Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT03507205
Status:
COMPLETED
Last Update Posted:
2018-04-24
First Post:
2018-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents
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': 'ACTUAL', 'count': 17286}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-15', 'studyFirstSubmitDate': '2018-04-15', 'studyFirstSubmitQcDate': '2018-04-15', 'lastUpdatePostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion failure', 'timeFrame': '36 months', 'description': 'A composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Patient-oriented composite outcome', 'timeFrame': '36 months', 'description': 'A composite of all-cause death, all-cause myocardial infarction, and any repeat revascularization'}, {'measure': 'All-cause death', 'timeFrame': '36 months', 'description': 'All-cause death'}, {'measure': 'Cardiac death', 'timeFrame': '36 months', 'description': 'Cardiac death'}, {'measure': 'All-cause myocardial infarction', 'timeFrame': '36 months', 'description': 'All-cause myocardial infarction'}, {'measure': 'Target-vessel myocardial infarction', 'timeFrame': '36 months', 'description': 'Target-vessel myocardial infarction'}, {'measure': 'Any repeat revascularization', 'timeFrame': '36 months', 'description': 'Any repeat revascularization'}, {'measure': 'Clinically-driven target vessel revascularization', 'timeFrame': '36 months', 'description': 'Clinically-driven target vessel revascularization'}, {'measure': 'Clinically-driven target lesion revascularization', 'timeFrame': '36 months', 'description': 'Clinically-driven target lesion revascularization'}, {'measure': 'Definite or probable stent thrombosis', 'timeFrame': '36 months', 'description': 'Definite or probable stent thrombosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Everolimus', 'Sirolimus', 'Zotarolimus', 'Biolimus', 'Drug-eluting stent'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '35491482', 'type': 'DERIVED', 'citation': 'Park J, Han JK, Kang J, Chae IH, Lee SY, Choi YJ, Rhew JY, Rha SW, Shin ES, Woo SI, Lee HC, Chun KJ, Kim D, Jeong JO, Bae JW, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. The Clinical Impact of beta-Blocker Therapy on Patients With Chronic Coronary Artery Disease After Percutaneous Coronary Intervention. Korean Circ J. 2022 Jul;52(7):544-555. doi: 10.4070/kcj.2021.0395. Epub 2022 Apr 4.'}, {'pmid': '35439958', 'type': 'DERIVED', 'citation': 'Hwang D, Park J, Yang HM, Yang S, Kang J, Han JK, Park KW, Kang HJ, Koo BK, Kim HS. Angiographic complete revascularization versus incomplete revascularization in patients with diabetes mellitus. Cardiovasc Diabetol. 2022 Apr 19;21(1):56. doi: 10.1186/s12933-022-01488-7.'}, {'pmid': '33817960', 'type': 'DERIVED', 'citation': 'Kim M, Park KW, Lee HS, Ki YJ, Kang J, Kim CH, Han JK, Yang HM, Kang HJ, Koo BK, Kim HS. The validation of the dual antiplatelet therapy score in East Asians receiving percutaneous coronary intervention with exclusively second generation drug-eluting stents. Catheter Cardiovasc Interv. 2021 Sep;98(3):E332-E341. doi: 10.1002/ccd.29682. Epub 2021 Apr 5.'}, {'pmid': '33541106', 'type': 'DERIVED', 'citation': 'Kang J, Park KW, Lee HS, Zheng C, Rhee TM, Ki YJ, Chang M, Han JK, Yang HM, Kang HJ, Koo BK, Kim HS. Relative Impact of Clinical Risk Versus Procedural Risk on Clinical Outcomes After Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2021 Feb;14(2):e009642. doi: 10.1161/CIRCINTERVENTIONS.120.009642. Epub 2021 Feb 5.'}, {'pmid': '32224030', 'type': 'DERIVED', 'citation': 'Zheng C, Kang J, Yang HM, Han JK, Park KW, Kang HJ, Koo BK, Kim HS. Safety and Efficacy of Glycoprotein IIb/IIIa Inhibitors in Patients With Acute Myocardial Infarction in the Presence of Intracoronary Thrombus: An Analysis From the Grand Drug-eluting Stent Registry. Clin Ther. 2020 May;42(5):954-958.e6. doi: 10.1016/j.clinthera.2020.02.022. Epub 2020 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the long-term efficacy and safety of coronary stenting with the various types of drug-eluting stents (DES) and to determine clinical device and procedural success during commercial use of DES in the real world.\n\nThe investigators will compare EES (Xience V/Promus and Xience Prime), SES (Cypher), ZES (Resolute Integrity, Endeavor Resolute, Endeavor), and BES (Biomatrix, Biomatrix Flex, and Nobori).', 'detailedDescription': "The Grand Drug-Eluting Stent (Grand-DES) Registry incorporated five different multicenter registries in South Korea. The EXCELLENT prospective cohort and the EXCELLENT-PRIME registry were dedicated for durable polymer-coated everolimus-eluting stents (DP-EES; Xience V/Promus and Xience Prime) or 1st-generation sirolimus-eluting stents (Cypher), the HOST-RESOLINTE and RESOLUTE-Korea registry for durable polymer-coated zotarolimus-eluting stents (DP-ZES; Resolute Integrity and Endeavor Resolute) or 1st-generation Endeavor-ZES, and the HOST-BIOLIMUS-3000-Korea registry for biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, and Nobori). During the period of 2008 through 2014, all registries enrolled all-comers without any exclusion criteria except patient's withdrawal of consent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 17,286 patients derived from a population of patients receiving percutaneous coronary intervention for ischemic heart disease will be enrolled in the present registry.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient agrees to participate in this study by signing the informed consent form.\n* Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this registry."}, 'identificationModule': {'nctId': 'NCT03507205', 'acronym': 'Grand-DES', 'briefTitle': 'Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents', 'orgStudyIdInfo': {'id': 'Grand-DES'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HOST-BIOLIMUS-Korea-3000', 'description': 'Active prospective registration of patients receiving biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, Nobori)', 'interventionNames': ['Device: Biomatrix; Biomatrix Flex; Nobori']}, {'label': 'EXCELLENT-PRIME', 'description': 'Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents (DP-EES; Xience Prime)', 'interventionNames': ['Device: Xience Prime']}, {'label': 'EXCELLENT Prospective cohort', 'description': 'Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents and sirolimus-eluting stents (Xience V/Promus; Cypher)', 'interventionNames': ['Device: Xience V/Promus; Cypher']}, {'label': 'HOST-RESOLINTE', 'description': 'Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES-RI; Resolute Integrity)', 'interventionNames': ['Device: DP-ZES-RI']}, {'label': 'RESOLUTE-Korea', 'description': 'Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES; Endeavor; Resolute)', 'interventionNames': ['Device: Endeavor; Resolute']}], 'interventions': [{'name': 'Biomatrix; Biomatrix Flex; Nobori', 'type': 'DEVICE', 'otherNames': ['BP-BES'], 'description': 'Biodegradable polymer-coated biolimus-eluting stents', 'armGroupLabels': ['HOST-BIOLIMUS-Korea-3000']}, {'name': 'Xience Prime', 'type': 'DEVICE', 'otherNames': ['DP-EES-Prime'], 'description': 'Durable polymer-coated everolimus-eluting stents', 'armGroupLabels': ['EXCELLENT-PRIME']}, {'name': 'Xience V/Promus; Cypher', 'type': 'DEVICE', 'otherNames': ['DP-EES; SES'], 'description': 'Durable polymer-coated everolimus-eluting stents; Sirolimus-eluting stents', 'armGroupLabels': ['EXCELLENT Prospective cohort']}, {'name': 'DP-ZES-RI', 'type': 'DEVICE', 'otherNames': ['Resolute Integrity'], 'description': 'Durable polymer-coated zotarolimus-eluting stents', 'armGroupLabels': ['HOST-RESOLINTE']}, {'name': 'Endeavor; Resolute', 'type': 'DEVICE', 'otherNames': ['DP-ZES'], 'description': 'Durable polymer-coated zotarolimus-eluting stents', 'armGroupLabels': ['RESOLUTE-Korea']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Sejong General Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Jongno-gu', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Anyang', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Dankook University Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Cheonan', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Gwangju Christian Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Kwangju Veterans Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Iksan', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'city': 'Iksan', 'country': 'South Korea', 'facility': 'Wonkwang University Hospital', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'city': 'Ilsan', 'country': 'South Korea', 'facility': 'Inje University Ilsan Paik Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Ilsan', 'country': 'South Korea', 'facility': 'National Health Insurance Corporation Ilsan Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Inchon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 35.55479, 'lon': 126.6251}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Presbyterian Medical Center', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Jinju', 'country': 'South Korea', 'facility': 'Gyeongsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Inje University Pusan Paik Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Bundang CHA Medical Center', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Medical Center Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Kangdong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Boramae Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suncheon', 'country': 'South Korea', 'facility': 'St. Carollo Hospital', 'geoPoint': {'lat': 34.9505, 'lon': 127.48784}}, {'city': 'Uijeongbu-si', 'country': 'South Korea', 'facility': "Uijeongbu St. Mary's Hospital", 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}], 'overallOfficials': [{'name': 'Hyo-Soo Kim, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Hyo-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}