TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program
NCT ID: NCT00569751
Last Updated: 2008-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
5016 participants
INTERVENTIONAL
2004-10-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System
Drug Eluting Stent used to treat de novo coronary artery lesions.
Eligibility Criteria
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Inclusion Criteria
* Known sensitivity to paclitaxel.
* Known allergy to stainless steel.
* Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated.
* Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
* Patients with unresolved vessel thrombus at the lesion site.
* Patients with coronary artery reference vessel diameters less than 2.5 mm or greater than 3.75 mm.
* Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation.
* Patients with diffuse disease or poor overflow distal to the identified lesions.
* Patients with tortuous vessels in the region of the obstruction or proximal to the lesion.
* Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Boston Scientific
Principal Investigators
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Eileen Rose, MS
Role: STUDY_DIRECTOR
Boston Scientific Corporation
John M Lasala, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
David A. Cox, MD
Role: PRINCIPAL_INVESTIGATOR
Lehigh Valley Physician Group
Locations
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Scottsdale Healthcare
Scottsdale, Arizona, United States
Bakersfield Memorial Hospital
Bakersfield, California, United States
Desert Cardiology Consultants
Rancho Mirage, California, United States
Kaiser San Francisco
San Francisco, California, United States
Saint Vincent's Medical Center
Jacksonville, Florida, United States
Health First Clinical Research Institute
Melbourne, Florida, United States
Cardiology Consultants
Pensacola, Florida, United States
The Heart and Vascular Institute of Florida
St. Petersburg, Florida, United States
Idaho Cardiology Associates
Boise, Idaho, United States
Midwest Heart Foundation
Lombard, Illinois, United States
Heart Care Research Foundation
Merrionette Park, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, United States
The Indiana Heart Hospital
Indianapolis, Indiana, United States
Community Hospital
Munster, Indiana, United States
Iowa Heart Center Research
Des Moines, Iowa, United States
University of Iowa Hospitals
Iowa City, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
CHRISTUS St. Frances Cabrini Hospital
Alexandria, Louisiana, United States
Cardiovascular Research Foundation of Louisiana
Baton Rouge, Louisiana, United States
Baystate Medical Center
Springfield, Massachusetts, United States
St. Vincent Hospital at Worcester Medical Center
Worcester, Massachusetts, United States
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States
Great Lakes Heart and Vascular Institute
Saint Joseph, Michigan, United States
Minnesota Heart and Vascular Center
Edina, Minnesota, United States
St. Paul Heart Clinic
Saint Paul, Minnesota, United States
Barnes / Jewish (Washington University)
St Louis, Missouri, United States
The Creighton Cardiac Center
Omaha, Nebraska, United States
Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
New Mexico Heart Institute, PA
Albuquerque, New Mexico, United States
Saint Vincent's Catholic Medical Center of New York
New York, New York, United States
Mid-Carolina Cardiology Presbyterian Hospital
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
HeartCare, Inc
Columbus, Ohio, United States
Parma Community General Hospital
Parma, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Heart Center of Tulsa
Tulsa, Oklahoma, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Moffitt Heart and Vascular Group
Wormleysburg, Pennsylvania, United States
Main Line Health Center
Wynnewood, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baptist Heart Institute
Knoxville, Tennessee, United States
St. Thomas Research Institute
Nashville, Tennessee, United States
Heart Center of North Texas
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Spectra Clinical Research Management Group
McAllen, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
North Cascade Cardiology, PLLC
Bellingham, Washington, United States
Cardiology Associates of Green Bay
Green Bay, Wisconsin, United States
South Central Wisconsin Heart
Madison, Wisconsin, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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S2200
Identifier Type: -
Identifier Source: org_study_id