic Findings of Significant Drug-Eluting Stent Malapposition. Circ Cardiovasc Interv. 2018 Dec;11(12):e007192. doi: 10.1161/CIRCINTERVENTIONS.118.007192.'}, {'pmid': '29454763', 'type': 'DERIVED', 'citation': 'Lee SY, Kim JS, Yoon HJ, Hur SH, Lee SG, Kim JW, Hong YJ, Kim KS, Choi SY, Shin DH, Nam CM, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Early Strut Coverage in Patients Receiving Drug-Eluting Stents and its Implications for Dual Antiplatelet Therapy: A Randomized Trial. JACC Cardiovasc Imaging. 2018 Dec;11(12):1810-1819. doi: 10.1016/j.jcmg.2017.12.014. Epub 2018 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is 1\\> to compare neointimal stent coverage after OCT-guided vs. Angio-guided PCI, 2\\> to compare neointimal stent coverage at 3 months after EES vs BES implantation, 3\\> to determine the duration of dual antiplatelet therapy by OCT measurement at 3 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 20 years old\n* Patients with ischemic heart disease who are considered for coronary revascularization with stent implantation.\n* Significant coronary de novo lesion (stenosis \\> 70% by quantitative angiographic analysis) treated by single DES ≤ 25mm\n* Reference vessel diameter of 2.5 to 3.5 mm by operator assessment\n\nExclusion Criteria:\n\n* Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis\n* Reference vessel diameter \\< 2.5 mm or \\> 4.0mm\n* Heavy calcified lesions (definite calcified lesions on angiogram)\n* Primary PCI for STEMI\n* Contraindication to anti-platelet agents\n* Treated with any DES within 3 months at other vessel\n* Creatinine level ≥ 2.0 mg/dL or ESRD\n* Severe hepatic dysfunction (3 times normal reference values)\n* Pregnant women or women with potential childbearing\n* Life expectancy \\< 1 year'}, 'identificationModule': {'nctId': 'NCT01752894', 'acronym': 'DETECT-OCT', 'briefTitle': 'DETErmination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents(EES) Versus Biolimus A9-eluting Stents(BES)', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '1-2012-0047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Angio guided PCI', 'interventionNames': ['Device: Angio-guided PCI with EES or BES']}, {'type': 'EXPERIMENTAL', 'label': 'OCT-guided PCI', 'interventionNames': ['Device: OCT-guided PCI with EES or BES']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BES', 'interventionNames': ['Device: PCI with BES under angio-guide or OCT guide']}, {'type': 'EXPERIMENTAL', 'label': 'EES', 'interventionNames': ['Device: PCI with EES under angio-guide or OCT guide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Keep dual antiplatelet therapy (DAPT)', 'description': 'Study subjects will be allocated into this arm with non-randomization method', 'interventionNames': ['Drug: Keep DAPT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Discontinue Dual antiplatelet therapy (DAPT)', 'description': 'Study subjects will be allocated into this arm with non-randomization method', 'interventionNames': ['Drug: Discontinue DAPT']}], 'interventions': [{'name': 'Angio-guided PCI with EES or BES', 'type': 'DEVICE', 'description': 'Angio-guided intervention', 'armGroupLabels': ['Angio guided PCI']}, {'name': 'OCT-guided PCI with EES or BES', 'type': 'DEVICE', 'description': 'OCT-guided intervention', 'armGroupLabels': ['OCT-guided PCI']}, {'name': 'PCI with BES under angio-guide or OCT guide', 'type': 'DEVICE', 'description': 'biolimus A9-eluting stent.', 'armGroupLabels': ['BES']}, {'name': 'PCI with EES under angio-guide or OCT guide', 'type': 'DEVICE', 'description': 'everolimus eluting stent.', 'armGroupLabels': ['EES']}, {'name': 'Keep DAPT', 'type': 'DRUG', 'description': 'maintain DAPT for 12 months according to level of uncovered strut (\\>6%) at 3months OCT follow up after stent implantation.', 'armGroupLabels': ['Keep dual antiplatelet therapy (DAPT)']}, {'name': 'Discontinue DAPT', 'type': 'DRUG', 'description': 'discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.', 'armGroupLabels': ['Discontinue Dual antiplatelet therapy (DAPT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}