Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-05 @ 6:04 PM
Study NCT ID:
NCT03068494
Status:
COMPLETED
Last Update Posted:
2019-05-08
First Post:
2017-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korean Coronary Bifurcation Stenting (COBIS) Registry III
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2648}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-06', 'studyFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2017-02-27', 'lastUpdatePostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion failure', 'timeFrame': '5 years', 'description': 'composite of cardiac death, myocardial infarction, or target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': '5 years', 'description': 'All deaths were considered cardiac cause unless obvious non-cardiac causes could be identified'}, {'measure': 'Myocardial infarction', 'timeFrame': '5 years', 'description': 'an elevation of creatine kinase-myocardial band or troponin level greater than the upper limit of normal with concomitant ischemic symptoms or electrocardiography findings indicative of ischemia'}, {'measure': 'Target lesion revascularization', 'timeFrame': '3 years', 'description': 'repeat PCI of the lesion within 5 mm of the inserted stent'}, {'measure': 'Stent thrombosis', 'timeFrame': '5 years', 'description': 'the Academic Research Consortium as definite, probable, or possible'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Bifurcation Lesion', '2nd generation drug-eluting stent'], 'conditions': ['Coronary Bifurcation Lesion']}, 'referencesModule': {'references': [{'pmid': '39895551', 'type': 'DERIVED', 'citation': "Choi KH, Nam CW, Bruno F, Cho YK, De Luca L, Kang J, Mattesini A, Song YB, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, Hur SH, D'Ascenzo F, Gwon HC, de Filippo O. Differential Prognosis of True Bifurcation Lesions According to Left Main Versus Non-Left Main Location and Treatment Strategy. J Am Heart Assoc. 2025 Feb 4;14(3):e037657. doi: 10.1161/JAHA.124.037657. Epub 2025 Feb 3."}, {'pmid': '39601395', 'type': 'DERIVED', 'citation': "Ahn HJ, Bruno F, Kang J, Hwang D, Yang HM, Han JK, De Luca L, de Filippo O, Mattesini A, Park KW, Truffa A, Wanha W, Song YB, Gili S, Chun WJ, Helft G, Hur SH, Cortese B, Han SH, Escaned J, Chieffo A, Choi KH, Gallone G, Doh JH, De Ferrari G, Hong SJ, Quadri G, Nam CW, Gwon HC, Kim HS, D'Ascenzo F, Koo BK. Sex Differences in Procedural Characteristics and Clinical Outcomes Among Patients Undergoing Bifurcation PCI. Korean Circ J. 2025 Jan;55(1):5-16. doi: 10.4070/kcj.2024.0172. Epub 2024 Oct 11."}, {'pmid': '38501187', 'type': 'DERIVED', 'citation': 'Lee JH, Youn YJ, Jeon HS, Lee JW, Ahn SG, Yoon J, Gwon HC, Song YB, Choi KH, Kim HS, Chun WJ, Hur SH, Nam CW, Cho YK, Han SH, Rha SW, Chae IH, Jeong JO, Heo JH, Lim DS, Park JS, Hong MK, Doh JH, Cha KS, Kim DI, Lee SY, Chang K, Hwang BH, Choi SY, Jeong MH, Lee HJ. Transradial Versus Transfemoral Access for Bifurcation Percutaneous Coronary Intervention Using Second-Generation Drug-Eluting Stent. J Korean Med Sci. 2024 Mar 18;39(10):e111. doi: 10.3346/jkms.2024.39.e111.'}, {'pmid': '37565964', 'type': 'DERIVED', 'citation': "Choi KH, Bruno F, Cho YK, De Luca L, Song YB, Kang J, Mattesini A, Gwon HC, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Hur SH, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, D'Ascenzo F, Nam CW, de Filippo O. Comparison of Outcomes Between 1- and 2-Stent Techniques for Medina Classification 0.0.1 Coronary Bifurcation Lesions. JACC Cardiovasc Interv. 2023 Sep 11;16(17):2083-2093. doi: 10.1016/j.jcin.2023.06.013. Epub 2023 Aug 9."}, {'pmid': '36620646', 'type': 'DERIVED', 'citation': 'Cha JJ, Hong SJ, Kim JH, Lim S, Joo HJ, Park JH, Yu CW, Kang J, Kim HS, Gwon HC, Chun WJ, Hur SH, Han SH, Rha SW, Chae IH, Jeong JO, Heo JH, Yoon J, Park JS, Hong MK, Doh JH, Cha KS, Kim DI, Lee SY, Chang K, Hwang BH, Choi SY, Jeong MH, Song YB, Choi KH, Nam CW, Koo BK, Lim DS. Bifurcation strategies using second-generation drug-eluting stents on clinical outcomes in diabetic patients. Front Cardiovasc Med. 2022 Dec 21;9:1018802. doi: 10.3389/fcvm.2022.1018802. eCollection 2022.'}, {'pmid': '36338374', 'type': 'DERIVED', 'citation': 'Lee CH, Nam CW, Cho YK, Yoon HJ, Kim KB, Gwon HC, Kim HS, Chun WJ, Han SH, Rha SW, Chae IH, Jeong JO, Heo JH, Yoon J, Lim DS, Park JS, Hong MK, Lee SY, Cha KS, Kim DI, Bae JW, Chang K, Hwang BH, Choi SY, Jeong MH, Choi KH, Song YB, Hong SJ, Doh JH, Koo BK, Hur SH. 5-Year Outcome of Simple Crossover Stenting in Coronary Bifurcation Lesions Compared With Side Branch Opening. JACC Asia. 2021 Jun 15;1(1):53-64. doi: 10.1016/j.jacasi.2021.04.002. eCollection 2021 Jun.'}, {'pmid': '36338362', 'type': 'DERIVED', 'citation': 'Choi KH, Song YB, Lee JM, Park TK, Yang JH, Hahn JY, Choi JH, Choi SH, Kim HS, Chun WJ, Hur SH, Han SH, Rha SW, Chae IH, Jeong JO, Heo JH, Yoon J, Lim DS, Park JS, Hong MK, Doh JH, Cha KS, Kim DI, Lee SY, Chang K, Hwang BH, Choi SY, Jeong MH, Hong SJ, Nam CW, Koo BK, Gwon HC. Differential Long-Term Effects of First- and Second-Generation DES in Patients With Bifurcation Lesions Undergoing PCI. JACC Asia. 2021 Jun 15;1(1):68-79. doi: 10.1016/j.jacasi.2021.04.006. eCollection 2021 Jun.'}, {'pmid': '34514841', 'type': 'DERIVED', 'citation': 'Lee JM, Lee SH, Kim J, Choi KH, Park TK, Yang JH, Song YB, Hahn JY, Choi JH, Choi SH, Kim HS, Chun WJ, Nam CW, Hur SH, Han SH, Rha SW, Chae IH, Jeong JO, Heo JH, Yoon J, Lim DS, Park JS, Hong MK, Doh JH, Cha KS, Kim DI, Lee SY, Chang K, Hwang BH, Choi SY, Jeong MH, Hong SJ, Koo BK, Gwon HC. Ten-Year Trends in Coronary Bifurcation Percutaneous Coronary Intervention: Prognostic Effects of Patient and Lesion Characteristics, Devices, and Techniques. J Am Heart Assoc. 2021 Sep 21;10(18):e021632. doi: 10.1161/JAHA.121.021632. Epub 2021 Sep 13.'}, {'pmid': '32069106', 'type': 'DERIVED', 'citation': 'Choi KH, Song YB, Lee JM, Park TK, Yang JH, Hahn JY, Choi JH, Choi SH, Kim HS, Chun WJ, Hur SH, Han SH, Rha SW, Chae IH, Jeong JO, Heo JH, Yoon J, Lim DS, Park JS, Hong MK, Doh JH, Cha KS, Kim DI, Lee SY, Chang K, Hwang BH, Choi SY, Jeong MH, Hong SJ, Nam CW, Koo BK, Gwon HC. Prognostic Effects of Treatment Strategies for Left Main Versus Non-Left Main Bifurcation Percutaneous Coronary Intervention With Current-Generation Drug-Eluting Stent. Circ Cardiovasc Interv. 2020 Feb;13(2):e008543. doi: 10.1161/CIRCINTERVENTIONS.119.008543. Epub 2020 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The COBIS III registry is a multi-center, real-world registry of 2nd generation drug-eluting stenting in coronary bifurcation lesions in South Korea. From 21 major coronary intervention centers in Korea, a total of 3,000 patients (anticipated) will be enrolled in this database between January 2010 and December 2014.\n\nThe aim of the study was to investigate long-term clinical results and predictors of adverse outcomes after percutaneous coronary intervention with 2nd generation drug-eluting stents for coronary bifurcation lesions in South Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary bifurcation lesion treated with 2nd generation drug-eluting stents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=19 years\n* Any type of de novo bifurcation lesion in major epicardial artery: unprotected left main coronary bifurcation lesion, LAD - diagonal, LCX-OM, distal RCA bifurcation. (Excluding RCA-RV branch bifurcation, branch bifurcation)\n* Side branch or LCX reference diameter \\>= 2.3 mm and at least stentable with 2.5 mm stent\n* Treated with drug-eluting stent during the period of 2010. 1 \\~ 2014. 12\n\nExclusion Criteria:\n\n* Protected left main disease previous CABG for LAD or LCX territory\n* Cardiogenic Shock\n* History of CPR in the same hospitalization\n* Patients with severe left ventricular systolic dysfunction (ejection fraction \\< 30%)'}, 'identificationModule': {'nctId': 'NCT03068494', 'acronym': 'COBIS III', 'briefTitle': 'Korean Coronary Bifurcation Stenting (COBIS) Registry III', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Multicenter, Retrospective Korean Coronary Bifurcation Stenting (COBIS) Registry III', 'orgStudyIdInfo': {'id': '2016-12-136'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Bifurcation Lesion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyeon-Cheol Gwon, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyeon-Cheol Gwon', 'investigatorAffiliation': 'Samsung Medical Center'}}}}