Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-02-03 @ 3:43 PM
Study NCT ID:
NCT02330861
Status:
WITHDRAWN
Last Update Posted:
2018-08-02
First Post:
2014-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Pressure and Flow Velocity on Coronary Physiology
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2014-12-24', 'studyFirstSubmitQcDate': '2015-01-02', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wave intensity', 'timeFrame': 'Immediately after coronary angiography or percutaneous coronary intervention'}], 'secondaryOutcomes': [{'measure': 'Coronary pressure', 'timeFrame': 'Immediately after coronary angiography or percutaneous coronary intervention'}, {'measure': 'Flow velocity', 'timeFrame': 'Immediately after coronary angiography or percutaneous coronary intervention'}, {'measure': 'Vessel diameter', 'timeFrame': 'Immediately after coronary angiography or percutaneous coronary intervention'}]}, 'conditionsModule': {'keywords': ['Coronary Circulation'], 'conditions': ['Coronary Stenosis']}, 'descriptionModule': {'briefSummary': 'Subjects are patients who are planned to do percutaneous coronary intervention for coronary stenosis in the left circumflex artery without other stenosis in the left ascending artery and the right coronary artery, or a patient with normal coronary artery. Immediately after coronary angiography or percutaneous coronary intervention, the investigators will evaluate for coronary hemodynamics by distribution of wave intensity which is calcurated by coronary pressure and flow velocity with Combowire in each coronary segment. Also, they will assess coronary morphology by View It in each coronary segment.', 'detailedDescription': 'Combowire (Volcano Therapeutics Inc., CA, USA) is a 0.014 inch pressure/Doppler sensor-tipped-guidewire which can measure coronary pressure and flow velocity.\n\nView It (Terumo Co., Japan) is a guide catheter with intravascular ultrasound which can measure coronary morphology such as vessel diamter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A patient who are planned to do percutaneous coronary intervention for stenosis in the left circumflex artery without any lesions in other coronary arteries\n* Or a patient who is performed coronary angiography without significant stenosis lesion in 3-coronary vessel\n\nExclusion Criteria:\n\n* A patient with coronary stenosis with LAD\n* Hemodialysis\n* Acute coronary syndrome\n* Congestive heart failure\n* A patient with shock vitals'}, 'identificationModule': {'nctId': 'NCT02330861', 'briefTitle': 'Relationship Between Pressure and Flow Velocity on Coronary Physiology', 'organization': {'class': 'OTHER', 'fullName': 'Hyogo Medical University'}, 'officialTitle': 'Relationship Between Pressure and Flow Velocity on Coronary Physiology', 'orgStudyIdInfo': {'id': 'KFujii-000000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Normal coronary artery', 'interventionNames': ['Device: combowire and IVUS']}], 'interventions': [{'name': 'combowire and IVUS', 'type': 'DEVICE', 'armGroupLabels': ['Normal coronary artery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6638501', 'city': 'Nishinomiya', 'country': 'Japan', 'facility': 'Hyogo College of Medicine', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyogo Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Relationship between pressure and flow velocity on coronary physiology', 'investigatorFullName': 'Kenichi Fujii', 'investigatorAffiliation': 'Hyogo Medical University'}}}}