- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00487604
Retrospective Study of the Impact of Drug Eluting Stents
Retrospective Study of the Impact of Drug Eluting Stents on Intermediate Term Survival, Cardiovascular Outcomes Including Revascularization, Bleeding Rates and Economic Costs
Study Overview
Status
Conditions
Detailed Description
A major limitation of percutaneous coronary stenting compared to coronary artery bypass grafting surgery has been the significantly higher need for repeat revascularization due to restenosis occurring at or near the stent site. By eluting a potent anti-proliferative agent from a polymer coated stent in a time-controlled manner, it has been possible to markedly inhibit intimal proliferation that results from implantation of a bare metal stent, dramatically reducing the need for future target lesion revascularization.
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lynn A. Shuler, RN, MA
- Phone Number: 509.474.4302
- Email: lshuler@this.org
Study Contact Backup
- Name: Sandra J. Albritton, RN, MSN
- Phone Number: 509.474.4345
- Email: salbritt@this.org
Study Locations
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Washington
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Spokane, Washington, United States, 99204
- Recruiting
- Sacred Heart Medical Center
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Contact:
- Lynn A. Shuler, RN, MA
- Phone Number: 509.474.4302
- Email: lshuler@this.org
-
Contact:
- Sandra J. Albritton, RN, MN
- Phone Number: 509-474-4345
- Email: salbritt@this.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Coronary artery stenting between March 1, 2001 and March 30, 2006
Exclusion Criteria:
- Implanted investigational drug eluting stents
Study Plan
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Retrospective
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael E. Ring, MD, Providence Health & Services
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMRC1371
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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