TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program
NCT ID: NCT00569491
Last Updated: 2008-09-25
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
2585 participants
INTERVENTIONAL
2004-02-29
2007-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TAXUS Express 2™
TAXUS Express™ Paclitaxel-Eluting Coronary Stent System
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 \< 2.5 mm or \> 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
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Scientific Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Boston Scientific
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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
Explore where the study is taking place and check the recruitment status at each participating site.
Advanced Cardiac Specialists
Gilbert, Arizona, United States
Cardiology Associates of NEA
Jonesboro, Arkansas, United States
University of California Davis Medical Center
Sacramento, California, United States
Salinas Valley Memorial Hospital
Salinas, California, United States
Good Samaritan
San Jose, California, United States
Little Company of Mary Hospital
Torrance, California, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Advanced Clinical Research Group, LLC
Juniper, Florida, United States
Florida Heart Institute
Orlando, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Georgia Heart and Vascular Center
Macon, Georgia, United States
Alexian Brothers Medical Center
Elk Grove, Illinois, United States
Lutheran Hospital/NIRA
Fort Wayne, Indiana, United States
St Francis Hospital
Indianapolis, Indiana, United States
Genesis Medical Center
Davenport, Iowa, United States
Our Lady of Lourdes
Lafayette, Louisiana, United States
Willis Knighton Medical Center
Shreveport, Louisiana, United States
Northeast Cardiology Associates
Bangor, Maine, United States
Maine Medical Center
Portland, Maine, United States
Delmarva Heart Research Foundation, Inc
Salisbury, Maryland, United States
Regional Cardiology Associates
Grand Blanc, Michigan, United States
Metro Cardiology Consultants
Coon Rapids, Minnesota, United States
Research Medical Center
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cardiovascular Consultants of Nevada
Las Vegas, Nevada, United States
Morristown Memorial
Morristown, New Jersey, United States
Westchester County Medical Center
Valhalla, New York, United States
Asheville Cardiology Associates, PA
Asheville, North Carolina, United States
Mid-Carolina Cardiology Presbyterian Hospital
Charlotte, North Carolina, United States
Pitt County Memorial Hospital
Greenville, North Carolina, United States
WakeMed - Wake Heart Associates
Raleigh, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
Cleveland Cardiovascular Research Foundation
Fairview Park, Ohio, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Presbyterian University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Greenville Hospital Systems
Greenville, South Carolina, United States
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota, United States
Cardiovascular Associates, PC
Kingsport, Tennessee, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
Texas Cardiac Center
Lubbock, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Trinity Mother Frances Hospital
Tyler, Texas, United States
Clear Lake Regional Medical Center
Webster, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
INOVA Fairfax Hospital
Falls Church, Virginia, United States
Hope Heart Institute
Bellevue, Washington, United States
St. Peters Hospital
Olympia, Washington, United States
St Mary's Hospital
Huntington, West Virginia, United States
Care Foundation, Inc.
Wausau, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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
Review additional registry numbers or institutional identifiers associated with this trial.
S2021
Identifier Type: -
Identifier Source: org_study_id