Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-03 @ 2:17 PM
Study NCT ID:
NCT01515228
Status:
COMPLETED
Last Update Posted:
2015-01-09
First Post:
2012-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)
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': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-08', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-23', 'lastUpdatePostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-segment late luminal loss', 'timeFrame': 'at 9 month angiographic follow-up'}], 'secondaryOutcomes': [{'measure': 'All Death', 'timeFrame': '12 months'}, {'measure': 'Cardiac death', 'timeFrame': '12 months'}, {'measure': 'Myocardial infarction', 'timeFrame': '12 months'}, {'measure': 'Target vessel revascularization (ischemia-driven)', 'timeFrame': '12 months'}, {'measure': 'Target lesion revascularization (ischemia-driven)', 'timeFrame': '12 months'}, {'measure': 'Stent thrombosis (by ARC definition)', 'timeFrame': '12 months'}, {'measure': 'Binary restenosis in both in-stent and in-segment', 'timeFrame': 'at 9 month angiographic follow-up'}, {'measure': 'Angiographic pattern of restenosis', 'timeFrame': 'at 9 month angiographic follow-up'}, {'measure': 'Procedural success', 'timeFrame': 'At discharge from the index hospitalization, an expected average of 3 days.', 'description': 'achievement of a final diameter stenosis of \\<30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay'}, {'measure': 'All Death', 'timeFrame': '1 month'}, {'measure': 'All Death', 'timeFrame': '4 months'}, {'measure': 'All Death', 'timeFrame': '9 months'}, {'measure': 'Cardiac death', 'timeFrame': '1 month'}, {'measure': 'Cardiac death', 'timeFrame': '4 months'}, {'measure': 'Cardiac death', 'timeFrame': '9 months'}, {'measure': 'Myocardial infarction', 'timeFrame': '1 month'}, {'measure': 'Myocardial infarction', 'timeFrame': '4 months'}, {'measure': 'Myocardial infarction', 'timeFrame': '9 months'}, {'measure': 'Target vessel revascularization (ischemia-driven)', 'timeFrame': '1 month'}, {'measure': 'Target vessel revascularization (ischemia-driven)', 'timeFrame': '4 months'}, {'measure': 'Target vessel revascularization (ischemia-driven)', 'timeFrame': '9 months'}, {'measure': 'Target lesion revascularization (ischemia-driven)', 'timeFrame': '1 month'}, {'measure': 'Target lesion revascularization (ischemia-driven)', 'timeFrame': '4 months'}, {'measure': 'Target lesion revascularization (ischemia-driven)', 'timeFrame': '9 months'}, {'measure': 'Stent thrombosis (by ARC definition)', 'timeFrame': '1 month'}, {'measure': 'Stent thrombosis (by ARC definition)', 'timeFrame': '4 months'}, {'measure': 'Stent thrombosis (by ARC definition)', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['requiring drug eluting stents'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.', 'detailedDescription': 'Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis \\>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Cilotax stent vs. b) Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nClinical:\n\n* Diabetic patients with active treatment (oral agent or insulin)\n* Patients with angina and documented ischemia or patients with documented silent ischemia\n* Patients who are eligible for intracoronary stenting\n* Age \\> 20 years, \\< 75 years\n\nAngiographic:\n\n* De novo lesion\n* Percent diameter stenosis ≥ 50%\n* Reference vessel size ≥ 2.5 mm by visual estimation\n\nExclusion Criteria:\n\n1. History of bleeding diathesis or coagulopathy\n2. Pregnant state\n3. Known hypersensitivity or contra-indication to contrast agent and heparin\n4. Limited life-expectancy (less than 1 year)\n5. ST-elevation acute myocardial infraction requiring primary stenting\n6. Characteristics of lesion: left main disease, in-stent restenosis, graft vessels\n7. Hematological disease (Neutropenia \\< 3000/mm3), Thrombocytopenia \\< 100,000/mm3)\n8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3times normal\n9. Renal dysfunction, creatinine ≥ 2.0mg/dL\n10. Contraindication to aspirin, clopidogrel or cilostazol\n11. Contraindication to Paclitaxel or everolimus\n12. Left ventricular ejection fraction \\< 30%\n13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period\n14. Non-cardiac co-morbid conditions are present with life expectancy \\< 1 year or that may result in protocol non-compliance (per site investigator's medical judgment for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)"}, 'identificationModule': {'nctId': 'NCT01515228', 'briefTitle': 'Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'Randomized Comparison of Dual Drug-Eluting Cilotax Stent and Everolimus -Eluting Stent Implantation for DE Novo Coronary Artery DisEase in Patients With DIABETES Mellitus', 'orgStudyIdInfo': {'id': 'CVRF2011-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Xience Prime stent', 'description': 'everolimus eluting stent', 'interventionNames': ['Device: Cilotax stent']}, {'type': 'EXPERIMENTAL', 'label': 'Cilotax stent', 'description': 'paclitaxel with cilostazol dual drug eluting stent', 'interventionNames': ['Device: Xience Prime']}], 'interventions': [{'name': 'Xience Prime', 'type': 'DEVICE', 'otherNames': ['everolimus-eluting stent'], 'description': 'everolimus-eluting stent implantation', 'armGroupLabels': ['Cilotax stent']}, {'name': 'Cilotax stent', 'type': 'DEVICE', 'otherNames': ['paclitaxel with cilostazol dual drug eluting stent'], 'description': 'paclitaxel with cilostazol dual drug eluting stent implantation', 'armGroupLabels': ['Xience Prime stent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Cheonan', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'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': 'Pusan', 'country': 'South Korea', 'facility': 'Inje University Pusan Paik 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': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Cheol-Whan Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHEOL WHAN LEE, MD, PhD.', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'CHEOL WHAN LEE, MD, PhD.', 'investigatorAffiliation': 'CardioVascular Research Foundation, Korea'}}}}