TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

NCT00569751 | Completed Phase 4

• 1 other identifier: S2200
• Study Type: interventional
• Target: 5,016
• Locations: 1 country
• Sites: 53

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.

Conditions

Cardiovascular Disease; de Novo Coronary Lesions

Keywords

de novo; coronary; coronary artery disease; coronary disease

Outcome Measures

Primary Outcomes (1)

• Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC).

  1-year post-implant procedure

Secondary Outcomes (3)

• 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

Interventions

TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System DEVICE

Drug Eluting Stent used to treat de novo coronary artery lesions.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (53)

Scottsdale Healthcare

Scottsdale, Arizona, 85260, United States

Location

Bakersfield Memorial Hospital

Bakersfield, California, 93301, United States

Location

Desert Cardiology Consultants

Rancho Mirage, California, 92270, United States

Location

Kaiser San Francisco

San Francisco, California, 94115, United States

Location

Saint Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Health First Clinical Research Institute

Melbourne, Florida, 32901, United States

Location

Cardiology Consultants

Pensacola, Florida, 32504, United States

Location

The Heart and Vascular Institute of Florida

St. Petersburg, Florida, 33705, United States

Location

Idaho Cardiology Associates

Boise, Idaho, 83704, United States

Location

Midwest Heart Foundation

Lombard, Illinois, 60148, United States

Location

Heart Care Research Foundation

Merrionette Park, Illinois, 60803, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

The Indiana Heart Hospital

Indianapolis, Indiana, 46250, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

Iowa Heart Center Research

Des Moines, Iowa, 50314, United States

Location

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

CHRISTUS St. Frances Cabrini Hospital

Alexandria, Louisiana, 71301, United States

Location

Cardiovascular Research Foundation of Louisiana

Baton Rouge, Louisiana, 70808, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

St. Vincent Hospital at Worcester Medical Center

Worcester, Massachusetts, 01608, United States

Location

Thoracic & Cardiovascular Healthcare Foundation

Lansing, Michigan, 48912, United States

Location

Great Lakes Heart and Vascular Institute

Saint Joseph, Michigan, 49085, United States

Location

Minnesota Heart and Vascular Center

Edina, Minnesota, 55435, United States

Location

St. Paul Heart Clinic

Saint Paul, Minnesota, 55102, United States

Location

Barnes / Jewish (Washington University)

St Louis, Missouri, 63110, United States

Location

The Creighton Cardiac Center

Omaha, Nebraska, 68131, United States

Location

Cardiovascular Associates of Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07754, United States

Location

New Mexico Heart Institute, PA

Albuquerque, New Mexico, 87102, United States

Location

Saint Vincent's Catholic Medical Center of New York

New York, New York, 10011, United States

Location

Mid-Carolina Cardiology Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

HeartCare, Inc

Columbus, Ohio, 43215, United States

Location

Parma Community General Hospital

Parma, Ohio, 44129, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Heart Center of Tulsa

Tulsa, Oklahoma, 74114, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

The Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Moffitt Heart and Vascular Group

Wormleysburg, Pennsylvania, 17043, United States

Location

Main Line Health Center

Wynnewood, Pennsylvania, 19096, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Baptist Heart Institute

Knoxville, Tennessee, 37920, United States

Location

St. Thomas Research Institute

Nashville, Tennessee, 37205, United States

Location

Heart Center of North Texas

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Spectra Clinical Research Management Group

McAllen, Texas, 78504, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

North Cascade Cardiology, PLLC

Bellingham, Washington, 98225, United States

Location

Cardiology Associates of Green Bay

Green Bay, Wisconsin, 54305-2425, United States

Location

South Central Wisconsin Heart

Madison, Wisconsin, 53715, United States

Location

Related Publications (3)

• 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.

  PMID: 20650436 DERIVED

• 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.

  PMID: 20031730 DERIVED

• 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.

  PMID: 19577985 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Eileen Rose, MS

  Boston Scientific Corporation

  STUDY DIRECTOR

• John M Lasala, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• David A. Cox, MD

  Lehigh Valley Physician Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 7, 2007
• Study Start: October 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: July 1, 2008
• Last Updated: September 29, 2008

Record last verified: 2008-09

Locations

US (53)