TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

Phase 4

Completed

• Conditions: Cardiovascular Disease; de Novo Coronary Lesions

• Registration Number: NCT00569751
• Lead Sponsor: Boston Scientific Corporation

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 available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2006-11
• Study First Submitted: 2007-12-06
• Study First Submitted QC: 2007-12-06
• Study First Posted: 2007-12-07
• Study Completion: 2008-07
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-25
• Last Update Posted: 2008-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5016

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC).	1-year post-implant procedure

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (53)

Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States

Bakersfield Memorial Hospital; 🇺🇸 Bakersfield, California, United States

Desert Cardiology Consultants; 🇺🇸 Rancho Mirage, California, United States

Kaiser San Francisco; 🇺🇸 San Francisco, California, United States

Saint Vincent's Medical Center; 🇺🇸 Jacksonville, Florida, United States

Health First Clinical Research Institute; 🇺🇸 Melbourne, Florida, United States

Cardiology Consultants; 🇺🇸 Pensacola, Florida, United States

The Heart and Vascular Institute of Florida; 🇺🇸 St. Petersburg, Florida, United States

Idaho Cardiology Associates; 🇺🇸 Boise, Idaho, United States

Midwest Heart Foundation; 🇺🇸 Lombard, Illinois, United States

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