Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-28 @ 7:38 AM
Study NCT ID:
NCT01035450
Status:
COMPLETED
Last Update Posted:
2015-12-10
First Post:
2009-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-09', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2009-12-17', 'lastUpdatePostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'target-lesion revascularization', 'timeFrame': '1-year'}, {'measure': 'all-cause death or myocardial infarction', 'timeFrame': '3-year'}], 'secondaryOutcomes': [{'measure': 'all-cause death', 'timeFrame': '3-year'}, {'measure': 'cardiac death', 'timeFrame': '3-year'}, {'measure': 'myocardial infarction', 'timeFrame': '3-year'}, {'measure': 'stent thrombosis (Academic Research Consortium definition)', 'timeFrame': '3-year'}, {'measure': 'ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes', 'timeFrame': '3-year'}, {'measure': 'bleeding complications (GUSTO and TIMI definition)', 'timeFrame': '3-year'}, {'measure': 'stent deployment success', 'timeFrame': 'at implantation'}, {'measure': 'procedure time', 'timeFrame': 'at implantation'}, {'measure': 'clinically-driven target-lesion revascularization', 'timeFrame': '3-year'}, {'measure': 'non-target-lesion revascularization', 'timeFrame': '3-year'}, {'measure': 'coronary artery bypass grafting', 'timeFrame': '3-year'}, {'measure': 'target-vessel revascularization', 'timeFrame': '3-year'}, {'measure': 'any repeat coronary revascularization', 'timeFrame': '3-year'}, {'measure': 'composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization', 'timeFrame': '3-year'}, {'measure': 'composite of all-cause death, any myocardial infarction or any repeat coronary revascularization', 'timeFrame': '3-year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary stent'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '30947938', 'type': 'DERIVED', 'citation': 'Shiomi H, Kozuma K, Morimoto T, Kadota K, Tanabe K, Morino Y, Akasaka T, Abe M, Takeji Y, Suwa S, Ito Y, Kobayashi M, Dai K, Nakao K, Tarutani Y, Taniguchi R, Nishikawa H, Yamamoto Y, Nakagawa Y, Ando K, Kobayashi K, Kawai K, Hibi K, Kimura T; RESET Investigators. 7-Year Outcomes of a Randomized Trial Comparing the First-Generation Sirolimus-Eluting Stent Versus the New-Generation Everolimus-Eluting Stent: The RESET Trial. JACC Cardiovasc Interv. 2019 Apr 8;12(7):637-647. doi: 10.1016/j.jcin.2019.01.234.'}, {'pmid': '29628128', 'type': 'DERIVED', 'citation': 'Ito S, Watanabe H, Morimoto T, Yoshikawa Y, Shiomi H, Shizuta S, Ono K, Yamaji K, Soga Y, Hyodo M, Shirai S, Ando K, Horiuchi H, Kimura T. Impact of Baseline Thrombocytopenia on Bleeding and Mortality After Percutaneous Coronary Intervention. Am J Cardiol. 2018 Jun 1;121(11):1304-1314. doi: 10.1016/j.amjcard.2018.02.010. Epub 2018 Mar 1.'}, {'pmid': '29508236', 'type': 'DERIVED', 'citation': 'Watanabe H, Morimoto T, Shiomi H, Yoshikawa Y, Kato T, Saito N, Shizuta S, Ono K, Yamaji K, Ando K, Kaji S, Furukawa Y, Akao M, Ishikawa T, Tamura T, Yamamoto Y, Muramatsu T, Suwa S, Nakagawa Y, Kadota K, Takatsu Y, Nishikawa H, Hiasa Y, Hayashi Y, Miyazaki S, Kimura T. Mortality impact of post-discharge myocardial infarction size after percutaneous coronary intervention: a patient-level pooled analysis from the 4 large-scale Japanese studies. Cardiovasc Interv Ther. 2019 Jan;34(1):47-58. doi: 10.1007/s12928-018-0517-x. Epub 2018 Mar 5.'}, {'pmid': '24803436', 'type': 'DERIVED', 'citation': 'Shiomi H, Kozuma K, Morimoto T, Igarashi K, Kadota K, Tanabe K, Morino Y, Akasaka T, Abe M, Suwa S, Muramatsu T, Kobayashi M, Dai K, Nakao K, Uematsu M, Tarutani Y, Fujii K, Simonton CA, Kimura T; RESET Investigators. Long-term clinical outcomes after everolimus- and sirolimus-eluting coronary stent implantation: final 3-year follow-up of the Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial. Circ Cardiovasc Interv. 2014 Jun;7(3):343-54. doi: 10.1161/CIRCINTERVENTIONS.113.001322. Epub 2014 May 6.'}, {'pmid': '23608784', 'type': 'DERIVED', 'citation': 'Kozuma K, Kimura T, Kadota K, Suwa S, Kimura K, Iwabuchi M, Kawai K, Miyazawa A, Kawamura M, Nakao K, Asano R, Yamamoto T, Suzuki N, Aoki J, Kyono H, Nakazawa G, Tanabe K, Morino Y, Igarashi K. Angiographic findings of everolimus-eluting as compared to sirolimus-eluting stents: angiographic sub-study from the Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET). Cardiovasc Interv Ther. 2013 Oct;28(4):344-51. doi: 10.1007/s12928-013-0179-7. Epub 2013 Apr 23.'}, {'pmid': '22824435', 'type': 'DERIVED', 'citation': 'Kimura T, Morimoto T, Natsuaki M, Shiomi H, Igarashi K, Kadota K, Tanabe K, Morino Y, Akasaka T, Takatsu Y, Nishikawa H, Yamamoto Y, Nakagawa Y, Hayashi Y, Iwabuchi M, Umeda H, Kawai K, Okada H, Kimura K, Simonton CA, Kozuma K; RESET Investigators. Comparison of everolimus-eluting and sirolimus-eluting coronary stents: 1-year outcomes from the Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting stent Trial (RESET). Circulation. 2012 Sep 4;126(10):1225-36. doi: 10.1161/CIRCULATIONAHA.112.104059. Epub 2012 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice.', 'detailedDescription': 'Sirolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Everolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in the first quarter of 2010 by the Japanese Ministry of Health, Labor and Welfare. It has recently been reported that everolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 1 year as compared with paclitaxel-eluting stent. However, trial results comparing everolimus-eluting stent with sirolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for percutaneous coronary intervention using drug-eluting stents\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01035450', 'acronym': 'RESET', 'briefTitle': 'Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kyoto University, Graduate School of Medicine'}, 'officialTitle': 'Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial', 'orgStudyIdInfo': {'id': 'C338'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus-eluting stent', 'interventionNames': ['Device: Everolimus-eluting stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sirolimus-eluting stent', 'interventionNames': ['Device: Sirolimus-eluting stent']}], 'interventions': [{'name': 'Everolimus-eluting stent', 'type': 'DEVICE', 'description': 'Everolimus-eluting stent', 'armGroupLabels': ['Everolimus-eluting stent']}, {'name': 'Sirolimus-eluting stent', 'type': 'DEVICE', 'description': 'Sirolimus-eluting stent', 'armGroupLabels': ['Sirolimus-eluting stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '606-8507', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Division of Cardiology, Kyoto University Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'overallOfficials': [{'name': 'Takeshi Kimura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeshi Morimoto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Takeshi Morimoto', 'investigatorAffiliation': 'Kyoto University, Graduate School of Medicine'}}}}