Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-30 @ 7:27 AM
Study NCT ID:
NCT00916695
Status:
UNKNOWN
Last Update Posted:
2009-07-23
First Post:
2009-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Everolimus-Eluting Stent for Bifurcation Coronary Lesions: Comparison of Simple Versus Complex Techniques
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': 'ESTIMATED', 'count': 332}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-22', 'studyFirstSubmitDate': '2009-06-01', 'studyFirstSubmitQcDate': '2009-06-08', 'lastUpdatePostDateStruct': {'date': '2009-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Combined rate of events (cardiac death, myocardial infarction and TLR)', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stents', 'Angioplasty', 'Coronary Artery Disease', 'Bifurcation Coronary Lesions'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of the treatment of true bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel and provisional T-stenting in the side branch) compared to the complex strategy (stent in main vessel and T-stenting in the side branch).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old.\n* True Bifurcation lesion (Medina classification 1-1-1), in at least one main coronary vessel. Diameter of main vessel between 2,5-4mm, and diameter of side branch 2mm or greater.\n\nExclusion Criteria:\n\n* Significant left main stenosis.\n* ST elevation myocardial infarction \\< 48 h.\n* Thrombus burden target lesion.\n* Ejection Fraction \\< 30%.\n* Severe Renal Insufficiency (creatinine \\> 3 mg/dl).'}, 'identificationModule': {'nctId': 'NCT00916695', 'briefTitle': 'Everolimus-Eluting Stent for Bifurcation Coronary Lesions: Comparison of Simple Versus Complex Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Society of Cardiology'}, 'officialTitle': 'Everolimus-Eluting Stent in the Treatment of Bifurcation Lesions: Comparison of Main Vessel Stent to Main Vessel and Side Branch Stent', 'orgStudyIdInfo': {'id': 'XV02RS'}, 'secondaryIdInfos': [{'id': 'XV02RS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Complex PCI strategy for bifurcation coronary lesions', 'description': 'Stenting main vessel and T-stenting for the side branch', 'interventionNames': ['Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simple PCI strategies for bifurcation coronary lesions', 'description': 'Stenting main vessel, with provisional stenting for the side branch.', 'interventionNames': ['Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.']}], 'interventions': [{'name': 'Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.', 'type': 'DEVICE', 'description': 'Complex PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), and subsequent implanting of the stent in the main vessel, the side branch is approached by implanting a new stent as T technique.\n\nSimple PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), a stent is deployed at main vessel. Side branch is approached by using provisional T stenting technique.', 'armGroupLabels': ['Complex PCI strategy for bifurcation coronary lesions', 'Simple PCI strategies for bifurcation coronary lesions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41007', 'city': 'Seville', 'state': 'Sevilla', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rafael J Ruiz-Salmeron, PhD', 'role': 'CONTACT', 'email': 'rjruizsalmeron@yahoo.es', 'phone': '+34955693440'}], 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41007', 'city': 'Seville', 'state': 'Seville', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rafael j Ruiz-Salmeron, PhD', 'role': 'CONTACT', 'email': 'rjruizsalmeron@yahoo.es', 'phone': '0034955693449'}, {'name': 'Rafael J Ruiz-Salmeron, Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Manuel Vizcaino, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sergio Rodriguez-Leiras, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cesar Carrascosa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Francisco Marcos, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Rafael J Ruiz-Salmeron, PhD', 'role': 'CONTACT', 'email': 'rjruizsalmeron@yahoo.es', 'phone': '0034955693440'}], 'overallOfficials': [{'name': 'Federico Gimeno, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinico Universitario Valladolid'}, {'name': 'Bruno Garcia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Valle de Hebron. Barcelona'}, {'name': 'Ramiro Trillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínico Santiago'}, {'name': 'Jose Moreu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Virgen de la Salud'}, {'name': 'Javier Goicolea, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Puerta de Hierro, Madrid'}, {'name': 'Raul Moreno, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Paz'}, {'name': 'Jose F Diaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Juan Ramon Jimenez. Huelva'}, {'name': 'Jose M Hernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinico de Malaga'}, {'name': 'Ramon Lopez-Palop, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital San Juan. Alicante'}, {'name': 'Mariano Valdes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Virgen de la Arrixaca'}, {'name': 'Pascual Bordes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario. Alicante'}, {'name': 'Jose R Rumoroso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Galdakao. Vizcaya'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spanish Society of Cardiology', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Fernando Martín Burrieza', 'oldOrganization': 'Spanish Society of Cardiology'}}}}