Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-22 @ 8:24 PM
Study NCT ID:
NCT01335659
Status:
COMPLETED
Last Update Posted:
2011-07-21
First Post:
2011-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Main Branch Versus Side Branch Ostial Lesion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-20', 'studyFirstSubmitDate': '2011-04-07', 'studyFirstSubmitQcDate': '2011-04-13', 'lastUpdatePostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lumen area', 'timeFrame': '1 day', 'description': 'lumen area at ostial lesion'}], 'secondaryOutcomes': [{'measure': 'angiographic stenosis, % plaque area', 'timeFrame': '1 day', 'description': 'angiographic and intravascular ultrasound parameters at ostial lesions of each major branch and side branch.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FFR', 'IVUS', 'QCA'], 'conditions': ['Coronary Artery Stenosis']}, 'referencesModule': {'references': [{'pmid': '22516397', 'type': 'DERIVED', 'citation': 'Koh JS, Koo BK, Kim JH, Yang HM, Park KW, Kang HJ, Kim HS, Oh BH, Park YB. Relationship between fractional flow reserve and angiographic and intravascular ultrasound parameters in ostial lesions: major epicardial vessel versus side branch ostial lesions. JACC Cardiovasc Interv. 2012 Apr;5(4):409-15. doi: 10.1016/j.jcin.2012.01.013.'}]}, 'descriptionModule': {'briefSummary': 'The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.', 'detailedDescription': 'Angiographic evaluation for ostial lesions is reported to be inaccurate in the assessment of the functional and clinical significance of a lesion. The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'from september 2009 to january 2011 patient who are undergone coronary angiography,IVUS and FFR for the evaluation of coronary artery disease at SNUH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21-85\n* Presence of at least one obstructive coronary artery stenosis at coronary ostium as defined by:\n* Previous catheterization with any coronary ostium lesion 50% or greater\n* Ability and Willingness to provide informed consent\n* Ability and Willingness to perform required follow up procedures\n\nExclusion Criteria:\n\n* History of coronary artery bypass graft surgery\n* left main coronary ostial lesion\n* significant stenosis at proximal or distal part of coronary ostium lesion\n* ostial lesion related to infarcton\n* Creatinine\\>1.6 mg/dL or GFR\\<30 pre-procedure per institutional standards\n* Ejection fraction lower than 40%\n* Known Pregnancy\n* Arrhythmia\n* Contrast agent allergy that cannot be adequately premedicated\n* Patient not a candidate for IVUS and FFR\n* Inability or unwillingness to provide informed consent\n* Inability or unwillingness to perform required follow up procedures'}, 'identificationModule': {'nctId': 'NCT01335659', 'briefTitle': 'Main Branch Versus Side Branch Ostial Lesion', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Relationship Between Fractional Flow Reserve and Coronary Angiography/Intravascular Ultrasound Parameters in Ostial Lesions: Major Coronary Ostial Lesions Versus Side Branch Ostial Lesions', 'orgStudyIdInfo': {'id': 'Bif_3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ostial lesion', 'description': 'ostial lesion will be evaluated by IVUS and FFR', 'interventionNames': ['Device: Fractional flow reserve', 'Device: IVUS']}], 'interventions': [{'name': 'Fractional flow reserve', 'type': 'DEVICE', 'otherNames': ['Radi Pressure Wire(Radi Medical Systems, Uppsala, Sweden)'], 'description': 'Fractional flow reserve measured by pressure wire', 'armGroupLabels': ['ostial lesion']}, {'name': 'IVUS', 'type': 'DEVICE', 'otherNames': ['iLab® Ultrasound Imaging System(Boston Scientific/SCIMED, Minneapolis, MN, USA)'], 'description': 'intravascular ultrasound\n\n:IVUS was performed in a standard fashion using an automated motorized pullback system (0.5mm/s) with commercially available imaging catheter', 'armGroupLabels': ['ostial lesion']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bon-kwon Koo, MD/PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bon-Kwon Koo / Professor', 'oldOrganization': 'Seoul National University hospital'}}}}