TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program (ARRIVE 2)

Tracking Information
First Submitted Date ICMJE	December 6, 2007
First Posted Date ICMJE	December 7, 2007
Last Update Posted Date	September 29, 2008
Study Start Date ICMJE	October 2004
Actual Primary Completion Date	November 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 6, 2007)	Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC). [ Time Frame: 1-year post-implant procedure ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00569751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 6, 2007)	Rate of TAXUS stent related cardiac events as classified by the CEC. [ Time Frame: within 30 days, 6 months and 2 years ]; Rate of target vessel related cardiac events as classified by the CEC. [ Time Frame: 30 days, at 6 months, at 1 and 2 years post-implant procedure ]; Rate of other TAXUS related events [ Time Frame: 30 days, 6 months, 1 and 2 years post-implant procedure ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program
Official Title ICMJE	TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Cardiovascular Disease; de Novo Coronary Lesions
Intervention ICMJE	Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System; Drug Eluting Stent used to treat de novo coronary artery lesions.
Study Arms	Not Provided
Publications *	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.; 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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 6, 2007)	5016
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	July 2008
Actual Primary Completion Date	November 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00569751
Other Study ID Numbers ICMJE	S2200
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Kellie Windle, Clinical Project Manager, Boston Scientific
Study Sponsor ICMJE	Boston Scientific Corporation
Collaborators ICMJE	Not Provided
Investigators ICMJE	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
PRS Account	Boston Scientific Corporation
Verification Date	September 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP