Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT01414361
Status:
UNKNOWN
Last Update Posted:
2011-08-11
First Post:
2011-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-10', 'studyFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lumen area', 'timeFrame': 'day 1', 'description': 'lumen area cut-off that can predict functional significance of a lesion'}], 'secondaryOutcomes': [{'measure': 'angiographic stenosis, % plaque area', 'timeFrame': 'day 1', 'description': 'angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary artery stenosis', 'Fractional flow reserve', 'Intravascular ultrasonography'], 'conditions': ['Coronary Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'Recent studies have shown that optimal IVUS criteria defining the functional significance (FFR \\< 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate these results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.', 'detailedDescription': 'Both physiologic information from fractional flow reserve (FFR) and anatomical information from intravascular ultrasound (IVUS) in assessing intermediate coronary stenotic lesions are useful. Functional significance of a coronary stenosis is determined by both the severity of a stenosis and the amount of myocardium supplied. Therefore, when the functional significance of a lesion is assessed by lumen area measured by IVUS, different criteria should be applied according to lesion location and anatomical variations of the coronary artery. However, previous studies included only patients with proximal lesions or small vessel disease, and the sample sizes were too small to assess these differences. In a recent study, the investigators have shown that optimal IVUS criteria defining the functional significance (FFR \\< 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate the our results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with intermediate coronary stenosis who underwent both FFR and IVUS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intermediate coronary stenosis by visual estimation\n\nExclusion Criteria:\n\n* history of coronary artery bypass graft surgery\n* previously revascularized lesion\n* creatinine \\> 1.6 mg/dL or eGFR \\< 30 ml/min/1.73m2 pre-procedure per institutional standards\n* known pregnancy\n* contrast agent allergy that cannot be adequately premedicated\n* severe PVD precluding cardiac catheterization\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': 'NCT01414361', 'briefTitle': 'Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Fractional Flow Reserve (FFR) and Minimal Luminal Area (MLA) by Intravascular Ultrasound (IVUS) in Evaluating Intermediate Coronary Artery Stenosis: International Multi-center Study', 'orgStudyIdInfo': {'id': 'H-1106-077-366'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intermediate lesion', 'description': 'intermediate lesions evaluated by both IVUS and FFR'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', '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'}, {'name': 'Bon-Kwon Koo, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', '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': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Inje University', 'class': 'OTHER'}, {'name': 'Keimyung University', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, {'name': 'University of Florida', 'class': 'OTHER'}, {'name': 'National University of Singapore', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Division of cardiology / Cardiovascular center', 'oldOrganization': 'Seoul National University Hospital'}}}}