Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-30 @ 6:35 AM
Study NCT ID:
NCT01366404
Status:
RECRUITING
Last Update Posted:
2024-11-14
First Post:
2011-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Natural History of FFR Guided Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2037-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2011-06-02', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2037-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target vessel failure', 'timeFrame': '2 year after index FFR measurement'}, {'measure': 'composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events', 'timeFrame': 'at 2 year after index FFR measurement'}], 'secondaryOutcomes': [{'measure': 'Death (all cause and cardiac)', 'timeFrame': 'at 2 year after index FFR measurement'}, {'measure': 'MI', 'timeFrame': 'at 2 year after index FFR measurement'}, {'measure': 'Target vessel revascularization', 'timeFrame': 'at 2 year after index FFR measurement'}, {'measure': 'Target lesion revascularization', 'timeFrame': 'at 2 year after index FFR measurement'}, {'measure': 'Any re-hospitalization with a cardiac cause', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'cardiac death and myocardial infarction', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'stented lesion related event including death, myocardial infarction, repeat revascularization', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'stroke', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'stent thrombosis', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'anginal status', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'number of anti-anginal medication prescribed', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'complication of FFR measurement', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'clinical predictors of events', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'change in plaque composition (%necrotic core volume) in target segment', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography)', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'change in total atheroma volume and percent atheroma volume', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'change in IVUS-measured MLA', 'timeFrame': '2 year follow-up after index FFR measurement'}, {'measure': 'change in FFR', 'timeFrame': '2 year follow-up after index FFR measurement'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FFR'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '32345039', 'type': 'DERIVED', 'citation': 'Ahn JM, Park DW, Kim SO, Kang DY, Lee CH, Lee PH, Lee SW, Park SW, Park SJ. Prognostic Value of Resting Distal-to-Aortic Coronary Pressure in Clinical Practice. Circ Cardiovasc Interv. 2020 May;13(5):e007868. doi: 10.1161/CIRCINTERVENTIONS.118.007868. Epub 2020 Apr 29.'}, {'pmid': '29895713', 'type': 'DERIVED', 'citation': 'Kang DY, Ahn JM, Kim YW, Moon JY, Lee JS, Koo BK, Lee PH, Park DW, Kang SJ, Lee SW, Kim YH, Park SW, Park SJ. Impact of Coronary Lesion Geometry on Fractional Flow Reserve: Data From Interventional Cardiology Research In-Cooperation Society-Fractional Flow Reserve and Intravascular Ultrasound Registry. Circ Cardiovasc Imaging. 2018 Jun;11(6):e007087. doi: 10.1161/CIRCIMAGING.117.007087.'}, {'pmid': '29529177', 'type': 'DERIVED', 'citation': 'Kang DY, Ahn JM, Lee CH, Lee PH, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park SJ. Deferred vs. performed revascularization for coronary stenosis with grey-zone fractional flow reserve values: data from the IRIS-FFR registry. Eur Heart J. 2018 May 7;39(18):1610-1619. doi: 10.1093/eurheartj/ehy079.'}, {'pmid': '28851731', 'type': 'DERIVED', 'citation': 'Lee JM, Hwang D, Park J, Zhang J, Tong Y, Kim CH, Bang JI, Suh M, Paeng JC, Cheon GJ, Koo BK. Exploring Coronary Circulatory Response to Stenosis and Its Association With Invasive Physiologic Indexes Using Absolute Myocardial Blood Flow and Coronary Pressure. Circulation. 2017 Nov 7;136(19):1798-1808. doi: 10.1161/CIRCULATIONAHA.117.029911. Epub 2017 Aug 29.'}, {'pmid': '28356440', 'type': 'DERIVED', 'citation': 'Ahn JM, Park DW, Shin ES, Koo BK, Nam CW, Doh JH, Kim JH, Chae IH, Yoon JH, Her SH, Seung KB, Chung WY, Yoo SY, Lee JB, Choi SW, Park K, Hong TJ, Lee SY, Han M, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park SJ; IRIS-FFR Investigatorsdagger. Fractional Flow Reserve and Cardiac Events in Coronary Artery Disease: Data From a Prospective IRIS-FFR Registry (Interventional Cardiology Research Incooperation Society Fractional Flow Reserve). Circulation. 2017 Jun 6;135(23):2241-2251. doi: 10.1161/CIRCULATIONAHA.116.024433. Epub 2017 Mar 29.'}, {'pmid': '27609817', 'type': 'DERIVED', 'citation': 'Lee JM, Kim CH, Koo BK, Hwang D, Park J, Zhang J, Tong Y, Jeon KH, Bang JI, Suh M, Paeng JC, Cheon GJ, Na SH, Ahn JM, Park SJ, Kim HS. Integrated Myocardial Perfusion Imaging Diagnostics Improve Detection of Functionally Significant Coronary Artery Stenosis by 13N-ammonia Positron Emission Tomography. Circ Cardiovasc Imaging. 2016 Sep;9(9):e004768. doi: 10.1161/CIRCIMAGING.116.004768.'}, {'pmid': '23787231', 'type': 'DERIVED', 'citation': 'Kang SJ, Ahn JM, Han S, Lee JY, Kim WJ, Park DW, Lee SW, Kim YH, Lee CW, Park SW, Mintz GS, Park SJ. Sex differences in the visual-functional mismatch between coronary angiography or intravascular ultrasound versus fractional flow reserve. JACC Cardiovasc Interv. 2013 Jun;6(6):562-8. doi: 10.1016/j.jcin.2013.02.016.'}, {'pmid': '23078732', 'type': 'DERIVED', 'citation': 'Park SJ, Kang SJ, Ahn JM, Shim EB, Kim YT, Yun SC, Song H, Lee JY, Kim WJ, Park DW, Lee SW, Kim YH, Lee CW, Mintz GS, Park SW. Visual-functional mismatch between coronary angiography and fractional flow reserve. JACC Cardiovasc Interv. 2012 Oct;5(10):1029-36. doi: 10.1016/j.jcin.2012.07.007.'}]}, 'descriptionModule': {'briefSummary': 'About 20,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up.', 'detailedDescription': 'This is a multicenter, prospective cohort. About 20,000 patients with FFR will be enrolled at multi centres in Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had FFR measurement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 35 years and older\n* FFR measurement on one and more coronary artery stenosis\n* Willing and able to provide informed, written consent\n\nExclusion Criteria:\n\n* Stenosis with TIMI\\<3 flow\n* Graft vessel\n* Ejection fraction \\< 30%\n* Angiographic evidence of extreme tortuosity or calcified coronary vessels\n* Suspected coronary spasm even after sufficient nitrate injected\n* Life expectancy \\<2 year\n* Planned cardiac surgery or planned major non cardiac surgery\n* Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study\n\nImaging study specific exclusion criteria\n\n* visually-estimated angiographic reference segment diameter of \\<2.75mm or \\>4.0mm\n* Inappropriate for IVUS/VH/OCT procedures : inability for imaging wire or catheter to pass through the tight stenosis, severe calcification, angulation'}, 'identificationModule': {'nctId': 'NCT01366404', 'acronym': 'IRIS FFR', 'briefTitle': 'Study of the Natural History of FFR Guided Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'CVRF2010-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FFR', 'description': 'Patients who had FFR measurement'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun-sook Kim, MD', 'role': 'CONTACT'}], 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Bucheon-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Nae-hee Lee, MD', 'role': 'CONTACT'}], 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Cheongju-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-yeub Lee, MD', 'role': 'CONTACT'}], 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'city': 'Chuncheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bong-ki Lee, MD', 'role': 'CONTACT'}, {'name': 'Bong-ki Kim, MD', 'role': 'CONTACT'}], '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'}], 'facility': 'Daegu Catholic University Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chang-wook Nam, MD', 'role': 'CONTACT'}], 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hun-sik Park, MD', 'role': 'CONTACT'}], 'facility': 'Kyungpook National university hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong-seon Park, MD', 'role': 'CONTACT'}], 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Si-wan Choi, MD', 'role': 'CONTACT'}], 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung-ho Her, MD', 'role': 'CONTACT'}], 'facility': "The Catholic University of Korea, Deajeon St.Mary's hospital", 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gangneung', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-sig Jung, MD', 'role': 'CONTACT'}], 'facility': 'Gangneung Asan Hospital', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-jun Hong, MD', 'role': 'CONTACT'}], 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Ilsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joon-hyung Doh, MD', 'role': 'CONTACT'}], 'facility': 'Inje University Ilsan Paik Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyung-il Park, MD', 'role': 'CONTACT'}], 'facility': 'Dong-A Medical Center', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Taeg-jong Hong, MD', 'role': 'CONTACT'}], 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seongnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'In-ho Chae, MD', 'role': 'CONTACT'}], 'facility': 'Seoul university Bundang hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-jung Park, MD', 'role': 'CONTACT', 'email': 'sjpark@amc.seoul.kr'}, {'name': 'Seung-jung Park, MD', 'role': 'CONTACT'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byoung-kwon Lee, MD', 'role': 'CONTACT'}], 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyoo-rok Han, MD', 'role': 'CONTACT'}], 'facility': 'Hallym University Kangdong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Do-sun Lim, MD', 'role': 'CONTACT'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-un Na, MD', 'role': 'CONTACT'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong-jin Kim, MD', 'role': 'CONTACT'}], 'facility': 'Kyung-Hee University Hospital at Kangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woo-young Chung, MD', 'role': 'CONTACT'}], 'facility': 'Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bon-kwon Koo, MD', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ki-bae Seung, MD', 'role': 'CONTACT'}], 'facility': "The Catholic University of Korea, Seoul St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chul-soo Park, MD', 'role': 'CONTACT'}], 'facility': "The Catholic University of Korea, Yeouido St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eun-seok Shin, MD', 'role': 'CONTACT'}], 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Wŏnju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung-han Yoon, MD', 'role': 'CONTACT'}], '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'}], 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'centralContacts': [{'name': 'Seung-Jung Park, MD, PhD', 'role': 'CONTACT', 'email': 'sjpark@amc.seoul.kr'}, {'name': 'Jung-min Ahn, MD', 'role': 'CONTACT', 'email': 'drjmahn@gmail.com'}], 'overallOfficials': [{'name': 'Seung-Jung Park, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}, {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Division of Cardiology', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'CardioVascular Research Foundation, Korea'}}}}