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NCT00344630 Clinical Trial

TC-WYRE: TAXUS Express Stent vs. Cypher Stent - What's Your Real Life Experience?

Coronary Artery Disease Clinical Trial

Official title:
TC-WYRE: TAXUS Express Stent vs. Cypher Stent - What's Your Real Life Experience?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00344630
Other study ID # S5572
Secondary ID BSC
Status Completed
Phase N/A
First received June 23, 2006
Last updated October 7, 2008
Start date May 2006
Est. completion date June 2006

Study information
Verified date October 2008
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 2500
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Device:
• TAXUS Stent and Cypher Stent

Locations
Country Name City State
United States Duke University Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

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