- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00344630
TC-WYRE: TAXUS Express Stent vs. Cypher Stent - What's Your Real Life Experience?
October 7, 2008 updated by: Boston Scientific Corporation
To compare the relative efficacy and safety of the TAXUS Express2 stents and the Cypher stents among a broad, unselected patient population treated in a nationwide, multi-center clinical registry representative of 'real-world,' contemporary clinical practice.
A secondary objective is to examine performance of the two stents in pre-specified subgroup populations and examine regional and national patterns in outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
2500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients treated with a TAXUS Express2 stent or a Cypher stent between April 1, 2005 and June 30, 2005.
Exclusion Criteria:
- Simultaneous treatment with both TAXUS and Cypher stents during the index revascularization. Patients who have undergone previous target vessel(s), stenting procedure within 9 months of the index procedure will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William O'Neill, MD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Completion
June 1, 2006
Study Registration Dates
First Submitted
June 23, 2006
First Submitted That Met QC Criteria
June 23, 2006
First Posted (Estimate)
June 27, 2006
Study Record Updates
Last Update Posted (Estimate)
October 8, 2008
Last Update Submitted That Met QC Criteria
October 7, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S5572
- BSC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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