Clinical trial NCT00569751: TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program
Official title: TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
de Novo Coronary Lesions
Keywords: de novo
coronary
coronary artery disease
coronary disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2007-12-07
Enrollment: 5016
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC).
timeFrame: 1-year post-implant procedure
Secondary outcomes:
measure: Rate of TAXUS stent related cardiac events as classified by the CEC.
timeFrame: within 30 days, 6 months and 2 years
measure: Rate of target vessel related cardiac events as classified by the CEC.
timeFrame: 30 days, at 6 months, at 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: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Bakersfield
country: United States
facility: Bakersfield Memorial Hospital
state: California
city: Rancho Mirage
country: United States
facility: Desert Cardiology Consultants
state: California
city: San Francisco
country: United States
facility: Kaiser San Francisco
state: California
city: Jacksonville
country: United States
facility: Saint Vincent's Medical Center
state: Florida
city: Melbourne
country: United States
facility: Health First Clinical Research Institute
state: Florida
city: Pensacola
country: United States
facility: Cardiology Consultants
state: Florida
city: St. Petersburg
country: United States
facility: The Heart and Vascular Institute of Florida
state: Florida
city: Boise
country: United States
facility: Idaho Cardiology Associates
state: Idaho
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Merrionette Park
country: United States
facility: Heart Care Research Foundation
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: Indianapolis
country: United States
facility: The Indiana Heart Hospital
state: Indiana
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center Research
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Alexandria
country: United States
facility: CHRISTUS St. Frances Cabrini Hospital
state: Louisiana
city: Baton Rouge
country: United States
facility: Cardiovascular Research Foundation of Louisiana
state: Louisiana
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: St. Vincent Hospital at Worcester Medical Center
state: Massachusetts
city: Lansing
country: United States
facility: Thoracic & Cardiovascular Healthcare Foundation
state: Michigan
city: St. Joseph
country: United States
facility: Great Lakes Heart and Vascular Institute
state: Michigan
city: Edina
country: United States
facility: Minnesota Heart and Vascular Center
state: Minnesota
city: St. Paul
country: United States
facility: St. Paul Heart Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Barnes / Jewish (Washington University)
state: Missouri
city: Omaha
country: United States
facility: The Creighton Cardiac Center
state: Nebraska
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of Delaware Valley
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute, PA
state: New Mexico
city: New York
country: United States
facility: Saint Vincent's Catholic Medical Center of New York
state: New York
city: Charlotte
country: United States
facility: Mid-Carolina Cardiology Presbyterian Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Columbus
country: United States
facility: HeartCare, Inc
state: Ohio
city: Parma
country: United States
facility: Parma Community General Hospital
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Heart Center of Tulsa
state: Oklahoma
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Western Pennsylvania Hospital
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Moffitt Heart and Vascular Group
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: Baptist Heart Institute
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Research Institute
state: Tennessee
city: Fort Worth
country: United States
facility: Heart Center of North Texas
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: McAllen
country: United States
facility: Spectra Clinical Research Management Group
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Bellingham
country: United States
facility: North Cascade Cardiology, PLLC
state: Washington
city: Green Bay
country: United States
facility: Cardiology Associates of Green Bay
state: Wisconsin
city: Madison
country: United States
facility: South Central Wisconsin Heart
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.