TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program (ARRIVE 2)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00569751 |
Recruitment Status
:
Completed
First Posted
: December 7, 2007
Last Update Posted
: September 29, 2008
|
Sponsor:
Boston Scientific Corporation
Information provided by:
Boston Scientific Corporation
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 |
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 |
|
|||||||||
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 |
|
|||||||||
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 * |
|
|||||||||
* 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 |
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:
Inappropriate Patient Criteria:
|
|||||||||
Sex/Gender |
|
|||||||||
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 |
|
|||||||||
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 |