TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00569491

Purpose

The TAXUS ARRIVE 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
Coronary Artery Disease	Device: TAXUS Express 2™	Phase IV

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee [ 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 Clinical Events Committee [ Time Frame: 30 days, 6 months, 2 years post-implant procedure ] [ Designated as safety issue: Yes ]
Rate of target vessel related cardiac events as classified by the Clinical Events Committee [ Time Frame: 30 days, 6 months, 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:	2585
Study Start Date:	February 2004
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Intervention Details:

TAXUS Express™ Paclitaxel-Eluting Coronary Stent System

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 Patients 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569491

Show 50 Study Locations

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

Responsible Party:	Boston Scientific ( Kellie Windle, Clinical Project Manager )
Study ID Numbers:	S2021
Study First Received:	December 6, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00569491
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Paclitaxel
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009