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

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00344630
First received: June 23, 2006
Last updated: October 7, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Device: TAXUS Stent and Cypher Stent

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: TC-WYRE: TAXUS Express Stent vs. Cypher Stent - What's Your Real Life Experience?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Estimated Enrollment: 2500
Study Start Date: May 2006
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344630

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: William O'Neill, MD Duke University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00344630     History of Changes
Other Study ID Numbers: S5572, BSC
Study First Received: June 23, 2006
Last Updated: October 7, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013