Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT02038127
Status:
RECRUITING
Last Update Posted:
2024-07-24
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gangwon PCI Prospective Registry
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'CBC, Electrolyte, Chemistry, Cardiac biomarker, Platelet function test'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device-oriented composite outcome', 'timeFrame': '24 months', 'description': 'Device-oriented composite consisted of cardiac death, MI not clearly attributable to a nontarget vessel, and clinically indicated TLR at 24-month clinical follow-up'}], 'secondaryOutcomes': [{'measure': 'Patient-oriented composite outcome', 'timeFrame': '24 months', 'description': 'Patient-oriented composite consisted of all-cause mortality, any MI, and any revascularization at 24-month clinical follow-up'}, {'measure': 'Target vessel revascularization', 'timeFrame': '12 months'}, {'measure': 'Target vessel revascularization', 'timeFrame': '24 months'}, {'measure': 'ARC defined stent thrombosis', 'timeFrame': '12 months'}, {'measure': 'ARC defined stent thrombosis', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '39691038', 'type': 'DERIVED', 'citation': 'Jeon HS, Youn YJ, Lee JH, Park YJ, Son JW, Lee JW, Ahn MS, Ahn SG, Kim JY, Yoo BS, Yoon J. Safety and Efficacy of Two Ultrathin Biodegradable Polymer Sirolimus-Eluting Stents in Real-World Practice: Genoss DES Stents Versus Orsiro Stents From a Prospective Registry. Clin Cardiol. 2024 Dec;47(12):e70060. doi: 10.1002/clc.70060.'}, {'pmid': '39297854', 'type': 'DERIVED', 'citation': 'Jeon HS, Kim YI, Lee JH, Park YJ, Son JW, Lee JW, Youn YJ, Ahn MS, Kim JY, Yoo BS, Ko SM, Ahn SG. Failed Thrombus Aspiration and Reduced Myocardial Perfusion in Patients With STEMI and Large Thrombus Burden. JACC Cardiovasc Interv. 2024 Oct 14;17(19):2216-2225. doi: 10.1016/j.jcin.2024.07.016. Epub 2024 Sep 18.'}, {'pmid': '36807273', 'type': 'DERIVED', 'citation': 'Youn YJ, Jeon HS, Kim YI, Lee JH, Park YJ, Cho DH, Son JW, Lee JW, Ahn MS, Ahn SG, Kim JY, Yoo BS, Lee SH, Yoon J. Impact of the ultra-long 48 mm drug-eluting stent on procedural and clinical outcomes in patients with diffuse long coronary artery disease. Clin Cardiol. 2023 Apr;46(4):416-424. doi: 10.1002/clc.23997. Epub 2023 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of\n\n* Biolimus-eluting stent, Biomatrix, or Biomatrix Flex stent, Biosensors, Singapore\n* Everolimus-eluting stent, Xience V, or Xience Prime, or Xience Xpedition stent, Abbott, USA\n* Zotarolimus-eluting stent, Endeavor Resolute, or Endeavor Resolute Integrity stent Medtronic, USA in patients with coronary artery disease treated with percutaneous coronary intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were at least 18 years of age, who have stable coronary artery disease (CAD) or acute coronary syndrome (ACS), including myocardial infarction (MI) with or without ST-segment elevation will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 19 years\n* Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the drug-eluting stent(s) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure\n* Subject must have significant stenosis (\\>50% by visual estimate) on a native or in-stent coronary artery\n* Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, positive functional study or a reversible changes in the ECG consistent with ischemia). In subjects with coronary artery stenosis \\>75%, evidence of myocardial ischemia does not have to be documented\n\nExclusion Criteria:\n\n* Subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, biolimus A9, everolimus, zotarolimus, stainless steel, cobalt chromium, contrast media (Patients with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.)\n* Subject in use of systemic (intravenous) biolimus A9, everolimus or zotarolimus within 12 months.\n* Female subject of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study\n* Subject planned an elective surgical procedure that would necessitate interruption of antiplatelet during the first 12 months post enrollment\n* Subject with non-cardiac co-morbid condition with life expectancy \\< 2 year or that may result in protocol non-compliance (per site investigator's medical judgment)\n* Subject with cardiogenic shock at presentation\n* Subject who are actively participating in another drug or device investigational study, who have not completed the primary end point follow-up period"}, 'identificationModule': {'nctId': 'NCT02038127', 'acronym': 'GWPCI', 'briefTitle': 'Gangwon PCI Prospective Registry', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province', 'orgStudyIdInfo': {'id': 'GangwonPCI'}}, 'contactsLocationsModule': {'locations': [{'city': 'Chuncheon', 'state': 'Gangwon-do', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun Hee Choi, M.D.', 'role': 'CONTACT', 'email': 'jumdure@hanmail.net'}, {'name': 'Hyun Hee Choi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chuncheon Hallym University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '220768', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Junghan Yoon, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'jyoon@yonsei.ac.kr', 'phone': '+82-33-741-0906'}, {'name': 'Young Jin Youn, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Junghan Yoon, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Seung-Hwan Lee, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sung-Gyun Ahn, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jun-Won Lee, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Yonsei University Wonju Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Cheol Ung Choi, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'wmagpie@korea.com'}, {'name': 'Cheol Ung Choi, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Junghan Yoon, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'jyoon@yonsei.ac.kr', 'phone': '+82-33-741-0906'}, {'name': 'Young Jin Youn, M.D.', 'role': 'CONTACT', 'email': 'younyj@yonsei.ac.kr', 'phone': '+82-33-741-0917'}], 'overallOfficials': [{'name': 'Junghan Yoon, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gangwon Cardiovascular Health Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Young Jin Youn, MD, PhD', 'investigatorAffiliation': 'Yonsei University'}}}}