Clinical trial NCT00569491: TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program
Official title: TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2007-12-07
Enrollment: 2585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee
timeFrame: 1 year post-implant procedure
Secondary outcomes:
measure: Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee
timeFrame: 30 days, 6 months, 2 years post-implant procedure
measure: Rate of target vessel related cardiac events as classified by the Clinical Events Committee
timeFrame: 30 days, 6 months, 1 and 2 years post-implant procedure
measure: Rate of other TAXUS related events
timeFrame: 30 days, 6 months, 1 and 2 years post-implant procedure
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Advanced Cardiac Specialists
state: Arizona
city: Jonesboro
country: United States
facility: Cardiology Associates of NEA
state: Arkansas
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Hospital
state: California
city: San Jose
country: United States
facility: Good Samaritan
state: California
city: Torrance
country: United States
facility: Little Company of Mary Hospital
state: California
city: Fort Collins
country: United States
facility: Poudre Valley Hospital
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Juniper
country: United States
facility: Advanced Clinical Research Group, LLC
state: Florida
city: Orlando
country: United States
facility: Florida Heart Institute
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Macon
country: United States
facility: Georgia Heart and Vascular Center
state: Georgia
city: Elk Grove
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Lutheran Hospital/NIRA
state: Indiana
city: Indianapolis
country: United States
facility: St Francis Hospital
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Lafayette
country: United States
facility: Our Lady of Lourdes
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton Medical Center
state: Louisiana
city: Bangor
country: United States
facility: Northeast Cardiology Associates
state: Maine
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Salisbury
country: United States
facility: Delmarva Heart Research Foundation, Inc
state: Maryland
city: Grand Blanc
country: United States
facility: Regional Cardiology Associates
state: Michigan
city: Coon Rapids
country: United States
facility: Metro Cardiology Consultants
state: Minnesota
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Cardiovascular Consultants of Nevada
state: Nevada
city: Morristown
country: United States
facility: Morristown Memorial
state: New Jersey
city: Valhalla
country: United States
facility: Westchester County Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates, PA
state: North Carolina
city: Charlotte
country: United States
facility: Mid-Carolina Cardiology Presbyterian Hospital
state: North Carolina
city: Greenville
country: United States
facility: Pitt County Memorial Hospital
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed - Wake Heart Associates
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Fairview Park
country: United States
facility: Cleveland Cardiovascular Research Foundation
state: Ohio
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian University of Pennsylvania Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital Systems
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Heart Hospital of South Dakota
state: South Dakota
city: Kingsport
country: United States
facility: Cardiovascular Associates, PC
state: Tennessee
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Lubbock
country: United States
facility: Texas Cardiac Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances Hospital
state: Texas
city: Webster
country: United States
facility: Clear Lake Regional Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Falls Church
country: United States
facility: INOVA Fairfax Hospital
state: Virginia
city: Bellevue
country: United States
facility: Hope Heart Institute
state: Washington
city: Olympia
country: United States
facility: St. Peters Hospital
state: Washington
city: Huntington
country: United States
facility: St Mary's Hospital
state: West Virginia
city: Wausau
country: United States
facility: Care Foundation, Inc.
state: Wisconsin
Study officials:
affiliation: Boston Scientific Corporation
name: Eileen Rose, MS
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: John M Lasala, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lehigh Valley Physician Group
name: David A Cox, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.