NCT00344630

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2006

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
Last Updated

October 8, 2008

Status Verified

October 1, 2008

First QC Date

June 23, 2006

Last Update Submit

October 7, 2008

Conditions

Coronary Artery Disease

Interventions

TAXUS Stent and Cypher StentDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients treated with a TAXUS Express2 stent or a Cypher stent between April 1, 2005 and June 30, 2005.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • William O'Neill, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

May 1, 2006

Study Completion

June 1, 2006

Last Updated

October 8, 2008

Record last verified: 2008-10

Locations

US(1)