TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program (ARRIVE 2)
This study has been completed.
Sponsor:
Boston Scientific Corporation
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00569751
First received: December 6, 2007
Last updated: September 25, 2008
Last verified: September 2008
| Tracking Information | ||||||||||
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| First Received Date ICMJE | December 6, 2007 | |||||||||
| Last Updated Date | September 25, 2008 | |||||||||
| Start Date ICMJE | October 2004 | |||||||||
| 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 ] [ Designated as safety issue: Yes ] | |||||||||
| 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 |
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| 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 Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System
Drug Eluting Stent used to treat de novo coronary artery lesions. |
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| Study Arm (s) | Not Provided | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Enrollment ICMJE | 5016 | |||||||||
| Completion Date | July 2008 | |||||||||
| Primary Completion Date | November 2006 (final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Appropriate Patient Criteria:
Inappropriate Patient Criteria:
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| Gender | Both | |||||||||
| 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 | |||||||||
| Plan to Share Data | Not Provided | |||||||||
| IPD Description | Not Provided | |||||||||
| Responsible Party | Kellie Windle, Clinical Project Manager, Boston Scientific | |||||||||
| Study Sponsor ICMJE | Boston Scientific Corporation | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| Information Provided By | Boston Scientific Corporation | |||||||||
| Verification Date | September 2008 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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