Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01078051
Status:
TERMINATED
Last Update Posted:
2019-08-02
First Post:
2010-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}}, 'statusModule': {'whyStopped': "at sponsor's discretion : Benefit is not guaranteed", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-31', 'studyFirstSubmitDate': '2010-03-01', 'studyFirstSubmitQcDate': '2010-03-01', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization', 'timeFrame': 'at 3 years', 'description': 'at the median of 3 years'}], 'secondaryOutcomes': [{'measure': 'All Death (Cardiac death)', 'timeFrame': 'at 3 years & 5 years'}, {'measure': 'Angina class; Quality of life, clinical outcomes at 5 years', 'timeFrame': 'at 3 years & 5 years'}, {'measure': 'Myocardial infarction, stroke,any revascularization, CTO-vessel related revascularization, hospitalization due to acute coronary syndrome, left ventricular ejection fraction', 'timeFrame': 'at 3 years & 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic total occlusion', 'stent', 'medical therapy'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '30813758', 'type': 'DERIVED', 'citation': 'Lee SW, Lee PH, Ahn JM, Park DW, Yun SC, Han S, Kang H, Kang SJ, Kim YH, Lee CW, Park SW, Hur SH, Rha SW, Her SH, Choi SW, Lee BK, Lee NH, Lee JY, Cheong SS, Kim MH, Ahn YK, Lim SW, Lee SG, Hiremath S, Santoso T, Udayachalerm W, Cheng JJ, Cohen DJ, Muramatsu T, Tsuchikane E, Asakura Y, Park SJ. Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion. Circulation. 2019 Apr 2;139(14):1674-1683. doi: 10.1161/CIRCULATIONAHA.118.031313.'}, {'pmid': '26434510', 'type': 'DERIVED', 'citation': 'Azzalini L, Vo M, Dens J, Agostoni P. Myths to Debunk to Improve Management, Referral, and Outcomes in Patients With Chronic Total Occlusion of an Epicardial Coronary Artery. Am J Cardiol. 2015 Dec 1;116(11):1774-80. doi: 10.1016/j.amjcard.2015.08.050. Epub 2015 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and effectiveness of drug-eluting stent implantation compared to optimal medical treatment in patients with chronic total occlusion.', 'detailedDescription': 'Prospective, two arms, randomized multi-center trial in Asian-pacific region. Following angiography, patients with chronic total occlusion (more than 3 months) have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) drug-eluting stent vs. b) optimal medical treatment. All patients will be followed for at least 3 year.\n\nThe subjects with chronic total occlusion but failed to random for any reason, they will be enrolled in registry group.\n\nThe random design was closed at the date of 22 July 2019 however already randomized subjects and subjects from registry design continue 10 years follow-up on IRIS-CTO registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nClinical\n\n1. Patients with angina or silent ischemia and documented ischemia\n2. Patients who are eligible for intracoronary stenting\n3. Age \\> 18 years\n\nAngiographic\n\n1. De novo lesion CTO\n2. Reference vessel size 2.5 mm by visual estimation\n3. At least one CTO lesions located in proximal or mid epicardial coronary artery. (If the patient has two CTO lesions, one CTO lesion should be located in proximal or mid epicardial coronary artery)\n\nCTO definition: TIMI flow 0 and estimated duration over 3 months The duration of the occlusion was determined by the interval from the last episode of acute coronary syndrome, or In patients without a history of acute coronary syndrome, from the first episode of effort angina consistent with the location of the occlusion\n\n1. Angiographically defined total occlusion over 3 months\n2. If no definite symptom with total occlusion, two experienced operators decide CTO in consideration of angiographical morphology (degree of calcification, bridging collaterals, non-tapered stump, angiographic filling from collaterals)\n\nExclusion Criteria:\n\n1. History of bleeding diathesis or coagulopathy\n2. Pregnant state\n3. Three vessel CTO\n4. Known hypersensitivity or contra-indication to contrast agent and heparin\n5. ST-elevation acute myocardial infarction requiring primary stenting\n6. Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions\n7. Hematological disease\n8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal\n9. Renal dysfunction, creatinine more than 2.0\n10. Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent\n11. Left ventricular ejection fraction\n12. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.\n13. Non-cardiac co-morbid conditions are present with limited life expectancy or that may result in protocol non-compliance (per site investigator's medical judgment)."}, 'identificationModule': {'nctId': 'NCT01078051', 'briefTitle': 'Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients', 'orgStudyIdInfo': {'id': '2009-0647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Optimal medical therapy', 'description': 'optimal medical therapy', 'interventionNames': ['Drug: optimal medical therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'drug-eluting stent', 'description': 'Cypher, xience, Endeavor, Taxus', 'interventionNames': ['Procedure: Cypher, xience, Endeavor, Taxus']}], 'interventions': [{'name': 'Cypher, xience, Endeavor, Taxus', 'type': 'PROCEDURE', 'otherNames': ['percutaneous coronary intervention'], 'description': 'all species of drug-eluting stent implantation', 'armGroupLabels': ['drug-eluting stent']}, {'name': 'optimal medical therapy', 'type': 'DRUG', 'otherNames': ['intensive medical therapy'], 'description': 'optimal medical therapy', 'armGroupLabels': ['Optimal medical therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'I', 'city': 'Pune', 'country': 'India', 'facility': 'Ruby Hall Clinic', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Medistra Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Anyang', 'country': 'South Korea', 'facility': 'Sam Anyang Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital, Buchen', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital, Cheonan', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Daejeon ST.Mary's Hospital", 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gangneung', 'country': 'South Korea', 'facility': 'GangNeung Asan Hospital', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Kwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 36.9122, 'lon': 127.1279}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Dong-A University Medical Center', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Medical Center, Hangang Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', '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': "The Catholic University of Korea, Kangnam ST.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Sŏngnam', 'country': 'South Korea', 'facility': 'Bundang CHA Hospital', 'geoPoint': {'lat': 36.53333, 'lon': 127.5}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Wonju Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Shin Kong Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'King chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Seung-Jung Park, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is not a publicly funded trial.'}, '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'}}}}