Retrospective Study of the Impact of Drug Eluting Stents
NCT ID: NCT00487604
Last Updated: 2007-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
9800 participants
OBSERVATIONAL
2007-05-31
2008-05-31
Brief Summary
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Detailed Description
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Recent angioscopic and autopsy studies have demonstrated markedly delayed and incomplete endothelialization following drug-eluting stent implantation. These events are rarely observed following bare metal stent implantation. In addition, drug-eluting stents have been associated with hypersensitivity reactions, which may predispose patients to subacute thrombosis. Finally, serial intra-coronary ultrasound studies demonstrate late stent mal-apposition, which is believed to create a possible nidus for thrombus formation.
By means of examining several extensive administrative databases, this study will retrospectively examine approximately 9,800 consecutive patients who underwent either bare metal or drug eluting coronary artery stenting at Sacred Heart Medical Center, Spokane, WA between March 1, 2001 and March 30, 2006. Time frame of follow-up is at least 18 months.
Comparison: The strategy of implanting stents during three time periods will be compared to each other. In the first study period which occurred prior to commercial release of the Cypher drug eluting stent, all patients received bare metal stents. The second study group will include all patients from the time frame between release of the Cypher stent and the Taxus drug eluting stent (approximately one year) after which a contractual decision was made to only utilize Taxus stents. During second time frame of corresponding to availability of the Cypher stent, about 30% of total stent cases received drug eluting stents predominately for "on label" indications. The third study group occurred during a time-frame when Taxus drug eluting stents were implanted in about 90% of overall patients including many with "off label" indications.
Conditions
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Study Design
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DEFINED_POPULATION
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Providence Health & Services
OTHER
Principal Investigators
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Michael E. Ring, MD
Role: PRINCIPAL_INVESTIGATOR
Providence Health & Services
Locations
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Sacred Heart Medical Center
Spokane, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PMRC1371
Identifier Type: -
Identifier Source: org_study_id