TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00569751

Collaborator

(none)

5,016

Enrollment

Locations

Duration (Months)

94.6

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

5016 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Jul 1, 2008

Outcome Measures

Primary Outcome Measures

Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC). [1-year post-implant procedure]

Secondary Outcome Measures

Rate of TAXUS stent related cardiac events as classified by the CEC. [within 30 days, 6 months and 2 years]
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]
Rate of other TAXUS related events [30 days, 6 months, 1 and 2 years post-implant procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Scottsdale Healthcare	Scottsdale	Arizona	United States	85260
2	Bakersfield Memorial Hospital	Bakersfield	California	United States	93301
3	Desert Cardiology Consultants	Rancho Mirage	California	United States	92270
4	Kaiser San Francisco	San Francisco	California	United States	94115
5	Saint Vincent's Medical Center	Jacksonville	Florida	United States	32204
6	Health First Clinical Research Institute	Melbourne	Florida	United States	32901
7	Cardiology Consultants	Pensacola	Florida	United States	32504
8	The Heart and Vascular Institute of Florida	St. Petersburg	Florida	United States	33705
9	Idaho Cardiology Associates	Boise	Idaho	United States	83704
10	Midwest Heart Foundation	Lombard	Illinois	United States	60148
11	Heart Care Research Foundation	Merrionette Park	Illinois	United States	60803
12	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
13	Krannert Institute of Cardiology	Indianapolis	Indiana	United States	46202
14	The Indiana Heart Hospital	Indianapolis	Indiana	United States	46250
15	Community Hospital	Munster	Indiana	United States	46321
16	Iowa Heart Center Research	Des Moines	Iowa	United States	50314
17	University of Iowa Hospitals	Iowa City	Iowa	United States	52242
18	University of Kansas Hospital	Kansas City	Kansas	United States	66160
19	CHRISTUS St. Frances Cabrini Hospital	Alexandria	Louisiana	United States	71301
20	Cardiovascular Research Foundation of Louisiana	Baton Rouge	Louisiana	United States	70808
21	Baystate Medical Center	Springfield	Massachusetts	United States	01199
22	St. Vincent Hospital at Worcester Medical Center	Worcester	Massachusetts	United States	01608
23	Thoracic & Cardiovascular Healthcare Foundation	Lansing	Michigan	United States	48912
24	Great Lakes Heart and Vascular Institute	St. Joseph	Michigan	United States	49085
25	Minnesota Heart and Vascular Center	Edina	Minnesota	United States	55435
26	St. Paul Heart Clinic	St. Paul	Minnesota	United States	55102
27	Barnes / Jewish (Washington University)	St. Louis	Missouri	United States	63110
28	The Creighton Cardiac Center	Omaha	Nebraska	United States	68131
29	Cardiovascular Associates of Delaware Valley	Haddon Heights	New Jersey	United States	08035
30	Jersey Shore University Medical Center	Neptune	New Jersey	United States	07754
31	New Mexico Heart Institute, PA	Albuquerque	New Mexico	United States	87102
32	Saint Vincent's Catholic Medical Center of New York	New York	New York	United States	10011
33	Mid-Carolina Cardiology Presbyterian Hospital	Charlotte	North Carolina	United States	28204
34	Duke University Medical Center	Durham	North Carolina	United States	27710
35	Bethesda North Hospital	Cincinnati	Ohio	United States	45242
36	HeartCare, Inc	Columbus	Ohio	United States	43215
37	Parma Community General Hospital	Parma	Ohio	United States	44129
38	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
39	Heart Center of Tulsa	Tulsa	Oklahoma	United States	74114
40	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141
41	The Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
42	Moffitt Heart and Vascular Group	Wormleysburg	Pennsylvania	United States	17043
43	Main Line Health Center	Wynnewood	Pennsylvania	United States	19096
44	Medical University of South Carolina	Charleston	South Carolina	United States	29403
45	Baptist Heart Institute	Knoxville	Tennessee	United States	37920
46	St. Thomas Research Institute	Nashville	Tennessee	United States	37205
47	Heart Center of North Texas	Fort Worth	Texas	United States	76104
48	University of Texas Medical Branch	Galveston	Texas	United States	77555
49	Spectra Clinical Research Management Group	McAllen	Texas	United States	78504
50	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
51	North Cascade Cardiology, PLLC	Bellingham	Washington	United States	98225
52	Cardiology Associates of Green Bay	Green Bay	Wisconsin	United States	54305-2425
53	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