Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-22 @ 2:13 AM
Study NCT ID:
NCT01670318
Status:
UNKNOWN
Last Update Posted:
2012-08-22
First Post:
2012-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-21', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-08-21', 'lastUpdatePostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization', 'timeFrame': '12 month'}], 'secondaryOutcomes': [{'measure': 'Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site', 'timeFrame': 'In hospital'}, {'measure': 'Target lesion revascularization', 'timeFrame': '12 month'}, {'measure': 'Target vessel revascularization', 'timeFrame': '12 month'}, {'measure': 'Myocardial infarction', 'timeFrame': '24 month'}, {'measure': 'Cardiac death', 'timeFrame': '24 month'}, {'measure': 'Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization', 'timeFrame': '24 month'}, {'measure': 'Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)', 'timeFrame': '24 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic total occlusion', 'Bifurcation lesion', 'Left main trunk lesion', 'Small vessel disease', 'Multi vessel disease'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome\n2. Male or non-pregnant female\n3. Key lesion inclusion criteria as follows\n\n 1. Multi-vessel diseases\n 2. Long lesion (lesion length \\>30mm by visual estimation)\n 3. Small vessel disease (reference diameter \\<2.5mm by visual estimation)\n 4. Bifurcation lesion\n 5. Ostial lesion\n 6. Calcified lesion\n 7. Protected or non-protected left main trunk disease\n 8. Chronic total occlusion\n 9. In stent restenosis of bare metal stent or everolimus-eluting stent\n\nExclusion Criteria:\n\n1. Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.\n2. Serum creatinine level \\>3.0 mg/dL\n3. Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.'}, 'identificationModule': {'nctId': 'NCT01670318', 'acronym': 'SPECIALIST', 'briefTitle': 'Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets', 'organization': {'class': 'NETWORK', 'fullName': 'The PCI Guideline Research Society'}, 'officialTitle': 'Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets', 'orgStudyIdInfo': {'id': 'SPECIALIST Registry'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'platinum chromium everolimus-eluting stent', 'interventionNames': ['Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)']}], 'interventions': [{'name': 'platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)', 'type': 'DEVICE', 'armGroupLabels': ['platinum chromium everolimus-eluting stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '480-1195', 'city': 'Nagakute', 'state': 'Aichi-ken', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hiroaki Takashima', 'role': 'CONTACT'}, {'name': 'Hiroaki Takashima, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aichi Medical University Hospital', 'geoPoint': {'lat': 35.17325, 'lon': 137.05667}}, {'zip': '441-8530', 'city': 'Toyohashi', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kenya Nasu, MD', 'role': 'CONTACT'}, {'name': 'Kenya Nasu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toyohashi Heart Center', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'zip': '279-0021', 'city': 'Urayasu', 'state': 'Chiba', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Ken Yokoyama', 'role': 'CONTACT'}, {'name': 'Ken Tokoyama, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Juntendo University Urayasu Hospital', 'geoPoint': {'lat': 35.65879, 'lon': 139.90055}}, {'zip': '810-0001', 'city': 'Fukuoka', 'state': 'Fukuoka', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takeshi Serikawa', 'role': 'CONTACT'}, {'name': 'Takeshi Serikawa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saiseikai Fukuoka General Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '802-8555', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Shinichi Shirai', 'role': 'CONTACT'}, {'name': 'Shinichi Shirai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kokura Memorial Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '963-8501', 'city': 'Kōriyama', 'state': 'Fukushima', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 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'country': 'Japan', 'contacts': [{'name': 'Yasuhiro Tanabe', 'role': 'CONTACT'}, {'name': 'Yasuhiro Tanabe, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tokyo Metropolitan Hiroo Hospital'}, {'zip': '141-8625', 'city': 'Shinagawa-ku', 'state': 'Tokyo', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Masashiro Matsushita', 'role': 'CONTACT'}, {'name': 'Masashiro Matsushita, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NTT Medical Center Tokyo'}], 'centralContacts': [{'name': 'Kenya Nasu, MD, FACC', 'role': 'CONTACT', 'email': 'yuyatomoya@gmail.com', 'phone': '+81532373377'}, {'name': 'Yuji Oikawa, MD,PｈD', 'role': 'CONTACT', 'email': 'nasu@heart-center.or.jp', 'phone': '+81532373377'}], 'overallOfficials': [{'name': 'Yuji Oikawa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cardiovascular Institute'}, {'name': 'Kenya Nasu, MD, FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toyohashi Heart Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The PCI Guideline Research Society', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}