Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00297661|
Recruitment Status : Completed
First Posted : February 28, 2006
Last Update Posted : October 20, 2006
Context: Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal stents, reduce the risk of restenosis. It is unclear whether there are differences in safety and efficacy between the two types of drug-eluting stents.
Objective: To determine differences in safety and efficacy between sirolimus and paclitaxel eluting stents.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease||Device: Sirolimus-eluting stent Device: Paclitaxel-eluting stent||Phase 4|
Design: Randomized controlled, observer-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents
Patients: 1012 patients undergoing percutaneous coronary intervention. The two groups had similar baseline clinical and angiographic characteristics.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1012 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization: SIRTAX Trial|
|Study Start Date :||April 2003|
- Major adverse cardiac events at nine months (composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization)
- Clinical: Ischemia-driven target lesion revascularization, target-vessel revascularization, and target-vessel failure (composite of cardiac death, myocardial infarction or ischemia-driven target-vessel revascularization)
- Angiographic: In-segment late luminal loss
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): NCT00297661
|University Hospital Bern|
|Bern, Switzerland, 3010|
|Principal Investigator:||Stephan Windecker, MD||Department of Cardiology, University Hospital Bern|
|Study Director:||Peter Juni, MD||Department of Social and Preventive Medicine, University of Bern|
|Study Chair:||Bernhard Meier, MD||Department of Cardiology, University Hospital Bern|