Retrospective Study of the Impact of Drug Eluting Stents
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|ClinicalTrials.gov Identifier: NCT00487604|
Recruitment Status : Unknown
Verified April 2007 by Providence Health & Services.
Recruitment status was: Recruiting
First Posted : June 18, 2007
Last Update Posted : August 2, 2007
|Condition or disease|
|Coronary Artery Disease|
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 :||Observational|
|Estimated Enrollment :||9800 participants|
|Observational Model:||Defined Population|
|Official Title:||Retrospective Study of the Impact of Drug Eluting Stents on Intermediate Term Survival, Cardiovascular Outcomes Including Revascularization, Bleeding Rates and Economic Costs|
|Study Start Date :||May 2007|
|Estimated Study Completion Date :||May 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487604
|Contact: Lynn A. Shuler, RN, MAfirstname.lastname@example.org|
|Contact: Sandra J. Albritton, RN, MSNemail@example.com|
|United States, Washington|
|Sacred Heart Medical Center||Recruiting|
|Spokane, Washington, United States, 99204|
|Contact: Sandra J. Albritton, RN, MN 509-474-4345 firstname.lastname@example.org|
|Contact: Lynn A. Shuler, RN, MA 509.474.4302 email@example.com|
|Principal Investigator:||Michael E. Ring, MD||Providence Health & Services|