Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-01 @ 4:36 PM
Study NCT ID:
NCT00569751
Status:
COMPLETED
Last Update Posted:
2008-09-29
First Post:
2007-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5016}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-25', 'studyFirstSubmitDate': '2007-12-06', 'studyFirstSubmitQcDate': '2007-12-06', 'lastUpdatePostDateStruct': {'date': '2008-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC).', 'timeFrame': '1-year post-implant procedure'}], 'secondaryOutcomes': [{'measure': 'Rate of TAXUS stent related cardiac events as classified by the CEC.', 'timeFrame': 'within 30 days, 6 months and 2 years'}, {'measure': 'Rate of target vessel related cardiac events as classified by the CEC.', 'timeFrame': '30 days, at 6 months, at 1 and 2 years post-implant procedure'}, {'measure': 'Rate of other TAXUS related events', 'timeFrame': '30 days, 6 months, 1 and 2 years post-implant procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['de novo', 'coronary', 'coronary artery disease', 'coronary disease'], 'conditions': ['Cardiovascular Disease', 'de Novo Coronary Lesions']}, 'referencesModule': {'references': [{'pmid': '20650436', 'type': 'DERIVED', 'citation': 'Brilakis ES, Lasala JM, Cox DA, Berger PB, Bowman TS, Starzyk RM, Dawkins KD. Outcomes after implantation of the TAXUS paclitaxel-eluting stent in saphenous vein graft lesions: results from the ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program. JACC Cardiovasc Interv. 2010 Jul;3(7):742-50. doi: 10.1016/j.jcin.2010.04.012.'}, {'pmid': '20031730', 'type': 'DERIVED', 'citation': 'Lasala JM, Cox DA, Dobies D, Baran K, Bachinsky WB, Rogers EW, Breall JA, Lewis DH, Song A, Starzyk RM, Mascioli SR, Dawkins KD, Baim DS; ARRIVE 1 and ARRIVE 2 Participating Physicians. Drug-eluting stent thrombosis in routine clinical practice: two-year outcomes and predictors from the TAXUS ARRIVE registries. Circ Cardiovasc Interv. 2009 Aug;2(4):285-93. doi: 10.1161/CIRCINTERVENTIONS.109.852178.109.852178. Epub 2009 Jul 22.'}, {'pmid': '19577985', 'type': 'DERIVED', 'citation': 'Lasala JM, Cox DA, Lewis SJ, Tadros PN, Haas RC, Schweiger MJ, Chhabra A, Untereker WJ, Starzyk RM, Mascioli SR, Dawkins KD, Baim DS. Expanded use of the TAXUS Express Stent: two-year safety insights from the 7,500 patient ARRIVE Registry programme. EuroIntervention. 2009 May;5(1):67-77. doi: 10.4244/eijv5i1a11.'}]}, 'descriptionModule': {'briefSummary': 'The TAXUS ARRIVE 2 study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Appropriate Patient Criteria:\n\n* Patient is eligible to receive a Boston Scientific TAXUS Stent\n\nInappropriate Patient Criteria:\n\n* Known sensitivity to paclitaxel.\n* Known allergy to stainless steel.\n* Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated.\n* Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.\n* Patients with unresolved vessel thrombus at the lesion site.\n* Patients with coronary artery reference vessel diameters less than 2.5 mm or greater than 3.75 mm.\n* Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation.\n* Patients with diffuse disease or poor overflow distal to the identified lesions.\n* Patients with tortuous vessels in the region of the obstruction or proximal to the lesion.\n* Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.'}, 'identificationModule': {'nctId': 'NCT00569751', 'acronym': 'ARRIVE 2', 'briefTitle': 'TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program', 'orgStudyIdInfo': {'id': 'S2200'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System', 'type': 'DEVICE', 'description': 'Drug Eluting Stent used to treat de novo coronary artery lesions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Healthcare', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Bakersfield Memorial Hospital', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Desert Cardiology Consultants', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United 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'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '78504', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Spectra Clinical Research Management Group', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98225', 'city': 'Bellingham', 'state': 'Washington', 'country': 'United States', 'facility': 'North Cascade Cardiology, PLLC', 'geoPoint': {'lat': 48.75955, 'lon': -122.48822}}, {'zip': '54305-2425', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Cardiology Associates of Green Bay', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'South Central Wisconsin Heart', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Eileen Rose, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Scientific Corporation'}, {'name': 'John M Lasala, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'David A. Cox, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lehigh Valley Physician Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kellie Windle, Clinical Project Manager', 'oldOrganization': 'Boston Scientific'}}}}