TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

Cardiovascular Disease Clinical Trial

— ARRIVE 2  

Official title:

TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569751
• Other study ID #: S2200
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2007
• Last updated: September 25, 2008
• Start date: October 2004
• Est. completion date: July 2008

Study information

• Verified date: September 2008
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5016
• Est. completion date: July 2008
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• de Novo Coronary Lesions

Intervention

Device:
• TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System
Drug Eluting Stent used to treat de novo coronary artery lesions.

Locations

Country	Name	City	State
United States	New Mexico Heart Institute, PA	Albuquerque	New Mexico
United States	CHRISTUS St. Frances Cabrini Hospital	Alexandria	Louisiana
United States	Bakersfield Memorial Hospital	Bakersfield	California
United States	Cardiovascular Research Foundation of Louisiana	Baton Rouge	Louisiana
United States	North Cascade Cardiology, PLLC	Bellingham	Washington
United States	Idaho Cardiology Associates	Boise	Idaho
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Mid-Carolina Cardiology Presbyterian Hospital	Charlotte	North Carolina
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	HeartCare, Inc	Columbus	Ohio
United States	Iowa Heart Center Research	Des Moines	Iowa
United States	Duke University Medical Center	Durham	North Carolina
United States	Minnesota Heart and Vascular Center	Edina	Minnesota
United States	Heart Center of North Texas	Fort Worth	Texas
United States	University of Texas Medical Branch	Galveston	Texas
United States	Cardiology Associates of Green Bay	Green Bay	Wisconsin
United States	Cardiovascular Associates of Delaware Valley	Haddon Heights	New Jersey
United States	Krannert Institute of Cardiology	Indianapolis	Indiana
United States	The Indiana Heart Hospital	Indianapolis	Indiana
United States	University of Iowa Hospitals	Iowa City	Iowa
United States	Saint Vincent's Medical Center	Jacksonville	Florida
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Baptist Heart Institute	Knoxville	Tennessee
United States	Thoracic & Cardiovascular Healthcare Foundation	Lansing	Michigan
United States	Midwest Heart Foundation	Lombard	Illinois
United States	South Central Wisconsin Heart	Madison	Wisconsin
United States	Spectra Clinical Research Management Group	McAllen	Texas
United States	Health First Clinical Research Institute	Melbourne	Florida
United States	Heart Care Research Foundation	Merrionette Park	Illinois
United States	Community Hospital	Munster	Indiana
United States	St. Thomas Research Institute	Nashville	Tennessee
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Saint Vincent's Catholic Medical Center of New York	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	The Creighton Cardiac Center	Omaha	Nebraska
United States	Parma Community General Hospital	Parma	Ohio
United States	Cardiology Consultants	Pensacola	Florida
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	The Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Desert Cardiology Consultants	Rancho Mirage	California
United States	Kaiser San Francisco	San Francisco	California
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Great Lakes Heart and Vascular Institute	St. Joseph	Michigan
United States	Barnes / Jewish (Washington University)	St. Louis	Missouri
United States	St. Paul Heart Clinic	St. Paul	Minnesota
United States	The Heart and Vascular Institute of Florida	St. Petersburg	Florida
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Heart Center of Tulsa	Tulsa	Oklahoma
United States	St. Vincent Hospital at Worcester Medical Center	Worcester	Massachusetts
United States	Moffitt Heart and Vascular Group	Wormleysburg	Pennsylvania
United States	Main Line Health Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC).		1-year post-implant procedure	Yes
Secondary	Rate of TAXUS stent related cardiac events as classified by the CEC.		within 30 days, 6 months and 2 years	Yes
Secondary	Rate of target vessel related cardiac events as classified by the CEC.		30 days, at 6 months, at 1 and 2 years post-implant procedure	Yes
Secondary	Rate of other TAXUS related events		30 days, 6 months, 1 and 2 years post-implant procedure	Yes