Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT01418794
Status:
UNKNOWN
Last Update Posted:
2011-08-17
First Post:
2011-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 606}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'lastUpdateSubmitDate': '2011-08-16', 'studyFirstSubmitDate': '2011-08-16', 'studyFirstSubmitQcDate': '2011-08-16', 'lastUpdatePostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)', 'timeFrame': '270 days'}], 'secondaryOutcomes': [{'measure': 'Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment', 'timeFrame': '270 days'}, {'measure': 'Composite end point of major adverse cardiac events(MACE)', 'timeFrame': '30 days, 6 months, 9 months, 1 year', 'description': 'Composite end point of cardiac death, all Q-wave and non-Q wave myocardial infarction, clinical-driven target lesion revascularisation'}, {'measure': 'Stent thrombosis events after PCI for 24 hours, 30 days and 1 year', 'timeFrame': '24 hours, 30 days and 1 year', 'description': 'according to ARC definition'}, {'measure': 'Success rate of stent implantation', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Coronary Syndromes', 'Drug eluting stent', 'Diffused lesion'], 'conditions': ['Acute Coronary Syndromes']}, 'descriptionModule': {'briefSummary': 'Polymer carried by drug-eluting stents may increase inflammatory response and thrombosis. Our previous study showed that polymer-free rapamycin-coated stents brings dose-dependent reduction in restenosis. This prospective, multicenter, randomized controlled clinical trials aimed to explore efficacy and safety of the YUKON drug eluting stent in diffuse coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18-85 years old, male or nonpregnant women\n* asymptomatic ischemia, stable or unstable angina, old myocardial infarction patients\n* at least one target lesion length ≥ 20 mm (Visual method)\n* Target lesion diameter 2.5mm-4.0 mm (Visual method)\n* Target lesion diameter stenosis ≥ 70%\n* Patients who has indications for coronary artery bypass graft (CABG) surgery\n* Patients who is voluntary, understand the purpose of the study, willing to accept angiography and clinical follow-up\n\nExclusion Criteria:\n\n* Acute myocardial infarction for less than 1 week\n* Bridge vascular disease\n* In-stent restenosis lesions\n* Patient with bleeding tendency, history of active peptic ulcer, History of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within half year, contraindications to anticoagulant therapy and antiplatelet\n* Allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast agent, rapamycin and metal\n* Life expectancy is less than 12 months\n* Patient who has participated in other clinical trials but does not meet the deadline of the primary endpoint\n* Poor patient compliance\n* Heart transplant recipient\n* Patient who had other stent implanted within 1 year\n* Patient who has multi-vessel disease(Long lesions) and has already received other stent implantation'}, 'identificationModule': {'nctId': 'NCT01418794', 'briefTitle': 'Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Shenyang Northern Hospital'}, 'orgStudyIdInfo': {'id': 'SYNH-20101010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose rapamycin group', 'description': 'Concentration of rapamycin was 1.5%', 'interventionNames': ['Device: Low dose rapamycin stent']}, {'type': 'EXPERIMENTAL', 'label': 'High dose rapamycin group', 'description': 'Concentration of rapamycin is 2.5%', 'interventionNames': ['Device: High dose rapamycin stent']}], 'interventions': [{'name': 'High dose rapamycin stent', 'type': 'DEVICE', 'description': 'Concentration of rapamycin is 2.5%', 'armGroupLabels': ['High dose rapamycin group']}, {'name': 'Low dose rapamycin stent', 'type': 'DEVICE', 'description': 'Concentration of rapamycin is 1.5%', 'armGroupLabels': ['Low dose rapamycin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bo Yu, MD', 'role': 'CONTACT', 'email': 'yubodr@163.com', 'phone': '+86-451-86605346'}], 'facility': 'The 2nd Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuan-Yu Gao, MD', 'role': 'CONTACT', 'email': 'Gaocy2000@yahoo.com.cn', 'phone': '+86-371-65580011'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '110016', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Li, MD', 'role': 'CONTACT', 'email': 'doctorliyi@126.com', 'phone': '+86-24-28851168'}], 'facility': 'Shenyang Northern Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '300162', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tie-Min Jiang, MD', 'role': 'CONTACT', 'email': 'wjyxyfy@126.com', 'phone': '+86-22-60578777'}], 'facility': 'Armed Police Force Medical College Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Ya-Ling Han, MD', 'role': 'CONTACT', 'email': 'hanyaling.nh@gmail.com', 'phone': '+86-24-23922184'}, {'name': 'Yi Li, MD', 'role': 'CONTACT', 'email': 'doctorliyi@126.com', 'phone': '+86-24-23991876'}], 'overallOfficials': [{'name': 'Ya-Ling Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shenyang Northern Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Northern Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yaling Han, M.D. PhD', 'oldOrganization': 'Shenyang Northern Hospital'}}}}