Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT01368627
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2011-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054855', 'term': 'Drug-Eluting Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-22', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-07', 'lastUpdatePostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MAJOR ADVERSE CARDIAC EVENTS (MACE)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Rates of procedural success', 'timeFrame': '24 month'}, {'measure': 'Rates of Major Adverse Cardiac Event (MACE)', 'timeFrame': 'In-hospital, 30 days, 6 and 24 months'}, {'measure': 'Rates of target lesion revascularization (TLR)', 'timeFrame': '6 and 12 months'}, {'measure': 'Rates of stent thrombosis (acute, sub-acute, late and very-late)', 'timeFrame': 'Up to 24 months follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Restenosis', 'Stent thrombosis', 'Coronary stents', 'Angioplasty', 'Drug Eluting Stents(DES)'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'E-SERIES Registry evaluate the procedural and clinical outcomes of the Supralimus® SES in the treatment of unselected, high risk patients having coronary Artery blockage in the real world clinical practice.', 'detailedDescription': 'E-SERIES Registry is Prospective, multinational (Asia, South America and Europe), non-randomized, post-marketing web-based registry.\n\nFor this Study Up to 100 clinical sites in Asia, South America and Europe. Patients "ALL COMERS" assigned for percutaneous coronary interventions who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with the Supralimus® SES.\n\nAll subjects who provided signed informed consent prior to procedure, and have at least one lesion in a major epicardial vessel or major branch (\\>2.25mm), and are suitable for percutaneous treatment including stenting procedure with the Supralimus® SES. There are no limit regarding the number of lesions and/or study stents to be used, and stenting technique will be left at the operator\'s discretion; however, it is recommended according to the BEST interventional practice according to the current guidelines.\n\nAll patients will undergo follow-up clinical evaluation at 1, 6, 12 and 24 months. Angiographic follow-up will be performed at 6 months in a subset of high risk lesions including bifurcations (first 100 lesions) and left main stem (first 100 lesions).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. CLINICAL INCLUSION CRITERIA: Patients \\>18 years, clinical indication for elective or emergency percutaneous coronary intervention with stent implantation of at least one angiographically documented coronary artery lesion; agreement to undergo ALL study protocol follow-ups.\n2. ANGIOGRAPHIC INCLUSION CRITERIA: Diseased coronary vessels with at least one lesion with ≥50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (\\>2.25mm) with anatomy suitable for percutaneous treatment with the Supralimus SES.\n\nExclusion Criteria:\n\n1. CLINICAL EXCLUSION CRITERIA: Known illness with life expectancy \\<12 months; impossibility to comply with all protocol follow-ups.\n2. ANGIOGRAPHIC EXCLUSION CRITERIA: Anatomy unsuitable for percutaneous treatment with implantation of the Supralimus SES.'}, 'identificationModule': {'nctId': 'NCT01368627', 'briefTitle': 'The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sahajanand Medical Technologies Limited'}, 'officialTitle': 'A Prospective, Multinational Investigation of the Supralimus® Sirolimus-Eluting Stent for the Treatment of Unselected Patients With Coronary Lesions in the "Real- World" Clinical Practice', 'orgStudyIdInfo': {'id': 'Version 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supralimus® Sirolimus-Eluting Coronary Stent', 'interventionNames': ['Device: Supralimus® Sirolimus-Eluting Coronary Stent']}], 'interventions': [{'name': 'Supralimus® Sirolimus-Eluting Coronary Stent', 'type': 'DEVICE', 'otherNames': ['Drug Eluting Stent (DES)'], 'description': 'Supralimus® Coronary Stent System consisting of the MATRIX® Coronary Stent having Sirolimus eluting from Biodegradable Polymeric Matrix on a Stainless Steel Platform, Drug concentration 1.4 µg/mm2', 'armGroupLabels': ['Supralimus® Sirolimus-Eluting Coronary Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29047-575', 'city': 'Vitória', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'CIAS- Unimed Vitória', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}, {'zip': '74823-320', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Centro de Cardiologia e Radiologia', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '30380-090', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Luxemburgo', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '36025-550', 'city': 'Juiz de Fora', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Monte Sinai', 'geoPoint': {'lat': -21.76417, 'lon': -43.35028}}, {'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Vita', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'H.C.Unesp', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'zip': '05022-001', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital São Camilo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Alexandre Abizaid,, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahajanand Medical Technologies Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cardiovascular Research Center, Brazil', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}