Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-01-04 @ 3:58 AM
Study NCT ID:
NCT02797561
Status:
RECRUITING
Last Update Posted:
2023-07-14
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-06-10', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target vessel failure', 'timeFrame': '2 years', 'description': 'defined as composite event of cardiac death, non-fatal myocardial infarction, target vessel revascularization'}], 'secondaryOutcomes': [{'measure': 'all cause death', 'timeFrame': '5 years'}, {'measure': 'cardiac death', 'timeFrame': '5 years'}, {'measure': 'myocardial infarction', 'timeFrame': '5 years'}, {'measure': 'target vessel revascularization', 'timeFrame': '5 years'}, {'measure': 'target lesion revascularization', 'timeFrame': '5 years'}, {'measure': 'Cardiac rehospitalization', 'timeFrame': '5 years'}, {'measure': 'Cardiac death and myocardial infarction', 'timeFrame': '5 years'}, {'measure': 'death, myocardial lnfarction, revascularization', 'timeFrame': '5 years', 'description': 'related with stented lesion'}, {'measure': 'stroke', 'timeFrame': '5 years'}, {'measure': 'stent thrombosis', 'timeFrame': '5 years'}, {'measure': 'angina', 'timeFrame': '5 years'}, {'measure': 'number of antianginal medications', 'timeFrame': '5 years'}, {'measure': 'complications with FFR', 'timeFrame': '5 years'}, {'measure': 'clinical predictors of events', 'timeFrame': '5 years'}, {'measure': 'functional index', 'timeFrame': '5 years', 'description': 'IMR(index of microcirculatory resistance), CFR(CFRthermo)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fractional flow reserve', 'Tandem', 'Percutaneous Coronary Intervention'], 'conditions': ['Percutaneous Transluminal Coronary Angioplasty']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of FFR (Fractional flow reserve) guided Percutaneous Coronary Intervention in coronary tandem lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with tandem lesion evaluated by FFR', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tandem lesion evaluated by FFR\n* Written consent\n\nExclusion Criteria:\n\n* TIMI flow \\< 3\n* Grafted vessel\n* Left ventricular ejection fraction \\< 30%\n* Severe calcification and/or severe tortuosity\n* Uncontrolled coronary spasm\n* Life expectancy \\< 2 years\n* Planned high risk surgery\n* Pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT02797561', 'acronym': 'IRISFFRTandem', 'briefTitle': 'Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'A Multicenter, Prospective Cohort to Evaluate the Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions', 'orgStudyIdInfo': {'id': 'AMCCV2016-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tandem lesion evaluated by FFR', 'interventionNames': ['Other: 5 year Follow-up']}], 'interventions': [{'name': '5 year Follow-up', 'type': 'OTHER', 'armGroupLabels': ['Tandem lesion evaluated by FFR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'state': 'Songpa-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Jung Park, MD', 'role': 'CONTACT'}, {'name': 'Seung-Jung Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Bucheon-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Nae-Hee Lee, MD', 'role': 'CONTACT'}, {'name': 'Nae-Hee Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Chuncheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bong-Ki Lee, MD', 'role': 'CONTACT'}, {'name': 'Bong-Ki Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangwon National Univ. Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin-bae Lee, MD', 'role': 'CONTACT'}, {'name': 'Jin-bae Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chang-Wook Nam, MD', 'role': 'CONTACT'}, {'name': 'Chang-Wook Nam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Si-Wan Choi, MD', 'role': 'CONTACT'}, {'name': 'Si-wan Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gangneung', 'status': 'WITHDRAWN', 'country': 'South Korea', 'facility': 'Gangneung Asan Hospital', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Ilsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joon-hyung Do, MD', 'role': 'CONTACT'}, {'name': 'Joon-hyung Do, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inje University Ilsan Paik Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Seongnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Won-jang Kim, MD', 'role': 'CONTACT'}, {'name': 'Won-jang Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bundang CHA Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seongnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'In-Ho Chae, MD', 'role': 'CONTACT'}, {'name': 'In-Ho Chae, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'status': 'WITHDRAWN', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bon-kwon Koo, MD', 'role': 'CONTACT'}, {'name': 'Bon-kwon Koo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Wŏnju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung-han Yoon, MD', 'role': 'CONTACT'}, {'name': 'Jung-han Yoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Yangsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jun-hong Kim, MD', 'role': 'CONTACT'}, {'name': 'Jun-hong Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'centralContacts': [{'name': 'Seung-jung Park, MD', 'role': 'CONTACT', 'email': 'sjpark@amc.seoul.kr'}, {'name': 'Jung-hee Ham, Project leader', 'role': 'CONTACT', 'email': 'cvcrc5@amc.seoul.kr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor of medicine', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}