TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Disease de Novo Coronary Lesions	Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

Resource links provided by NLM:

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC). [ Time Frame: 1-year post-implant procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Rate of TAXUS stent related cardiac events as classified by the CEC. [ Time Frame: within 30 days, 6 months and 2 years ] [ Designated as safety issue: Yes ]
Rate of target vessel related cardiac events as classified by the CEC. [ Time Frame: 30 days, at 6 months, at 1 and 2 years post-implant procedure ] [ Designated as safety issue: Yes ]
Rate of other TAXUS related events [ Time Frame: 30 days, 6 months, 1 and 2 years post-implant procedure ] [ Designated as safety issue: Yes ]

Enrollment:	5016
Study Start Date:	October 2004
Study Completion Date:	July 2008
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Drug Eluting Stent used to treat de novo coronary artery lesions.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Appropriate Patient Criteria:

Patient is eligible to receive a Boston Scientific TAXUS Stent

Inappropriate Patient 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569751

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Locations

United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85260
United States, California
Bakersfield Memorial Hospital
Bakersfield, California, United States, 93301
Desert Cardiology Consultants
Rancho Mirage, California, United States, 92270
Kaiser San Francisco
San Francisco, California, United States, 94115
United States, Florida
Saint Vincent's Medical Center
Jacksonville, Florida, United States, 32204
Health First Clinical Research Institute
Melbourne, Florida, United States, 32901
Cardiology Consultants
Pensacola, Florida, United States, 32504
The Heart and Vascular Institute of Florida
St. Petersburg, Florida, United States, 33705
United States, Idaho
Idaho Cardiology Associates
Boise, Idaho, United States, 83704
United States, Illinois
Midwest Heart Foundation
Lombard, Illinois, United States, 60148
Heart Care Research Foundation
Merrionette Park, Illinois, United States, 60803
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Indiana
Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
The Indiana Heart Hospital
Indianapolis, Indiana, United States, 46250
Community Hospital
Munster, Indiana, United States, 46321
United States, Iowa
Iowa Heart Center Research
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
United States, Louisiana
CHRISTUS St. Frances Cabrini Hospital
Alexandria, Louisiana, United States, 71301
Cardiovascular Research Foundation of Louisiana
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
St. Vincent Hospital at Worcester Medical Center
Worcester, Massachusetts, United States, 01608
United States, Michigan
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States, 48912
Great Lakes Heart and Vascular Institute
St. Joseph, Michigan, United States, 49085
United States, Minnesota
Minnesota Heart and Vascular Center
Edina, Minnesota, United States, 55435
St. Paul Heart Clinic
St. Paul, Minnesota, United States, 55102
United States, Missouri
Barnes / Jewish (Washington University)
St. Louis, Missouri, United States, 63110
United States, Nebraska
The Creighton Cardiac Center
Omaha, Nebraska, United States, 68131
United States, New Jersey
Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, United States, 08035
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07754
United States, New Mexico
New Mexico Heart Institute, PA
Albuquerque, New Mexico, United States, 87102
United States, New York
Saint Vincent's Catholic Medical Center of New York
New York, New York, United States, 10011
United States, North Carolina
Mid-Carolina Cardiology Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
HeartCare, Inc
Columbus, Ohio, United States, 43215
Parma Community General Hospital
Parma, Ohio, United States, 44129
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
United States, Oklahoma
Heart Center of Tulsa
Tulsa, Oklahoma, United States, 74114
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Moffitt Heart and Vascular Group
Wormleysburg, Pennsylvania, United States, 17043
Main Line Health Center
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
United States, Tennessee
Baptist Heart Institute
Knoxville, Tennessee, United States, 37920
St. Thomas Research Institute
Nashville, Tennessee, United States, 37205
United States, Texas
Heart Center of North Texas
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Spectra Clinical Research Management Group
McAllen, Texas, United States, 78504
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
North Cascade Cardiology, PLLC
Bellingham, Washington, United States, 98225
United States, Wisconsin
Cardiology Associates of Green Bay
Green Bay, Wisconsin, United States, 54305-2425
South Central Wisconsin Heart
Madison, Wisconsin, United States, 53715

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Study Director:	Eileen Rose, MS	Boston Scientific Corporation
Principal Investigator:	John M Lasala, MD, PhD	Washington University School of Medicine
Principal Investigator:	David A. Cox, MD	Lehigh Valley Physician Group

More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. 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.

Responsible Party:	Kellie Windle, Clinical Project Manager, Boston Scientific
ClinicalTrials.gov Identifier:	NCT00569751 History of Changes
Other Study ID Numbers:	S2200
Study First Received:	December 6, 2007
Last Updated:	September 25, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:

de novo
coronary
coronary artery disease
coronary disease

Additional relevant MeSH terms:

Cardiovascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013