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TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program (ARRIVE)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TAXUS Express 2™
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Advanced Cardiac Specialists
  • Cardiology Associates of NEA
  • University of California Davis Medical Center
  • Salinas Valley Memorial Hospital
  • Good Samaritan
  • Little Company of Mary Hospital
  • Poudre Valley Hospital
  • Hartford Hospital
  • Advanced Clinical Research Group, LLC
  • Florida Heart Institute
  • Tallahassee Memorial Hospital
  • Georgia Heart and Vascular Center
  • Alexian Brothers Medical Center
  • Lutheran Hospital/NIRA
  • St Francis Hospital
  • Genesis Medical Center
  • Our Lady of Lourdes
  • Willis Knighton Medical Center
  • Northeast Cardiology Associates
  • Maine Medical Center
  • Delmarva Heart Research Foundation, Inc
  • Regional Cardiology Associates
  • Metro Cardiology Consultants
  • Research Medical Center
  • Washington University School of Medicine
  • Cardiovascular Consultants of Nevada
  • Morristown Memorial
  • Westchester County Medical Center
  • Asheville Cardiology Associates, PA
  • Mid-Carolina Cardiology Presbyterian Hospital
  • Pitt County Memorial Hospital
  • WakeMed - Wake Heart Associates
  • Aultman Hospital
  • Cleveland Cardiovascular Research Foundation
  • Abington Memorial Hospital
  • Presbyterian University of Pennsylvania Medical Center
  • Greenville Hospital Systems
  • Avera Heart Hospital of South Dakota
  • Cardiovascular Associates, PC
  • Methodist Dallas Medical Center
  • Texas Cardiac Center
  • South Texas Cardiovascular Consultants
  • Trinity Mother Frances Hospital
  • Clear Lake Regional Medical Center
  • LDS Hospital
  • INOVA Fairfax Hospital
  • Hope Heart Institute
  • St. Peters Hospital
  • St Mary's Hospital
  • Care Foundation, Inc.

Outcomes

Primary Outcome Measures

Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee

Secondary Outcome Measures

Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee
Rate of target vessel related cardiac events as classified by the Clinical Events Committee
Rate of other TAXUS related events

Full Information

First Posted
December 6, 2007
Last Updated
September 24, 2008
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00569491
Brief Title
TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program
Acronym
ARRIVE
Official Title
TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2585 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
TAXUS Express 2™
Intervention Description
TAXUS Express™ Paclitaxel-Eluting Coronary Stent System
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Rate of other TAXUS related events
Time Frame
30 days, 6 months, 1 and 2 years post-implant procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen Rose, MS
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John M Lasala, MD, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David A Cox, MD
Organizational Affiliation
Lehigh Valley Physician Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Cardiac Specialists
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85233
Country
United States
Facility Name
Cardiology Associates of NEA
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Salinas Valley Memorial Hospital
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
Good Samaritan
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Little Company of Mary Hospital
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Advanced Clinical Research Group, LLC
City
Juniper
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Florida Heart Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Georgia Heart and Vascular Center
City
Macon
State/Province
Georgia
ZIP/Postal Code
31208
Country
United States
Facility Name
Alexian Brothers Medical Center
City
Elk Grove
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Lutheran Hospital/NIRA
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
St Francis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Our Lady of Lourdes
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Willis Knighton Medical Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Northeast Cardiology Associates
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Delmarva Heart Research Foundation, Inc
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Facility Name
Regional Cardiology Associates
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Metro Cardiology Consultants
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cardiovascular Consultants of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Morristown Memorial
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07079
Country
United States
Facility Name
Westchester County Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Asheville Cardiology Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Mid-Carolina Cardiology Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Pitt County Memorial Hospital
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
WakeMed - Wake Heart Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Cleveland Cardiovascular Research Foundation
City
Fairview Park
State/Province
Ohio
ZIP/Postal Code
44126
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Presbyterian University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Greenville Hospital Systems
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Avera Heart Hospital of South Dakota
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Cardiovascular Associates, PC
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75265
Country
United States
Facility Name
Texas Cardiac Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
South Texas Cardiovascular Consultants
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Trinity Mother Frances Hospital
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Clear Lake Regional Medical Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22041
Country
United States
Facility Name
Hope Heart Institute
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
St. Peters Hospital
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506
Country
United States
Facility Name
St Mary's Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25702
Country
United States
Facility Name
Care Foundation, Inc.
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20650436
Citation
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.
Results Reference
derived
PubMed Identifier
20031730
Citation
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.
Results Reference
derived
PubMed Identifier
19577985
Citation
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.
Results Reference
derived

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

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