Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT01186133
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2010-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'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': 50000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2010-08-19', 'studyFirstSubmitQcDate': '2010-08-20', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)', 'timeFrame': 'at 12 months post procedure'}], 'secondaryOutcomes': [{'measure': 'Death (all-cause and cardiac)', 'timeFrame': 'at 12 months and annually up to 5 years'}, {'measure': 'Myocardial infarction', 'timeFrame': 'at 12 months and annually up to 5 years'}, {'measure': 'Stent thrombosis', 'timeFrame': 'at 12 months and annually up to 5 years'}, {'measure': 'Target-lesion and target-vessel revascularization', 'timeFrame': 'at 12 months and annually up to 5 years'}, {'measure': 'Stroke', 'timeFrame': 'at 12 months and annually up to 5 years'}, {'measure': 'Procedural success', 'timeFrame': 'at 1 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary disease', 'drug eluting stent'], 'conditions': ['Coronary Artery Disease', 'Percutaneous Transluminal Coronary Angioplasty']}, 'referencesModule': {'references': [{'pmid': '38199751', 'type': 'DERIVED', 'citation': 'Kim TO, Kang DY, Ahn JM, Kim MJ, Lee PH, Kim H, Choi Y, Lee J, Lee JM, Jo HH, Park YS, Lim SM, Park SJ, Park DW. Impact of Target Lesion Revascularization on Long-Term Mortality After Percutaneous Coronary Intervention for Left Main Disease. JACC Cardiovasc Interv. 2024 Jan 8;17(1):32-42. doi: 10.1016/j.jcin.2023.10.068.'}, {'pmid': '36339122', 'type': 'DERIVED', 'citation': 'Jeong YJ, Hyun J, Lee J, Kim JH, Yang Y, Choe K, Lee JS, Park H, Cho SC, Kang DY, Lee PH, Ahn JM, Park DW, Park SJ; IRIS-DES Registry Investigators. Comparison of Contemporary Drug-Eluting Stents in Patients Undergoing Complex High-Risk Indicated Procedures. JACC Asia. 2022 Mar 1;2(2):182-193. doi: 10.1016/j.jacasi.2021.10.008. eCollection 2022 Apr.'}, {'pmid': '36338165', 'type': 'DERIVED', 'citation': 'Yang Y, Hyun J, Lee J, Kim JH, Lee JB, Kang DY, Lee PH, Ahn JM, Park DW, Park SJ; IRIS-DES Registry Investigators. Effectiveness and Safety of Contemporary Drug-Eluting Stents in Patients With Diabetes Mellitus. JACC Asia. 2021 Sep 21;1(2):173-184. doi: 10.1016/j.jacasi.2021.07.009. eCollection 2021 Sep.'}, {'pmid': '32891400', 'type': 'DERIVED', 'citation': 'Park S, Ahn JM, Kim TO, Park H, Cho SC, Kang DY, Lee PH, Park DW, Park SJ; IRIS-DES Registry Investigators. Incidence and Impact of Thrombocytopenia in Patients Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents. Am J Cardiol. 2020 Nov 1;134:55-61. doi: 10.1016/j.amjcard.2020.07.059. Epub 2020 Aug 16.'}, {'pmid': '32473888', 'type': 'DERIVED', 'citation': 'Park H, Ahn JM, Kang DY, Lee JB, Park S, Ko E, Cho SC, Lee PH, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park SJ. Optimal Stenting Technique for Complex Coronary Lesions: Intracoronary Imaging-Guided Pre-Dilation, Stent Sizing, and Post-Dilation. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1403-1413. doi: 10.1016/j.jcin.2020.03.023. Epub 2020 May 27.'}, {'pmid': '32310851', 'type': 'DERIVED', 'citation': 'Lee CH, Ahn JM, Lee KS, Kang DY, Lee PH, Lee SW, Lee CW, Park SW, Park DW, Park SJ; IRIS-DES Registry Investigators. Prevalence, predictors, prognostic significance, and effect of techniques on outcomes of coronary lesion calcification following implantation of drug-eluting stents: a patient-level pooled analysis of stent-specific, multicenter, prospective IRIS-DES registries. Coron Artery Dis. 2021 Jan;32(1):42-50. doi: 10.1097/MCA.0000000000000896.'}, {'pmid': '30745256', 'type': 'DERIVED', 'citation': 'Lee CH, Kang DY, Han M, Hur SH, Rha SW, Her SH, Seung KB, Kim KS, Lee PH, Ahn JM, Lee SW, Park SW, Park DW, Park SJ; IRIS-DES Registry Investigators. Differential cutoff points and clinical impact of stent parameters of various drug-eluting stents for predicting major adverse clinical events: An individual patient data pooled analysis of seven stent-specific registries and 17,068 patients. Int J Cardiol. 2019 May 1;282:17-23. doi: 10.1016/j.ijcard.2019.01.108. Epub 2019 Feb 2.'}, {'pmid': '29471933', 'type': 'DERIVED', 'citation': 'Lee PH, Kwon O, Ahn JM, Lee CH, Kang DY, Lee JB, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park DW, Park SJ. Safety and Effectiveness of Second-Generation Drug-Eluting Stents in Patients With Left Main Coronary Artery Disease. J Am Coll Cardiol. 2018 Feb 27;71(8):832-841. doi: 10.1016/j.jacc.2017.12.032.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate effectiveness and safety of the new drug-eluting stent (DES), as compared with the first-,second-,third-, and fourth-generation DES, in the "real world" daily practice.', 'detailedDescription': 'Consecutive patients receiving New DES without a mixture of other DES'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive patients amenable to PCI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* coronary disease amenable to percutaneous coronary intervention (PCI)\n* no clinical and lesion limitations\n\nExclusion Criteria:\n\n* patients with a mixture of several DES\n* terminal illness with life expectancy less than 1 year\n* patients with cardiogenic shock'}, 'identificationModule': {'nctId': 'NCT01186133', 'acronym': 'IRIS-DES', 'briefTitle': 'Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice', 'orgStudyIdInfo': {'id': '2010-035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DESSIAN', 'description': 'consecutive patients receiving CYPHER stent'}, {'label': 'K-XIENCE', 'description': 'consecutive patients receiving Xience stent'}, {'label': 'GENOUS', 'description': 'consecutive patients receiving GENOUS stent'}, {'label': 'ELEMENT', 'description': 'consecutive patients receiving PROMUS-ELEMENT stent'}, {'label': 'PRIME', 'description': 'consecutive patients receiving XIENCE-PRIME stent'}, {'label': 'NOBORI', 'description': 'consecutive patients receiving NOBORI stent'}, {'label': 'INTEGRITY', 'description': 'consecutive patients receiving RESOLUTE-INTEGRITY stent'}, {'label': 'XPEDITION', 'description': 'consecutive patients receiving XIENCE-XPEDITION stent'}, {'label': 'BIOMATRIX', 'description': 'consecutive patients receiving BIOMATRIX stent'}, {'label': 'CILOTAX', 'description': 'consecutive patients receiving CILOTAX stent'}, {'label': 'DEB', 'description': 'consecutive patients receiving Drug eluting balloon'}, {'label': 'DESYNE', 'description': 'consecutive patients receiving DESYNE stent'}, {'label': 'PREMIER', 'description': 'consecutive patients receiving PROMUS-PREMIER stent'}, {'label': 'ORSIRO', 'description': 'consecutive patients receiving ORSIRO stent'}, {'label': 'ONYX', 'description': 'consecutive patients receiving ONYX stent'}, {'label': 'BVS', 'description': 'consecutive patients receiving Bioresorbable Vascular Scaffold'}, {'label': 'BVS AMI', 'description': 'consecutive acute myocardial infarction patients receiving Bioresorbable Vascular Scaffold'}, {'label': 'Ultimaster', 'description': 'consecutive patients receiving Ultimaster stent'}, {'label': 'Synergy', 'description': 'consecutive patients receiving Synergy stent'}, {'label': 'Biofreedom', 'description': 'consecutive patients receiving Biofreedom stent'}, {'label': 'Firehawk', 'description': 'consecutive patients receiving Firehawk stent'}, {'label': 'DESyne X2', 'description': 'consecutive patients receiving DESyne X2 stent'}, {'label': 'Sierra', 'description': 'consecutive patients receiving Sierra stent'}, {'label': 'Tansei', 'description': 'consecutive patients receiving Tansei stent'}, {'label': 'Synergy XD and Synergy Megatron™', 'description': 'consecutive patients receiving Synergy XD or Synergy Megatron™ stent'}, {'label': 'Xience-Skypoint', 'description': 'consecutive patients receiving Xience-Skypoint stent'}, {'label': 'Coroflex ISAR NEO', 'description': 'consecutive patients receiving Coroflex ISAR NEO stent'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Korean centres'}], 'centralContacts': [{'name': 'Seung-Jung Park, MD', 'role': 'CONTACT', 'email': 'sjpark@amc.seoul.kr'}, {'name': 'Duk-Woo Park, MD', 'role': 'CONTACT', 'email': 'dwpark@amc.seoul.kr'}], 'overallOfficials': [{'name': 'Seung-Jung Park, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'CardioVascular Research Foundation, Korea'}}}}